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An	Internet-Based	Diabetes	Management
Platform	Improves	Team	Care	and	Outcomes	in
an	Urban	Latino	Population
ARTICLE		in		DIABETES	CARE	·	JANUARY	2015
Impact	Factor:	8.57	·	DOI:	10.2337/dc14-1412	·	Source:	PubMed
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Garry	Welch
betweenMD	LLC
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Sven-Erik	Bursell
University	of	Melbourne
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Milagros	C.	Rosal
University	of	Massachusetts	Medical	School
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Robert	A	Gabbay
Pennsylvania	State	University
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Available	from:	Garry	Welch
Retrieved	on:	08	September	2015
An Internet-Based Diabetes
Management Platform Improves
Team Care and Outcomes in an
Urban Latino Population
DOI: 10.2337/dc14-1412
OBJECTIVE
To compare usual diabetes care (UDC) to a comprehensive diabetes care inter-
vention condition (IC) involving an Internet-based “diabetes dashboard” manage-
ment tool used by clinicians.
RESEARCH DESIGN AND METHODS
We used a parallel-groups randomized design. Diabetes nurses, diabetes dieti-
tians, and providers used the diabetes dashboard as a clinical decision support
system to deliver a five-visit, 6-month intervention to n = 199 poorly controlled
(HbA1c >7.5% [58 mmol/mol]) Latino type 2 diabetic (T2D) patients (mean age
55 years, 60% female) at urban community health centers. We compared this
intervention to an established, in-house UDC program (n = 200) for its impact
on blood glucose control and psychosocial outcomes.
RESULTS
Recruitment and retention rates were 79.0 and 88.5%, respectively. Compared
with UDC, more IC patients reached HbA1c targets of <7% (53 mmol/mol; 15.8 vs.
7.0%, respectively, P < 0.01) and <8% (64 mmol/mol; 45.2 vs. 25.3%, respectively,
P < 0.001). In multiple linear regression adjusting for baseline HbA1c, adjusted
mean 6 SE HbA1c at follow-up was significantly lower in the IC compared with the
UDC group (P < 0.001; IC 8.4 6 0.10%; UDC 9.2 6 0.10%). The results showed lower
diabetes distress at follow-up for IC patients (40.4 6 2.1) as compared with UDC
patients (48.3 6 2.0) (P < 0.01), and also lower social distress (32.2 6 1.3 vs. 27.2 6
1.4, P < 0.01). There was a similar, statistically significant (P < 0.01) improvement
for both groups in the proportion of patients moving from depressed status at
baseline to nondepressed at follow-up (41.8 vs. 40%; no significance between
groups).
CONCLUSIONS
The diabetes dashboard intervention significantly improved diabetes-related out-
comes among Latinos with poorly controlled T2D compared with a similar diabe-
tes team condition without access to the diabetes dashboard.
Type 2 diabetes (T2D) is a rapidly growing epidemic in the U.S., currently affecting
29.1 million Americans (1) and projected to impact .40 million individuals by 2034
(2). National surveys show that the large majority of individuals with T2D are not
at recommended treatment goals for its underlying risk factors, namely,
1
Behavioral Medicine Research, Baystate Medi-
cal Center, Springfield, MA
2
University of Hawaii at Manoa, Honolulu, HI
3
Division of Preventive and Behavioral Medicine,
University of Massachusetts Medical School,
Worcester, MA
4
Joslin Diabetes Center, Boston, MA
Corresponding author: Garry Welch, garry.welch@
bhs.org.
Received 5 June 2014 and accepted 19 December
2014.
Clinical trial reg. no. NCT02156037, clinicaltrials
.gov.
This article contains Supplementary Data online
at http://care.diabetesjournals.org/lookup/
suppl/doi:10.2337/dc14-1412/-/DC1.
© 2015 by the American Diabetes Association.
Readers may use this article as long as the work
is properly cited, the use is educational and not
for profit, and the work is not altered.
Garry Welch,1
Sofija E. Zagarins,1
Paula Santiago-Kelly,1
Zoraida Rodriguez,1
Sven-Erik Bursell,2
Milagros C. Rosal,3
and
Robert A. Gabbay4
Diabetes Care 1
CLINCARE/EDUCATION/NUTRITION/PSYCHOSOCIAL
Diabetes Care Publish Ahead of Print, published online January 29, 2015
hyperglycemia, hypertension, and dysli-
pidemia (3). These combine to promote
serious and costly complications of the
cardiovascular system, eyes, kidneys,
and feet (3). Healthcare delivery factors,
such as lack of care coordination and
provider clinical inertia (i.e., slowness
to appropriately intensify diabetes
treatment) are significant contributing
factors to poor metabolic control seen
in T2D (4,5). Also, patient psychosocial
factors, such as diabetes distress, social
distress, and depression, that impact
patient engagement and treatment adher-
ence are not systematically managed as
part of routine medical care in T2D (6,7).
The Affordable Care Act is a landmark
piece of healthcare legislation that pro-
motes more proactive and patient-
centered management of T2D and other
chronic diseases and, to accomplish this,
promotes significant clinical care deliv-
ery and provider payment reforms.
Other significant national healthcare
legislation has mandated the national
adoption of electronic medical records
(EMRs) in clinical care to allow more ef-
ficient capture and “meaningful use” of
patient clinical data across providers
and clinical settings to facilitate greater
patient engagement in self-care (8). For
U.S. healthcare system reforms to suc-
ceed, it will be critical that providers are
equipped with well-designed clinical de-
cision support (CDS) tools that can facil-
itate patient-centered care and improve
team communication and efficiency
(9,10). CDS tools typically include clinical
alerts and reminders, order sets, and drug-
dosecalculatorsthatautomaticallyprompt
the clinician to implement a specific action
and include care summary dashboards
that provide performance feedback on im-
portant quality indicators. Although signif-
icant recent progress has been made in
the creation of CDS applications for T2D
(11–14), they remain at an early stage of
development and evaluation.
We report here on the results of a
randomized clinical trial that examined
the clinical effectiveness of a compre-
hensive diabetes care intervention in
which an Internet-based “diabetes
dashboard” disease management appli-
cation was used as a CDS system for
team care delivered at urban poor safety
net clinics. We compared the clinical ben-
efit of the diabetes dashboard interven-
tion with that of a control condition
providing usual diabetes care (UDC).
RESEARCH DESIGN AND METHODS
We used a parallel-groups randomized
design for this clinical trial. Eligible pa-
tients were randomized either to the
diabetes dashboard intervention condi-
tion (IC) or to an in-house UDC program
delivered without access to the diabetes
dashboard. The study was conducted
at two affiliated Federally Qualified
Healthcare Centers (FQHCs) located in
Western Massachusetts in an area
where .30% of families locally live be-
low the federal poverty line (15). The
clinics are located in a medically under-
served and health professional shortage
area. The 29 clinic providers serve a pre-
dominantly (;80%) Latino urban poor
community including .2,400 diabetic
patients.
For this study, eligible T2D patients
were recruited from December 2010 to
December 2012. Patients were identi-
fied from a clinic diabetes registry and
using referrals from an ophthalmology
practice affiliated with the participating
clinics. Patient inclusion criteria were as fol-
lows: age 18 years or older, self-identified
Hispanic ethnicity, diagnosis of T2D,
HbA1c .7.5% (58 mmol/mol), and pro-
vider approval given for patient par-
ticipation. Exclusion criteria included
inability to consent, pregnant or plan-
ning to become pregnant in the next
year, taking glucocorticoid therapy, or
having serious psychiatric or medical
complications (e.g., late-stage diabetes
complications, seizures, dementia, or psy-
chiatric hospitalization) that would pre-
vent participation in study activities.
Patients were paid a stipend for comple-
tion of baseline and 6-month follow-up
research assessments ($25 each). The in-
tervention was implemented at medical
officeslocated withinthe FQHCs. The pro-
tocol was approved by the Baystate Med-
ical Center Institutional Review Board.
Diabetes Dashboard IC
The IC involved a program of five, in-
person, one-on-one diabetes education
visits with a diabetes nurse or diabetes
dietitian, scheduled at baseline, 2 weeks,
1 month, 3 months, and 6 months post-
enrollment. The initial visit was an hour
long, and the remaining visits were a half
hour long each. The IC was delivered
by a team of four bicultural, bilingual
diabetes educators (two diabetes nurses
and two diabetes dietitians), with pa-
tients scheduled to see specific educators
by request or based on availability (e.g.,
patients could request to see the same
educator for repeated visits or could see
all four educators over the course of
their study participation).
The diabetes nurse and diabetes die-
titian interventionists used an Internet-
based “diabetes dashboard” disease
management tool (see Supplementary
Fig. 1) to structure each education visit
and to share information collected dur-
ing each visit with each other and with
clinic providers. This dashboard, re-
ferred to during this study as the Com-
prehensive Diabetes Management
Program, has been described previously
(16,17) and combines existing clinical
data obtained from paper chart–based
and electronic health records (i.e., vital
signs, laboratories, medications, admis-
sions, procedures, and diagnoses) with
additional patient data gathered using
integrated surveys (described below)
and during the course of ongoing care.
Two of the diabetes educators (P.S.-K.
and Z.R.) had extensive experience using
the diabetes dashboard in an earlier pi-
lot study (16).
The diabetes dashboard provides the
following: 1) a system of individual clin-
ical alerts and reminders (e.g., missing
or elevated HbA1c) and a diabetes com-
plications risk profile (five composite
risks of glycemia, retinopathy, cardiac,
peripheral vascular disease/peripheral
neuropathy, and nephropathy) that sup-
ports the delivery of evidence-based
treatment protocols (18,19) (for exam-
ple, the glycemia risk complications
alert reflects the current level of
HbA1c, annual frequency of testing of
HbA1c, and diagnoses hypoglycemia);
2) a set of nursing, medical nutrition
therapy, and physical activity treatment
plan encounter forms involving drop-
down menus and a structured data col-
lection process; 3) a library of diabetes
education teaching resources based on
American Association of Diabetes Edu-
cator guidelines (AADE7) (20); and 4) a
series of clinical reports, including a pro-
vider summary (see Supplementary
Fig. 2) generated after each intervention
visit that is emailed to the provider to
support clinical decision making and in-
cludes recommendations for changes in
medication management for hypergly-
cemia, hypertension, and dyslipidemia.
For the current study, each education
visit with the diabetes nurse or diabetes
2 Diabetes Dashboard and Team Care for Latinos Diabetes Care
dietitian interventionists began with a
review based on a summary of patient-
reported self-management behaviors
and barriers (i.e., blood glucose testing,
diet, physical activity, and medication
adherence) and psychosocial challenges
(i.e., diabetes distress, social distress,
depression, hypoglycemia, binge eating,
alcohol abuse, and low social support)
collected using an established survey in-
tegrated within the dashboard (i.e., the
Diabetes Self-Care Profile [21]). Next,
the interventionist reviewed the pa-
tient’s vital signs and laboratory data,
conducted a medication review and rec-
onciliation process and updated the
medication list, reviewed clinical alerts
and reminders generated by the system,
and updated the nursing or dietetic
treatment plan using encounter forms.
Following these steps, the interventionist
delivered diabetes education tailored to
the patient’s individual clinical, behav-
ioral, and psychosocial profile and re-
ferred the patient for psychosocial
services (e.g., adjacent mental health
clinic for depression) as needed and
with notification to the primary care pro-
vider. Interventionists recorded clinical
notes for each visit by free text using a
“whiteboard” panel on the dashboard to
facilitate internal team communication
and patient hand off between sessions.
The diabetes nurse and diabetes die-
titian interventionists created clinical
care recommendations for providers
on pharmacological management of ab-
normal blood glucose, blood pressure
(BP), and lipid levels (e.g., Supplemen-
tary Fig. 2) after several initial diabetes
education evaluation and education ses-
sions to develop rapport, assess current
medication adherence, and provide in-
dividualized diabetes education and
support. A patient safety and triage
plan refined by the primary care providers
was used for patients who presented at
intervention visits as symptomatic for
shortness ofbreath,chest pain, headache,
BP .180 mmHg, or BG .350 mg/dL with
presence of ketones. Presence of these
symptoms triggered a notification to the
provider, covering physician, or clinical
nurse for action.
To address the cultural needs of the
Latino patients that were the focus of
this study, the intervention included the
following: 1) delivery of the intervention
and diabetes education materials in the
patient’s preferred language (Spanish or
English), 2) literacy and numeracy
screening using a brief, practical assess-
ment tool we had used in prior research
(22), 3) encouragement of attendance by
family members in intervention sessions,
4) inclusion of ethnic foods and modified
ethnic recipes in the provision of medical
nutrition therapy, and 5) assessment of
alternative healers and home remedies
by patients and encouragement of pa-
tients to discuss these alternative practi-
ces for their safety and risk with their
primary care provider.
Training for the diabetes interven-
tionist team included training in the
use of the dashboard as well as a diabe-
tes medication treatment protocol pro-
vided for the management of blood
glucose, BP, and blood lipid medications
in T2D based on national guidelines (19).
Three hours of training were provided to
the diabetes team as one in-person ses-
sion and two conference calls by study
MDs with expertise in the clinical man-
agement of diabetes, hypertension, and
hyperlipidemia. FQHC providers re-
ceived three 1-hour informational and
educational sessions conducted by
G.W., R.A.G., and P.S.-K. on the diabetes
program and CDS reports they would re-
ceive during the study.
UDC
The UDC condition was delivered by four
additional bicultural, bilingual diabetes
nurses and diabetes dietitians who com-
prised the clinical site’s long-standing,
in-house diabetes program. This pro-
gram was designed as part of the Robert
Wood Johnson Foundation Diabetes Ini-
tiative to advance the delivery of cultur-
ally sensitive care for patients with T2D
in primary care (23,24). The UDC condi-
tion involved a series of individual pa-
tient visits with education content.
Visit frequency was based on individual
patient needs as determined by program
clinicians. Patients also had access to life-
style and diabetes self-management sup-
port groups run at the clinics by peer
volunteers and clinical staff. Patients in
the UDC condition completed the same
assessment battery (i.e., Diabetes Self-
Care Profile [18]) as that completed by
patients in the IC. However, data from
this assessment was used only for re-
search purposes and was not used to
guide clinical care delivered within the
UDC condition. Both IC and UDC patients
received routine medical care from their
healthcare providers for any acute and
emergent problems based on estab-
lished clinic standards and procedures.
Measurements
Clinical Measures
Patients attended a 1-hour baseline re-
search assessment and a 30-min follow-
up assessment at 6 months. The primary
study outcome was defined as the per-
centage of patients achieving good
blood glucose control (i.e., HbA1c ,7%
[53 mmol/mol]). HbA1c was obtained
using a validated finger stick blood test
kit (Appraise Home HbA1c Kit; Heritage
Laboratories International LLC). Heritage
Laboratories is certified by the National
Glycohemoglobin Standardization Pro-
gram. The Appraise Home HbA1c Kit pro-
duces accurate and reliable test results
equivalent to whole blood tests col-
lected in physicians’ offices. Other clini-
cal variables assessed the percentage of
patients at target BP (,130/80 mmHg)
and BMI. Systolic and diastolic BP mea-
surements were obtained by research
staff during baseline and follow-up re-
search visits based on a single seated
assessment using an automatic digital
BP monitor (Omron model HEM-705CP).
BMI was calculatedas weight in kilograms
divided by the square of height in meters.
Hypoglycemia was defined in the Diabe-
tes Self-Care Profile as any “low blood
sugars or sweating, nausea, heart pound-
ing, trembling, cold and clammy skin, dif-
ficulty concentrating, and irritability” over
the past month.
Psychosocial Measures
We used the Diabetes Self-Care Profile
survey (18) to assess diabetes distress,
social distress, and depression (secondary
study outcomes). Assessment of diabetes
distress involved the short (five-item)
version of the Problem Areas In Diabetes
(PAID) questionnaire that assesses the
emotional burden of diabetes and its
treatment. PAID is a valid and widely
used measure that uses a 0–100 scale,
with higher scores denoting greater
distress (25,26). We measured social dis-
tress on a 0–100 scale using the 20-item
Tool for Assessing Patients’ Stress (TAPS)
questionnaire, a measure with evidence
of internal reliability and construct valid-
ity and found acceptable to urban poor
T2D patients (6,16,27). TAPS assesses re-
cent distress related to taking care of
family needs and problems, lack of
money for basic living needs or having
care.diabetesjournals.org Welch and Associates 3
family conflicts, legal problems, overcrowd-
ing, living in an unsafe neighborhood, phys-
ical or mental abuse, discrimination, and
job loss or underemployment, among
other significant social and family issues
targeted. We measured depression us-
ing the Patient Health Questionnaire, a
validated, widely used nine-item self-
report measure of depression (28). Other
patient data collected at baseline in-
cluded age, sex, race, ethnicity, and dura-
tion of diabetes in years.
Data Analyses
We described characteristics of the study
population using means and SDs for con-
tinuous covariates and Student t test to
assess whether differences in means be-
tween thetwo treatmentconditions were
statistically significant. For categorical co-
variates, we reported the number and
percentage of patients within each cate-
gory and examined differences between
treatment groups using Fisher exact test,
which is more conservative than the x2
and is appropriate for both large and
small cell frequencies.
We conducted outcome analyses as
intention to treat, such that we analyzed
patients with the group they were ran-
domized to regardless of how many in-
tervention visits they completed. We
conducted an efficacy subset analysis
approach to address missing research
data, as loss to follow-up was small,
with ,10% of patients having missing
research data at follow-up. For compar-
isons of outcomes by treatment status,
we conducted a sensitivity analysis in
which we used multiple imputation
methods to address missing data.
We evaluated associations between
treatment group and the dichotomous
HbA1c control status variables using un-
adjusted and multiple logistic regres-
sion, with HbA1c control status as the
dependent variable. We evaluated asso-
ciations between treatment group and
the continuous outcome variables using
unadjusted and multiple linear regres-
sion. We adjusted models for baseline
values and considered covariates that
were associated with treatment status
or HbA1c at P , 0.20 on univariable anal-
ysis for inclusion in our final multiple re-
gression models. We included covariates
in the final multiple regression models if
their addition resulted in at least a 10%
change in the b coefficient for the treat-
ment status variable.
We performed analyses using SAS
software version 9.3 (SAS Institute,
Cary, NC) and Stata (version 12.0; Stata-
Corp, College Station, TX) (29). The SAS
commands we used included proc freq
for categorical comparisons and proc
GLM for modeling continuous variables.
To examine the influence of missing
data, we used multiple imputation to
replace missing values (i.e., Stata’s “mi
impute mvn” command). Assuming an
underlying multivariate normal distribu-
tion, the command imputes missing
values through an iterative MCMC ap-
proach. We created 20 imputed data-
sets to reduce sampling variability
from the imputation process.
RESULTS
Screening, Recruitment, and
Retention
Figure 1 shows the recruitment and re-
tention of patients into this clinical trial.
In brief, 75.4% of eligible patients in-
vited to participate in the study were
subsequently enrolled and randomized
to either the intervention (n = 199) or
control (n = 200) study conditions.
IC patients completed an average of
3.8 6 1.5 visits with the study interven-
tionists. Although data were not col-
lected on the number of clinic visits for
individual UDC patients, patients receiv-
ing UDC at our clinical site attended an
average of 5.2 visits with clinic providers
during a 5–6-month time frame based
on an unpublished internal clinic report
and from interviews of diabetes staff
members following the intervention
phase. Follow-up research visits were
completed by 86.4% of IC patients and
90.5% of UDC patients.
Sample Characteristics
Participant baseline characteristics are
shown in Table 1. There were no signif-
icant differences between the study
conditions in terms of demographic
(sex, age, and race), clinical (HbA1c, BP,
and BMI), and most psychosocial (depres-
sion status, social distress, and perceived
social support) variables. However, a sig-
nificant baseline difference between the
groups was observed in diabetes distress
(62.9% forICvs. 50.5% for UDC,P , 0.03),
although both groups were at clinically
high levels.
Clinical Outcomes
Rates of HbA1c control were higher among
IC patientsat follow-up, such that 15.8% of
IC patients were at the treatment goal of
HbA1c ,7% (53 mmol/mol), as compared
with 7.0% of UDCpatients (P,0.01). In an
analysis of patients with an HbA1c .8.0%
(64 mmol/mol) at baseline, 45.2% of IC
patients vs. 25.3% of UDC patients met
the goal of HbA1c ,8.0% at follow-up
(P , 0.001). In multiple linear regression
adjusting for baseline HbA1c, adjusted
mean 6 SE HbA1c at follow-up was signif-
icantly lower by 0.81 6 0.15% units in the
IC group as compared with the UDC group
(P , 0.001; IC 8.4 6 0.10%; UDC 9.2 6
0.10%) (Table 2). Results for mean HbA1c
at follow-up were similar in our sensitivity
analysis based on imputed data, such that
HbA1c at follow-up was 0.82 6 0.15%
units lower in IC versus UDC participants
(P , 0.001).
We also examined descriptive clinical
data on BP and BMI at follow-up using
multiple linear regression adjusted for
baseline values and found no significant
difference between the groups in terms
of these variables (Table 2). Results
were similar when multiple imputation
methods were used to fill in missing data
(data not shown).
Self-reported hypoglycemia symp-
toms improved in both groups. In the
IC group, 34.7% of patients reported
having hypoglycemia symptoms in
the prior month to baseline. Of those
patients, only 49.3% reported hypogly-
cemia symptoms at follow-up. In the
UDC group, 38% of patients reported
Figure 1—Flowchart showing participant
enrollment and retention rates. Pt, patient;
R2, research visit number two at six months
follow-up.
4 Diabetes Dashboard and Team Care for Latinos Diabetes Care
hypoglycemia symptoms at baseline,
and only 44.7% of those patients re-
ported symptoms at follow-up. There
were no statistical differences between
the IC and UDC conditions. There were
also no differences between the two
conditions in new reports of hypogly-
cemia at follow-up (22 vs. 20.6%, no
significance).
Psychosocial Outcomes
The results showed lower diabetes dis-
tress at follow-up for IC patients (40.4 6
2.1) as compared with UDC patients
(48.3 6 2.0) (P , 0.01) and also lower
social distress (32.2 6 1.3 vs. 27.2 6 1.4,
P , 0.01) (Table 2). There was a similar,
statistically significant (P , 0.01) im-
provement for both groups in the pro-
portion of patients moving from
depressed status at baseline to nonde-
pressed at follow-up (i.e., 41.8 vs. 40%),
with no significant difference between
groups in terms of change in depression
status.
CONCLUSIONS
This clinical trial conducted at two affil-
iated urban safety net clinics focused on
Latino T2D patients in poor glycemic
control and demonstrated the clinical
effectiveness of a diabetes care program
enriched by use of a diabetes dashboard
application to support team care. The
dashboard provided the diabetes team
with timely clinical alerts and reminders
of diabetes-specific medical and psycho-
social issues, encounter and treatment
plan templates, and diabetes education
resources and generated summary re-
ports of intervention sessions to share
with providers. Despite the artificiality
inherent in delivering a time-limited
(6-month) clinical research intervention
within a busy primary care setting, the
diabetes dashboard helped organize the
work of the diabetes educator team
(i.e., diabetes nurses and diabetes dieti-
tians) and supported the provision of
patient-centered and evidence-based
diabetes care. The diabetes dashboard
also created a bridge to the clinic pro-
viders via the individual session sum-
mary reports and medication change
recommendations sent to the providers
following intervention sessions. The
UDC control condition consisted of a
long-standing comprehensive diabetes
care program designed as part of a
Robert Wood Johnson Foundation Dia-
betes Initiative to advance the delivery
of culturally sensitive care for patients
with T2D (23,24).
The study findings showed that twice
as many IC patients achieved a goal of
HbA1c ,7% (53 mmol/mol) compared
with the UDC condition (i.e., 15.8 vs.
7.0%, respectively). For an HbA1c cutoff
of ,8% (64 mmol/mol), the results were
45.2 vs. 25.3%, respectively. The in-
tervention provided a statistically
and clinically significant mean HbA1c
improvement (reduction) of 20.6%
(26.6 mmol/mol) compared with a
worsening for the UDC condition of
+0.2% (+2.2 mmol/mol). As a benchmark
to interpret this difference in intermedi-
ate diabetes outcomes, landmark na-
tional studies have shown that for every
1% (10.9 mmol/mol) reduction in HbA1c,
the risk of developing eye, kidney, and
nerve disease is reduced by 40% while
the risk of heart attack is reduced by
14% (30).
Analysis of our secondary psychoso-
cial outcomes showed a significant re-
duction in both diabetes distress and
social distress for the IC compared
with the UDC condition. Both conditions
showed high baseline levels of distress,
consistent with findings from prior stud-
ies of urban poor T2D populations
Table 1—Comparison of intervention groups at baseline
Usual diabetes
care, n = 200
Intervention
condition, n = 199
P
value1
Continuous variables Mean 6 SD Mean 6 SD
Age (years) 55.2 6 11.9 54.8 6 10.3 0.72
BMI (kg/m2
) 33.9 6 7.5 35.4 6 7.7 0.06
HbA1c (% units) 9.0 6 1.5 8.9 6 1.4 0.74
HbA1c (mmol/mol) 75.0 6 16.4 74.0 6 5.3 0.74
Systolic BP (mmHg) 136.2 6 19.4 135.3 6 21.3 0.68
Diastolic BP (mmHg) 77.0 6 10.4 78.3 6 11.3 0.22
Diabetes distress2
51.9 6 32.3 59.0 6 30.5 0.03
Social distress3
34.5 6 1.6 35.8 6 1.6 0.55
Categorical variables (%) % %
Female 59.0 60.8 0.71
White race4
98.5 98.0 0.69
Hispanic ethnicity 100.0 100.0 d
High diabetes distress2
50.5 62.9 0.01
Major depression5
41.2 32.7 0.09
1
Based on Student t test for continuous variables and Fisher exact test for categorical variables.
2
Measured using the PAID questionnaire, scored from 0 to 100, with higher scores indicative of
greater diabetes distress; a score of .50 is indicative of high diabetes distress. 3
Measured using
TAPS, scored from 0 to 100, with higher scores indicative of greater social distress. 4
Remaining
patients self-identified as black/African American. 5
Measured using the Patient Health
Questionnaire nine-item depression measure; patients endorsing five or more items are
categorized as having major depression
Table 2—Clinical and psychosocial outcomes by IC
Usual diabetes
care, n = 200
(mean 6 SE)
Intervention
condition, n = 199
(mean 6 SE)
P
value1
Clinical outcomes
BMI (kg/m2
) 35.0 6 0.1 34.9 6 0.1 0.50
HbA1c (% units) 9.2 6 0.10 8.4 6 0.10 ,0.001
HbA1c (mmol/mol) 77.0 6 1.1 68.0 6 1.1 ,0.001
Systolic BP (mmHg) 137.0 6 1.3 137.2 6 1.3 0.93
Diastolic BP (mmHg) 76.9 6 0.7 77.5 6 0.7 0.54
Psychosocial outcomes
Diabetes distress2
48.3 6 2.0 40.4 6 2.1 ,0.01
Social distress3
32.2 6 1.3 27.2 6 1.4 ,0.01
1
Adjusted P values based on linear regression; models are adjusted for baseline values, with no
additional variables retained in these final models. 2
Measured using the PAID questionnaire,
scored from 0 to 100, with higher scores indicative of greater diabetes distress; a score of .50 is
indicative of high diabetes distress. 3
Measured using TAPS, scored from 0 to 100, with higher
scores indicative of greater social distress.
care.diabetesjournals.org Welch and Associates 5
(16,31,32). Improvement in depression
status was seen among patients in both
study conditions (;40% of those screen-
ing positive for major depression at base-
line were subsequently in remission at
follow-up) but with no statistically signif-
icant difference found between the con-
ditions at follow-up.
These results for psychosocial out-
comes provide empirical support for
the value of systematically assessing
and actively managing T2D patients
who report diabetes-related psychoso-
cial challenges, as has been recommen-
ded in prior reviews (7,33). It is notable
that the Institute of Medicine has re-
cently recommended that patient-
reported assessments capturing a
patient’s experience of illness should
be routinely incorporated into the
EMRs, including emotional distress and
depression (34). The diabetes dash-
board thus provides a strategy for pri-
mary care clinics to meet these new
recommendations, with modifications
and updates over time, as appropriate.
We explored the effect of interven-
tion treatment dose on outcomes in
poststudy sensitivity analyses and found
that greater exposure produced greater
clinical benefit for HbA1c, diabetes dis-
tress, and social distress. Future studies
could therefore consider the implemen-
tation of practical strategies to enhance
patient engagement over the full course
of the intervention. For example, recent
evidence supports the value of integrat-
ing community health workers into the
diabetes team to improve patient
engagement (35,36). Also, the replace-
ment ofsome face-to-face visits delivered
in the clinic with low-cost telehealth
strategies, including brief telephone calls
combined with remote home monitoring
of diabetes vital signs and medication
adherence, may improve patient engage-
ment and access to care among urban
poor T2D patient groups, and may also
overcome common barriers to regular
clinic attendance, including lack of reliable
transportation, adverse weather, and
competing family and work demands.
There were several strengths of the
study, including a high patient retention
rate (88.0%) in the research follow-up
visits that involved use of a bicultural,
bilingual research team as well as strong
patient participation in the intervention
program (i.e., 78.8% of patients at-
tended three visits and 48.2% attended
all five) that similarly involved use of a
bilingual, bicultural clinical team.
There were several weaknesses of the
study, including our inability to track the
frequency and content of UDC clinic vis-
its that could have provided a more ac-
curate description of the study control
group and allowed adjustments for any
potential differences between study
conditions in terms of exposure to treat-
ment (e.g., number of individual patient
education sessions during the study
time period). Future research could also
extend our outcome tracking to include a
formal assessment of BP and blood lipid
levels over time and also explore differ-
ences in diabetes medication manage-
ment by providers taking part in the
intervention and control conditions
using a validated research protocol to
capture the necessary granularity and ac-
curacy of the structured information that
would be needed for this future goal.
It is notable that our diabetes dash-
board was used as a stand-alone clinical
application by the diabetes team, with
the application hosted on a secure
server separate from the clinic’s EMR.
As is the case for any new CDS tool,
wider adoption of our diabetes dash-
board will require the provision of clinic
leadership support, adequate provider
and support staff training and their in-
put to allow successful adaptation to lo-
cal clinical care processes, as well as
availability of sufficient IT and change
management support similar to that
seen for the current national EMR roll-
out and meaningful use of patient data
as part of the HITECH Act (8).
Inconclusion,thediabetesdashboardin-
tervention significantly reduced diabetes-
relatedmedicalandpsychosocialdisparities
among Latinos with poorly controlled T2D
compared with a similar diabetes team
condition without access to the diabetes
dashboard. The use of a disease-specific
clinical dashboard that addresses medical
and psychosocial aspects of T2D treat-
ment has broad applicability to other
common chronic diseases that also
require a focus on patient-centered, com-
prehensive, and efficient team care.
Acknowledgments. The authors thank
Gbenga Ogedegbe of NYU Langone Medical
Center and Ana Ronderos and Kathy Berdecia
of Holyoke Health Center for their clinical
expertise and support during the completion
of the study.
Funding. This project was supported by the
National Institute of Diabetes and Digestive and
Kidney Diseases, National Institutes of Health,
through grant 5R01-DK-084325-04.
Duality of Interest. G.W. is the Chief Scientific
Officer of Silver Fern Healthcare. No other
potential conflicts of interest relevant to this
article were reported.
Author Contributions. G.W. designed the
study, oversaw the study conduct as principle
investigator, and wrote the manuscript. S.E.Z.
oversaw data collection and management, con-
ducted the data analysis, and edited the man-
uscript. P.S.-K. and Z.R. developed and
implemented the intervention and assisted in
manuscript development. S.-E.B. assisted in
intervention planning and edited the manu-
script. M.C.R. assisted in assessing intervention
fidelity and edited the manuscript. R.A.G. acted
as medical supervisor, conducted the training of
providers and diabetes educators, and edited the
manuscript. G.W. is the guarantor of this work
and, as such, had full access to all the data in the
study and takes responsibility for the integrity of
the data and the accuracy of the data analysis.
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Welch Diabetes team care 2015

  • 1. See discussions, stats, and author profiles for this publication at: http://www.researchgate.net/publication/271594060 An Internet-Based Diabetes Management Platform Improves Team Care and Outcomes in an Urban Latino Population ARTICLE in DIABETES CARE · JANUARY 2015 Impact Factor: 8.57 · DOI: 10.2337/dc14-1412 · Source: PubMed CITATION 1 DOWNLOADS 35 VIEWS 111 7 AUTHORS, INCLUDING: Garry Welch betweenMD LLC 65 PUBLICATIONS 2,052 CITATIONS SEE PROFILE Sven-Erik Bursell University of Melbourne 32 PUBLICATIONS 1,697 CITATIONS SEE PROFILE Milagros C. Rosal University of Massachusetts Medical School 112 PUBLICATIONS 2,241 CITATIONS SEE PROFILE Robert A Gabbay Pennsylvania State University 42 PUBLICATIONS 989 CITATIONS SEE PROFILE Available from: Garry Welch Retrieved on: 08 September 2015
  • 2. An Internet-Based Diabetes Management Platform Improves Team Care and Outcomes in an Urban Latino Population DOI: 10.2337/dc14-1412 OBJECTIVE To compare usual diabetes care (UDC) to a comprehensive diabetes care inter- vention condition (IC) involving an Internet-based “diabetes dashboard” manage- ment tool used by clinicians. RESEARCH DESIGN AND METHODS We used a parallel-groups randomized design. Diabetes nurses, diabetes dieti- tians, and providers used the diabetes dashboard as a clinical decision support system to deliver a five-visit, 6-month intervention to n = 199 poorly controlled (HbA1c >7.5% [58 mmol/mol]) Latino type 2 diabetic (T2D) patients (mean age 55 years, 60% female) at urban community health centers. We compared this intervention to an established, in-house UDC program (n = 200) for its impact on blood glucose control and psychosocial outcomes. RESULTS Recruitment and retention rates were 79.0 and 88.5%, respectively. Compared with UDC, more IC patients reached HbA1c targets of <7% (53 mmol/mol; 15.8 vs. 7.0%, respectively, P < 0.01) and <8% (64 mmol/mol; 45.2 vs. 25.3%, respectively, P < 0.001). In multiple linear regression adjusting for baseline HbA1c, adjusted mean 6 SE HbA1c at follow-up was significantly lower in the IC compared with the UDC group (P < 0.001; IC 8.4 6 0.10%; UDC 9.2 6 0.10%). The results showed lower diabetes distress at follow-up for IC patients (40.4 6 2.1) as compared with UDC patients (48.3 6 2.0) (P < 0.01), and also lower social distress (32.2 6 1.3 vs. 27.2 6 1.4, P < 0.01). There was a similar, statistically significant (P < 0.01) improvement for both groups in the proportion of patients moving from depressed status at baseline to nondepressed at follow-up (41.8 vs. 40%; no significance between groups). CONCLUSIONS The diabetes dashboard intervention significantly improved diabetes-related out- comes among Latinos with poorly controlled T2D compared with a similar diabe- tes team condition without access to the diabetes dashboard. Type 2 diabetes (T2D) is a rapidly growing epidemic in the U.S., currently affecting 29.1 million Americans (1) and projected to impact .40 million individuals by 2034 (2). National surveys show that the large majority of individuals with T2D are not at recommended treatment goals for its underlying risk factors, namely, 1 Behavioral Medicine Research, Baystate Medi- cal Center, Springfield, MA 2 University of Hawaii at Manoa, Honolulu, HI 3 Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA 4 Joslin Diabetes Center, Boston, MA Corresponding author: Garry Welch, garry.welch@ bhs.org. Received 5 June 2014 and accepted 19 December 2014. Clinical trial reg. no. NCT02156037, clinicaltrials .gov. This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/ suppl/doi:10.2337/dc14-1412/-/DC1. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. Garry Welch,1 Sofija E. Zagarins,1 Paula Santiago-Kelly,1 Zoraida Rodriguez,1 Sven-Erik Bursell,2 Milagros C. Rosal,3 and Robert A. Gabbay4 Diabetes Care 1 CLINCARE/EDUCATION/NUTRITION/PSYCHOSOCIAL Diabetes Care Publish Ahead of Print, published online January 29, 2015
  • 3. hyperglycemia, hypertension, and dysli- pidemia (3). These combine to promote serious and costly complications of the cardiovascular system, eyes, kidneys, and feet (3). Healthcare delivery factors, such as lack of care coordination and provider clinical inertia (i.e., slowness to appropriately intensify diabetes treatment) are significant contributing factors to poor metabolic control seen in T2D (4,5). Also, patient psychosocial factors, such as diabetes distress, social distress, and depression, that impact patient engagement and treatment adher- ence are not systematically managed as part of routine medical care in T2D (6,7). The Affordable Care Act is a landmark piece of healthcare legislation that pro- motes more proactive and patient- centered management of T2D and other chronic diseases and, to accomplish this, promotes significant clinical care deliv- ery and provider payment reforms. Other significant national healthcare legislation has mandated the national adoption of electronic medical records (EMRs) in clinical care to allow more ef- ficient capture and “meaningful use” of patient clinical data across providers and clinical settings to facilitate greater patient engagement in self-care (8). For U.S. healthcare system reforms to suc- ceed, it will be critical that providers are equipped with well-designed clinical de- cision support (CDS) tools that can facil- itate patient-centered care and improve team communication and efficiency (9,10). CDS tools typically include clinical alerts and reminders, order sets, and drug- dosecalculatorsthatautomaticallyprompt the clinician to implement a specific action and include care summary dashboards that provide performance feedback on im- portant quality indicators. Although signif- icant recent progress has been made in the creation of CDS applications for T2D (11–14), they remain at an early stage of development and evaluation. We report here on the results of a randomized clinical trial that examined the clinical effectiveness of a compre- hensive diabetes care intervention in which an Internet-based “diabetes dashboard” disease management appli- cation was used as a CDS system for team care delivered at urban poor safety net clinics. We compared the clinical ben- efit of the diabetes dashboard interven- tion with that of a control condition providing usual diabetes care (UDC). RESEARCH DESIGN AND METHODS We used a parallel-groups randomized design for this clinical trial. Eligible pa- tients were randomized either to the diabetes dashboard intervention condi- tion (IC) or to an in-house UDC program delivered without access to the diabetes dashboard. The study was conducted at two affiliated Federally Qualified Healthcare Centers (FQHCs) located in Western Massachusetts in an area where .30% of families locally live be- low the federal poverty line (15). The clinics are located in a medically under- served and health professional shortage area. The 29 clinic providers serve a pre- dominantly (;80%) Latino urban poor community including .2,400 diabetic patients. For this study, eligible T2D patients were recruited from December 2010 to December 2012. Patients were identi- fied from a clinic diabetes registry and using referrals from an ophthalmology practice affiliated with the participating clinics. Patient inclusion criteria were as fol- lows: age 18 years or older, self-identified Hispanic ethnicity, diagnosis of T2D, HbA1c .7.5% (58 mmol/mol), and pro- vider approval given for patient par- ticipation. Exclusion criteria included inability to consent, pregnant or plan- ning to become pregnant in the next year, taking glucocorticoid therapy, or having serious psychiatric or medical complications (e.g., late-stage diabetes complications, seizures, dementia, or psy- chiatric hospitalization) that would pre- vent participation in study activities. Patients were paid a stipend for comple- tion of baseline and 6-month follow-up research assessments ($25 each). The in- tervention was implemented at medical officeslocated withinthe FQHCs. The pro- tocol was approved by the Baystate Med- ical Center Institutional Review Board. Diabetes Dashboard IC The IC involved a program of five, in- person, one-on-one diabetes education visits with a diabetes nurse or diabetes dietitian, scheduled at baseline, 2 weeks, 1 month, 3 months, and 6 months post- enrollment. The initial visit was an hour long, and the remaining visits were a half hour long each. The IC was delivered by a team of four bicultural, bilingual diabetes educators (two diabetes nurses and two diabetes dietitians), with pa- tients scheduled to see specific educators by request or based on availability (e.g., patients could request to see the same educator for repeated visits or could see all four educators over the course of their study participation). The diabetes nurse and diabetes die- titian interventionists used an Internet- based “diabetes dashboard” disease management tool (see Supplementary Fig. 1) to structure each education visit and to share information collected dur- ing each visit with each other and with clinic providers. This dashboard, re- ferred to during this study as the Com- prehensive Diabetes Management Program, has been described previously (16,17) and combines existing clinical data obtained from paper chart–based and electronic health records (i.e., vital signs, laboratories, medications, admis- sions, procedures, and diagnoses) with additional patient data gathered using integrated surveys (described below) and during the course of ongoing care. Two of the diabetes educators (P.S.-K. and Z.R.) had extensive experience using the diabetes dashboard in an earlier pi- lot study (16). The diabetes dashboard provides the following: 1) a system of individual clin- ical alerts and reminders (e.g., missing or elevated HbA1c) and a diabetes com- plications risk profile (five composite risks of glycemia, retinopathy, cardiac, peripheral vascular disease/peripheral neuropathy, and nephropathy) that sup- ports the delivery of evidence-based treatment protocols (18,19) (for exam- ple, the glycemia risk complications alert reflects the current level of HbA1c, annual frequency of testing of HbA1c, and diagnoses hypoglycemia); 2) a set of nursing, medical nutrition therapy, and physical activity treatment plan encounter forms involving drop- down menus and a structured data col- lection process; 3) a library of diabetes education teaching resources based on American Association of Diabetes Edu- cator guidelines (AADE7) (20); and 4) a series of clinical reports, including a pro- vider summary (see Supplementary Fig. 2) generated after each intervention visit that is emailed to the provider to support clinical decision making and in- cludes recommendations for changes in medication management for hypergly- cemia, hypertension, and dyslipidemia. For the current study, each education visit with the diabetes nurse or diabetes 2 Diabetes Dashboard and Team Care for Latinos Diabetes Care
  • 4. dietitian interventionists began with a review based on a summary of patient- reported self-management behaviors and barriers (i.e., blood glucose testing, diet, physical activity, and medication adherence) and psychosocial challenges (i.e., diabetes distress, social distress, depression, hypoglycemia, binge eating, alcohol abuse, and low social support) collected using an established survey in- tegrated within the dashboard (i.e., the Diabetes Self-Care Profile [21]). Next, the interventionist reviewed the pa- tient’s vital signs and laboratory data, conducted a medication review and rec- onciliation process and updated the medication list, reviewed clinical alerts and reminders generated by the system, and updated the nursing or dietetic treatment plan using encounter forms. Following these steps, the interventionist delivered diabetes education tailored to the patient’s individual clinical, behav- ioral, and psychosocial profile and re- ferred the patient for psychosocial services (e.g., adjacent mental health clinic for depression) as needed and with notification to the primary care pro- vider. Interventionists recorded clinical notes for each visit by free text using a “whiteboard” panel on the dashboard to facilitate internal team communication and patient hand off between sessions. The diabetes nurse and diabetes die- titian interventionists created clinical care recommendations for providers on pharmacological management of ab- normal blood glucose, blood pressure (BP), and lipid levels (e.g., Supplemen- tary Fig. 2) after several initial diabetes education evaluation and education ses- sions to develop rapport, assess current medication adherence, and provide in- dividualized diabetes education and support. A patient safety and triage plan refined by the primary care providers was used for patients who presented at intervention visits as symptomatic for shortness ofbreath,chest pain, headache, BP .180 mmHg, or BG .350 mg/dL with presence of ketones. Presence of these symptoms triggered a notification to the provider, covering physician, or clinical nurse for action. To address the cultural needs of the Latino patients that were the focus of this study, the intervention included the following: 1) delivery of the intervention and diabetes education materials in the patient’s preferred language (Spanish or English), 2) literacy and numeracy screening using a brief, practical assess- ment tool we had used in prior research (22), 3) encouragement of attendance by family members in intervention sessions, 4) inclusion of ethnic foods and modified ethnic recipes in the provision of medical nutrition therapy, and 5) assessment of alternative healers and home remedies by patients and encouragement of pa- tients to discuss these alternative practi- ces for their safety and risk with their primary care provider. Training for the diabetes interven- tionist team included training in the use of the dashboard as well as a diabe- tes medication treatment protocol pro- vided for the management of blood glucose, BP, and blood lipid medications in T2D based on national guidelines (19). Three hours of training were provided to the diabetes team as one in-person ses- sion and two conference calls by study MDs with expertise in the clinical man- agement of diabetes, hypertension, and hyperlipidemia. FQHC providers re- ceived three 1-hour informational and educational sessions conducted by G.W., R.A.G., and P.S.-K. on the diabetes program and CDS reports they would re- ceive during the study. UDC The UDC condition was delivered by four additional bicultural, bilingual diabetes nurses and diabetes dietitians who com- prised the clinical site’s long-standing, in-house diabetes program. This pro- gram was designed as part of the Robert Wood Johnson Foundation Diabetes Ini- tiative to advance the delivery of cultur- ally sensitive care for patients with T2D in primary care (23,24). The UDC condi- tion involved a series of individual pa- tient visits with education content. Visit frequency was based on individual patient needs as determined by program clinicians. Patients also had access to life- style and diabetes self-management sup- port groups run at the clinics by peer volunteers and clinical staff. Patients in the UDC condition completed the same assessment battery (i.e., Diabetes Self- Care Profile [18]) as that completed by patients in the IC. However, data from this assessment was used only for re- search purposes and was not used to guide clinical care delivered within the UDC condition. Both IC and UDC patients received routine medical care from their healthcare providers for any acute and emergent problems based on estab- lished clinic standards and procedures. Measurements Clinical Measures Patients attended a 1-hour baseline re- search assessment and a 30-min follow- up assessment at 6 months. The primary study outcome was defined as the per- centage of patients achieving good blood glucose control (i.e., HbA1c ,7% [53 mmol/mol]). HbA1c was obtained using a validated finger stick blood test kit (Appraise Home HbA1c Kit; Heritage Laboratories International LLC). Heritage Laboratories is certified by the National Glycohemoglobin Standardization Pro- gram. The Appraise Home HbA1c Kit pro- duces accurate and reliable test results equivalent to whole blood tests col- lected in physicians’ offices. Other clini- cal variables assessed the percentage of patients at target BP (,130/80 mmHg) and BMI. Systolic and diastolic BP mea- surements were obtained by research staff during baseline and follow-up re- search visits based on a single seated assessment using an automatic digital BP monitor (Omron model HEM-705CP). BMI was calculatedas weight in kilograms divided by the square of height in meters. Hypoglycemia was defined in the Diabe- tes Self-Care Profile as any “low blood sugars or sweating, nausea, heart pound- ing, trembling, cold and clammy skin, dif- ficulty concentrating, and irritability” over the past month. Psychosocial Measures We used the Diabetes Self-Care Profile survey (18) to assess diabetes distress, social distress, and depression (secondary study outcomes). Assessment of diabetes distress involved the short (five-item) version of the Problem Areas In Diabetes (PAID) questionnaire that assesses the emotional burden of diabetes and its treatment. PAID is a valid and widely used measure that uses a 0–100 scale, with higher scores denoting greater distress (25,26). We measured social dis- tress on a 0–100 scale using the 20-item Tool for Assessing Patients’ Stress (TAPS) questionnaire, a measure with evidence of internal reliability and construct valid- ity and found acceptable to urban poor T2D patients (6,16,27). TAPS assesses re- cent distress related to taking care of family needs and problems, lack of money for basic living needs or having care.diabetesjournals.org Welch and Associates 3
  • 5. family conflicts, legal problems, overcrowd- ing, living in an unsafe neighborhood, phys- ical or mental abuse, discrimination, and job loss or underemployment, among other significant social and family issues targeted. We measured depression us- ing the Patient Health Questionnaire, a validated, widely used nine-item self- report measure of depression (28). Other patient data collected at baseline in- cluded age, sex, race, ethnicity, and dura- tion of diabetes in years. Data Analyses We described characteristics of the study population using means and SDs for con- tinuous covariates and Student t test to assess whether differences in means be- tween thetwo treatmentconditions were statistically significant. For categorical co- variates, we reported the number and percentage of patients within each cate- gory and examined differences between treatment groups using Fisher exact test, which is more conservative than the x2 and is appropriate for both large and small cell frequencies. We conducted outcome analyses as intention to treat, such that we analyzed patients with the group they were ran- domized to regardless of how many in- tervention visits they completed. We conducted an efficacy subset analysis approach to address missing research data, as loss to follow-up was small, with ,10% of patients having missing research data at follow-up. For compar- isons of outcomes by treatment status, we conducted a sensitivity analysis in which we used multiple imputation methods to address missing data. We evaluated associations between treatment group and the dichotomous HbA1c control status variables using un- adjusted and multiple logistic regres- sion, with HbA1c control status as the dependent variable. We evaluated asso- ciations between treatment group and the continuous outcome variables using unadjusted and multiple linear regres- sion. We adjusted models for baseline values and considered covariates that were associated with treatment status or HbA1c at P , 0.20 on univariable anal- ysis for inclusion in our final multiple re- gression models. We included covariates in the final multiple regression models if their addition resulted in at least a 10% change in the b coefficient for the treat- ment status variable. We performed analyses using SAS software version 9.3 (SAS Institute, Cary, NC) and Stata (version 12.0; Stata- Corp, College Station, TX) (29). The SAS commands we used included proc freq for categorical comparisons and proc GLM for modeling continuous variables. To examine the influence of missing data, we used multiple imputation to replace missing values (i.e., Stata’s “mi impute mvn” command). Assuming an underlying multivariate normal distribu- tion, the command imputes missing values through an iterative MCMC ap- proach. We created 20 imputed data- sets to reduce sampling variability from the imputation process. RESULTS Screening, Recruitment, and Retention Figure 1 shows the recruitment and re- tention of patients into this clinical trial. In brief, 75.4% of eligible patients in- vited to participate in the study were subsequently enrolled and randomized to either the intervention (n = 199) or control (n = 200) study conditions. IC patients completed an average of 3.8 6 1.5 visits with the study interven- tionists. Although data were not col- lected on the number of clinic visits for individual UDC patients, patients receiv- ing UDC at our clinical site attended an average of 5.2 visits with clinic providers during a 5–6-month time frame based on an unpublished internal clinic report and from interviews of diabetes staff members following the intervention phase. Follow-up research visits were completed by 86.4% of IC patients and 90.5% of UDC patients. Sample Characteristics Participant baseline characteristics are shown in Table 1. There were no signif- icant differences between the study conditions in terms of demographic (sex, age, and race), clinical (HbA1c, BP, and BMI), and most psychosocial (depres- sion status, social distress, and perceived social support) variables. However, a sig- nificant baseline difference between the groups was observed in diabetes distress (62.9% forICvs. 50.5% for UDC,P , 0.03), although both groups were at clinically high levels. Clinical Outcomes Rates of HbA1c control were higher among IC patientsat follow-up, such that 15.8% of IC patients were at the treatment goal of HbA1c ,7% (53 mmol/mol), as compared with 7.0% of UDCpatients (P,0.01). In an analysis of patients with an HbA1c .8.0% (64 mmol/mol) at baseline, 45.2% of IC patients vs. 25.3% of UDC patients met the goal of HbA1c ,8.0% at follow-up (P , 0.001). In multiple linear regression adjusting for baseline HbA1c, adjusted mean 6 SE HbA1c at follow-up was signif- icantly lower by 0.81 6 0.15% units in the IC group as compared with the UDC group (P , 0.001; IC 8.4 6 0.10%; UDC 9.2 6 0.10%) (Table 2). Results for mean HbA1c at follow-up were similar in our sensitivity analysis based on imputed data, such that HbA1c at follow-up was 0.82 6 0.15% units lower in IC versus UDC participants (P , 0.001). We also examined descriptive clinical data on BP and BMI at follow-up using multiple linear regression adjusted for baseline values and found no significant difference between the groups in terms of these variables (Table 2). Results were similar when multiple imputation methods were used to fill in missing data (data not shown). Self-reported hypoglycemia symp- toms improved in both groups. In the IC group, 34.7% of patients reported having hypoglycemia symptoms in the prior month to baseline. Of those patients, only 49.3% reported hypogly- cemia symptoms at follow-up. In the UDC group, 38% of patients reported Figure 1—Flowchart showing participant enrollment and retention rates. Pt, patient; R2, research visit number two at six months follow-up. 4 Diabetes Dashboard and Team Care for Latinos Diabetes Care
  • 6. hypoglycemia symptoms at baseline, and only 44.7% of those patients re- ported symptoms at follow-up. There were no statistical differences between the IC and UDC conditions. There were also no differences between the two conditions in new reports of hypogly- cemia at follow-up (22 vs. 20.6%, no significance). Psychosocial Outcomes The results showed lower diabetes dis- tress at follow-up for IC patients (40.4 6 2.1) as compared with UDC patients (48.3 6 2.0) (P , 0.01) and also lower social distress (32.2 6 1.3 vs. 27.2 6 1.4, P , 0.01) (Table 2). There was a similar, statistically significant (P , 0.01) im- provement for both groups in the pro- portion of patients moving from depressed status at baseline to nonde- pressed at follow-up (i.e., 41.8 vs. 40%), with no significant difference between groups in terms of change in depression status. CONCLUSIONS This clinical trial conducted at two affil- iated urban safety net clinics focused on Latino T2D patients in poor glycemic control and demonstrated the clinical effectiveness of a diabetes care program enriched by use of a diabetes dashboard application to support team care. The dashboard provided the diabetes team with timely clinical alerts and reminders of diabetes-specific medical and psycho- social issues, encounter and treatment plan templates, and diabetes education resources and generated summary re- ports of intervention sessions to share with providers. Despite the artificiality inherent in delivering a time-limited (6-month) clinical research intervention within a busy primary care setting, the diabetes dashboard helped organize the work of the diabetes educator team (i.e., diabetes nurses and diabetes dieti- tians) and supported the provision of patient-centered and evidence-based diabetes care. The diabetes dashboard also created a bridge to the clinic pro- viders via the individual session sum- mary reports and medication change recommendations sent to the providers following intervention sessions. The UDC control condition consisted of a long-standing comprehensive diabetes care program designed as part of a Robert Wood Johnson Foundation Dia- betes Initiative to advance the delivery of culturally sensitive care for patients with T2D (23,24). The study findings showed that twice as many IC patients achieved a goal of HbA1c ,7% (53 mmol/mol) compared with the UDC condition (i.e., 15.8 vs. 7.0%, respectively). For an HbA1c cutoff of ,8% (64 mmol/mol), the results were 45.2 vs. 25.3%, respectively. The in- tervention provided a statistically and clinically significant mean HbA1c improvement (reduction) of 20.6% (26.6 mmol/mol) compared with a worsening for the UDC condition of +0.2% (+2.2 mmol/mol). As a benchmark to interpret this difference in intermedi- ate diabetes outcomes, landmark na- tional studies have shown that for every 1% (10.9 mmol/mol) reduction in HbA1c, the risk of developing eye, kidney, and nerve disease is reduced by 40% while the risk of heart attack is reduced by 14% (30). Analysis of our secondary psychoso- cial outcomes showed a significant re- duction in both diabetes distress and social distress for the IC compared with the UDC condition. Both conditions showed high baseline levels of distress, consistent with findings from prior stud- ies of urban poor T2D populations Table 1—Comparison of intervention groups at baseline Usual diabetes care, n = 200 Intervention condition, n = 199 P value1 Continuous variables Mean 6 SD Mean 6 SD Age (years) 55.2 6 11.9 54.8 6 10.3 0.72 BMI (kg/m2 ) 33.9 6 7.5 35.4 6 7.7 0.06 HbA1c (% units) 9.0 6 1.5 8.9 6 1.4 0.74 HbA1c (mmol/mol) 75.0 6 16.4 74.0 6 5.3 0.74 Systolic BP (mmHg) 136.2 6 19.4 135.3 6 21.3 0.68 Diastolic BP (mmHg) 77.0 6 10.4 78.3 6 11.3 0.22 Diabetes distress2 51.9 6 32.3 59.0 6 30.5 0.03 Social distress3 34.5 6 1.6 35.8 6 1.6 0.55 Categorical variables (%) % % Female 59.0 60.8 0.71 White race4 98.5 98.0 0.69 Hispanic ethnicity 100.0 100.0 d High diabetes distress2 50.5 62.9 0.01 Major depression5 41.2 32.7 0.09 1 Based on Student t test for continuous variables and Fisher exact test for categorical variables. 2 Measured using the PAID questionnaire, scored from 0 to 100, with higher scores indicative of greater diabetes distress; a score of .50 is indicative of high diabetes distress. 3 Measured using TAPS, scored from 0 to 100, with higher scores indicative of greater social distress. 4 Remaining patients self-identified as black/African American. 5 Measured using the Patient Health Questionnaire nine-item depression measure; patients endorsing five or more items are categorized as having major depression Table 2—Clinical and psychosocial outcomes by IC Usual diabetes care, n = 200 (mean 6 SE) Intervention condition, n = 199 (mean 6 SE) P value1 Clinical outcomes BMI (kg/m2 ) 35.0 6 0.1 34.9 6 0.1 0.50 HbA1c (% units) 9.2 6 0.10 8.4 6 0.10 ,0.001 HbA1c (mmol/mol) 77.0 6 1.1 68.0 6 1.1 ,0.001 Systolic BP (mmHg) 137.0 6 1.3 137.2 6 1.3 0.93 Diastolic BP (mmHg) 76.9 6 0.7 77.5 6 0.7 0.54 Psychosocial outcomes Diabetes distress2 48.3 6 2.0 40.4 6 2.1 ,0.01 Social distress3 32.2 6 1.3 27.2 6 1.4 ,0.01 1 Adjusted P values based on linear regression; models are adjusted for baseline values, with no additional variables retained in these final models. 2 Measured using the PAID questionnaire, scored from 0 to 100, with higher scores indicative of greater diabetes distress; a score of .50 is indicative of high diabetes distress. 3 Measured using TAPS, scored from 0 to 100, with higher scores indicative of greater social distress. care.diabetesjournals.org Welch and Associates 5
  • 7. (16,31,32). Improvement in depression status was seen among patients in both study conditions (;40% of those screen- ing positive for major depression at base- line were subsequently in remission at follow-up) but with no statistically signif- icant difference found between the con- ditions at follow-up. These results for psychosocial out- comes provide empirical support for the value of systematically assessing and actively managing T2D patients who report diabetes-related psychoso- cial challenges, as has been recommen- ded in prior reviews (7,33). It is notable that the Institute of Medicine has re- cently recommended that patient- reported assessments capturing a patient’s experience of illness should be routinely incorporated into the EMRs, including emotional distress and depression (34). The diabetes dash- board thus provides a strategy for pri- mary care clinics to meet these new recommendations, with modifications and updates over time, as appropriate. We explored the effect of interven- tion treatment dose on outcomes in poststudy sensitivity analyses and found that greater exposure produced greater clinical benefit for HbA1c, diabetes dis- tress, and social distress. Future studies could therefore consider the implemen- tation of practical strategies to enhance patient engagement over the full course of the intervention. For example, recent evidence supports the value of integrat- ing community health workers into the diabetes team to improve patient engagement (35,36). Also, the replace- ment ofsome face-to-face visits delivered in the clinic with low-cost telehealth strategies, including brief telephone calls combined with remote home monitoring of diabetes vital signs and medication adherence, may improve patient engage- ment and access to care among urban poor T2D patient groups, and may also overcome common barriers to regular clinic attendance, including lack of reliable transportation, adverse weather, and competing family and work demands. There were several strengths of the study, including a high patient retention rate (88.0%) in the research follow-up visits that involved use of a bicultural, bilingual research team as well as strong patient participation in the intervention program (i.e., 78.8% of patients at- tended three visits and 48.2% attended all five) that similarly involved use of a bilingual, bicultural clinical team. There were several weaknesses of the study, including our inability to track the frequency and content of UDC clinic vis- its that could have provided a more ac- curate description of the study control group and allowed adjustments for any potential differences between study conditions in terms of exposure to treat- ment (e.g., number of individual patient education sessions during the study time period). Future research could also extend our outcome tracking to include a formal assessment of BP and blood lipid levels over time and also explore differ- ences in diabetes medication manage- ment by providers taking part in the intervention and control conditions using a validated research protocol to capture the necessary granularity and ac- curacy of the structured information that would be needed for this future goal. It is notable that our diabetes dash- board was used as a stand-alone clinical application by the diabetes team, with the application hosted on a secure server separate from the clinic’s EMR. As is the case for any new CDS tool, wider adoption of our diabetes dash- board will require the provision of clinic leadership support, adequate provider and support staff training and their in- put to allow successful adaptation to lo- cal clinical care processes, as well as availability of sufficient IT and change management support similar to that seen for the current national EMR roll- out and meaningful use of patient data as part of the HITECH Act (8). Inconclusion,thediabetesdashboardin- tervention significantly reduced diabetes- relatedmedicalandpsychosocialdisparities among Latinos with poorly controlled T2D compared with a similar diabetes team condition without access to the diabetes dashboard. The use of a disease-specific clinical dashboard that addresses medical and psychosocial aspects of T2D treat- ment has broad applicability to other common chronic diseases that also require a focus on patient-centered, com- prehensive, and efficient team care. Acknowledgments. The authors thank Gbenga Ogedegbe of NYU Langone Medical Center and Ana Ronderos and Kathy Berdecia of Holyoke Health Center for their clinical expertise and support during the completion of the study. Funding. This project was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, through grant 5R01-DK-084325-04. Duality of Interest. G.W. is the Chief Scientific Officer of Silver Fern Healthcare. No other potential conflicts of interest relevant to this article were reported. Author Contributions. G.W. designed the study, oversaw the study conduct as principle investigator, and wrote the manuscript. S.E.Z. oversaw data collection and management, con- ducted the data analysis, and edited the man- uscript. P.S.-K. and Z.R. developed and implemented the intervention and assisted in manuscript development. S.-E.B. assisted in intervention planning and edited the manu- script. M.C.R. assisted in assessing intervention fidelity and edited the manuscript. R.A.G. acted as medical supervisor, conducted the training of providers and diabetes educators, and edited the manuscript. G.W. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. References 1. Centers for Disease Control and Prevention (CDC). National diabetes statistics report: esti- mates of diabetes and its burden in the United States, 2014. Atlanta, GA, U.S. Department of Health and Human Services, 2014 2. Huang ES, Basu A, O’Grady M, Capretta JC. 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