JONA
Volume 41, Number 3, pp 129-137
Copyright B 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins
T H E J O U R N A L O F N U R S I N G A D M I N I S T R A T I O N
Rural Hospital Nursing
Results of a National Survey of Nurse Executives
Robin P. Newhouse, PhD, RN, NEA-BC
Laura Morlock, PhD
Peter Pronovost, MD, PhD
Sara Breckenridge Sproat, PhD, RN
Objective: The objective of the study was to describe
nursing characteristics in small and larger rural
hospitals and determine whether differences exist in
market, hospital, and nursing characteristics.
Background: A better description of nursing in rural
settings is needed to understand the work context.
Methods: A national sample of rural hospital nurse
executives (n = 280) completed the Nurse Environ-
ment Survey and Essentials of Magnetism instrument.
Results: Larger rural hospitals are more likely than
small hospitals to have a clinical ladder (32.4% vs
19.4%), more baccalaureate-prepared RNs (20.8%
vs 17.1%), greater perceived economic (mean, 9.5 vs
8.5) and external influences (mean, 41.1 vs 39.8),
lower shared vision among hospital staff (mean, 18.4
vs 19.4), and higher levels of quality and safety
engagement (mean, 16.9 vs 16.1). Most nurses em-
ployed in rural hospitals are educated at the associate
degree (77.4%) level.
Conclusions: Contextual differences exist between
small and larger rural hospitals. To promote the
best patient outcomes, attention to contextual
differences is needed to tailor nursing interventions
to fit the resources, environment, and patient needs
in a given healthcare setting.
America’s rural populations encounter barriers to
quality healthcare.1 These quality barriers corre-
spond with an alarming increase in healthcare costs,
placing a direct and specific economic burden on
rural areas.2 Rural populations are expected to
experience heightened healthcare needs (aging pop-
ulation and increase in minorities), greater income
disparities (lower income and education than urban
settings), provider price hikes, and increased de-
mand for expensive technology (to which rural
residents do not always have access).2
Forty percent (1,998 of 5,010) of US community
hospitals registered with the American Hospital Asso-
ciation (AHA) are rural (nonmetropolitan).3 These hos-
pitals provided care for 12.8% (5.1 million) of all US
hospitalizations in 2007.4 The definition of Brural[ is var-
iable, with estimates for the rural population ranging
between 10% and 28% of the US total population.5,6
Rural was defined in this study based on the sam-
pling frame from a prior study using the Office of Man-
agement and Budget (OMB) pre-2003 classification
system for metropolitan/ nonmetropolitan areas.7,8
This system is based on metropolitan statistical areas
(MSAs) generated by the US Census Bureau, which
uses a county-level classification. Rural hospitals are
defined as those located in counties that do not
qualify as MSAs. Although there are many alternative
definitio.
JONAVolume 41, Number 3, pp 129-137Copyright B 2011 Wolter.docx
1. JONA
Volume 41, Number 3, pp 129-137
Copyright B 2011 Wolters Kluwer Health | Lippincott Williams
& Wilkins
T H E J O U R N A L O F N U R S I N G A D M I N I S T R A
T I O N
Rural Hospital Nursing
Results of a National Survey of Nurse Executives
Robin P. Newhouse, PhD, RN, NEA-BC
Laura Morlock, PhD
Peter Pronovost, MD, PhD
Sara Breckenridge Sproat, PhD, RN
Objective: The objective of the study was to describe
nursing characteristics in small and larger rural
hospitals and determine whether differences exist in
market, hospital, and nursing characteristics.
Background: A better description of nursing in rural
settings is needed to understand the work context.
Methods: A national sample of rural hospital nurse
executives (n = 280) completed the Nurse Environ-
ment Survey and Essentials of Magnetism instrument.
Results: Larger rural hospitals are more likely than
small hospitals to have a clinical ladder (32.4% vs
19.4%), more baccalaureate-prepared RNs (20.8%
vs 17.1%), greater perceived economic (mean, 9.5 vs
2. 8.5) and external influences (mean, 41.1 vs 39.8),
lower shared vision among hospital staff (mean, 18.4
vs 19.4), and higher levels of quality and safety
engagement (mean, 16.9 vs 16.1). Most nurses em-
ployed in rural hospitals are educated at the associate
degree (77.4%) level.
Conclusions: Contextual differences exist between
small and larger rural hospitals. To promote the
best patient outcomes, attention to contextual
differences is needed to tailor nursing interventions
to fit the resources, environment, and patient needs
in a given healthcare setting.
America’s rural populations encounter barriers to
quality healthcare.1 These quality barriers corre-
spond with an alarming increase in healthcare costs,
placing a direct and specific economic burden on
rural areas.2 Rural populations are expected to
experience heightened healthcare needs (aging pop-
ulation and increase in minorities), greater income
disparities (lower income and education than urban
settings), provider price hikes, and increased de-
mand for expensive technology (to which rural
residents do not always have access).2
Forty percent (1,998 of 5,010) of US community
hospitals registered with the American Hospital Asso-
ciation (AHA) are rural (nonmetropolitan).3 These hos-
pitals provided care for 12.8% (5.1 million) of all US
hospitalizations in 2007.4 The definition of Brural[ is var-
iable, with estimates for the rural population ranging
between 10% and 28% of the US total population.5,6
Rural was defined in this study based on the sam-
pling frame from a prior study using the Office of Man-
3. agement and Budget (OMB) pre-2003 classification
system for metropolitan/ nonmetropolitan areas.7,8
This system is based on metropolitan statistical areas
(MSAs) generated by the US Census Bureau, which
uses a county-level classification. Rural hospitals are
defined as those located in counties that do not
qualify as MSAs. Although there are many alternative
definitions of Brural,[ the OMB definition has been
JONA � Vol. 41, No. 3 � March 2011 129
Authors’ Affiliations: Associate Professor and Assistant Dean
for the Doctor of Nursing Practice Program (Dr Newhouse),
University of Maryland School of Nursing, Baltimore; Professor
(Dr Morlock), Department of Health Policy and Management,
Bloomberg School of Public Health, Johns Hopkins University,
Baltimore, Maryland; Professor (Dr Pronovost), Department of
Anesthesiology and Critical Care Medicine, Johns Hopkins
University School of Medicine, Center for Innovation in Quality
Patient Care, Johns Hopkins University, Baltimore, Maryland;
US Army Nurse Corps (Dr Breckenridge Sproat), Walter Reed
Army Medical Center, Washington, District of Columbia.
Corresponding author: Dr Newhouse, University of Maryland
School of Nursing, 655 W Lombard St, Suite 516B, Baltimore,
MD
21201 ([email protected]).
Funding: This study was supported by grant KO8HS015548
from the Agency for Healthcare Research and Quality.
The content is solely the responsibility of the authors and
does not necessarily represent the official views of the Agency
for Healthcare Research and Quality. The information or
contents and conclusions do not necessarily represent the
4. official
position or policy of, nor should any official endorsement be
inferred by, the Department of Defense or the US Government.
Supplemental digital content is available for this article.
Direct URL citations appear in the printed text and are provided
in the HTML and PDF versions of this article on the journal’s
Web site (www.jonajournal.com).
DOI: 10.1097/NNA.0b013e31820c7212
Copyright @ 201 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.1
used by more than 30 federal programs to determine
program eligibility and reimbursement levels. A Brural[
designation using core-based statistical area (CBSA)
indicates that the area has a population of less than
10,000 (personal communication, AHA, March 30,
2010). BMetropolitan[ designation indicates an urban-
ized area with a population of 50,000 or more, and
Bmicropolitan[ indicates an urban cluster of population
of at least 10,000 but less than 50,000.9
Although rural settings face some of the same
quality challenges as urban areas, older rural pop-
ulations with higher levels of chronic illnesses have
unique healthcare needs that place them at risk for
suffering preventable harm.10 Attention to quality
improvement in rural settings with focused efforts
on education, training, and deployment of health-
care professionals is required.10
Nursing, the largest provider of healthcare, af-
5. fects patient outcomes.11 In a systematic review and
meta-analysis of 28 studies, better nurse staffing was
significantly associated with lower mortality, fewer
adverse patient events, and shorter length of stay.11
This relationship was present in a wide range of set-
tings and patients, across a variety of adverse events
(hospital-acquired pneumonia, unplanned extubation,
respiratory failure, cardiac arrest, and failure to rescue).11
Patient outcomes are nurse sensitive if the outcome
varies with the quantity of nurses (such as more nursing
hours per patient or higher nurse-to-patient ratios).
Patient and hospital attributes also contribute to nurse-
sensitive outcomes and must be considered when
examining relationships between nursing and patient
outcomes.11 Rural settings are underrepresented in these
studies.
One-fifth of all RNs (20.8%) live in rural areas.12
Most nurses who live in rural areas report hospitals
as their primary work setting (57.5% in larger rural
and 50.1% in small rural areas).12 Compared with
their urban counterparts, nurses who work in rural
areas are paid lower annual salaries (average,
$40,516 vs $49,627). Urban RNs typically work in
urban locations (97.4%), whereas nurses living in
rural areas tend to commute outside their rural lo-
cations.12 This pattern of RNs commuting outside
their geographic area of residency can exacerbate the
nursing shortage in rural areas. Consistent gaps exist
in rural areas between predicted RN need and the
number of RNs employed.13
The Balanced Budget Act of 1997 included the
6. Medicare Rural Hospital Flexibility Program, in-
tended to support rural healthcare.14 This program
allows licensed acute-care rural hospitals to apply to
become critical access hospitals (CAHs) if they meet
specific criteria. Hospitals must be located in a rural
area, more than 35 miles from another hospital, at
least 15 miles from another hospital if in mountainous
terrain or over secondary roads, or state certified as a
necessary provider of healthcare services to area
residents.14 Additional requirements include main-
taining an average annual length of stay of 96 hours
or less, having a maximum of 25 beds, providing
24-hour emergency services, and having patient re-
ferral and transfer agreements with other acute-care
hospitals in place. The Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 in-
creased the number of beds permitted to qualify as a
CAH, making it easier for hospitals to convert.15
One of the major benefits of conversion from a rural
hospital designation to a CAH is that Medicare reim-
burses CAHs on a cost basis rather than a capitation
basis, which financially benefits CAHs.14 There were
1,315 CAHs in the United States as of June 2010.14
A better description of nursing characteristics is
needed to understand the rural hospital work con-
text. The purposes of this study were to (1) describe
the characteristics of nursing in small and larger rural
hospitals and (2) determine whether differences exist
in the market, hospital, and nursing characteristics of
small and larger rural hospitals. The term rural
hospital is used to describe all rural hospitals. Small
rural hospital is used to describe a rural hospital or
CAH with 25 or fewer beds. A larger rural hospital
7. is a rural hospital with more than 25 beds.
Methods
Study Population
After study approval from the Johns Hopkins Medi-
cine institutional review board, a national conve-
nience sample of 688 rural hospital nurse executives
from 47 states was invited to complete a telephone
or written survey. Nurse executives worked in rural
hospitals included in a prior study in which Brural[
was defined by the OMB pre-2003 classification
system for metropolitan/nonmetropolitan areas.7,8
The first 54 nurse executives received a letter of
invitation with a follow-up call 2 weeks later to
schedule a telephone interview. Subsequent subjects
were invited to complete a written survey using a
modified Dillman16 method.17 Respondents received
a $20 gift certificate for completing the survey.
Data Sources
The surveys administered were the Nursing Environ-
ment Survey (NES) and the Essentials of Magnetism
(EOM) instrument.18
Nursing Environment Survey
The NES was developed for use in this study. See Doc-
ument, Supplemental Digital Content 1, to view the full
130 JONA � Vol. 41, No. 3 � March 2011
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reproduction of this article is prohibited.1
8. survey with all items, http://links.lww.com/JONA/A43.
Items were constructed based on a qualitative study19
and review of instruments used in prior studies.7,8,20,21
Table 1 includes a description of the NES scales,
definitions, number of items in each scale, response
format, and range of total scores. Adequate estimates of
reliability and validity were obtained (item test-retest
reliability [r Q 0.444 to 0.999], content validity index
of 1.0, construct validity of factors using exploratory
factor analysis with varimax rotation, a cutoff eigen-
value of 1.0, and a lower limit of 0.40 for factor
loadings to create internally consistent scales [! Q .74
except for quality and safety which was a = .68]). The
scales are market (economic influences, isolation, and
external nursing influences), hospital (shared vision
and quality and safety), and nursing (nursing chal-
lenges and evidence-based practice [EBP]). A 4-item
response format is used for all items. Additional detail
on the psychometric evaluation of the NES is pub-
lished elsewhere.22 (See Table, Supplemental Digital
Content 2, which shows a description of the market
and hospitals scales, Cronbach !’s, items and fac-
tor loadings, http://links.lww.com/JONA/A44. See
Table, Supplemental Digital Content 3, which
shows a description of the item means and stan-
dard deviations for the market and hospital scales,
http://links.lww.com/JONA/A45.)
Nursing challenges include 4 items: EBP, main-
taining competency of staff, fostering ongoing edu-
cation, and staff nurse academic education. EBP
9. includes 7 barriers to enabling EBP: education of
staff, availability of expert, availability of educator,
availability of mentor, wearing many hats, lack of
familiarity with EBP, and no time. Nursing challenges
and EBP scale items can be reviewed in Figure 1.
Essentials of Magnetism
The EOM instrument measures the attributes of
the work environment that nurses find essential to
quality care.18 Acceptable estimates of reliability in-
clude test-retest reliability and internal consistency
(Cronbach ! between .80 and .90 for all scales ex-
cept clinically competent/support for education,
! = .78). Validity was supported through principal
component factor analysis and content validity
greater than 0.90 for all scales.
Scales in the EOM include clinically competent,
support for education, RN-physician relationships,
autonomy, control over nursing practice, nurse man-
ager support (managerial and leadership), cultural
values, and adequacy of staffing.18
Hospital Characteristics
Hospital data for employers of responding nurse ex-
ecutives were obtained from the 2006 AHA Annual
Survey.23
Analysis
Data were entered, and all analyses were conducted
using SPSS 15 (SPSS Inc, Chicago, Illinois). Contin-
uous data were analyzed with independent t tests
and categorical data with 22 tests. A Mann-Whitney
U test was used if assumptions for the t test were
10. not met. P G .05 was considered significant.
Results
The response rate was 41% (280/688), which varied
by US Census Bureau region (56% Northeast, 45%
Midwest, 34% South, and 45% West). In the final
sample, the distribution of rural hospitals by region
was as follows: 10% Northeast (28/280), 36%
Midwest (101/280), 38% South (45/280), and 16%
West (45/280). The locations of hospitals included in
this sample were similar to national estimates for
rural hospitals (South, 38% vs 37%; Midwest, 36%
vs 40%; Northeast, 10% vs 7.1%; and West, 16% vs
16%).4 Compared with nonrespondents, most
Table 1. NES Scales
Scales Market, Hospital, or Nursing Variables Definition No. of
Items (Range of Score)
Market
Economic influences The impact of changes in hospital revenue
on nursing 4 (4-16)
Isolation The impact of physical and professional remoteness 4
(4-16)
External nursing influences Important forces outside the
organization that influence
nursing (such as nurse recruitment)
12 (12-48)
Hospital
Shared vision Extent to which the group works together for
common
11. patient-centered goals
6 (6-24)
Quality and safety Engagement in quality and safety activities 6
(6-24)
Nursing
Nursing challenges Major issues confronted by nursing 4 (4-16)
EBP barriers Major issues to implementing EBPs 7 (7-28)
JONA � Vol. 41, No. 3 � March 2011 131
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respondents were from the South and Midwest
(46% vs 36%), had lower average daily census
(ADC) (43 vs 55), and were less likely to be a mem-
ber of a system (40% vs 47%). There were no dif-
ferences in hospital types (larger vs small).
Nurse Executive Characteristics
Nurse executive respondents were primarily white
(95%) and female (92%), with an average of 5.9
years in their current positions. There were no sig-
nificant differences between larger and small rural
hospital nurse executive characteristics. Character-
istics are also similar to national samples of nurse
executives from acute-care hospitals (white, 95% vs
96%; female, 92% vs 94%; average years in current
position, 5.9 vs 5.6).24
12. Hospital Characteristics
Table 2 compares the characteristics of small and
larger rural hospitals. The ADC for larger rural hos-
pitals (mean, 53.6) was higher than small rural hos-
pitals (mean, 21.1). More larger rural hospitals were
Joint Commission (JC) accredited (84.7% vs 25.5%).
Both types of hospitals had similar distance away
from educational settings (42.6 miles) and were as
likely to be members of a system (38.6%) or network
(33.2%) or to be MagnetA accredited or seeking ac-
creditation (11.4%). Significantly more small hospitals
Table 2. Hospital Characteristics
Larger Rural (n = 186) Small Rural (n = 94) Total (n = 280)
Hospital Characteristics Mean (SD) Mean (SD) Mean (SD)
ADCa 53.6 (53.3) 21.1 (22.3) 42.6 (47.7)b
Miles away from educationc 40.5 (68.2) 48.6 (43.1) 43.2 (61.0)
Proportion (n) Proportion (n) Proportion (n)
Member of systema 40.9 (76/186) 34.0 (32/94) 38.6 (108/280)
Member of a networka 31.2 (58/186) 37.2 (35/94) 33.2 (93/280)
JC accrediteda 84.7 (133/184) 25.5 (24/94) 56.5 (157/278)b
MagnetA or seekingc 13.7 (24/175) 6.7 (6/89) 11.4 (30/264)
Rural CBSA 27.2 (50/184) 79.8 (75/94) 45.0 (125/278)b
aSource: AHA 2006 Annual Survey.23
bP G .05 using 22 test for categorical and t test for continuous
variables.
cSource: Nurse Executive Survey.
13. Figure 1. EBP barriers and nursing challenges scales, directions,
items, and internal consistency.
132 JONA � Vol. 41, No. 3 � March 2011
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(79.8%) than larger hospitals (27.2%) were desig-
nated as Brural[ by CBSA criteria.
RN Characteristics
Table 3 describes RN attributes. Larger hospitals
with more beds employ more RNs than small rural
hospitals (mean, 129.9 vs 36.4). RNs predominantly
hold associate degrees in nursing (ADN) (77.4% in
both settings, with more baccalaureate nurses [BS]
working in larger rural hospitals [20.8% vs 17.1%]).
Clinical ladders are available more often in larger
(32.4%) than in small (19.4%) rural hospitals. In
both settings, nurses usually float across units
(91.1%), with similar vacancy (9%) and turnover
(17%) rates. Nurses are occasionally represented by
unions (18.2%), and nurse executives perceive that
RN wages are competitive (84.5%).
Perceptions of Market, Hospital, and
Nursing Influences
Table 4 compares larger and small rural hospital
nurse executives’ perceptions of market, hospital,
14. nursing, and EOM total scores. Larger rural hospital
nurse executives report higher mean scores than those
in small rural hospitals in the following areas: ex-
ternal nursing influences (41.1 vs 39.8), economic
influences (9.5 vs 8.5), and hospital quality and safety
activities (16.9 vs 16.1). Larger rural hospital nurse
executives report lower scores than those in small
rural hospitals in 1 area, shared vision (18.4 vs 19.4).
Table 3. RN Characteristics
RN Characteristics
Larger Rural (n = 186) Small Rural (n = 94) Total (n = 280)
Mean (SD) Mean (SD) Mean (SD)
No. of RNs employed 129.9 (136.8) 36.4 (30.0) 98.9 (121.3)a
No. of RNs who left the organization in FY 2005 13.0 (13.7) 4.4
(4.6) 9.8 (12.0)a
Turnover rateb 0.18 (0.57) 0.15 (0.21) 0.17 (0.47)
Vacant full-time equivalentc 8.7 (16.8) 2.0 (2.3) 6.4 (14.0)
Vacancy rate 0.10 (0.20) 0.07 (0.11) 0.09 (0.17)
Percentage of RNs with AA degree 75.5 (17.1) 80.7 (15.3) 77.4
(16.6)a
Percentage of RNs with BS degree 20.8 (14.7) 17.1 (15.1) 19.4
(14.9)a
Percentage of RNs with MS degree 3.2 (3.7) 2.2 (2.9) 2.9 (3.5)a
Proportion (n) Proportion (n) Proportion (n)
RNs represented by unions 21.1 (39/185) 12.9 (12/93) 18.3
15. (51/278)
Have a clinical ladder 32.4 (60/185) 19.4 (18/93) 28.1
(78/278)d
RNs float across units 93.0 (173/186) 88.2 (82/93) 91.4
(255/279)
Wages are competitive 85.5 (159/186) 83.9 (78/93) 84.9
(237/279)
aP G .05 using Mann-Whitney U test.
bNumber of RNs who left the organization in 2005 / average
number of nurses employed � 100.
cSource: AHA Annual Survey.23
dP G .05 using 22 test for categorical and t test for continuous
variables.
Table 4. Market, Hospital, and Nursing Factors
Market, Hospital, and Nursing Factors Larger Rural (n = 186)
Small Rural (n = 94) Total (n = 280)
Domains Mean (SD) Mean (SD) Mean (SD)
Market
External nursing influences 41.1 (4.6) 39.8 (5.0) 40.7 (4.8)a
Economic influences 9.5 (2.2) 8.5 (2.1) 9.2 (2.2)a
Isolation 8.7 (2.2) 8.8 (2.6) 8.7 (2.4)
Hospital
Shared vision 18.4 (2.8) 19.4 (2.7) 18.8 (2.8)a
Quality/safety engagement 16.9 (2.3) 16.1 (2.7) 16.6 (2.5)a
Nursing
16. Evidenced-based practice barriers 20.4 (4.5) 21.2 (4.7) 20.7
(4.6)
Nursing challenges 10.5 (2.7) 11.1 (2.5) 10.7 (2.6)
EOM total score 305.0 (33.6) 304.3 (33.3) 304.8 (33.4)
aP G .05 using t test.
JONA � Vol. 41, No. 3 � March 2011 133
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No differences exist between larger and small
rural hospital settings with regard to the perceptions
of isolation. In addition, there is no significant
correlation between isolation and CBSA designation
for larger, small, or all rural hospitals.
There was no difference in perceptions of mar-
ket, hospital, or nursing influences for network or
nonnetwork hospitals. There were significant differ-
ences for system and nonsystem hospitals. System
hospital nurse executives report a higher level of
external nursing influences (mean, 42 vs 40, P G .001)
and higher quality and safety activities (17 vs 16,
P = .045) compared with nonsystem hospitals.
Discussion
Although nursing in small and larger rural hospitals
have multiple similarities, the settings are contex-
tually different in market and hospital character-
istics. The nurse executive, hospital, and nursing
characteristics and influence of hospital and market
17. factors on nursing are further discussed.
Rural Hospital Nurse Executives
The characteristics of nurse executives in this sam-
ple are similar in larger and small rural hospitals.
These characteristics are also similar to attributes of
nurse executives in national samples that represent
both rural and nonrural settings.
Hospital
Significant differences exist between small and larger
rural hospitals in ADC, JC accreditation, and rural
designation by CBSA definitions. It is expected that
hospitals with more beds (larger rural) have a higher
ADC. Larger rural hospitals (compared with small)
are accredited by the JC. The JC began to accredit
small rural hospitals (CAHs) in 2001.25 Accredita-
tion is associated with improvements in processes
and infrastructure. In a survey of 107 hospitals, JC
accreditation was significantly related to a higher
level of patient safety system implementation.26 The
JC has been a leader in measuring hospital quality,
realizing significant improvements in process meas-
ures over time.27 It is unknown whether accredita-
tion is linked to better patient outcomes, as studies
demonstrate inconsistent results.28,29
Significantly more small rural hospitals were lo-
cated in areas designated as rural with lower popu-
lation density. In addition, 73% of larger and 20% of
small rural hospitals were located in a micropolitan
or metropolitan areas using CBSA. This is not un-
usual, as counties used to designate CBSAs contain
both rural and urban settings.30 For example, using
18. 2005 classifications, approximately 13% of the
population considered to be metropolitan is rural.30
Nursing
Significant differences exist between small and larger
rural hospitals in the number of RNs employed,
educational preparation of RNs, and availability of
clinical ladders. It is not unexpected that larger
hospitals would employ more RNs given their higher
bed count. It is important to note that larger rural
hospitals are more likely to employ a higher percent-
age of BS-prepared RNs and have a clinical ladder
available more often.
The level of BS-prepared RNs within organiza-
tions is important, as some evidence suggests that
more BS-prepared nurses in acute-care hospitals are
associated with better patient outcomes.31 Beyond
the evidence, the complex nature and demands of
inpatient admissions require a high level of expert
practice and critical thinking. The degree held by
most nurses in rural hospitals was an ADN, which is
consistent with other studies.12 It is important to
note that, in this sample, rural hospitals were ap-
proximately 43 miles from educational settings. The
remote location of these hospitals makes re-
cruitment of BS graduates difficult. In addition, the
distance is a deterrent to the availability of RN-to-
BS or BSN programs if the program is offered on
site instead of through distance education.
Clinical ladders structure levels of nursing prac-
tice, with higher levels indicating advanced expertise.
Clinical ladders are linked to nurse retention and
19. increase nurses’ professional responsibility with
accompanying reimbursement.32 Clinical ladders
are a satisfier that is important for nurse retention.
Given the concern that projections of rural nurse
workforce shortages may be underestimates,13 rural
nursing needs to be a priority focus for professional
development, recruitment, and retention efforts.
Influence of Market, Hospital, and Nursing Forces
on Nursing
Significant differences exist between small and larger
rural hospital nurse executives in the perceptions of
market (external nursing influences, economic influ-
ences) and hospital factors (hospital quality and safety
activities and shared vision). There were no significant
differences in the influence of nursing factors.
Market
There were significant differences between small and
larger rural hospitals in the perceived influence of
external and economic factors. External forces in-
clude pressures to report core quality measures as well
as various legislative changes. Larger rural hospitals
134 JONA � Vol. 41, No. 3 � March 2011
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reproduction of this article is prohibited.1
are JC accredited more often. It is not surprising that
nurse executives experience a higher impact from
external sources with the acceleration of quality and
safety initiatives and the advent of public reporting of
20. quality metrics. With lower patient volume and dif-
ferences in the population, quality measures for rural
hospitals require specificity for the rural context.33
Lower volumes may prevent rural hospitals from re-
porting some quality measures, because there is a
minimum number of patients required for the denom-
inator data. In addition, there may be other indicators
important to quality such as internal systems to iden-
tify patients who require interventions or care not
available in the rural hospital setting. A more ap-
propriate measure of quality may be timely transfer
of patients to settings where required care can be
provided.
Larger rural hospital nurse executives feel the
burden of economic influences. Conversion to
CAHs may have buffered the negative economic
effects for small rural hospitals, because Medicare
reimbursement is cost based. Larger rural hospitals
are typically reimbursed for care by federal, state,
and private insurers on a per case basis. Per case
reimbursement creates an incentive to reduce costs
per admission and results in financial losses if efforts
are unsuccessful.
It is interesting to note that there is no relation-
ship between the perception of isolation and CBSA
designation for larger, small, or all rural hospitals in
this sample. This indicates that the perception of
isolation is not related to population density. The
sense of isolation may be overcome through rela-
tively easy solutions, such as linkages with profes-
sional organizations and quality or EBP networks of
similar rural hospitals.
21. Hospital
There were significant differences in the perception
of small and larger hospital factors that influence
nursing in the areas of hospital quality and safety
activities and shared vision. Nurse executives per-
ceive a higher shared vision in small rural hospitals.
This higher shared vision may be related to the nature
of a smaller organization and more direct interac-
tions with hospital staff and physicians. Shared vision
is an essential interdisciplinary attribute, with team
members committing to common patient-centered
goals. As disciplines work together and bring unique
contributions to the care of the patient, better
outcomes result. For example, lower rates of patient
complications and death are associated with surgical
teams that share information.34
Lower quality and safety engagement for small
rural hospitals may reflect the scale of the work-
force, with fewer staff available to lead quality and
safety initiatives. Rural hospitals have reported
lower adherence to evidence-based guidelines in
national public reporting efforts.35 High-risk, low-
frequency procedures, such as neonatal resuscitation,
may be problematic, with variances in knowledge
and skills for nurses and physicians.36
Shared vision and quality and safety engage-
ment have positive independent effects for better
nursing practice environments.22 Increased quality
and safety initiatives and attention to evidence-
based guidelines are important components in per-
formance improvement in all settings.
Nursing
22. There were no significant differences in the per-
ception of small and larger hospital factors that
influence nursing. Nurse executives in both settings
perceive the same nursing challenges and EBP
barriers. The perception of professional satisfaction
of nurses is also similar. This would indicate that
similar strategies to promote adoption of EBPs
could be implemented in both settings.
Implications
The results of this study have implications for rural
hospital nurse executives, policy makers, and re-
searchers. Nurse executives in small rural hospitals
should consider how they can enable professional
development of their staff, including the use of
clinical ladders. Networking with other small hospi-
tals or partners to develop programs that can be
accessed remotely can engage nurses in local, state,
and national initiatives. Engagement in quality and
safety initiatives can be promoted by linkages with
professional organizations. For example, the Na-
tional Rural Health Association should be accessed
to share best practices, network, and provide con-
tinuing education specific to rural settings.
Nurse executives in larger rural hospitals should
focus on developing teams focused on a common
patient-centered goal to promote a shared vision
within their organization. Team building among
disciplines will foster shared vision and promote
high levels of proficiency for high-risk, low-volume
procedures.
Policy makers at the state and national level will
need to endorse programs to promote baccalaureate
23. education for nurses. All rural hospitals employ a
large number of ADN-prepared nurses, with more
employed by small rural hospitals. To promote BS
education for RNs, linkages should be fostered with
colleges and universities that offer RN-to-BS pro-
grams locally or through distance education. Increas-
ing the presence of BS-prepared nurses within the
JONA � Vol. 41, No. 3 � March 2011 135
Copyright @ 201 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.1
rural hospital setting will prime the organization
with staff that can interpret and apply new evidence
as it emerges.
Researchers can use these results to inform in-
terventions tailored to the rural setting. Small and
larger rural hospitals will require different strategies
to promote the adoption of best practices. Acute-care
settings with less resources and professional develop-
ment opportunities will require a higher level of
mentorship and expert consultation.
Study Limitations
There are 3 limitations to this study. First, the NES
was developed for this study, so psychometric testing
is limited. However, the available psychometric data
suggest the instruments performed well with accept-
able estimates. Second, the perspective of a single
respondent (the nurse executive) represented each
hospital. The NES focuses on content for which the
24. nurse executive is the best source of information.
Third, the sample was a convenience sample repre-
senting hospitals with lower census than the sam-
pling frame and variation in response rate by region.
Despite drawing the study sample nationally, sam-
pling bias may limit the generalizability of results.
Conclusion
This study describes the characteristics and context
of rural hospital nursing. When comparing larger
and small rural hospitals, differences exist in market,
hospital, and nursing attributes. Standards of nursing
care apply to all settings. To promote the best patient
outcomes, attention to contextual differences is
needed to tailor nursing interventions to fit the re-
sources, environment, and patient needs in the given
healthcare setting. Results of this study are informa-
tive regarding these contextual differences.
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Nursing Research � January/February 2010 � Vol 59, No 1,
18–25
31. Effectiveness of an Aspiration
Risk-Reduction Protocol
Norma A. Metheny 4 Jami Davis-Jackson 4 Barbara J. Stewart
b Background: Aspiration of gastric contents is a serious prob-
lem in critically ill, mechanically ventilated patients receiving
tube feedings.
b Objectives: The purpose of this study was to evaluate the
effectiveness of a three-pronged intervention to reduce as-
piration risk in a group of critically ill, mechanically ventilated
patients receiving tube feedings.
b Methods: A two-group quasi-experimental design was used
to compare outcomes of a usual care group (December
2002YSeptember 2004) with those of an Aspiration Risk-
Reduction Protocol (ARRP) group (January 2007YApril
2008). The incidence of aspiration and pneumonia was
compared between the usual care group (n = 329) and the
ARRP group (n = 145). The ARRP had three components:
maintaining head-of-bed elevation at 30- or higher, unless
contraindicated; inserting feeding tubes into distal small
bowel, when indicated; and using an algorithmic approach
for high gastric residual volumes.
32. b Results: Two of the three ARRP components were imple-
mented successfully. Almost 90% of the ARRP group had
mean head-of-bed elevations of 30- or higher as compared to
38% in the usual care group. Almost three fourths of the ARRP
group had feeding tubes placed in the small bowel as com-
pared with less than 50% in the usual care group. Only three
patients met the criteria for the high gastric residual volume
algorithm. Aspiration was much lower in the ARRP group than
that in the usual care group (39% vs. 88%, respectively).
Similarly, pneumonia was much lower in the ARRP group than
that in the usual care group (19% vs. 48%, respectively).
b Discussion: Findings from this study suggest that a combi-
nation of a head-of-bed position elevated to at least 30- and
use of a small-bowel feeding site can reduce the incidence
of aspiration and aspiration-related pneumonia dramatically
in critically ill, tube-fed patients.
b Key Words: enteral nutrition & preventive measures &
respiratory
aspiration
Frequent aspiration of gastric contents predisposes tube-fed
33. patients to pneumonia, especially those who are
critically ill and mechanically ventilated. Airway protection
from regurgitated gastric contents often is impaired in these
patients by underlying illness, sedation, or both. A number of
interventions have been proposed to minimize aspiration. For
example, a research-based guideline issued by the Centers for
Disease Control and Prevention recommends a head-of-bed
position elevated to at least 30- to reduce risk for aspiration-
related pneumonia (Tablan et al., 2004). Further, a fre-
quently cited study of aspiration in mechanically ventilated
patients found that aspiration was significantly more likely
when patients were supine; however, it also occurred when
they were semirecumbent (Torres et al., 1992). Findings
from the Torres et al. (1992) study are convincing in that the
methods used to detect aspiration were scientifically sound
(radiolabeled enteral formula and comparisons between
organisms found in the subjects’ stomachs and lungs). Other
investigators have found that risk for pneumonia is increased
by a low backrest elevated position (Grap et al., 2005). In-
vestigators have shown that written medical orders for head-of-
bed elevation are helpful in encouraging staff to maintain the
appropriate backrest elevation (Helman, Sherner, Fitzpatrick,
Callender, & Shorr, 2003). There is widespread agreement
that an elevated head-of-bed position is helpful in reducing
aspiration and pneumonia (Grap et al., 2005; Tablan et al.,
2004; Torres et al., 1992).
A distal small-bowel feeding site has also been recom-
mended to reduce aspiration risk, although it is less well sub-
stantiated by research; presumably a small-bowel feeding site
reduces the likelihood of gastroesophageal reflux (Heyland,
Drover, Dhaliwal, & Greenwood, 2002). Studies of the re-
lationship between small-bowel feedings and aspiration have
produced conflicting results. For example, in a study of 33
critically ill patients, Heyland, Drover, MacDonald, Novak,
34. and Lam (2001) used radiolabeled formula to assess the
extent of aspiration when feeding tubes were situated in var-
ious segments of the gastrointestinal tract. The rate of as-
piration was 5.8% in the stomach (n = 21), 4.1% in the first
portion of the duodenum (n = 8), 1.8% in the second portion
of the duodenum (n = 3), and 0% in the fourth portion of
the duodenum (n = 1). Overall, patients fed in the stomach
tended to have more microaspiration than patients fed
beyond the pylorus (7.5% vs. 3.9%, p = .22). When the
18 Nursing Research January/February 2010 Vol 59, No 1
Norma A. Metheny, PhD, RN, is Professor, School of Nursing,
Saint Louis University, Missouri.
Jami Davis-Jackson, MSN, RN, ACNP-BC, is Nurse
Practitioner,
Department of Heart Services, Barnes-Jewish Hospital, St.
Louis,
Missouri.
Barbara J. Stewart, PhD, is Professor Emeritus, Oregon Health
and Science University, Portland.
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
logarithmic mean of the radioactivity count was compared
across groups, there was also a trend toward increased
microaspiration (1.9 vs. 1.4 counts/g, p = .09) in patients fed
into the stomach (Heyland et al., 2001). However, also using
radiolabeled enteral formula, other investigators found no
significant difference in aspiration in 27 patients fed in the
stomach and 24 fed transpylorically (7% vs. 13%, respec-
tively; Esparza, Boivin, Hartshorne, & Levy, 2001). Al-
though Heyland et al. (2001) and Esparza et al. used a
35. reliable test for aspiration, both studies had relatively small
sample sizes. Another problem with the Esparza et al. study
was failure to provide information about the degree of as-
piration encountered in patients fed in different portions of the
small bowel. Despite the conflicting research findings regard-
ing feeding tube location, many physicians prefer small-bowel
feedings in patients at high risk for aspiration, provided the
procedure can be performed at the bedside by bedside nurses
(Heyland, Cook, & Dodek, 2002). There is evidence that bed-
side nurses can be taught how to successfully place feeding
tubes into the distal small bowel (Welch, 1996).
Finally, an algorithmic approach to deal with high gastric
residual volumes (GRVs) has been proposed (Bourgault, Ipe,
Weaver, Swartz, & O’dea, 2007; Kattelmann et al., 2006).
For example, it has been recommended that gastric feedings
be interrupted when a residual volume of 500 ml or more is
identified (McClave et al., 2002), and it has been suggested
that prokinetic drugs be initiated when GRVs of 250 ml or
greater are identified (Booth, Heyland, & Paterson, 2002;
Nguyen et al., 2007). A drawback to the use of prokinetics
is their potential to produce undesirable side effects, such as
dystonic reactions (Dubow, Leikin, & Rezak, 2006; Kenney,
Hunter, Davidson, & Jankovic, 2008; Pasricha, Pehlivanov,
Sugumar, & Jankovic, 2006; van der Padt, van Schalk, &
Sonneveld, 2006).
Although the effects of single risk factors for aspiration
have been studied previously, no studies were identified in
which the combined effects of postpyloric tube site, head-of-
bed elevation, and GRV were evaluated. Because it is likely
that a combination of aspiration-risk-reducing interventions
will be more beneficial than a single intervention, the study
reported here was used to evaluate the effectiveness of a three-
pronged intervention to reduce aspiration risk in a group of
critically ill, mechanically ventilated tube-fed patients.
36. Methods
Design
A two-group quasi-experimental design was used to compare
outcomes of a usual care group with those of an Aspiration
Risk-Reduction Protocol (ARRP) group. Both groups in-
cluded critically ill, mechanically ventilated tube-fed patients
cared for in the same intensive care units (ICUs). The primary
outcomes of interest were the frequency of aspiration and the
incidence of pneumonia. A secondary outcome was the use of
hospital resources (length of hospitalization, length of inten-
sive care stay, and number of days of mechanical ventilation).
The study was approved by the appropriate institutional
review boards. A secondary data analysis was performed on
the usual care group. Patients in the usual care group who had
surgically or endoscopically placed tubes were eliminated
from the analysis for the work reported here.
Setting
Both phases of the study took place in the same five ICUs at
a Level 1 trauma center in the Midwest. Major services pro-
vided in the ICUs included neuromedicine/neurosurgery,
trauma/surgery, and general medicine/pulmonary medicine.
Subjects
The usual care group (n = 329) was studied prospectively
between December 2002 and September 2004 (Metheny et al.,
2006). The ARRP group (n = 145) was studied prospectively
between January 2007 and April 2008. Inclusion criteria for
the ARRP group were the same as for the usual care group:
(a) admitted to one of the five ICUs at the study site, (b) age
Q18 years, (c) informed consent of patient or legal guardian,
(d) mechanical ventilation, and (e) medical order for blind
insertion of feeding tube at bedside. Exclusion criteria were
as follows: (a) pneumonia present before tube feeding
37. started, and (b) medical order for surgically or endoscopi-
cally placed feeding tube.
All patients who met the criteria were invited to par-
ticipate for a 3-day period. Although the ARRP was im-
plemented for all tube-fed patients in the ICUs, data were
collected only on those who gave informed consent. Regis-
tered nurse research assistants were present 16 hours a day,
7 days a week, to recruit patients, to obtain informed con-
sents, and to collect data. The same measurements were made
on the usual care group and ARRP group.
Independent Variable
The independent variable consisted of the two treatment
conditions (usual care and the ARRP).
Usual care was defined as the absence of a systematic
approach to minimize risk for aspiration. In 2002Y2004,
standing medical orders on the ICUs did not routinely in-
clude information about head-of-bed elevation, and nurses
did not chart head-of-bed angles on the patients’ flow
sheets. Further, no formal program was in place to teach
ICU nurses how to place small-bowel feeding tubes. Fi-
nally, there was no standardized approach for dealing with
high GRVs.
The ARRP had three components: (a) maintain head-of-
bed elevation at 30- or higher, unless medically contra-
indicated; (b) insert feeding tube into distal small bowel,
when requested by the attending physician; and (c) initiate an
algorithmic approach for high GRVs.
Before initiation of the study in 2007, the hospital nurs-
ing practice committee and the ICU medical directors ap-
proved the ARRP for use in the ICUs, and 2 months before
data collection, an advanced practice nurse skilled in critical
38. care and nasoenteral tube placement initiated an educational
program to introduce the protocol to the ICU staff. This
nurse was present 40 hours a week during the ARRP phase
of the study to encourage adoption of the protocol in the
ICUs involved. Coaching by the advanced practice nurse con-
sisted of a combination of teaching, training, and counsel-
ing designed to promote diffusion of the ARRP components.
The advanced practice nurse also provided monthly feedback
about implementation of the interventions and reinforced
desired behaviors by emphasizing successful aspects of the
protocol delivery.
Nursing Research January/February 2010 Vol 59, No 1
Reducing Risk for Aspiration in Tube-Fed Patients 19
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
Maintain Head-of-Bed Elevation at 30o or Higher, Unless Med-
ically Contraindicated Attending physicians were encour-
aged to write orders for the desired head-of-bed elevation,
and this action promoted appropriate patient positioning.
Also, bedside nurses were encouraged to record head-of-bed
angles at hourly intervals on the patients’ ICU flow sheets;
this action reminded the nurses to check the bed position
frequently and make corrections as necessary.
Insert Feeding Tube Into Distal Small Bowel, When Requested
by Attending Physician Physicians were informed that the
advanced practice nurse would assist ICU nurses with small-
bowel tube insertions at the bedside. Thus, physicians were
able to write orders more freely for bedside small-bowel
tube insertions when they were deemed important for high-
risk patients. The advanced practice nurse demonstrated
39. small-bowel tube insertion to bedside nurses who were un-
skilled in this procedure and coached these nurses during
small-bowel tube insertions until they gained proficiency in
the procedure. A videotape of a successful tube insertion
was made available in all of the ICUs for nurses to view at
their discretion to facilitate learning further.
The tube insertion procedure consisted of several steps.
First, the patient’s attending physician was contacted to ob-
tain permission to administer metoclopramide, 10 mg, in-
travenously. If permission was obtained, the medication was
administered 10 minutes before introduction of the feeding
tube through the patient’s mouth or right or left naris
(whichever was most appropriate). Metoclopramide increases
gastric and small intestinal motility and thus facilitates place-
ment of a feeding tube into the small bowel (Rohm, Boldt, &
Piper, 2009). The feeding tube was advanced to the 55- to
60-cm mark, and an attempt was made to aspirate gastric
contents. If an aspirate was obtained, its pH was measured
with a pH test strip and the appearance of the aspirate was
observed. If the pH was 6 or higher and the aspirate had the
appearance of sputum, the tube was removed and a second
attempt was made to insert the tube via the esophagus into
the stomach. A pH less than 6 and an aspirate with a gastric
appearance were used as an indication of tube placement in
the stomach. The feeding tube was advanced gently with a
rotating motion. When the 90- to 100-cm mark was reached,
another attempt to aspirate fluid was made. This attempt
was facilitated by injecting 30 ml of air through the tube to
force the tube’s ports away from the intestinal mucosa. An
aspirate pH Q6 with bile staining was used as an indication
of tube placement past the pylorus. A confirmatory radio-
graph was obtained to determine actual tube location.
Detect and Manage High GRVs The algorithmic approach
used to manage high GRVs during gastric feedings is de-
40. picted in Figure 1.
Measurements
Measurements performed on the usual care and ARRP
groups are summarized in Table 1 and described later. All
of the registered nurse data collectors were trained by the
principal investigator and the project director on scoring of
the measurements before data collection.
Pepsin Assay to Detect Aspiration of Gastric Contents Bedside
nurses collected tracheal secretions in sputum traps during
routine suctioning (between 0800 and 2400 hours) on Days
1, 2, and 3. The specimens were treated and frozen at j20-C
in a hospital laboratory before being transported to a
research laboratory for pepsin analysis. The immunoassay
used for pepsin analysis has been described previously
(Metheny et al., 2006). In an animal model study, the assay
was shown to have a sensitivity of 92.5% and a specificity of
100% (Metheny et al., 2004). The same biochemist, blinded
to patients’ clinical status, interpreted all of the assays and
recorded the results as either positive or negative. A positive
reading indicated that the specimen contained pepsin in a
concentration Q1 Hg/ml. The percentage of pepsin-positive
tracheal secretions was calculated for each patient. The mean
number of tracheal secretions assayed per patient was 15.9
(SD = 4.7) in the usual care group and 13.1 (SD = 4.2) in the
ARRP group.
Clinical Pulmonary Infection Score The Clinical Pulmonary
Infection Score (CPIS) described in Table 2 was used to assess
for pneumonia at the end of Days 1, 2, 3, and 4 (Luna et al.,
2006). Data on infiltrates were obtained from radiographic
reports. The first blood gas of the day was used to calculate
the oxygenation PaO2/FiO2 ratio. Bedside nurses estimated
the volume and appearance of tracheal secretions at the time
41. of routine suctioning. Blood leukocyte data were obtained
from laboratory reports, and temperature data were obtained
from the medical records. When an infiltrate was present, a
FIGURE 1. Algorithm outlining actions for high gastric residual
volumes
observed during gastric feedings.
20 Reducing Risk for Aspiration in Tube-Fed Patients Nursing
Research January/February 2010 Vol 59, No 1
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
CPIS score Q6 was used as a proxy for pneumonia. The same
individual, blinded to the pepsin assay results, calculated all of
the CPIS scores. In an earlier study, investigators found sig-
nificant agreement (r = .96) between the simplified CPIS results
and 34 bronchoalveolar lavages (p G .001; Metheny et al.,
2006). Another group of investigators compared postmortem
examinations of 38 patients who had died after at least
72 hours of mechanical ventilation and compared their CPIS
scores with bronchoscopic and histological techniques; accord-
ing to their findings, the CPIS had a sensitivity of 72% and
a specificity of 85% for pneumonia (Papazian et al., 1995).
Use of Hospital Resources Information needed to calculate
hospital length of stay, ICU length of stay, and ventilator days
was obtained through chart review.
Head-of-Bed Angle During both phases of the study, regis-
tered nurse data collectors determined hourly backrest angles
from digital readouts available on the patients’ beds (Stryker
42. Medical, Kalamazoo, MI). During the ARRP phase of the
study, the bedside nurses were encouraged to use the beds’
digital readouts to determine hourly backrest elevations and
to record their findings on the patients’ flow sheets. The same
beds were in use during both phases of the study. In a previous
study, investigators compared 1,002 readings made between
digital readouts on the Stryker Apex or Stryker EPIC II Criti-
cal Care beds and those obtained from a handheld angle
reader; the Pearson correlation was .87, p G .001. However,
the mean bed readouts tended to be higher than the mean
readings obtained from the handheld device (21.3 T 13.3 vs.
18.9 T 11.7; Metheny et al., 2006).
Feeding Tube Site Radiographic confirmation of tube lo-
cation was obtained immediately after tube insertion; also at
this time, the length of tubing extending from the exit site
was measured with a centimeter tape. This measure was
repeated at 4-hour intervals between 0800 and 2400 on Days
1, 2, and 3; also assessed at these times were the pH and the
appearance of fluid aspirated from the feeding tubes. The
efficacy of these measures in detecting tube dislocation has
been described previously (Metheny et al., 2005).
When there was concern about possible tube dislocation,
the need for a radiograph was discussed with the patient’s at-
tending physician. In addition, reports of radiographic stud-
ies performed on Days 1, 2, and 3 were reviewed to observe
for radiographic evidence of tube movement. About half of
the patients had at least one treatment-related X-ray during
the study period that included information about the feeding
tube’s location.
Residual Volumes From Feeding Tubes Research nurses used
60-ml syringes to measure volumes from feeding tubes every
4 hours. Approximately 30 ml of air was injected into the
43. q
TABLE 1. Patient Measurements, Scoring, and
Frequency
Measurements Scoring Frequency
Aspiration of gastric contents
(pepsin immunoassay
performed on tracheal
secretions)
1 = present,
0 = absent
Each time
patient is
suctioned
Pneumonia
(simplified CPIS)
Range 0Y10 Every 24 hours
Q6 positive for
pneumonia
Days 1, 2, 3, 4
Use of hospital resources
Hospital length of stay Time of
discharge or
death
ICU length of stay Days
44. Ventilator use
Head-of-bed angle 0-Y90- Every hour
Feeding site
Stomach
First portion of duodenum
Second and third portion
duodenum
Fourth portion of duodenum
Proximal jejunum
Time of initial
X-ray and
every 4 hours
thereafter
Level of consciousness (GCS) Range 3Y15 Every 4 hours
Level of sedation (Vancouver
Interaction and Calmness
Score)
Range 10Y60 Every 4 hours
GRV Number
Q250 ml
Every 4 hours
APACHE II score 0Y71 At time of
admission to
ICU
45. Note. CPIS = Clinical Pulmonary Infection Score; ICU =
intensive care
unit; GCS = Glasgow Coma Scale; GRV = gastric residual
volume;
APACHE II = Acute Physiology and Chronic Health Evaluation
II.
q
TABLE 2. Simplified CPIS
Component Value Points
Temperature (-C) Q36.5 and e38.4 0
Q38.5 and e38.9 1
Q39.9 and e36.0 2
Blood leukocytes
per mm3
Q4,000 and e11,000 0
G4,000 or 911,000 1
Tracheal secretions Few 0
Moderate 1
Large 2
Purulent +1
Oxygenation
46. (PaO2/FiO2 mm Hg)
9240 or presence of ARDS 0
e240 and absence of ARDS 2
Chest radiograph No infiltrate 0
Patchy or diffuse infiltrate 1
Localized infiltrate 2
Note. CPIS = Clinical Pulmonary Infection Score; ARDS =
acute
respiratory distress syndrome.
Nursing Research January/February 2010 Vol 59, No 1
Reducing Risk for Aspiration in Tube-Fed Patients 21
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
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feeding tube before each attempt to withdraw fluid from the
tube, then slow and steady negative pressure was applied with
the plunger. The procedure was repeated until no more fluid
could be withdrawn. The total volume of fluid removed from
the feeding tube was reported in milliliters. Policy at the data
collection site called for returning a GRV of 200 ml or less to
the patient and discarding of any amount greater than 200 ml.
Level of Consciousness The Glasgow Coma Scale (GCS),
adjusted for use with intubated patients, was used by the
research nurses to assess patients’ level of consciousness at
47. 4-hour intervals from 0800 through 2400 hours. Scoring of the
GCS is based on three components (best eye response, best
motor response, and best verbal response). The worst possible
total score is 3, and the best possible total score is 15. Because
all of the patients were intubated tracheally, the verbal response
was scored as generally unresponsive, ability to converse is in
question, or appears able to converse. In a prospective, ob-
servational study, two observers determined the GCS of 39
poisoned patients; the weighted kappa score for the total GCS
was .85, and the weighted kappa scores for individual com-
ponents of the GCS ranged between .63 and .78 (Heard &
Bebarta, 2004). In a review of published studies in which
GCS was used, the tool was found to have good reliability
(intraclass correlation coefficient, .8 to 1.0 for trained users);
further, it was found to have well-established cross-sectional
construct validity (Prasad, 1996).
Level of Sedation The Vancouver Interaction and Calmness
Scale was used to assess patients’ level of sedation (de Lemos,
Tweeddale, & Chittock, 2000). This scale was developed for
use with adult, critically ill, mechanically ventilated patients,
and it consists of two 5-item subscales quantifying inter-
action along a continuum from 5 to 30 points; the scores
may range from 10 to 60. A low score indicates a high level
of sedation. The tool’s developers report interrater reliability
for the two scales as .89 and .90 and internal consistency as
.95 for both subscales (de Lemos et al., 2000).
Severity of Disease The Acute Physiology and Chronic
Health Evaluation II (APACHE II) score was calculated at
the time of the patient’s admission to the ICU. This tool is
designed to measure the severity of disease for adult patients
admitted to ICUs. The tool has three components: acute
physiology score, age, and chronic health. Overall, an integer
score from 0 to 71 is computed on the basis of temperature,
mean arterial pressure, heart rate, respiration rate, oxygen-
48. ation, serum sodium, serum potassium, serum creatinine,
hematocrit, white blood count, GCS score, age, and chronic
health points (Knaus, Draper, Wagner, Zimmerman, 1985).
Higher scores imply more severe disease state and greater
risk for death. The acute physiology score component of the
APACHE II instrument is highly reproducible (intraclass
correlation coefficient = .90), and the age component of the
instrument has an even higher reproducibility (intraclass
correlation coefficient = .998). The chronic health compo-
nent of the instrument does not fare as well (kappa = .66;
Damiano, Bergner, Draper, Knaus, & Wagner, 1992).
Other Observations Demographic information was obtained
by chart review. The number of vomiting episodes was de-
termined by interviewing bedside nurses and by chart review.
Data Analysis
Simple descriptive statistics were used to describe the sam-
ple. To determine the effect of the ARRP on frequency of
aspiration, we used a t test for independent groups to com-
pare patients in the usual care and ARRP groups on the mean
percentage of pepsin-positive tracheal secretions. To deter-
mine the effect of the ARRP on the incidence of pneumonia,
we used a z test for comparing proportions in independent
groups to compare the proportion of usual care patients with
the proportion of ARRP patients with a positive CPIS for
q
TABLE 3. Description of Usual Care and ARRP
Groups
Variable
Usual care
(n = 329)
ARRP group
49. (n = 145)
Age (years) 52.5 T 18.1 48.8 T 17.8*
Gender
Female 42.9% 35.2%
Male 57.1% 64.8%
APACHE II 22.7 T 6.4 19.5 T 5.7**
Service
Neuromedicine/neurosurgery 30.4% 33.2%
Trauma/surgery 39.8% 44.8%
General medicine/pulmonary
medicine
29.8% 22.1%
Level of consciousness
(mean GCS score)
7.0 T 2.8 6.9 T 2.2
Level of sedation (mean Vancouver
Interaction and Calmness Score)
35.7 T 4.1 36.5 T 4.1*
Feeding site
Stomach throughout study 47.7% 27.6%**
50. Small bowel throughout study 40.7% 69.7%
Switch from stomach to small bowel 4.0% 0.0%
Switch from small bowel to stomach 7.6% 2.8%
Type of device during gastric feedings
10-Fr polyurethane tube 47.1% 75.0%**
14- to 18-Fr polyvinyl chloride tube 52.9% 25.0%
Type of device during small-bowel
feedings
10-Fr polyurethane tube 100% 100%
One or more GRVs Q250 ml in
gastric-fed patients
15.9% 7.5%
Vomited at least once 5.8% 5.5%
Mean backrest elevation (-) 23.7 T 12.4 37.8 T 9.1**
Mean percent backrest
elevation Q30-
37.7% 88.4%**
Died during hospitalization 19% 14%
Note. ARRP = Aspiration Risk-Reduction Protocol Group;
APACHE II =
51. Acute Physiology and Chronic Health Evaluation II.
*p e .05.
**p e .001.
22 Reducing Risk for Aspiration in Tube-Fed Patients Nursing
Research January/February 2010 Vol 59, No 1
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
pneumonia on Day 4. Significant baseline differences be-
tween the two groups were controlled for in the analyses. To
evaluate the effect of the ARRP on hospital resources, we
compared usual care and ARRP groups using a z test from
the MannYWhitney U test because the secondary outcomes
of hospital length of stay, ICU length of stay, and days of
ventilator use had skewed distributions.
Results
Descriptive Data
Descriptive data on both groups are provided in Table 3. As
shown in Table 3, the ARRP and the usual care groups did
not differ in gender, level of consciousness, and service that
provided care. However, the ARRP group was younger, had
a lower mean APACHE II score, and was less sedated than
the usual care group.
The mean head-of-bed elevation was significantly higher
in the ARRP group than that in the usual care group
(37.8- T 9.1- vs. 23.7- T 12.4-, respectively, p G .001). Fur-
52. ther, a mean head-of-bed elevation Q30- was achieved in
88% of the ARRP group as opposed to 38% of the usual
care group (p G .001; Figure 2). Physicians included orders
for the desired head-of-bed angle in 90% (n = 130) of the
145 ARRP patients. Bedside nurses charted the head-of-bed
angle in 44% of the possible observations.
As shown in Figure 3, a small-bowel feeding site was
achieved in 72.4% of the ARRP group compared with
48.3% of the usual care group (p G .001). Further, tube
placement past the proximal duodenum was achieved in
53.1% of the ARRP group compared with 18.2% of the
usual care group (p G .001).
Three patients in the ARRP group met the criteria for im-
plementation of the high GRV algorithm depicted in Figure 1.
One patient had nine high GRVs (ranging between 300 and
700 ml), a second had two high GRVs (both 350 ml), and a
third had one GRV of 325 ml. However, physicians chose
not to implement the algorithm in any of the cases.
Effect of the ARRP on Aspiration, Pneumonia, and Use of
Hospital Resources
Aspiration was significantly lower in patients in the ARRP
group than that in usual care group, as evidenced by a lower
mean percentage of pepsin-positive tracheal secretions
(12.4% T 21.8% vs. 30.9% T 24.2%, p G .001). Aspirating
at least once was half as likely in the ARRP group as in
the usual care group (39.3% vs. 88.4%, p G .001). Further,
pneumonia occurred in less than one fifth of the ARRP
group but in nearly half of the usual care group (19.3% vs.
48.2%, p G .001; Figure 4). The ARRP patients were
hospitalized on average 2.2 fewer days than usual care pa-
tients (25.1 T 14.9 vs. 27.3 T 13.4, z from MannYWhitney
U test = j2.39, p = .017), and the average ICU length of
53. stay for ARRP patients was 1.9 fewer days than for usual
care patients (21.3 T 10.5 vs. 19.4 T 12.1, z from MannY
Whitney U test = j2.46, p = .014). Finally, ARRP patients
averaged 1.5 fewer days of mechanical ventilation than the
usual care patients (16.2 T 9.7 vs. 17.7 T 9.8, respectively,
z from MannYWhitney U test = j1.46, p = .14; Figure 5).
When the usual care and the ARRP groups were compared
on the outcome variables using age, APACHE II, and
sedation as covariates, the results were nearly identical.
Discussion
Success in Delivery of the ARRP
Two of the three components of the ARRP were imple-
mented successfully. That is, almost 90% of the ARRP group
FIGURE 2. Comparison of percentages of mean head-of-bed
elevations
equal to or greater than 30- in the usual care and ARRP groups.
FIGURE 3. Comparison of feeding tube sites in the usual care
and
ARRP groups.
FIGURE 4. Comparison of aspiration and pneumonia (present or
absent)
in the usual care and ARRP groups.
Nursing Research January/February 2010 Vol 59, No 1
Reducing Risk for Aspiration in Tube-Fed Patients 23
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
54. had mean head-of-bed elevations of 30- or higher and almost
three fourths had feeding tubes placed in the small bowel
(most beyond the proximal duodenum).
Successful implementation of a head-of-bed elevated po-
sition probably was influenced by a number of factors. Writ-
ten medical orders regarding the desired backrest angle
eliminated the possibility of elevating the backrest inap-
propriately and reminded staff of the importance of proper
positioning. Frequent documentation of the backrest angle
ensured corrections as needed. Also, the documentation
probably enhanced the nurses’ sense of responsibility for
appropriate patient positioning. A factor that also may
have had a significant effect on the greater use of an elevated
head-of-bed position in the ARRP group, as compared
with the usual care group, was the growing number of
publications emphasizing the need for an elevated head-of-
bed position to prevent pneumonia (Grap et al., 2005;
Tablan et al., 2004).
Successful implementation of small-bowel feeding tube
insertions also probably was influenced by several factors.
Many physicians prefer small-bowel feedings in patients
at high risk for aspiration, provided the procedure can be
performed at the bedside by bedside nurses, and in this
study, the educational program provided by the advanced
practice nurse allowed a cadre of bedside nurses in the five
ICUs to significantly improve their success in placing small-
bowel feeding tubes.
Poor use of the algorithm was due to reluctance of the
attending physicians to prescribe prokinetic agents for the
three patients who met the criteria in the algorithm depicted
in Figure 1. In all three cases, the physicians expressed con-
cern about recent published reports of possible undesirable
effects associated with prokinetic agents (Dubow et al.,
55. 2006; Kenney et al., 2008; Pasricha et al., 2006; van der
Padt et al., 2006).
Improvement in Outcomes
To determine if younger age, better APACHE II score, and
lower level of sedation had a significant effect on outcomes
(aspiration and pneumonia), we entered these factors as
covariates in the analyses. These factors had no significant
effect on outcomes when the two groups were compared.
The combination of an elevated head-of-bed position and
a mid-to-distal small-bowel feeding site probably contributed
to the significantly less aspiration and pneumonia in the
ARRP group than that in the usual care group. The shorter
hospital and ICU lengths of stay in the ARRP group were
modest and doubtless influenced by the lower incidence of
pneumonia.
Head-of-Bed Elevation The supine position is a well-recognized
risk factor for aspiration. As indicated earlier, there is a wide-
spread agreement that an elevated head-of-bed position is
helpful in reducing aspiration and pneumonia (Grap et al.,
2005; Tablan et al., 2004; Torres et al., 1992).
Small-Bowel Feeding Site Findings from the study reported
here support those of other investigators who used a sensitive
and specific test for aspiration of gastric contents (Heyland
et al., 2001).
Gastric Residual Volume Because the algorithm for high
GRVs during gastric feedings was not implemented in the
three ARRP patients with one or more GRVs Q250 ml, it was
not possible to determine what effect it might have had on their
rates of aspiration (which ranged between 50% and 100%).
56. The study reported here adds to the evidence that an ele-
vated head-of-bed position is helpful in preventing aspiration
and pneumonia; further, it adds to the evidence that a distal
small-bowel feeding site is associated with less aspiration than
is the gastric feeding site. It is regrettable that the GRV
component of the protocol could not be implemented and
evaluated.
Strengths of the Study
The highly sensitive and specific pepsin assay allowed an
accurate comparison of the two groups on aspiration, and the
large sample size provided adequate power to compare the
usual care and ARRP groups on the major outcome variables
(aspiration and pneumonia). The presence of skilled regis-
tered nurse research assistants for 16 hours a day, 7 days a
week throughout both phases of the study allowed for
uniformity in data collection procedures.
Limitations
A limitation of the study was the 28-month time lapse be-
tween the end of the usual care phase of the study and
the beginning of the ARRP phase. It is conceivable that
changes that occurred in the clinical site during that period
could have accounted for some of the differences in out-
comes. Another limitation was our sole reliance on the
Clinical Pulmonary Infection Score to estimate the incidence
of pneumonia.
Conclusions
Findings from this study suggest that a combination of a
head-of-bed position elevated to at least 30- and the use of
a small-bowel feeding site (especially beyond the first por-
tionof the duodenum) can reduce the incidence of aspiration
and aspiration-related pneumonia dramatically in critically ill,
mechanically ventilated patients. It is highly probable that the
presence of a skilled critical care nurse with special training in
57. the placement of small-bowel feeding tubes played a signifi-
cant role in encouraging ICU personnel at the study site to
adopt the aspiration-reducing interventions and bring about
the desired outcomes shown in this study. q
FIGURE 5. Comparison of use of hospital resources by the
usual care
and ARRP groups.
24 Reducing Risk for Aspiration in Tube-Fed Patients Nursing
Research January/February 2010 Vol 59, No 1
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
Accepted for publication August 17, 2009.
This study was funded by the National Institute of Nursing
Research,
grant no. R01NR05007.
Corresponding author: Norma A. Metheny, PhD, RN, School of
Nursing, Saint Louis University, 3525 Caroline Mall, St. Louis,
MO
63104 (e-mail: [email protected]).
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Nursing Research January/February 2010 Vol 59, No 1
Reducing Risk for Aspiration in Tube-Fed Patients 25
Copyright @ 20 Lippincott Williams & Wilkins. Unauthorized
reproduction of this article is prohibited.10
Effects of Coping Skills Training in School-age Children with
Type 1 Diabetes
Margaret Grey, DrPH, RN, FAAN[Dean and Annie Goodrich
Professor],
Yale School of Nursing, New Haven, CT
63. Robin Whittemore, PhD, APRN[Associate Professor],
Yale School of Nursing
Sarah Jaser, PhD[Post-doctoral Associate],
Yale School of Nursing
Jodie Ambrosino, PhD[Clinical Instructor],
Department of Pediatrics, Yale School of Medicine
Evie Lindemann, LMFT, ATR[Assistant Professor],
Albertus Magnus College, New Haven, CT
Lauren Liberti, MS[Trial Coordinator],
Yale School of Nursing
Veronika Northrup, MPH, and
Yale Center for Clinical Investigations, New Haven, CT
James Dziura, PhD
Yale Center for Clinical Investigations, New Haven, CT
Abstract
Children with type 1 diabetes are at risk for negative
psychosocial and physiological outcomes,
particularly as they enter adolescence. The purpose of this
randomized trial (n=82) was to
determine the effects, mediators, and moderators of a coping
skills training intervention (n=53) for
school-aged children compared to general diabetes education
(n=29). Both groups improved over
time, reporting lower impact of diabetes, better coping with
diabetes, better diabetes self-efficacy,
fewer depressive symptoms, and less parental control.
Treatment modality (pump vs. injections)
moderated intervention efficacy on select outcomes. Findings
suggest that group-based
64. interventions may be beneficial for this age group.
Keywords
coping skills training; child; type 1 diabetes
Effects of Coping Skills Training in School-age Children with
Type 1
Diabetes
Type 1 diabetes (T1D) is one of the most common severe
chronic illnesses in children,
affecting 1 in every 400 individuals under the age of 20, over
176,000 American youth
Corresponding Author: Robin Whittemore, Yale School of
Nursing, 100 Church Street South, New Haven, CT 06536-0740,
[email protected]
NIH Public Access
Author Manuscript
Res Nurs Health. Author manuscript; available in PMC 2010
August 1.
Published in final edited form as:
Res Nurs Health. 2009 August ; 32(4): 405–418.
doi:10.1002/nur.20336.
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(National Institute of Diabetes and Digestive and Kidney
Disease, 2002). Diabetes is the
seventh leading cause of death in the United States, and adults
with T1D are twice as likely
to die prematurely from complications compared to adults
without T1D National Institute of
Diabetes and Digestive and Kidney Disease, 2007). Management
of T1D is demanding,
requiring frequent monitoring of blood glucose levels,
monitoring and controlling
carbohydrate intake, daily insulin treatment (3-4 injections/day
or infusion from a pump),
66. and adjusting insulin dose to match diet and activity patterns
(American Diabetes
Association, 2008). Such an intensive treatment regimen and
maintenance of near-normal
glycemic control may delay or prevent long-term complications
of T1D by 27-76%
(Diabetes Control and Complications Trial [DCCT] Research
Group, 1994). Interventions
are needed to assist children and families in coping with the
considerable demands of living
with T1D. The purpose of this study was to evaluate the
efficacy of a coping skills training
(CST) intervention, specific to school-aged children and their
parents, on metabolic control
and psychosocial outcomes, and to examine mediators and
moderators of these outcomes.
Tasks of childhood development can compromise diabetes
management. Metabolic control
declines during adolescence (Travis, Brouhard, & Schreiner,
1987). Although the
physiological changes of puberty contribute to insulin
resistance, a premature transfer of
responsibility for diabetes-related tasks from parents to children
also may result in poor
adherence and metabolic control (Anderson, Ho, Brackett,
Finkelstein, & Laffel, 1997;
Holmes et al., 2006; Schilling, Knafl, & Grey, 2006). As
children enter adolescence and
strive for autonomy, parents' attempts to monitor or control
their child's treatment may be
viewed as intrusive or nagging, which may result in adolescents
becoming resistant, defiant,
and noncompliant (Berg et al., 2007; Cameron et al., 2008;
Weinger, O'Donnell, & Ritholz,
2001). Low levels of family support and increased family
67. conflict have been consistently
associated with poor diabetes self-management, metabolic
control, psychosocial adaptation,
and quality of life (QOL) in adolescents with T1D (Pendley et
al., 2002; Whittemore,
Kanner, & Grey, 2004; Wysocki, 1993). In addition, T1D is a
risk factor for depression in
youth, with the prevalence of clinically significant depressive
symptoms ranging from
12-15% in children to 15-27% in adolescents with T1D (Hood et
al., 2006; Kokkonen,
Lautala, & Salmela, 1997; Kovacs, Goldston, Obrosky, &
Bonar, 1997; Whittemore et al.,
2002).
Due to the risks associated with poor metabolic control and
psychosocial adjustment for
adolescents with T1D, increasing attention is being paid to the
developmental transition
between pre-adolescence and adolescence for the promotion of
better health outcomes.
Parents may need to adjust their level of involvement, so that
children can exercise
developmentally-appropriate gains in autonomy, while
continuing to rely upon parents for
support, guidance, and encouragement (Anderson, Auslander,
Jung, Miller, & Santiago,
1990). Research supports the need for children and parents to
work cooperatively with open
communication and flexible problem-solving skills in order to
negotiate shared
responsibility for treatment management (Schilling et al., 2006;
Wysocki, 1993). Parental
guidance, warm and caring family behaviors, open
communication, and expression of
feelings have demonstrated protective effects on metabolic
68. control and psychosocial
adjustment (Davis et al., 2001; Faulkner & Chang, 2007; Grey,
Boland, Davidson, &
Tamborlane 2001).
Family-based psychosocial interventions have been developed
to improve family
interactions and enhance the well-being of youth with T1D. In
several randomized trials
family-based interventions improved family relations,
communication, problem-solving
skills, treatment adherence, and metabolic control. For example,
Anderson and colleagues
showed that a low-intensity office-based, family intervention
increased parental
involvement, while decreasing diabetes-related family conflict
(Anderson, Brackett, Ho, &
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Laffel, 1999; Laffel et al., 2003). Other researchers have
targeted families at high risk for
problems. Wysocki and colleagues (2008) demonstrated that
intensive behavior family
systems therapy improved outcomes in families with high levels
of conflict. Ellis and
colleagues (2007) demonstrated that a comprehensive home- and
community-based
intervention improved outcomes in families with low
socioeconomic status. The majority of
these family-based interventions targeted adolescents and were
focused primarily on
problem solving and communication. However, variables such
as coping and self-efficacy
also have been associated with improved adherence, family
70. functioning, psychosocial
adjustment, and metabolic control in youth with T1D (Graue,
Wentzel-Larsen, Bru,
Hanestad, & Sovik, 2004; Grey, Lipman, Cameron, & Thurber,
1997; Griva, Myers, &
Newman, 2000).
Coping skills training (CST) is based on social cognitive theory,
which proposes that
individuals can actively influence many areas of their lives,
particularly coping and health
behaviors (Bandura, 1997). A major premise of this approach is
that practicing and
rehearsing a new behavior, such as learning how to cope
successfully with a problem
situation, can enhance self-efficacy and promote positive
behaviors (Marlott & Gordon,
1985). The goal of CST is to increase competence and mastery
by retraining non-
constructive coping styles and behaviors into more constructive
behaviors. There is evidence
supporting the potential efficacy of CST to promote positive
health outcomes in youth with
and without a chronic illness (see review by Davidson, Boland,
& Grey, 1997). A
randomized clinical trial of a CST program, based on Forman's
(1993) protocol, and
modified for adolescents with T1D (Grey, Boland, Davidson,
Yu, & Tamborlane, 1999),
demonstrated improvements in metabolic control, psychosocial
adjustment, and QOL at 6
and 12 month follow-up (Grey, Boland, Davidson, Li, &
Tamborlane, 2000). Because a CST
intervention demonstrated efficacy for adolescents with T1D,
the potential to provide the
intervention to other developmental phases, such as school-aged
71. children, seems warranted.
In this study, we report long-term treatment effects of a coping
skills training (CST)
program for school age children (8-12 years old) and their
parents compared to an attention
control group who received supplemental diabetes education. A
report of the preliminary
short-term efficacy indicated that children and parents who
received CST showed promising
trends for more adaptive family functioning and greater life
satisfaction than those families
in group education (Ambrosino et al., 2008). These results
support the potential application
of CST in the developmental phase of 8-12 year olds. If school-
aged children and parents
can learn effective coping skills, a positive transition to
adolescence may occur, one in
which parents and children collaborate to maintain effective
diabetes management.
Conceptual Framework
Stress-adaptation models provide a framework for the study of
interventions to promote
adaptation to chronic illness and posit that adaptation may be
viewed as an active process
whereby the individual adjusts to the environment and the
challenges of a chronic illness.
(Grey et al., 2001; Grey & Thurber, 1991; Pollock, 1993).
Adaptation, in this framework, is
the degree to which an individual adjusts both physiologically
and psychosocially to the
stress of living with a long-term illness. The framework
suggests that individual
characteristics, such as age, socioeconomic status, and in
children with T1D, treatment
72. modality (pump vs. injections), individual responses (depressive
symptoms), and context
(coping, self-efficacy, family functioning) influence the level of
individual adaptation. In
this model, adaptation has both physiologic (metabolic control)
and psychosocial (QOL)
components (see Figure 1). The CST was hypothesized to
influence the individual's
responses (depressive symptoms) and context (coping, self-
efficacy, family functioning)
directly and level of adaptation (metabolic control, QOL) both
indirectly and directly.
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Purpose
The primary aim of this randomized clinical trial was to
determine the effect of group-based
CST for school-aged children with T1D and their parents
compared to an attention-control
group receiving supplemental general diabetes education (GE)
over a period of a year on
children's metabolic control, QOL, depressive symptoms,
coping, self-efficacy, and family
functioning at 12-month follow-up. The data in this analysis
include only child outcomes.
The secondary aim was to explore mediators (coping, self-
efficacy, family functioning) and
moderators (age, sex, socioeconomic status, treatment modality)
of intervention efficacy
based on the conceptual framework. The following hypotheses
were tested:
1. Children with T1D who participate in CST will demonstrate
better metabolic
74. control (lower HbA1c levels), better QOL, fewer depressive
symptoms, fewer
issues in coping, better diabetes self-efficacy, and better family
functioning (stable
or less family guidance and control and more family warmth and
caring) compared
to children with T1D who participate in GE.
2. Age, sex, socioeconomic status, and treatment modality will
moderate the
intervention effect on metabolic control and QOL.
3. Changes in coping, self-efficacy, and family functioning will
mediate the
intervention effect on metabolic control and QOL.
Method
Design and Sample
A two-group experimental design was used. Data were collected
at baseline and 1, 3, 6, and
12 months post-randomization by trained research assistants
who were blinded to group
assignment. Children were eligible to participate if they were:
(a) between the ages of 8 and
12 years; (b) diagnosed with T1D and treated with insulin for at
least 6 months; (c) free of
other significant health problems; and, (d) in school grade
appropriate to within 1 year of
child's age.
A sample of 100 subjects was determined by a power analysis
based on the effect size seen
in our adolescent study (Grey et al., 2000) and in our pilot work
with younger children
(difference in HbA1c was .7%). A two-way analysis of variance
75. with 100 subjects with a .05
significance level would have 98% power to detect a variance
among the 2 group means of .
04, 99% power to detect a variance among the 3 time means of
.051, and 80% power to
detect a interaction among the 2 group levels and the 3 time
levels of .022, assuming that the
common standard deviation is .04, when the sample size in each
group is 50 (Elashoff,
1995). Due to problems scheduling groups, we were unable to
meet our projected goal of
100 subjects (Figure 2).
Of those approached for participation, approximately 58%
agreed; 18% expressed interest
and asked to be approached later, and 21% refused (e.g., too
busy). Twenty-four percent of
participants were unable to be scheduled for the group-based
intervention and were excluded
from the analysis due to lack of exposure to any aspects of the
intervention (18% in the CST
group and 33% in the GE group). This report is based on the 82
children who were exposed
to the interventions. There were 53 children in the CST group
and 20 in the GE group.
Comparison of those who received the intervention (CST or GE)
to those who enrolled but
did not receive either intervention demonstrated that groups
were comparable on baseline
measures, other than an increased likelihood for white children
and children whose mothers
had higher education to receive the intervention. Data
comparing attenders to nonattenders
has previously been reported (Ambrosino et al., 2008). Attrition
was low with only 10
participants dropping out or lost to follow up over the 1-year
76. period (14%). Once scheduled,
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attendance at sessions was good. Participants of CST attended
an average of 4.6 of 6
sessions (range=1-6; SD = 1.21); those in GE attended on
average 3.3 of 4 sessions
(range=1-4; SD = .75).
Descriptive statistics for the sample are provided in Table 1.
Children were predominately
white and of high income, which is consistent with the overall
clinic composition. On
average, children's duration of diabetes was 3.5 years; most
were on pump therapy and had
metabolic control comparable with the ADA's recommendations
for age.
Setting and Procedures
Children and their parents were approached for participation in
the trial during regularly
scheduled visits at a pediatric diabetes clinic in the northeast.
Families interested in the study
completed a consent/assent process approved by the university's
Human Subjects Research
Review Committee, as well as baseline questionnaires. Children
who scored above criteria
for elevated depressive symptoms on standardized
questionnaires were referred for follow
up, but not excluded from the intervention unless they required
hospitalization for
suicidality. After consent, participants were randomized by a
sealed envelope technique to
either CST or GE. Both groups received diabetes team care