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Implementation and evaluation of a
nursing assessment/standing orders–
based inpatient pneumococcal
vaccination program
Carl Eckrode, MPH, RRT-NPS,b Nancy Church, RN, MT,a and
Woodruff J. English III, MDa
Portland and Gresham, Oregon
Background: Pneumococcal vaccination is recommended for
patients aged 65 years and greater; inpatient vaccination has
been
suggested as means to increase vaccination rates is this
population. Our hospital implemented an inpatient
pneumococcal vacci-
nation program, and expanded the population of interest to
include patients aged 2 to 64 years with risk factors for
pneumococcal
bacteremia. We studied the outcomes of this program to
determine if the rate of pneumococcal vaccination opportunities
and
pneumococcal vaccination rate could be significantly increased
through the application of an in-hospital pneumococcal vaccina-
tion program, based on standing orders and assessment by
Registered Nurses, when compared to our previous method of
physi-
cian assessment and written vaccination order for each patient.
Methods: Subjects were inpatients admitted to non-intensive
care units of our hospital from August to December of 2004.
Cases
were aged greater than 65 years, or were greater than 2 years of
age with selected risk factors. Patients with previous
pneumococcal
vaccination with the past five years, in terminal or comfort care,
those allergic to vaccine components, patients who received
organ
or bone marrow transplants in the year prior to the study, and
those physicians barred them from the vaccination protocol
were
excluded. Program effectiveness was evaluated through
retrospective evaluation of medical records to determine if
subjects had
been evaluated for vaccination eligibility, and if subjects were
eligible, whether or not they had received pneumococcal
vaccination.
Results: Overall vaccination opportunity rate after
implementation of the standing orders-based program increased
form 8.6% to
59.1%, and overall vaccination rates improved form 0% to
15.4%. The study found a statistically significant difference in
the rate
of pneumococcal vaccination opportunities (x2 = 182.46, p =
.00) and the pneumococcal vaccination rate (x2 = 56, p = .00)
between the two methods of assessment and vaccination; these
results are attributable to the study intervention.
Conclusions: The study program contributed to increased
overall vaccination opportunity and vaccination rates, when
compared
to the previous method. The overall rates of vaccination
attained by this program were often lower than those reported in
the ex-
isting literature for other program designs; however, this may
be due to an unusually high rate of vaccination refusal. (Am J
Infect
Control 2007;35:508-15.)
The significance of invasive pneumococcal disease
cannot be understated, because disease caused by
Streptococcus pneumoniae has been reported to be
responsible for an estimated 36% of community-
acquired pneumonia, an estimated 50% of nosocomial
pneumonias, 50,000 cases of bacteremia, and an esti-
mated 3000 to 6000 cases of meningitis each year in
the United States.1 Forty thousand deaths have been re-
ported each year from pneumococcal infection,2,3 with
an estimated 175,000 hospitalizations due to the dis-
ease each year in the United States.1 The case-fatality
From the Infection Control Department,a Providence St.
Vincent Hos-
pital and Medical Center, Portland, Oregon; and Respiratory
Care
Program,b Mt. Hood Community College, Gresham, Oregon.
Address correspondence to Carl Eckrode, MPH, RRT-NPS, Mt.
Hood
Community College, 26000 SE Stark Street, Gresham, OR
97222.
0196-6553/$32.00
Copyright ÂȘ 2007 by the Association for Professionals in
Infection
Control and Epidemiology, Inc.
doi:10.1016/j.ajic.2006.08.005
508
can range up to 60% for elderly patients who have
pneumococcal bacteremia.1 The comorbid condition
of bacteremic pneumococcal disease, pneumococcal
pneumonia, has a case-fatality of 5% to 7%;1-6 as
one of the leading infectious causes of death in the
United States,7 it has killed more persons annually
than AIDS, tuberculosis, meningitis, and endocarditis
combined.8 This degree of morbidity and mortality
from a vaccine-preventable disease is unacceptable;
vaccination has been proven to reduce morbidity and
mortality significantly.9
The current pneumococcal vaccine for adults, the
23-Valent Pneumococcal Polysaccharide Vaccine (23PPV)
(Pneumovax, Pasteur-Merieux MSD, Malvern, PA; Pnu-
Imune, Wyeth-Lederle, Pearl River, NY), is well targeted
against many of the S pneumoniae serotypes that
are responsible for illness. For example, in a study of
pneumococcal disease, 78 isolates were recovered
from patients who had pneumococcal pneumonia.
Seventy-one of those isolates (91%) were remarkable,
in that the serotype of the isolated organism was one
that was included in the 23-valent pneumococcal
Eckrode, Church, and English October 2007 509
vaccine.10 The pneumococcal vaccine has been found
safe, with reports of serious reactions rare,11-13 although
they are more likely on revaccination.14 Reactions that
do occur to the 23PPV typically are local reactions and
low-grade fever, which generally are self-limiting,15
and may be more likely in patients who have coinciden-
tal upper respiratory illness.12 One of the rare systemic
reactions reported was reversible, and may have been
associated with a simultaneous influenza vaccination.16
Although the efficacy of the 23PPV for prevention
of pneumonia is still subject to discussion and study,
an overwhelming amount of evidence and expert
opinion support the contention that it is efficacious
and cost-effective in immunocompetent patients and
those whose diminished immune responses place
them at risk for bacteremic pneumococcal dis-
ease.3,4,11,17-26 The body of evidence clearly supports
the vaccine’s efficacy; however, historically the pneu-
mococcal polysaccharide vaccine has been underutil-
ized.11,27-29 In response, the Centers for Disease
Control and Prevention (CDC) Healthy People 2010 ob-
jective for pneumococcal vaccination in people greater
than 65 years of age was set at 90% of elderly ever vac-
cinated, and objectives were set for vaccination targets
of 60% coverage with pneumococcal vaccines among
high-risk adults aged 16 to 64 years.30 Nonetheless,
by 2002, only 62% of adults older than 65 years had
received the pneumococcal vaccine.8 A recent report
shows only slight progress in 2003, to a median of
64.2%, still well below the national health objectives
for 2010 of 90%.31 These low rates may be due to a
lack of formal programs to ensure proper screening
and vaccine administration,32 various beliefs on vacci-
nation held by the targeted populations,33 or a combi-
nation of factors. Whatever the reasons, these low
vaccination rates can have serious negative sequelae.
For instance, two thirds of persons who had serious
pneumococcal disease had been hospitalized within
the previous 4 years before their pneumococcal illness,
yet few had received pneumococcal vaccine.2,7,9,10
Many strategies for increasing pneumococcal vacci-
nation rates have been examined. Among the many
methods for increasing vaccination opportunity, hospi-
tal-based vaccination programs are appealing, given
that inpatients often are within the populations that
are at high risk for invasive pneumococcal disease.26,34
Support for inpatient pneumococcal vaccination dates
back to the early 1990s.11,20 Thus, the Advisory Com-
mittee on Immunization Practices (ACIP)35 and the Task
Force on Community Preventive Services have recom-
mended administration of pneumococcal polysaccharide
vaccines to inpatients.11,34,36 Hospital-based vaccination
also may be more cost-effective than a mass vaccination
effort, because of the selective targeting of the at-risk
population. To take advantage of this selective targeting,
a variety of approaches to inpatient pneumococcal vacci-
nation has been attempted, such as the use of nurses,
pharmacists, and other nonphysician providers for
screening and identification of eligible patients.1,26,37,38
Programs also have relied on written physician orders
or patient education to increase vaccination rates,37,38
whereas others attempted to combine pneumococcal
vaccination into a clinical pathway for pneumonia treat-
ment.39 The degree of success of these programs varied
widely.
Because of the clear value of hospital-based pneu-
mococcal vaccination programs, the CDC and ACIP
have promoted proactive approaches, such as the use
of standing orders to simplify the vaccination process
and ensure that every patient who enters the health
care system is immunized.8,40,41 To aid institutions in
implementing a standing orders–based program, the
Centers for Medicare and Medicaid Services (CMS)
promulgated a significant administrative rule change.
Relieving one of the major barriers to implementa-
tion of inpatient vaccination programs, CMS standards
changed to allow the use of standing orders for pneu-
mococcal and influenza vaccination.42 Additionally,
CMS levied the requirement to provide pneumococcal
vaccination to inpatients aged 65 years or greater.
The CMS administrative rule change on standing orders
enabled institutions to devise programs that permitted
nonphysician providers to assess patients and adminis-
ter medications, including vaccines, according to an
institution-approved protocol, without a physician’s
examination or individual, patient-specific orders.
Our program was designed in response to an unac-
ceptably low pneumococcal vaccination rate. For the
year prior to program inception (ie, 2003), the inpatient
pneumococcal immunization rate in our hospital was
only 13%. Given the scope of our problem, it was nec-
essary to plan and implement a vaccination program
carefully, but quickly. This was an institutional priority,
facilitated by the new CMS positions on pneumococcal
vaccination and standing orders. Thus, the organization
elected to use Borg and Gall’s Research and Develop-
ment Cycle, as applied to creating a health promotion
program;43 the use of this model allowed for a rapid pro-
gram development. We elected to use the registered
nurse in the role of assessor and for vaccination deliv-
ery. This study assessed the success of this program
for the first 90 days after program implementation.
METHODS
The research method chosen for our study was the
field experiment; the study design chosen was the
Comparison Group Posttest-Only Design.44 The com-
parison group was selected from the population of inpa-
tients who met the program criteria for pneumococcal
510 Vol. 35 No. 8 Eckrode, Church, and English
vaccination during the 90 days prior to program imple-
mentation. The study group was selected from the pop-
ulation who met the program criteria for vaccination
during the 90 days after program implementation. Ran-
dom assignment within the groups was performed.
The outcomes of interest—the percentage of eligible
subjects provided with vaccination opportunity and
vaccine delivery—can be measured accurately, despite
variations in and between the sample groups.
Data collection
A computer-generated list of patients who were
admitted to the inpatient units was provided to the
Providence St. Vincent Hospital and Medical Center
Infection Control Department, and medical chart docu-
ments were obtained electronically. These documents
are collected routinely, and these records were used
to obtain the information for evaluation of the pro-
gram. The use of this existing data did not require the
development or implementation of a survey instru-
ment or questionnaire.
The records for the sampled patients were evaluated
to determine if the patient was offered vaccination,
and, if the patient consented, received the pneumococ-
cal vaccination. The records evaluated included the
medication administration record, signed pneumococ-
cal vaccine orders, or signed vaccine consent forms
(a local requirement) with the date, dose, and vaccine
lot number entered. This data was converted to, and
recorded as, categorical (nominal) data (eg, the patient
was offered vaccination or the patient was not offered
vaccination, and the patient received the vaccination
or the patient did not receive the vaccination). The data
were entered into a coding sheet, using the Microsoft
Excel 2002 software package (Microsoft, Redmond,
WA). After conversion and coding, the percentage of
eligible randomly sampled patients who were or
were not offered vaccination, and who did or did not
receive the vaccination was calculated and compared
with the number of randomly sampled patients who
were or were not offered vaccination and who did or
did not receive vaccination prior to program
implementation.
Security and confidentiality of data were maintained
throughout the process, through multiple security mea-
sures (eg, use of passwords on computers, ‘‘sanitizing’’
records to remove protected health information, secur-
ing records in locked storage when not in use, and the
use of strong encryption (PGP 7.03, Network Associates,
Dallas, TX) for data stored in portable media). Patient
identifiers, such as name or medical record number,
were not recorded on coding forms or in newly created
databases. Documents containing protected health infor-
mation were destroyed by shredding subsequent to use.
Human/animal subjects
This was a study of a system for ensuring vaccina-
tion opportunity and administration, and no human
or animal experimentation was performed. The pneu-
mococcal polysaccharide vaccine is approved for use
in the study population, and no deviation from the pur-
pose of the approved use (‘‘off-label’’ use) occurred.
Thus, Institutional Review Board approval was not re-
quired. All patients or their representatives were pro-
vided with language-appropriate vaccine information
statements as part of the vaccination protocol. This
reflected local hospital policy.
Study sample
Study subjects included the population of Provi-
dence St. Vincent Hospital and Medical Center inpa-
tients during the months of September, October, and
November, aged 65 years or greater, and inpatients be-
tween 2 and 64 years of age with the presence of one
or more risk factors for pneumococcal disease. For this
study, high-risk patients were defined as those with
medical conditions that significantly increase a patient’s
vulnerability to pneumococcal pneumonia or invasive
pneumococcal disease, making them eligible for pneu-
mococcal vaccination if aged between 2 and 64 years.
These factors included cardiovascular disease (IDC-
9-CM 331-336, 340-345, 347, 358, 359, 393-429, 440.9),
cerebrovascular disease (ICD-9-CM 430-438), lower
and chronic respiratory diseases (ICD-9-CM 466, 480-
487, 490-496, 500-505, 506.4, 508, 510-519), renal
disease (ICD-9-CM 580-586), diabetes mellitus (ICD-
9-CM 250), chronic alcoholism and its complications
(ICD-9-CM 291, 303, 571, 577), sickle cell disease (ICD-
9-CM 282.5), asplenia (functional or anatomic) (ICD-9-
CM 45.1), and malignant neoplasms (ICD-9-CM 140-233).
These risk factors were selected by physicians and other
practitioners during design of the Providence St. Vin-
cent program, reflecting ACIP-identified risk factors. Pa-
tients who were excluded from the study were those in
terminal or comfort care; those allergic to vaccine com-
ponents; patients who received organ or bone marrow
transplants in the year prior to the study; anyone who
received pneumococcal vaccination in the 5 years prior
to the study; patients in critical care, short-stay, emer-
gency, and obstetrics units; and those whose physicians
have excluded them from the vaccination protocol.
Statistical analysis
The intervention factor (independent variable) in
this study was the implementation of a program for
administration of the pneumococcal vaccine prior
to discharge. Measurements included evaluation of
medical record documentation of assessment for
Eckrode, Church, and English October 2007 511
vaccination eligibility (opportunity), actual vaccina-
tion, patient age, and presence of ACIP-identified risk
factors in the primary diagnosis (by ICD-9-CM code).
The outcome (dependent) variables of interest were as-
sessment for vaccination eligibility (provision of vacci-
nation opportunity) and actual vaccinations given.
All statistical analyses were accomplished using
the SPSS 10.1 for Windows (SPSS, Chicago, IL) software
package. The x2 (goodness of fit/likelihood ratio tests)
statistics were used for analysis of categorical variables,
to determine the strength of association between the
program implementation and rates of opportunity
and vaccination, using the uncorrected x2 statistic for
2 3 2 contingency tables.45,46 Statistical significance
was considered at P , .05.
RESULTS
Data gathered for the first 90 days after program
implementation revealed that, of 5072 inpatients in
the affected units, 1106 (28%) met the program criteria
for pneumococcal vaccination. Data for the 90 days
prior to program implementation revealed that, of
5543 inpatients in the affected units, 2874 (52%) met
the program criteria for pneumococcal vaccination.
Based on these data, a random sample of patients
was drawn for further evaluation. Actual calculation
of sample size was performed by use of the Raosoft
Sample Size Calculator (Raosoft 2004, Seattle, WA).
For the population eligible for pneumococcal vaccina-
tion during the 90-day period after program interven-
tion (N = 1106), the sample size was 286 (Table 1).
Two hundred and eighty-six subjects were randomly
selected from the postintervention population, based
on a value obtained from a random number table. For
the population eligible for pneumococcal vaccination
during the comparison period (N = 2874), the sample
Table 1. Demographic characteristics of sampled
patients, first 90 days postintervention (study group)
Characteristics N = 286 (%)
Patients
Male 99 (34.6%)
Age in years (mean) 70.91
Risk factors (n = 137)
Cardiac disease 64 (22.4%)
Cancer 51 (19%)
Pulmonary disease 12 (4.2%)
Renal disease 4 (1.4%)
Cerebrovascular disease 4 (1.4%)
Diabetes 1 (0.3%)
Chronic alcoholism 1 (0.3%)
Asplenia 0 (0%)
Sickle cell disease 0 (0%)
size was 338 (Table 2). A sample of 338 subjects from
the population of vaccination-eligible inpatients in
the 90-day period prior to program selection was se-
lected randomly, using the same calculator and in the
same random fashion as the study group. Of note, ex-
amination of the demographics of the samples re-
vealed anomalies, such as only one sampled patient
with a diagnosis of diabetes, and smaller than expected
numbers of patients whose sole risk factor was age
greater than 65 years. These anomalies were noted,
and were not considered significant when analyzing
the data for the outcomes of interest.
For the 90 days prior to program implementation,
29 (8.6%) of the 338 sampled patients (comparison
group) were provided vaccination opportunity. In this
comparison group, none of the 338 vaccination-eligible
patients received the pneumococcal vaccine. Of note,
the demographics of the comparison group did not
match those of the study group exactly. We did not
consider these variations in demographics to be sig-
nificant. Still, seasonal variations in disease patterns
and aperiodic, nonseasonal changes in patient demo-
graphics must be acknowledged.
For the 90 days after implementation of the vaccina-
tion program, where registered nurses assessed the
patients for vaccination eligibility and provided vaccina-
tion under standing orders, 169 (59%) of the 286 sam-
pled patients were provided vaccination opportunity,
and 44 (15%) of the 286 sampled patients received
pneumococcal vaccination. The vaccination rate for
those subjects assessed under the standing order pro-
gram was 26% (44 of 169). Again, the demographics of
the comparison group did not match those of the study
group exactly, but the variations were not considered to
be significant. There are several plausible reasons for
missed vaccination opportunities and the low vaccina-
tion rate, and these are addressed in the Discussion.
Table 2. Demographic characteristics of sampled
patients, 90 days preintervention (comparison group)
Characteristics N = 338 (%)
Patients
Male 119 (35.2%)
Age in years (mean) 72.92
Risk factors (n = 148)
Cardiac disease 73 (21.6%)
Cancer 42 (12.4%)
Pulmonary disease 15 (4.4%)
Cerebrovascular disease 13 (3.8%)
Renal disease 4 (1%)
Chronic alcoholism 1 (0.3%)
Diabetes 0 (0%)
Asplenia 0 (0%)
Sickle cell disease 0 (0%)
512 Vol. 35 No. 8 Eckrode, Church, and English
Further examination of the data revealed differences
in vaccination opportunity between the population
aged 65 years and older and the population aged be-
tween 2 and 64 years of age. In the comparison group,
vaccination opportunity was provided to 17 (26%) of the
340 patients aged 65 years and older; in the subpopula-
tion aged between 2 and 64 years of age, vaccination op-
portunity was provided to 12 (3.6%) of 334 subjects. In
the study group, vaccination opportunity was provided
to 140 (73.3%) of the 191 patients aged 65 years and
older; in subpopulation aged between 2 and 64 years,
vaccination opportunity was provided to 29 (30.5%) of
95 subjects. Again, the results revealed missed vaccina-
tion opportunities that must be addressed.
Differences in actual vaccination rate also were
identified within the study group, when stratified by
age. The vaccination rate for the subpopulation of pa-
tients aged 65 years and older was 24.3%. In the sub-
population aged between 2 and 64 years, the actual
vaccination rate was 52.6% (Table 3). The study pro-
gram achieved an overall vaccination rate of 15.4%.
Following the descriptive analysis, the study data
were examined and subjected to inferential analysis
to determine whether the rates of opportunity and
vaccination were influenced by the standing orders–
based pneumococcal vaccination program. Using the
x
2 (goodness of fit/likelihood ratio) test, the study
found a significant statistical difference in the rate of
pneumococcal vaccination opportunities (x2 = 182.46;
P = .00) and the pneumococcal vaccination rate
(x2 = 56; P = .00).
DISCUSSION
The field experiment method that was chosen for
this study has a high external validity, and is well suited
Table 3. Results of pneumococcal vaccination program
Comparison
group
Study
group
Total number, (%) provided
vaccination opportunity
29 (8.6) 169 (59.1)
Total number, (%) given
pneumococcal vaccination
0 (0) 44 (15.4)
Subset analysis
Number, (%) provided
vaccination opportunity,
patients aged $ 65 years
17 (5.0) 140 (73.3)
Number, (%) patients given
pneumococcal vaccination,
aged $ 65 years
0 (0) 34 (24.3)
Number, (%) provided vaccination
opportunity, aged 2-64 years
with risk factors
12 (3.6) 29 (30.5)
Number, (%) patients given
pneumococcal vaccination,
aged 2-64 years with risk factors
0 (0) 10 (52.6)
for applied research that is focused on problem solving.
This design was chosen as the alternative to dividing
the postimplementation population into comparison
and study groups, with one group eligible for evalua-
tion and vaccination by the registered nurse and the
other group reliant on the previous procedure of physi-
cian evaluation and order (which may not have
provided an opportunity for vaccination, perhaps be-
cause many physicians and nurses did not actively
encourage pneumococcal polysaccharide vaccination).
There is a weakness associated with this study method,
however. The weakness that directly affects this study
is a result of the sample selection process, which did
not draw sample subjects for the comparison and study
groups from the same population. This was due to
ethical considerations; we believed that patients could
not be denied an efficacious vaccine to determine the
success of a newly designed vaccination program.
Another area of concern was the accuracy of the
existing data. The results of this study could be biased
by errors in the original documents, because docu-
mentation errors could lead to error in measurement.
To avoid counting a study subject erroneously as not
immunized or not provided with the opportunity for
immunization, multiple documents were evaluated to
determine if a lack of opportunity or nonadministra-
tion of vaccine was in appearance only, due to poor
or erroneous documentation. The evaluation of multi-
ple documents was undertaken to avoid a potential
source of bias identified in a previous study. In the pre-
vious study, approximately 18% of vaccines ordered
were not documented on the medication administra-
tion record.32 Thus, multiple documents were evalu-
ated to determine if opportunity for, and delivery of,
the vaccine did, in fact, occur.
A limitation of this study that may impact on its ex-
ternal validity is its timing. This study collected data
that addressed only the 90 days immediately before
and immediately after program implementation. The
first 90 days after program implementation may rep-
resent a period of time when interest in, and training
on, the program are high. Thus, the results of this
study may not predict program performance outside
of the initial 90-day period, when the novelty may
have worn off, training is in the past, and supervisory
attention may be directed elsewhere. The Hawthorne
Effect, whereby a new program brings about a short-
term improvement in performance, cannot be dis-
counted as an explanation for the results of this study,
as well. Supporting this premise was an observed de-
cline in assessment rates for the month immediately
following this study, although assessment rates have
improved since. Influenza vaccination was not offered
during this study period, and as such, had no influ-
ence on the results.
Eckrode, Church, and English October 2007 513
Many of the findings of this study are consistent
with previous investigations. For instance, the initial
vaccination rate for this study was 0%, as determined
by analysis of the comparison group data. This is the
same as the preprogram rate reported by Vondracek
and colleagues.26 Scarbrough and Landis38 reported a
vaccination rate of 1.2% when physicians managed
the vaccinations, and a rate of 0.65% was reported un-
der similar circumstances by Bloom and colleagues.2
These low vaccination rates are not surprising, and
they typically provide much of the impetus for pro-
gram design and implementation. An example of a pro-
gram that exhibited these kinds of results was the
previous Providence St. Vincent program, which relied
on physician management of vaccination (without
chart reminders), to little success. Others have had pos-
itive results using chart reminders; one program used
simple chart reminders to increase vaccination rates,
and increased pneumococcal vaccination rates from
0% to 53% for patients on a general medical service.26
The outcomes of the study program are comparable
to the outcomes reported for programs that were not
based on standing orders (eg, a program that relied
on family nurse practitioners for assessments, orders,
and vaccinations). That program achieved a vaccina-
tion rate of 16%, compared with the preimplementa-
tion rate of 1.2%.38 As another example, Skledar
et al,32 studying the outcomes of a hospital-based
pneumococcal vaccination program that was depen-
dent on a collaborative effort between physicians and
pharmacists, reported vaccination rates of 11% and
31% for newly admitted patients and high-risk pa-
tients, respectively. The overall rate of vaccination in
the Providence St. Vincent program was higher than
the overall rate reported by Skledar et al, but more sig-
nificant is the report of a difference in vaccination rates
between the total population and the high-risk subpop-
ulation. This difference in vaccination rates between all
patients and the subpopulation of high-risk patients
occurred in the study program as well, with 52.6% of
high-risk patients accepting and receiving pneumococ-
cal vaccination.
When compared with other standing orders–based
programs, whether nursing or pharmacy-driven, the
overall vaccination rates of the Providence St. Vincent
program often were lower than those reported in the
literature. For example, in a pharmacy-based program,
assessment rates of 90% and vaccination rates of
29.3% were achieved.47 Significantly, this program
was based on a standing order that directed pharma-
cists to do the patient assessment. In contrast, also
following standing orders, the Providence St. Vincent
registered nurses achieved an assessment rate of
59.1%, yielding 34.33% lower rates of vaccination op-
portunity than did the pharmacy-based program. A
comparison with nursing-driven programs reveals sim-
ilar outcomes. Rhew et al48 reported on a comparison
between patient and provider reminders, a nurse stand-
ing orders system, and a combination of patient and
provider reminders and a nurse standing order system.
The nurse standing order system achieved an opportu-
nity rate (assessment for vaccination) of 39% and a
vaccination rate of 22%. The St. Vincent program com-
pares favorably with its assessment rate of 59.1%, but
not the overall vaccination rate.
In an outpatient program that was reliant on stand-
ing orders for nurses, the pneumococcal vaccination
rate increased from a starting point of 34% to an end
point of 63% overall.37 The outcomes for the outpa-
tient study were for a 10-year period, however; the out-
comes for the Providence St. Vincent study were for the
first 90-day period. It could be argued that 10 years of
program operation may have resulted in the incorpora-
tion of the program into the organizational culture, and
a habit of assessing and vaccinating may have been
gained over this time period. Another result of this study
warrants discussion and comparison. The pneumococ-
cal vaccination rate for the high-risk population in the
outpatient program (52%) was lower than that for
the overall population.37 This is in direct contrast to
the results of our study; the high-risk population was
vaccinated at a higher rate (52.6%) than was the overall
population (15.4%), despite lower rates of vaccination
opportunity (30.5% versus 73.3% for the high-risk
and 65 years and older populations, respectively).
Unfortunately, vaccination opportunities were
missed frequently in the study program. Several bar-
riers were identified as obstacles to successful imple-
mentation of standing orders–based programs by
Middleton et al,49 and provide plausible reasons for
the missed opportunities in the study program. Among
the provider-related barriers that were delineated by
Middleton et al, several were identified within the study
program. Concerns for additional workload were ex-
pressed during pilot testing of the program; these con-
cerns may have been carried forward to the program
during the study period. Additionally, some nurses ex-
pressed reluctance to administer a vaccination based
on a standing order; they desired individual physician
orders for each vaccination. Process breakdowns may
have contributed to the missed vaccination opportuni-
ties, as well; simple failure to assess newly admitted
patients and documentation omissions or errors could
account for a portion of the missed opportunities. The
Providence St. Vincent program addressed patients on
multiple services (eg, medical, cardiac, oncology, pul-
monology); however, because the registered nurses
were responsible for performing the assessment under
standing orders that were not service-specific (and no
service exempted its patients from vaccination), this
514 Vol. 35 No. 8 Eckrode, Church, and English
should not have had any influence on the overall
outcome.
For the population of primary interest to most
governmental and nongovernmental agencies (ie, pa-
tients aged 65 years and older), the results of the study
program show that vaccination opportunity increased
significantly, from 5% to 73%. Although an increase
of this degree was welcome, it was not as significant
an outcome as it appears. Despite this increase in vac-
cination opportunity, a considerable share of the sam-
pled patients who were provided with that opportunity
(74%) declined vaccination. This is more than twice
the rate that was reported by Scarbrough and Landis,38
who documented a 35% refusal rate. The rate of decli-
nation was slightly more than 2 times higher in the sub-
population that was aged 65 years and older (75.7%)
than it was in the high-risk subpopulation (34.5%).
This negated any advantage that the 65 years and older
group may have gained from increased vaccination op-
portunity. Reasons for vaccination declination in this
study program were documented rarely, which pre-
cluded determination of the underlying factors without
direct patient interview. Although determination of the
factors that drive these declinations are outside the
scope of this study, this characteristic also was identi-
fied during pilot testing of the Providence St. Vincent
program, and has a deleterious effect on vaccination
rates. Internal discussion and further review of the lit-
erature suggest that lack of direct physician recom-
mendation for vaccination, and the fact that some
patients were unclear on, or could not recall, their cur-
rent vaccination status may have been reasons for dec-
lination of the vaccine; however, further study is
needed to support this hypothesis.33 Patient or patient
representative concerns about the vaccine, concerns
that vaccination may not reflect the wishes of the
patient’s physician, and resistance to vaccination
were suggested as patient barriers to vaccination by
Middleton et al.49 It does not seem unreasonable to pro-
pose that these barriers existed in the study program,
as well. Regardless of the reason, the refusal of vaccina-
tion by patients after they have been provided with
vaccination opportunity, and in some cases, the appro-
priate vaccine information statement and encourage-
ment by health care practitioners, is of concern. The
reasons for these refusals need examination if vaccina-
tion rates are to increase much beyond current levels.
Our inpatient pneumococcal vaccination program,
targeted to all patients 65 years and older and those
patients ranging from 2 to 64 years with risk factors
for pneumococcal bacteremia, resulted in an overall
increase in vaccination opportunity and vaccination
rates, when compared with our previous method. The
overall rates of vaccination that were attained by this
program often were lower than those reported in the
existing literature for other program designs; however,
this may have been due to an unusually high rate of
vaccination refusal.
The program that was evaluated in this study seems
to generate sustainable gains over time. Examination of
the data 1 year after the end of this study revealed an
overall vaccination rate of 39%, compared with the
overall vaccination rate of 15.4% during the study pe-
riod. Still, this rate was less than our institutional goal
of 80% vaccination, and the program continues to re-
ceive strong support and emphasis.
Based upon the results of this study, we believe that
a standing orders–based, nursing-driven pneumococ-
cal vaccination program can increase vaccination rates
in the inpatient setting. Barriers to program function,
and particularly vaccination receipt, must be examined
and overcome if the program is to generate acceptable
levels of vaccination opportunity and administration.
Given the significance of pneumococcal bacteremia
to morbidity and mortality, the increasing prevalence
of drug-resistant strains of S pneumoniae, and the
positive outcomes of our program, we believe that
inpatient pneumococcal vaccination programs have
usefulness and merit and can improve public health.
We strongly encourage their implementation.
References
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A. Invasive
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Am J Health System Pharm 2003;60:1471-6.
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M, Lexau
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among
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influenza and
pneumococcal vaccination through standing orders programs.
MMWR
Morb Mortal Wkly Rep 2003;52(4):68-9.
42. Department of Health and Human Services. Federal Register
61808.
Baltimore, MD. 2002.
43. McKenzie JF, Smeltzer JL. Implementation: strategies and
associated
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47. Noped JC, Schomberg R. Implementing an inpatient
pharmacy-based
pneumococcal vaccination program. Am J Health System Pharm
2001;
58:1852-5.
48. Rhew DC, Glassman PA, Goetz MB. Improving
pneumococcal vaccine
rates-nurse protocols versus clinical reminders. J Gen Intern
Med
1999;14:351-6.
49. Middleton DB, Fox DE, Nowalk MP, Skledar SJ, Sokos DR,
Zimmerman
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program for pneumococcus using standing orders. Infect Control
Hosp Epidemiol 2005;26:874-81.
http://www.cdc.gov/nip/ACIP/default.htm
http://www.cdc.gov/nip/ACIP/default.htmImplementation and
evaluation of a nursing assessment/standing
orders–based inpatient pneumococcal vaccination
programMethodsData collectionHuman/animal subjectsStudy
sampleStatistical analysisResultsDiscussionReferences

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Implementation and evaluation of anursing assessmentstandin.docx

  • 1. Implementation and evaluation of a nursing assessment/standing orders– based inpatient pneumococcal vaccination program Carl Eckrode, MPH, RRT-NPS,b Nancy Church, RN, MT,a and Woodruff J. English III, MDa Portland and Gresham, Oregon Background: Pneumococcal vaccination is recommended for patients aged 65 years and greater; inpatient vaccination has been suggested as means to increase vaccination rates is this population. Our hospital implemented an inpatient pneumococcal vacci- nation program, and expanded the population of interest to include patients aged 2 to 64 years with risk factors for pneumococcal bacteremia. We studied the outcomes of this program to determine if the rate of pneumococcal vaccination opportunities and pneumococcal vaccination rate could be significantly increased through the application of an in-hospital pneumococcal vaccina- tion program, based on standing orders and assessment by Registered Nurses, when compared to our previous method of physi- cian assessment and written vaccination order for each patient. Methods: Subjects were inpatients admitted to non-intensive care units of our hospital from August to December of 2004. Cases were aged greater than 65 years, or were greater than 2 years of age with selected risk factors. Patients with previous
  • 2. pneumococcal vaccination with the past five years, in terminal or comfort care, those allergic to vaccine components, patients who received organ or bone marrow transplants in the year prior to the study, and those physicians barred them from the vaccination protocol were excluded. Program effectiveness was evaluated through retrospective evaluation of medical records to determine if subjects had been evaluated for vaccination eligibility, and if subjects were eligible, whether or not they had received pneumococcal vaccination. Results: Overall vaccination opportunity rate after implementation of the standing orders-based program increased form 8.6% to 59.1%, and overall vaccination rates improved form 0% to 15.4%. The study found a statistically significant difference in the rate of pneumococcal vaccination opportunities (x2 = 182.46, p = .00) and the pneumococcal vaccination rate (x2 = 56, p = .00) between the two methods of assessment and vaccination; these results are attributable to the study intervention. Conclusions: The study program contributed to increased overall vaccination opportunity and vaccination rates, when compared to the previous method. The overall rates of vaccination attained by this program were often lower than those reported in the ex- isting literature for other program designs; however, this may be due to an unusually high rate of vaccination refusal. (Am J Infect Control 2007;35:508-15.) The significance of invasive pneumococcal disease cannot be understated, because disease caused by Streptococcus pneumoniae has been reported to be
  • 3. responsible for an estimated 36% of community- acquired pneumonia, an estimated 50% of nosocomial pneumonias, 50,000 cases of bacteremia, and an esti- mated 3000 to 6000 cases of meningitis each year in the United States.1 Forty thousand deaths have been re- ported each year from pneumococcal infection,2,3 with an estimated 175,000 hospitalizations due to the dis- ease each year in the United States.1 The case-fatality From the Infection Control Department,a Providence St. Vincent Hos- pital and Medical Center, Portland, Oregon; and Respiratory Care Program,b Mt. Hood Community College, Gresham, Oregon. Address correspondence to Carl Eckrode, MPH, RRT-NPS, Mt. Hood Community College, 26000 SE Stark Street, Gresham, OR 97222. 0196-6553/$32.00 Copyright ÂȘ 2007 by the Association for Professionals in Infection Control and Epidemiology, Inc. doi:10.1016/j.ajic.2006.08.005 508 can range up to 60% for elderly patients who have pneumococcal bacteremia.1 The comorbid condition of bacteremic pneumococcal disease, pneumococcal pneumonia, has a case-fatality of 5% to 7%;1-6 as one of the leading infectious causes of death in the United States,7 it has killed more persons annually than AIDS, tuberculosis, meningitis, and endocarditis combined.8 This degree of morbidity and mortality
  • 4. from a vaccine-preventable disease is unacceptable; vaccination has been proven to reduce morbidity and mortality significantly.9 The current pneumococcal vaccine for adults, the 23-Valent Pneumococcal Polysaccharide Vaccine (23PPV) (Pneumovax, Pasteur-Merieux MSD, Malvern, PA; Pnu- Imune, Wyeth-Lederle, Pearl River, NY), is well targeted against many of the S pneumoniae serotypes that are responsible for illness. For example, in a study of pneumococcal disease, 78 isolates were recovered from patients who had pneumococcal pneumonia. Seventy-one of those isolates (91%) were remarkable, in that the serotype of the isolated organism was one that was included in the 23-valent pneumococcal Eckrode, Church, and English October 2007 509 vaccine.10 The pneumococcal vaccine has been found safe, with reports of serious reactions rare,11-13 although they are more likely on revaccination.14 Reactions that do occur to the 23PPV typically are local reactions and low-grade fever, which generally are self-limiting,15 and may be more likely in patients who have coinciden- tal upper respiratory illness.12 One of the rare systemic reactions reported was reversible, and may have been associated with a simultaneous influenza vaccination.16 Although the efficacy of the 23PPV for prevention of pneumonia is still subject to discussion and study, an overwhelming amount of evidence and expert opinion support the contention that it is efficacious and cost-effective in immunocompetent patients and those whose diminished immune responses place
  • 5. them at risk for bacteremic pneumococcal dis- ease.3,4,11,17-26 The body of evidence clearly supports the vaccine’s efficacy; however, historically the pneu- mococcal polysaccharide vaccine has been underutil- ized.11,27-29 In response, the Centers for Disease Control and Prevention (CDC) Healthy People 2010 ob- jective for pneumococcal vaccination in people greater than 65 years of age was set at 90% of elderly ever vac- cinated, and objectives were set for vaccination targets of 60% coverage with pneumococcal vaccines among high-risk adults aged 16 to 64 years.30 Nonetheless, by 2002, only 62% of adults older than 65 years had received the pneumococcal vaccine.8 A recent report shows only slight progress in 2003, to a median of 64.2%, still well below the national health objectives for 2010 of 90%.31 These low rates may be due to a lack of formal programs to ensure proper screening and vaccine administration,32 various beliefs on vacci- nation held by the targeted populations,33 or a combi- nation of factors. Whatever the reasons, these low vaccination rates can have serious negative sequelae. For instance, two thirds of persons who had serious pneumococcal disease had been hospitalized within the previous 4 years before their pneumococcal illness, yet few had received pneumococcal vaccine.2,7,9,10 Many strategies for increasing pneumococcal vacci- nation rates have been examined. Among the many methods for increasing vaccination opportunity, hospi- tal-based vaccination programs are appealing, given that inpatients often are within the populations that are at high risk for invasive pneumococcal disease.26,34 Support for inpatient pneumococcal vaccination dates back to the early 1990s.11,20 Thus, the Advisory Com- mittee on Immunization Practices (ACIP)35 and the Task
  • 6. Force on Community Preventive Services have recom- mended administration of pneumococcal polysaccharide vaccines to inpatients.11,34,36 Hospital-based vaccination also may be more cost-effective than a mass vaccination effort, because of the selective targeting of the at-risk population. To take advantage of this selective targeting, a variety of approaches to inpatient pneumococcal vacci- nation has been attempted, such as the use of nurses, pharmacists, and other nonphysician providers for screening and identification of eligible patients.1,26,37,38 Programs also have relied on written physician orders or patient education to increase vaccination rates,37,38 whereas others attempted to combine pneumococcal vaccination into a clinical pathway for pneumonia treat- ment.39 The degree of success of these programs varied widely. Because of the clear value of hospital-based pneu- mococcal vaccination programs, the CDC and ACIP have promoted proactive approaches, such as the use of standing orders to simplify the vaccination process and ensure that every patient who enters the health care system is immunized.8,40,41 To aid institutions in implementing a standing orders–based program, the Centers for Medicare and Medicaid Services (CMS) promulgated a significant administrative rule change. Relieving one of the major barriers to implementa- tion of inpatient vaccination programs, CMS standards changed to allow the use of standing orders for pneu- mococcal and influenza vaccination.42 Additionally, CMS levied the requirement to provide pneumococcal vaccination to inpatients aged 65 years or greater. The CMS administrative rule change on standing orders enabled institutions to devise programs that permitted
  • 7. nonphysician providers to assess patients and adminis- ter medications, including vaccines, according to an institution-approved protocol, without a physician’s examination or individual, patient-specific orders. Our program was designed in response to an unac- ceptably low pneumococcal vaccination rate. For the year prior to program inception (ie, 2003), the inpatient pneumococcal immunization rate in our hospital was only 13%. Given the scope of our problem, it was nec- essary to plan and implement a vaccination program carefully, but quickly. This was an institutional priority, facilitated by the new CMS positions on pneumococcal vaccination and standing orders. Thus, the organization elected to use Borg and Gall’s Research and Develop- ment Cycle, as applied to creating a health promotion program;43 the use of this model allowed for a rapid pro- gram development. We elected to use the registered nurse in the role of assessor and for vaccination deliv- ery. This study assessed the success of this program for the first 90 days after program implementation. METHODS The research method chosen for our study was the field experiment; the study design chosen was the Comparison Group Posttest-Only Design.44 The com- parison group was selected from the population of inpa- tients who met the program criteria for pneumococcal 510 Vol. 35 No. 8 Eckrode, Church, and English vaccination during the 90 days prior to program imple- mentation. The study group was selected from the pop- ulation who met the program criteria for vaccination
  • 8. during the 90 days after program implementation. Ran- dom assignment within the groups was performed. The outcomes of interest—the percentage of eligible subjects provided with vaccination opportunity and vaccine delivery—can be measured accurately, despite variations in and between the sample groups. Data collection A computer-generated list of patients who were admitted to the inpatient units was provided to the Providence St. Vincent Hospital and Medical Center Infection Control Department, and medical chart docu- ments were obtained electronically. These documents are collected routinely, and these records were used to obtain the information for evaluation of the pro- gram. The use of this existing data did not require the development or implementation of a survey instru- ment or questionnaire. The records for the sampled patients were evaluated to determine if the patient was offered vaccination, and, if the patient consented, received the pneumococ- cal vaccination. The records evaluated included the medication administration record, signed pneumococ- cal vaccine orders, or signed vaccine consent forms (a local requirement) with the date, dose, and vaccine lot number entered. This data was converted to, and recorded as, categorical (nominal) data (eg, the patient was offered vaccination or the patient was not offered vaccination, and the patient received the vaccination or the patient did not receive the vaccination). The data were entered into a coding sheet, using the Microsoft Excel 2002 software package (Microsoft, Redmond, WA). After conversion and coding, the percentage of eligible randomly sampled patients who were or
  • 9. were not offered vaccination, and who did or did not receive the vaccination was calculated and compared with the number of randomly sampled patients who were or were not offered vaccination and who did or did not receive vaccination prior to program implementation. Security and confidentiality of data were maintained throughout the process, through multiple security mea- sures (eg, use of passwords on computers, ‘‘sanitizing’’ records to remove protected health information, secur- ing records in locked storage when not in use, and the use of strong encryption (PGP 7.03, Network Associates, Dallas, TX) for data stored in portable media). Patient identifiers, such as name or medical record number, were not recorded on coding forms or in newly created databases. Documents containing protected health infor- mation were destroyed by shredding subsequent to use. Human/animal subjects This was a study of a system for ensuring vaccina- tion opportunity and administration, and no human or animal experimentation was performed. The pneu- mococcal polysaccharide vaccine is approved for use in the study population, and no deviation from the pur- pose of the approved use (‘‘off-label’’ use) occurred. Thus, Institutional Review Board approval was not re- quired. All patients or their representatives were pro- vided with language-appropriate vaccine information statements as part of the vaccination protocol. This reflected local hospital policy. Study sample Study subjects included the population of Provi- dence St. Vincent Hospital and Medical Center inpa-
  • 10. tients during the months of September, October, and November, aged 65 years or greater, and inpatients be- tween 2 and 64 years of age with the presence of one or more risk factors for pneumococcal disease. For this study, high-risk patients were defined as those with medical conditions that significantly increase a patient’s vulnerability to pneumococcal pneumonia or invasive pneumococcal disease, making them eligible for pneu- mococcal vaccination if aged between 2 and 64 years. These factors included cardiovascular disease (IDC- 9-CM 331-336, 340-345, 347, 358, 359, 393-429, 440.9), cerebrovascular disease (ICD-9-CM 430-438), lower and chronic respiratory diseases (ICD-9-CM 466, 480- 487, 490-496, 500-505, 506.4, 508, 510-519), renal disease (ICD-9-CM 580-586), diabetes mellitus (ICD- 9-CM 250), chronic alcoholism and its complications (ICD-9-CM 291, 303, 571, 577), sickle cell disease (ICD- 9-CM 282.5), asplenia (functional or anatomic) (ICD-9- CM 45.1), and malignant neoplasms (ICD-9-CM 140-233). These risk factors were selected by physicians and other practitioners during design of the Providence St. Vin- cent program, reflecting ACIP-identified risk factors. Pa- tients who were excluded from the study were those in terminal or comfort care; those allergic to vaccine com- ponents; patients who received organ or bone marrow transplants in the year prior to the study; anyone who received pneumococcal vaccination in the 5 years prior to the study; patients in critical care, short-stay, emer- gency, and obstetrics units; and those whose physicians have excluded them from the vaccination protocol. Statistical analysis The intervention factor (independent variable) in this study was the implementation of a program for administration of the pneumococcal vaccine prior
  • 11. to discharge. Measurements included evaluation of medical record documentation of assessment for Eckrode, Church, and English October 2007 511 vaccination eligibility (opportunity), actual vaccina- tion, patient age, and presence of ACIP-identified risk factors in the primary diagnosis (by ICD-9-CM code). The outcome (dependent) variables of interest were as- sessment for vaccination eligibility (provision of vacci- nation opportunity) and actual vaccinations given. All statistical analyses were accomplished using the SPSS 10.1 for Windows (SPSS, Chicago, IL) software package. The x2 (goodness of fit/likelihood ratio tests) statistics were used for analysis of categorical variables, to determine the strength of association between the program implementation and rates of opportunity and vaccination, using the uncorrected x2 statistic for 2 3 2 contingency tables.45,46 Statistical significance was considered at P , .05. RESULTS Data gathered for the first 90 days after program implementation revealed that, of 5072 inpatients in the affected units, 1106 (28%) met the program criteria for pneumococcal vaccination. Data for the 90 days prior to program implementation revealed that, of 5543 inpatients in the affected units, 2874 (52%) met the program criteria for pneumococcal vaccination. Based on these data, a random sample of patients was drawn for further evaluation. Actual calculation of sample size was performed by use of the Raosoft Sample Size Calculator (Raosoft 2004, Seattle, WA).
  • 12. For the population eligible for pneumococcal vaccina- tion during the 90-day period after program interven- tion (N = 1106), the sample size was 286 (Table 1). Two hundred and eighty-six subjects were randomly selected from the postintervention population, based on a value obtained from a random number table. For the population eligible for pneumococcal vaccination during the comparison period (N = 2874), the sample Table 1. Demographic characteristics of sampled patients, first 90 days postintervention (study group) Characteristics N = 286 (%) Patients Male 99 (34.6%) Age in years (mean) 70.91 Risk factors (n = 137) Cardiac disease 64 (22.4%) Cancer 51 (19%) Pulmonary disease 12 (4.2%) Renal disease 4 (1.4%) Cerebrovascular disease 4 (1.4%) Diabetes 1 (0.3%) Chronic alcoholism 1 (0.3%)
  • 13. Asplenia 0 (0%) Sickle cell disease 0 (0%) size was 338 (Table 2). A sample of 338 subjects from the population of vaccination-eligible inpatients in the 90-day period prior to program selection was se- lected randomly, using the same calculator and in the same random fashion as the study group. Of note, ex- amination of the demographics of the samples re- vealed anomalies, such as only one sampled patient with a diagnosis of diabetes, and smaller than expected numbers of patients whose sole risk factor was age greater than 65 years. These anomalies were noted, and were not considered significant when analyzing the data for the outcomes of interest. For the 90 days prior to program implementation, 29 (8.6%) of the 338 sampled patients (comparison group) were provided vaccination opportunity. In this comparison group, none of the 338 vaccination-eligible patients received the pneumococcal vaccine. Of note, the demographics of the comparison group did not match those of the study group exactly. We did not consider these variations in demographics to be sig- nificant. Still, seasonal variations in disease patterns and aperiodic, nonseasonal changes in patient demo- graphics must be acknowledged. For the 90 days after implementation of the vaccina- tion program, where registered nurses assessed the patients for vaccination eligibility and provided vaccina- tion under standing orders, 169 (59%) of the 286 sam- pled patients were provided vaccination opportunity, and 44 (15%) of the 286 sampled patients received pneumococcal vaccination. The vaccination rate for those subjects assessed under the standing order pro-
  • 14. gram was 26% (44 of 169). Again, the demographics of the comparison group did not match those of the study group exactly, but the variations were not considered to be significant. There are several plausible reasons for missed vaccination opportunities and the low vaccina- tion rate, and these are addressed in the Discussion. Table 2. Demographic characteristics of sampled patients, 90 days preintervention (comparison group) Characteristics N = 338 (%) Patients Male 119 (35.2%) Age in years (mean) 72.92 Risk factors (n = 148) Cardiac disease 73 (21.6%) Cancer 42 (12.4%) Pulmonary disease 15 (4.4%) Cerebrovascular disease 13 (3.8%) Renal disease 4 (1%) Chronic alcoholism 1 (0.3%) Diabetes 0 (0%) Asplenia 0 (0%)
  • 15. Sickle cell disease 0 (0%) 512 Vol. 35 No. 8 Eckrode, Church, and English Further examination of the data revealed differences in vaccination opportunity between the population aged 65 years and older and the population aged be- tween 2 and 64 years of age. In the comparison group, vaccination opportunity was provided to 17 (26%) of the 340 patients aged 65 years and older; in the subpopula- tion aged between 2 and 64 years of age, vaccination op- portunity was provided to 12 (3.6%) of 334 subjects. In the study group, vaccination opportunity was provided to 140 (73.3%) of the 191 patients aged 65 years and older; in subpopulation aged between 2 and 64 years, vaccination opportunity was provided to 29 (30.5%) of 95 subjects. Again, the results revealed missed vaccina- tion opportunities that must be addressed. Differences in actual vaccination rate also were identified within the study group, when stratified by age. The vaccination rate for the subpopulation of pa- tients aged 65 years and older was 24.3%. In the sub- population aged between 2 and 64 years, the actual vaccination rate was 52.6% (Table 3). The study pro- gram achieved an overall vaccination rate of 15.4%. Following the descriptive analysis, the study data were examined and subjected to inferential analysis to determine whether the rates of opportunity and vaccination were influenced by the standing orders– based pneumococcal vaccination program. Using the x 2 (goodness of fit/likelihood ratio) test, the study
  • 16. found a significant statistical difference in the rate of pneumococcal vaccination opportunities (x2 = 182.46; P = .00) and the pneumococcal vaccination rate (x2 = 56; P = .00). DISCUSSION The field experiment method that was chosen for this study has a high external validity, and is well suited Table 3. Results of pneumococcal vaccination program Comparison group Study group Total number, (%) provided vaccination opportunity 29 (8.6) 169 (59.1) Total number, (%) given pneumococcal vaccination 0 (0) 44 (15.4) Subset analysis Number, (%) provided
  • 17. vaccination opportunity, patients aged $ 65 years 17 (5.0) 140 (73.3) Number, (%) patients given pneumococcal vaccination, aged $ 65 years 0 (0) 34 (24.3) Number, (%) provided vaccination opportunity, aged 2-64 years with risk factors 12 (3.6) 29 (30.5) Number, (%) patients given pneumococcal vaccination, aged 2-64 years with risk factors 0 (0) 10 (52.6) for applied research that is focused on problem solving. This design was chosen as the alternative to dividing the postimplementation population into comparison and study groups, with one group eligible for evalua- tion and vaccination by the registered nurse and the other group reliant on the previous procedure of physi- cian evaluation and order (which may not have
  • 18. provided an opportunity for vaccination, perhaps be- cause many physicians and nurses did not actively encourage pneumococcal polysaccharide vaccination). There is a weakness associated with this study method, however. The weakness that directly affects this study is a result of the sample selection process, which did not draw sample subjects for the comparison and study groups from the same population. This was due to ethical considerations; we believed that patients could not be denied an efficacious vaccine to determine the success of a newly designed vaccination program. Another area of concern was the accuracy of the existing data. The results of this study could be biased by errors in the original documents, because docu- mentation errors could lead to error in measurement. To avoid counting a study subject erroneously as not immunized or not provided with the opportunity for immunization, multiple documents were evaluated to determine if a lack of opportunity or nonadministra- tion of vaccine was in appearance only, due to poor or erroneous documentation. The evaluation of multi- ple documents was undertaken to avoid a potential source of bias identified in a previous study. In the pre- vious study, approximately 18% of vaccines ordered were not documented on the medication administra- tion record.32 Thus, multiple documents were evalu- ated to determine if opportunity for, and delivery of, the vaccine did, in fact, occur. A limitation of this study that may impact on its ex- ternal validity is its timing. This study collected data that addressed only the 90 days immediately before and immediately after program implementation. The first 90 days after program implementation may rep- resent a period of time when interest in, and training
  • 19. on, the program are high. Thus, the results of this study may not predict program performance outside of the initial 90-day period, when the novelty may have worn off, training is in the past, and supervisory attention may be directed elsewhere. The Hawthorne Effect, whereby a new program brings about a short- term improvement in performance, cannot be dis- counted as an explanation for the results of this study, as well. Supporting this premise was an observed de- cline in assessment rates for the month immediately following this study, although assessment rates have improved since. Influenza vaccination was not offered during this study period, and as such, had no influ- ence on the results. Eckrode, Church, and English October 2007 513 Many of the findings of this study are consistent with previous investigations. For instance, the initial vaccination rate for this study was 0%, as determined by analysis of the comparison group data. This is the same as the preprogram rate reported by Vondracek and colleagues.26 Scarbrough and Landis38 reported a vaccination rate of 1.2% when physicians managed the vaccinations, and a rate of 0.65% was reported un- der similar circumstances by Bloom and colleagues.2 These low vaccination rates are not surprising, and they typically provide much of the impetus for pro- gram design and implementation. An example of a pro- gram that exhibited these kinds of results was the previous Providence St. Vincent program, which relied on physician management of vaccination (without chart reminders), to little success. Others have had pos- itive results using chart reminders; one program used
  • 20. simple chart reminders to increase vaccination rates, and increased pneumococcal vaccination rates from 0% to 53% for patients on a general medical service.26 The outcomes of the study program are comparable to the outcomes reported for programs that were not based on standing orders (eg, a program that relied on family nurse practitioners for assessments, orders, and vaccinations). That program achieved a vaccina- tion rate of 16%, compared with the preimplementa- tion rate of 1.2%.38 As another example, Skledar et al,32 studying the outcomes of a hospital-based pneumococcal vaccination program that was depen- dent on a collaborative effort between physicians and pharmacists, reported vaccination rates of 11% and 31% for newly admitted patients and high-risk pa- tients, respectively. The overall rate of vaccination in the Providence St. Vincent program was higher than the overall rate reported by Skledar et al, but more sig- nificant is the report of a difference in vaccination rates between the total population and the high-risk subpop- ulation. This difference in vaccination rates between all patients and the subpopulation of high-risk patients occurred in the study program as well, with 52.6% of high-risk patients accepting and receiving pneumococ- cal vaccination. When compared with other standing orders–based programs, whether nursing or pharmacy-driven, the overall vaccination rates of the Providence St. Vincent program often were lower than those reported in the literature. For example, in a pharmacy-based program, assessment rates of 90% and vaccination rates of 29.3% were achieved.47 Significantly, this program was based on a standing order that directed pharma- cists to do the patient assessment. In contrast, also
  • 21. following standing orders, the Providence St. Vincent registered nurses achieved an assessment rate of 59.1%, yielding 34.33% lower rates of vaccination op- portunity than did the pharmacy-based program. A comparison with nursing-driven programs reveals sim- ilar outcomes. Rhew et al48 reported on a comparison between patient and provider reminders, a nurse stand- ing orders system, and a combination of patient and provider reminders and a nurse standing order system. The nurse standing order system achieved an opportu- nity rate (assessment for vaccination) of 39% and a vaccination rate of 22%. The St. Vincent program com- pares favorably with its assessment rate of 59.1%, but not the overall vaccination rate. In an outpatient program that was reliant on stand- ing orders for nurses, the pneumococcal vaccination rate increased from a starting point of 34% to an end point of 63% overall.37 The outcomes for the outpa- tient study were for a 10-year period, however; the out- comes for the Providence St. Vincent study were for the first 90-day period. It could be argued that 10 years of program operation may have resulted in the incorpora- tion of the program into the organizational culture, and a habit of assessing and vaccinating may have been gained over this time period. Another result of this study warrants discussion and comparison. The pneumococ- cal vaccination rate for the high-risk population in the outpatient program (52%) was lower than that for the overall population.37 This is in direct contrast to the results of our study; the high-risk population was vaccinated at a higher rate (52.6%) than was the overall population (15.4%), despite lower rates of vaccination opportunity (30.5% versus 73.3% for the high-risk and 65 years and older populations, respectively).
  • 22. Unfortunately, vaccination opportunities were missed frequently in the study program. Several bar- riers were identified as obstacles to successful imple- mentation of standing orders–based programs by Middleton et al,49 and provide plausible reasons for the missed opportunities in the study program. Among the provider-related barriers that were delineated by Middleton et al, several were identified within the study program. Concerns for additional workload were ex- pressed during pilot testing of the program; these con- cerns may have been carried forward to the program during the study period. Additionally, some nurses ex- pressed reluctance to administer a vaccination based on a standing order; they desired individual physician orders for each vaccination. Process breakdowns may have contributed to the missed vaccination opportuni- ties, as well; simple failure to assess newly admitted patients and documentation omissions or errors could account for a portion of the missed opportunities. The Providence St. Vincent program addressed patients on multiple services (eg, medical, cardiac, oncology, pul- monology); however, because the registered nurses were responsible for performing the assessment under standing orders that were not service-specific (and no service exempted its patients from vaccination), this 514 Vol. 35 No. 8 Eckrode, Church, and English should not have had any influence on the overall outcome. For the population of primary interest to most governmental and nongovernmental agencies (ie, pa- tients aged 65 years and older), the results of the study program show that vaccination opportunity increased
  • 23. significantly, from 5% to 73%. Although an increase of this degree was welcome, it was not as significant an outcome as it appears. Despite this increase in vac- cination opportunity, a considerable share of the sam- pled patients who were provided with that opportunity (74%) declined vaccination. This is more than twice the rate that was reported by Scarbrough and Landis,38 who documented a 35% refusal rate. The rate of decli- nation was slightly more than 2 times higher in the sub- population that was aged 65 years and older (75.7%) than it was in the high-risk subpopulation (34.5%). This negated any advantage that the 65 years and older group may have gained from increased vaccination op- portunity. Reasons for vaccination declination in this study program were documented rarely, which pre- cluded determination of the underlying factors without direct patient interview. Although determination of the factors that drive these declinations are outside the scope of this study, this characteristic also was identi- fied during pilot testing of the Providence St. Vincent program, and has a deleterious effect on vaccination rates. Internal discussion and further review of the lit- erature suggest that lack of direct physician recom- mendation for vaccination, and the fact that some patients were unclear on, or could not recall, their cur- rent vaccination status may have been reasons for dec- lination of the vaccine; however, further study is needed to support this hypothesis.33 Patient or patient representative concerns about the vaccine, concerns that vaccination may not reflect the wishes of the patient’s physician, and resistance to vaccination were suggested as patient barriers to vaccination by Middleton et al.49 It does not seem unreasonable to pro- pose that these barriers existed in the study program, as well. Regardless of the reason, the refusal of vaccina-
  • 24. tion by patients after they have been provided with vaccination opportunity, and in some cases, the appro- priate vaccine information statement and encourage- ment by health care practitioners, is of concern. The reasons for these refusals need examination if vaccina- tion rates are to increase much beyond current levels. Our inpatient pneumococcal vaccination program, targeted to all patients 65 years and older and those patients ranging from 2 to 64 years with risk factors for pneumococcal bacteremia, resulted in an overall increase in vaccination opportunity and vaccination rates, when compared with our previous method. The overall rates of vaccination that were attained by this program often were lower than those reported in the existing literature for other program designs; however, this may have been due to an unusually high rate of vaccination refusal. The program that was evaluated in this study seems to generate sustainable gains over time. Examination of the data 1 year after the end of this study revealed an overall vaccination rate of 39%, compared with the overall vaccination rate of 15.4% during the study pe- riod. Still, this rate was less than our institutional goal of 80% vaccination, and the program continues to re- ceive strong support and emphasis. Based upon the results of this study, we believe that a standing orders–based, nursing-driven pneumococ- cal vaccination program can increase vaccination rates in the inpatient setting. Barriers to program function, and particularly vaccination receipt, must be examined and overcome if the program is to generate acceptable levels of vaccination opportunity and administration. Given the significance of pneumococcal bacteremia
  • 25. to morbidity and mortality, the increasing prevalence of drug-resistant strains of S pneumoniae, and the positive outcomes of our program, we believe that inpatient pneumococcal vaccination programs have usefulness and merit and can improve public health. We strongly encourage their implementation. References 1. Centers for Disease Control and Prevention. Pneumococcal disease. In: Epidemiology and prevention of vaccine-preventable diseases. 9th ed. Atlanta (GA): Centers for Disease Control and Prevention; 2006. p. 256-7. 2. Bloom HG, Wheeler DA, Lynn J. A managed care organization’s attempt to increase influenza and pneumococcal immunizations for older adults in an acute care setting. J Am Geriatr Soc 1999;47(1):106-10. 3. McDaniel LS, Swialto E. Pneumococcal disease: pathogenesis, treat- ment, and prevention. Infect Dis Clin Pract 2004;12(2):93-8. 4. Jackson LA, Neuzil KM, Yu O, Benson P, Barlow WE, Adams AL, et al. Effectiveness of pneumococcal polysaccharide vaccine in older
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  • 35. concerns. In: Planning, implementing, and evaluating health promotion programs: a primer. 3rd ed. Boston: Allyn and Bacon; 2001. p. 258-9. 44. Shi L. Experimental research. In: Health services research methods. Albany (NY): Delmar Publishers; 1997. p. 143-64. 45. Motulksy H. The design of clinical trials. In: Intuitive biostatistics. New York: Oxford University Press; 1995. p. 183-91. 46. Rosner B. Hypothesis testing: categorical data. In: Study guide for fundamentals of biostatistics. 4th ed. Belmont (CA): Wadsworth Pub- lishing; 1995. p. 135-72. 47. Noped JC, Schomberg R. Implementing an inpatient pharmacy-based pneumococcal vaccination program. Am J Health System Pharm 2001; 58:1852-5. 48. Rhew DC, Glassman PA, Goetz MB. Improving pneumococcal vaccine rates-nurse protocols versus clinical reminders. J Gen Intern
  • 36. Med 1999;14:351-6. 49. Middleton DB, Fox DE, Nowalk MP, Skledar SJ, Sokos DR, Zimmerman RK, et al. Overcoming barriers to establishing an inpatient vaccination program for pneumococcus using standing orders. Infect Control Hosp Epidemiol 2005;26:874-81. http://www.cdc.gov/nip/ACIP/default.htm http://www.cdc.gov/nip/ACIP/default.htmImplementation and evaluation of a nursing assessment/standing orders–based inpatient pneumococcal vaccination programMethodsData collectionHuman/animal subjectsStudy sampleStatistical analysisResultsDiscussionReferences