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A Systematic Approach to Risk
Stratification and Intervention Within a
Managed Care Environment Improves
Diabetes Outcomes and Patient
Satisfaction
CHARLES M. CLARK, JR., MD
1
JAMES W. SNYDER, MD
2
ROBERT L. MEEK, MS
3
LINDA M. STUTZ, RN, MBA
4
CHRISTOPHER G. PARKIN, MS
5
OBJECTIVE — To determine whether a comprehensive diabetes management program that
included risk stratification and social marketing would improve clinical outcomes and patient
satisfaction within a managed care organization (MCO).
RESEARCH DESIGN AND METHODS — The 12-month prospective trial was con-
ducted at primary care clinics within a MCO and involved 370 adults with diabetes. Measure-
ments included 1) the frequency of dilated eye and foot examinations, microalbuminuria
assessment, blood pressure measurement, lipid profile, and HbA1c measurement; 2) changes in
blood pressure, lipid levels, and HbA1c levels; and 3) changes in patient satisfaction.
RESULTS — Complete data are reported for the 193 patients who had been enrolled for 12
months; life table analysis is reported for all patients who remained enrolled at the study’s end as
well as for a comparative control group of 623 patients. For the 193 patients for whom 12-month
data were available, the number of patients in the low-risk category (HbA1c Ͻ7%) increased by
51.1%. A total of 97.4% of patients with an HbA1c Ͼ8% at baseline had a change in treatment
regimen. Patients at the highest risk for coronary heart disease (LDL Ͼ130 mg/dl) decreased
from 25.4% at baseline to 20.2%. Patients with a blood pressure Ͻ130/85 mmHg increased from
23.8 to 44.6%. Of these patients, 63.0% had changes in medication. Patients and providers
expressed significant increases in satisfaction with the program.
CONCLUSIONS — The program was successful in initiating the recommended changes in
the diabetic therapeutic regimen, resulting in improved glycemic control, increased monitoring/
management of diabetic complications, and greater patient and provider satisfaction. These
results should have great significance in the design of future programs in MCOs aimed at
improving the care of people with diabetes and other chronic diseases.
Diabetes Care 24:1079–1086, 2001
S
tudies have shown that control of
glycemia, hypertension, and hyper-
lipidemia significantly reduces the
risk of microvascular and cardiovascular
complications in patients with diabetes
(1–4). Nevertheless, diabetes remains
poorly controlled in the U.S., with Ͻ2%
of adult diabetic patients receiving opti-
mal quality of care as defined by the Clin-
ical Practice Recommendations of the
American Diabetes Association (ADA)
(5,6).
This study incorporated the findings
of several previous studies suggesting that
to improve patient outcomes, it is neces-
sary for the patient to interact with a prac-
tice team prepared with the appropriate
information, skills, and resources (7–11).
The comprehensive approach used was
based on processes of social marketing to
influence physician behaviors (12–19)
(Table 1). The study was predicated on
the utilization of previously agreed-upon
protocols that could be acted on as a re-
sult of the patient interview and the data
obtained.
The purpose of this study was to de-
termine whether improvements could be
made in clinical outcomes, patient/provider
compliance, and patient/provider satis-
faction within a managed care organiza-
tion (MCO) through an assessment and
intervention initiative. The program ad-
dressed the needs of diabetes care within
the primary care setting, bringing to-
gether a team with the patient as a central
and empowered participant. An en-
hanced data management system was de-
vised to facilitate communication and
practice-initiated follow-up. Outputs al-
lowed for both risk stratification to iden-
tify patients in the greatest need of
medical intervention and reports that
prompted providers with suggested inter-
ventions and care plans. They also al-
lowed for the systematic allocation of
personnel resources (i.e., primary care
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
From 1
Indiana University, Indianapolis, Indiana; the 2
VA Southern Nevada Healthcare System, Las Vegas,
Nevada; the 3
Roche Diagnostics Corporation; the 4
Meszzia Corporation; and 5
CGParkin Communications,
Indianapolis, Indiana.
Address correspondence and reprint requests to Charles M. Clark, Jr. MD, Regenstrief Institute, 1050
Wishard Boulevard, Indianapolis, IN 46202. E-mail: Chclark@iupui.edu.
Received for publication 29 June 2000 and accepted in revised form 23 February 2001.
J.W.S. served on the advisory panel of Sierra Health Services, which helped conduct the study and
received grant funding. L.M.S. was employed by Roche Diagnostics during the implementation of this study.
Abbreviations: ADA, American Diabetes Association; DQIP, Diabetes Quality Improvement Project;
HEDIS, Health Plan Employer Data and Information Set; HMO, health maintenance organization; MAU,
microalbumin; MCO, managed care organization; PAID, Problem Areas In Diabetes; SMBG, self-monitoring
of blood glucose.
A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion
factors for many substances.
E p i d e m i o l o g y / H e a l t h S e r v i c e s / P s y c h o s o c i a l R e s e a r c h
O R I G I N A L A R T I C L E
DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1079
physicians, extenders, diabetes educa-
tors, and administrative staff) to optimize
the function and value of each provider.
The objectives of the study were to: 1)
improve compliance with Health Plan
Employer Data and Information Set
(HEDIS) 1999 Diabetes Quality Improve-
ment Project (DQIP) measures (20) (i.e.,
following defined guidelines for fre-
quency of dilated eye examinations, foot
examinations, urinary microalbumin
[MAU] assessment, blood pressure mea-
surement, lipid profile, and HbA1c mea-
surement); 2) improve patient outcomes
as measured by HbA1c levels, blood pres-
sure, and lipid levels; 3) improve patient
satisfaction with the services provided; 4)
improve patient understanding and com-
pliance with therapeutic regimens; and 5)
improve provider satisfaction.
This study was conducted at an MCO
based in Las Vegas, Nevada. This report
describes study objectives, protocol, and
12-month results for 193 patients who
participated in the program.
RESEARCH DESIGN AND
METHODS
Clinical setting
The MCO studied has Ͼ180,000 health
maintenance organization (HMO) mem-
bers. Most (ϳ70%) of the HMO members
obtain primary care services at the MCO-
owned clinics, with the balance of mem-
bers receiving care at network clinics. The
MCO has Ͼ8,500 members with diabe-
tes. A majority of these members are
Medicare Risk enrollees.
The two clinics studied were staff-
model primary care clinics. Each provid-
er had his/her own panel of patients.
Clinic 1 had nine providers. Clinic 2 had
seven providers. Data from 623 members
at a third clinic were analyzed to identify
secular trends over the 12-month study
period.
Participants
Patient selection. Using a computerized
database from the MCO, 1,121 subjects
were identified. Letters were sent to all
1,121 subjects, inviting them to partici-
pate in the study. We then randomly se-
lected 655 patients for telephone follow-
up; we were able to contact 555 (85%)
patients. Of the 555 patients contacted,
431 met the study criteria. The study ex-
cluded members who were Ͻ21 or Ͼ75
years of age; had end-stage renal disease;
were on dialysis; had cancer, blindness,
drug or alcohol addiction, or stage III
or IV congestive heart failure; were in
another clinical trial; had gestational dia-
betes or were pregnant; or were institu-
tionalized or unable to provide self-care.
Of the 431 eligible patients, 370
(86%) were included in the study. At the
study’s end, 315 patients remained en-
rolled. This represents 85% of the pa-
tients who were initially enrolled in the
study. We have 12-month data for 193
subjects, which are herein reported. An
overview of the selection and enrollment
process is presented in Fig. 1.
Although no data are available re-
garding the reasons for patient with-
drawal (14.9%), it should be noted that
the annual patient turnover rate within
the MCO studied averaged ϳ26%.
Patient demographics. The average age
of the subjects enrolled was 64.0 years;
the average duration of diabetes was
10.7 years. Of the patients enrolled,
76% were Caucasian, 14% were African-
American, 7% were Hispanic, and 2%
were Asian. Median annual income was
$10,000–20,000; 70% had a median an-
nual income of Ͻ$40,000. There were no
significant differences between the con-
trol and study groups with regard to age,
duration of diabetes, race, or income.
Treatment modalities. At baseline, sub-
jects controlled their diabetes with an in-
sulin–oral therapy combination (11.4%),
Figure 1—Enrollment process.
Table 1—Changing practitioner behavior: what works?
Intervention Description/Findings
Audit and feedback Particularly effective for prescribing and diagnostic testing
Reminders Prompts the provider to perform clinical action
Outreach visits Meetings with providers in practice settings to provide information and feedback
Patient-mediated interventions Educating and informing patients – particularly useful when combined with outreach Visits
Opinion leaders Providers explicitly nominated by their colleagues to be “educationally influential”
Conferences Need to be explicit and related to the practice environment
Marketing Use of interviews, focus groups, or surveys to identify barriers
Multifaceted The use of a variety of interventions is most effective
Summary: there must be agreement that there is a problem and that the solution agreed-upon is the solution to the problem, combined with a system of information
and feedback necessary to resolve the problem.
Risk stratification improves diabetes outcomes
1080 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
insulin (14.0%), oral medications
(59.6%), or diet and exercise (15.0%).
The control group used similar treatment
modalities.
Comorbidities. At baseline, 1.0% sub-
jects self-reported having kidney disease;
the subjects also reported having diabetic
foot disease (12.8%), diabetic eye disease
(15.1%), heart disease (31.6%), and dia-
betic neuropathy (35.4%). High blood
pressure and high cholesterol occurred in
67.2 and 57.8% of the subjects, respec-
tively. Comorbidities were similar in the
control group.
Protocol
The program was implemented in the fol-
lowing phases: 1) enrollment; 2) initial
encounter; 3) risk stratification and action
planning; 4) intervention; 5) patient edu-
cation; 6) interim visits; and 7) follow-up
visits. Program personnel included a team
care coordinator, who was responsible for
administrative tasks, maintaining contact
with patients, data management, and
scheduling. Program personnel also in-
cluded a team care leader, who was a reg-
istered nurse who implemented the
orders and assumed responsibilities for
care as directed by the patients’ primary
care providers. In addition to these indi-
viduals, each clinic had available diabetes
educators, nutritionists, advanced prac-
tice nurses, and physician assistants;
these people, with the physicians, com-
prised the health care team.
Enrollment. Potential subjects were
identified by diagnosis (ICD-9 250.xx)
through patient records, and their data
were downloaded into the software. Pa-
tients were eligible if they were continu-
ously enrolled in the health plan for at
least 2 years and had at least two clinical
encounters coded specifically for diabetes
procedure/diagnostic codes. Patients re-
ceived letters of invitation from their pro-
vider. Patients were asked to complete a
questionnaire enclosed with the letter,
obtain necessary lab tests, and call the
team care coordinator to schedule an ini-
tial visit. The questionnaire (administered
pre- and postintervention) solicited de-
mographic information, self-reported co-
morbidities, current healthcare practices
and medical therapies, self-assessment of
current status of diabetes control, and
overall satisfaction with the healthcare
plan, healthcare staff, and level of knowl-
edge about diabetes care. Patients were
instructed to bring the completed ques-
tionnaire to the first clinic visit, along with
their current blood glucose meter and
medications. An overview of the enroll-
ment process is presented in Fig. 1.
Initial encounter. At the first visit, the
team care coordinator measured blood
pressure, height, and weight; conducted a
foot examination (pedal pulses, deformi-
ties, 10 gm monofilament test); and mea-
sured microalbuminuria using the Micral
test (Roche Diagnostics, Indianapolis,
IN). Patients were also instructed in the
self-monitoring of blood glucose (SMBG)
and were provided with a blood glucose
Accu-Chek Advantage blood glucose
meter (Roche Diagnostics) and supplies.
Risk stratification and action planning.
Laboratory tests and data from completed
patient questionnaires were entered into
the software. Risk profiles were generated
using stratification algorithms and clini-
cal intervention guidelines based on the
ADA Clinical Practice Recommendations.
Patients were stratified into high-, mod-
erate-, or low-risk groups in seven
categories: 1) glycemic control, 2) cardio-
vascular disease, 3) nephropathy, 4) reti-
nopathy, 5) hyper/hypoglycemia, 6)
amputation, and 7) psychosocial disorders.
Interventions. Interventions were based
on previously agreed-upon standing or-
ders (protocols) after approval from the
primary care physician. The team care co-
ordinator printed risk profile reports
(physician and patient versions) and en-
tered data elements into patient trending
flowcharts. The team care coordinator
and team care leader met to review the
reports and develop action plans. The
team care leader then met with primary
care providers to review risk stratification
reports and approve action plans. The
appropriate follow-up action was deter-
mined by the healthcare team based on
the degree of medical intervention
deemed necessary. For example, if fol-
low-up was needed, the team care coor-
dinator scheduled the patient for nurse
consultation and/or a provider visit. If no
immediate follow-up was needed, a tele-
phone call to the patient may have been
sufficient to update the patient on his/her
status or to make a minor medication
change, followed by a mailing of the pa-
tient’s report. The patient reports con-
tained information about the patient’s
level of risk in each category and provided
self-care recommendations for improving
his/her diabetes (Fig. 2).
Patient education. All patients attended
three educational programs (2 h each)
and received educational materials. Edu-
cational programs focused on adult learn-
ing principles and actively engaged the
patients in their care. As a result, when
patients presented for physician office vis-
its, they were knowledgeable about their
risk status and what actions would be
necessary. Patients also were invited to
attend optional support groups.
Interim visits. Interim visits were
scheduled at 3 and 6 months after the ini-
tial encounter. The team care coordinator
verified that patients were performing
SMBG at least twice per day and recording
test-strip usage. If patients were not per-
forming SMBG at the minimal frequency,
the team care coordinator worked with
patients to identify barriers and propose
solutions. Other potential self-care barri-
ers related to meal-planning adherence,
exercise, smoking cessation, medication
administration, and so forth were identi-
fied, and solutions were explored with the
patient. At these visits, patients com-
pleted an interim survey regarding their
health care utilization.
Follow-up visits. The team care coordi-
nator reviewed patient records monthly
(via an internet application) to monitor
patient compliance; this was facilitated by
an automated reminder function pro-
vided by the software. The team care co-
ordinator made reminder telephone calls
to patients, answered questions, and re-
ferred patients to the team care leader
when appropriate.
Statistical and analytical methods
Methods/technologies used to assess
complications. The patients’ blood
work was performed by a local certified
laboratory contracted by the MCO. HbA1c
determinations were performed using a
high-performance liquid chromatogra-
phy method. Foot examinations included
the use of the Semmes-Weinstein 5.07
monofilament (21) to test cutaneous sen-
sitivity. Eye examinations were obtained
by referral to optometrists supervised by
ophthalmologists at several MCO practice
locations. Lipid panels included a calcu-
lated LDL cholesterol. Random urine dip-
sticks using Micral were used to obtain a
MAU result. MAU results Ͼ100 mg/l were
sent to a local laboratory for quantitative
evaluation.
Design/validity of questionnaires used
to assess patient satisfaction and statis-
Clark and Associates
DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1081
tical analysis of all data. Metabolic,
clinical lab, and patient survey response
data were extracted from the database
based on a priori hypotheses established
for the statistical analyses. For DQIP (20)
analysis, measures (e.g., lab HbA1c or
metabolic blood pressure group values)
were categorized by DQIP criteria;
changes over time were tested for statisti-
cal significance using McNemar’s test
(22).
The diabetes-specific patient satisfac-
tion survey tool, which incorporates a
five-point Likert-response scale, was de-
veloped by a research group at the Office
of Health Policy and Clinical Outcomes,
Thomas Jefferson University (Philadel-
phia, PA). Changes over time for the sat-
isfaction multiple-response items were
tested using Agresti’s test of marginal ho-
mogeneity for ordinal data (23). This sta-
tistical significance test is based on the
generalization of the McNemar test; it ap-
plies for more than two response catego-
ries and takes advantage of the ordered
responses of the questions. All analyses
were performed using SAS software, ver-
sion 6.12 for MacIntosh (SAS Institute,
Cary, NC).
RESULTS — At 12 months, data from
193 patients were available to assess met-
abolic outcomes, which were evaluated
by changes in HbA1c, blood pressure, and
lipids. Additionally, an assessment was
made of provider adherence to care
guidelines with regard to frequency of
HbA1c measurements, blood pressure
readings, lipid panel utilization, foot ex-
aminations, and dilated eye examinations
(Table 2). Assessments were also made re-
garding the number of patients who re-
ceived diabetes self-management
education, nutrition counseling, and
smoking cessation counseling. Patient
satisfaction with the health care services
provided and patient understanding and
compliance with the therapeutic regimen
were evaluated by questionnaire.
Data showed a significant improve-
ment in glycemic control as measured by
HbA1c (Fig. 3). During the 12-month pe-
riod, the number of patients in the low-
risk category (HbA1c Ͻ7%) increased by
51.1%, from 47 members at baseline to
71 after 12 months. The number of pa-
tients in the moderate category (7 to
Ͻ8%) increased 2.5%. The number of pa-
tients in the high-risk category (Ն8.0%)
decreased by 58.3%, from 76 to 48 par-
ticipants. Furthermore, of those patients
with HbA1c levels Ն8% at baseline,
97.4% had a change in treatment regimen
during the 12 months in the program.
In addition to analyzing the HbA1c
data for the 193 patients for whom 12-
month data were available, we also ana-
lyzed the time course of 356 patients from
the experimental group (which included
Figure 2—Example of a risk stratification report generated from the application server.
Risk stratification improves diabetes outcomes
1082 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
data from the 315 patients who were still
enrolled and the 41 patients who had
dropped out of the study) and 623 pa-
tients from the control group. These data
are summarized in Fig. 4. The control
group remained essentially unchanged,
whereas significant decreases in HbA1c in
the experimental group were seen at the
first interval at which it was measured.
The change remained constant through-
out the remainder of the study.
A reduction in hypertension was also
seen at 12 months. The percentage of pa-
tients with blood pressure readings
Ͻ140/90 mmHg, an accountability mea-
sure for HEDIS accreditation, increased
from 38.9% at baseline to 66.8% at 12
months (Fig. 5). The percentage of pa-
tients with blood pressure readings
Ͻ130/85 mmHg (our pilot clinical deci-
sion threshold for hypertension) in-
creased from 23.8 to 44.6%. Of those
patients with blood pressure readings
Ͼ130/85 mmHg at baseline, 63.0% had a
change in medication within 12 months
in the program.
The percentage of patients receiving
lipid profile tests increased from 66% at
baseline to 100% at 12 months, and mi-
croalbuminuria testing increased from 17
to 100%, respectively (Table 2). The per-
centage of patients at the highest risk for
coronary heart disease (LDL Ͼ130 mg/dl)
decreased from 25.4% at baseline to
20.2% at 12 months. Of those patients
identified at the highest risk for nephrop-
athy, 76.7% had a change in medication
within the 12 months of program partic-
ipation after the initial visit. In addition, at
the end of 12 months, the percentage of
patients who had received a dilated eye
examination increased from 53.9 to
80.3%, and documented foot examina-
tions increased from 0 to 100%.
Improvements were also observed in
patient and provider satisfaction scores
(Table 3 and Fig. 6). Patients expressed a
significant increase in satisfaction with
the program and staff performance. Of the
70% of providers that responded to the
survey, 100% indicated that they were
“very satisfied” with the program, 100%
believed that their patients’ diabetes was
better controlled as a result of the diabetes
management program, and 93% believed
the program saved them time on patient
visits. In addition, 100% of the providers
said they would recommend the use of
this program to other physicians.
CONCLUSIONS — In our program,
it was necessary to convert the ADA’s
Clinical Practice Recommendations into
concrete actions that could be carried out
by the care team, supported by a interre-
lated set of practice enhancements. The
most significant of these enhancements
was to translate the protocols into a data
system that stratified each patient into
risk categories based on his/her data.
Therapeutic recommendations were then
generated in an easy-to-follow format that
could be quickly reviewed and signed by
the provider and then implemented with
guidance from the team care leader.
The provider and the patient received
an illustrated summary of the data and the
resultant recommendations, allowing a
productive discussion at the time of the
patient visit on how to act upon the data.
Based on data from the provider survey,
this process resulted in more efficient vis-
its and improved use of both the provid-
er’s and the patient’s time. The patient
survey data showed that in combination
with the educational programs, it also re-
sulted in improved patient satisfaction be-
cause the patient understood a priori the
changes necessary and the rationale.
Whereas the program is simple to de-
scribe, it was complex to initiate for sev-
eral reasons. First, the providers had to be
involved from the start to assure that the
standards and their recommended ac-
tions were consistent with the practitio-
ners’ views. Perhaps even more important
than creating provider buy-in to this pro-
gram was creating awareness that there
were significant gaps in performance. In
several instances, this involved interactive
discussion with the practitioners as well
as nonpunitive provider-specific feed-
back on prior performance. This feedback
was provided by the authors (C.M.C. and
Figure 3—Change in glycemic control risk (% HbA1c) for the treatment cohort. Ⅺ, Low (HbA1c
Ͻ7.0%); u, moderate (HbA1c 7–8%); f, high (HbA1c Ͼ8.0%).
Table 2—Summary of changes in clinical outcomes and provider adherence at 12 months
Baseline 12 Months
Clinical outcome measures
High-risk glycohemoglobin, HbA1c Ͼ9.5% 10.9 3.1
Members with drop in HbA1c Ն0.5% — 45.6
Blood pressure Ͻ140/90 mmHg 38.9 66.8
Provider adherence measures
Lipid profile testing within the last 2 years 66 100
Microalbuminuria within the last year 17 100
Retinal eye exam within the last year 53.9 80.3
Foot exam with monofilament test within the last year N/A 100
Data are %.
Clark and Associates
DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1083
J.W.S.) reviewing the scientific basis for
both the recommendation and the accep-
tance of the need for change in the ap-
proach to diabetes care.
These educational sessions and the
presentation of data on prior performance
were viewed as critical links in the process
of prompting the recognition that a
change in the way care is delivered could
have positive consequences. However, it
was also critical to devise a process that
included the necessary support and
resources to enable providers to achieve
results without being overburdened. Al-
though the clinic structure was left intact,
patient flow was altered, and tasks were
delegated to the team care coordinator
and team care leader. The team care coor-
dinator and leader assured that the data
were available before the patient’s visit
with the provider and that the appropri-
ate patient education occurred before that
visit. The patients were involved in edu-
cation programs from the start of the pro-
gram and received a printout (in
condensed form) of their data and risk
status (Fig. 2). Thus, they were prepared
for the visit and the discussion about how
they might improve their health-risk
status. The providers saw this process as
improving effectiveness and productivity,
which greatly facilitated ongoing partici-
pation and support of the program within
their clinics.
Another enhancement in the program
was the initiation at the onset of a psycho-
social evaluation using the Problem Areas
In Diabetes (PAID) questionnaire devel-
oped and validated by Polonsky et al.
(24). This was viewed as an important
part of the initial assessment because a
large percentage of adult patients with di-
abetes have significant psychological co-
morbidities, usually depression or anxiety
disorders (25,26). Patients with abnormal
PAID scores were identified to the practi-
tioners for appropriate action. Educa-
tional courses by the clinic psychologist
were conducted with all providers to as-
sist them in managing such patients.
Thus, before recommendations were
made for changes in therapy, it was nec-
essary to address those comorbidities.
Finally, it was necessary to develop a
system that collated the data and pre-
sented it in a format that was immediately
understandable by (and useful to) the pa-
tient and the provider. Thus, the data
needed to be summarized in such a fash-
ion as to be clear and accurate, yet of suf-
ficient brevity that it could be the basis of
discussion by the patient and provider.
The system developed also had two addi-
tional important features. First, it gener-
ated a set of orders for the clinicians to
review and initiate, making the recom-
mended changes easy, yet permitting in-
dividualization as needed. Visual graphic
and analytical reporting components
were shared between the patient and pro-
vider report formats, facilitating the com-
munication between the patient and the
healthcare team. Second, it generated a
reminder list for the team care coordina-
tor, providing a fail-safe system to ensure
that recommended actions were not over-
looked or omitted. For example, if an eye
exam was recommended, the system
would repeatedly remind the team care
coordinator until the exam took place.
The success of the program in initiat-
ing the recommended changes in the
diabetes therapeutic regimen was the
most striking; 95.8% of the patients out-
side of the recommended therapeutic
range had a prescribed change in therapy.
These data suggest that the program was
successful in convincing both patients
and providers that the goals were of value
and that changes were necessary to reach
those goals. As the number of therapeutic
choices available to treat diabetes ex-
Figure 4—Time trend in average HbA1c value for Diabetes Advantage Program treatment and
control groups. Average HbA1c is shown at 3-month intervals for the 12-month periods before and
after enrollment. Note that the treatment group includes patients who dropped out of the program.
F, Control (n ϭ 623); Ⅺ, treatment (n ϭ 356).
Figure 5—Reduction in hypertension risk for treatment cohort.
Risk stratification improves diabetes outcomes
1084 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
pands, the metabolic success of the pro-
gram should increase. It is also important
to note that based on provider surveys at
the completion of the study, the program
did not add work to the already “overbur-
dened” physician. In fact, the program
served to improve workflow efficiencies
for both providers and staff. The noted
improvements demonstrated that excel-
lent diabetes care can be achieved
through enhancements in the primary
care setting and that “carve-outs,” or sep-
arate systems of care involving mass refer-
rals of patients with diabetes to specialty
clinics, are not necessary.
In addition, the success of the pro-
gram in initiating new therapies and im-
proving patient outcomes did not come at
the expense of patient satisfaction. Quite
the contrary, the most striking finding of
the study was the improvement in patient
satisfaction that accompanied the program.
Whereas the striking results of the
study could have been attributable to
some unique features of the patients se-
lected, there are several reasons why we
do not feel this is the case. Although only
193 of the patients had complete 12-
month data at the completion of the
study, Ͼ85% of the patients entered into
the study remained in the study at its end.
The data over time for the compete co-
hort revealed a significant fall in HbA1c
by 3 months that persisted through-
out the study, whereas the HbA1c levels
of a comparative control group remained
constant.
We believe the program was success-
ful because it effectively capitalized on an
array of interventions based on social
marketing that have been shown to
change physician behavior. Our overall
strategy was to provide necessary infor-
mation regarding diabetes management
to care providers while removing obsta-
cles that have traditionally inhibited the
delivery of quality diabetes care. To this
end, we developed interventions to ad-
dress each of the areas previously demon-
strated to influence physician behaviors,
as summarized in Table 1. For example,
with regard to audit and feedback, ex-
plicit standards were agreed upon by the
practitioners, and feedback was provided.
Furthermore, once these standards were
inputted into the system, they were im-
plemented automatically; there was no
deviation or partial compliance with the
established protocols. With regard to the
“opinion leader” involvement, both pri-
mary care leadership and endocrine lead-
ership were enthusiastic and supportive
of the program. Additionally, an auto-
matic system of risk stratification and re-
minders was put into place. Through
these interventions and others previously
described, we created an environment
that was supportive of comprehensive di-
abetes management.
Regarding the economic benefits of
the intervention, this study did not ad-
dress the financial implications of im-
proved diabetes control. However, two
recent publications suggest that there are
significant and immediate economic ad-
vantages to improving glycemic control
and treatment of diabetes risk factors
(27,28).
The intervention studied was com-
prehensive, and we are unable to tease out
the relative role of the various interven-
tions. Additionally, the study was con-
ducted in a staff-model MCO and may not
be applicable to other types of delivery
systems. Despite these limitations, we feel
that the results provide a sound basis for
Figure 6—Staff provider responses to satisfaction survey. f, Yes; Ⅺ, no.
Table 3—Results from patient satisfaction survey
Category/question
Responses
Baseline
12
months
Knowledge and information
“In the past 3 months, how satisfied have you been with your
knowledge of your diabetes?”
49.2 81.3
“How helpful is the information that you received from your
health plan about taking care of your diabetes?”
82.4 96.9
Program staff
“How satisfied are you with the way the staff in the diabetes
program treated you?”
63.8 97.4
“How satisfied are you with the number of times that the diabetes
program staff talked with you?”
51.3 96.9
Program recommendation
“Overall, how satisfied are you with your health plan’s diabetes
program?”
57.5 94.3
“How likely are you to recommend your health plan’s diabetes
program to someone else who has your kind of diabetes?”
56.4 94.8
Data are %. Responses column refers to the percentage of patients responding “very” and “slightly” satisfied,
“helpful,” or “likely” to the questions on the survey.
Clark and Associates
DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1085
the design of future programs within
MCOs directed at improving the care of
patients with diabetes and other chronic
diseases. To determine whether these
protocols can be adapted to other care set-
tings, we have developed a CD-ROM–
based continuing medical education
program that targets primary care physi-
cians; we are now in the process of eval-
uating this program (29).
Acknowledgments— Funding for the pro-
gram was made possible by an educational
grant from Roche Diagnostics Corporation.
The authors thank the following people and
institutions who participated in the develop-
ment and implementation of this program:
Southwest Medical Associates (B. Mitchell, R.
Parr, C. Belle, P. Sparks, C. DelRosario, J. Mar-
tin, and R. Appelt), Sierra Health Services (Y.
Riggan and G. Teeter), Indiana University (C.
Clark), Stanford University (G. Singh),
AvailTek (R. Bogue), HCIA (G. Lenhart and T.
Reinsch), the Clinical Education Group (K.
Swenson), and Roche Diagnostics Corpora-
tion (D. Burgh, S. Earl, L. Halcomb, L. Hen-
derson, R. Peyton, J.M. Quach, M. Schafer, K.
Schmelig, L. Stutz, and R. Wishnowsky). We
also thank Elizabeth Warren-Boulton (Roche
Diagnostics), upon whose literature review
Table 1 is based. Part of the data included in
this article was presented previously in ab-
stract form at the Building Bridges VI Confer-
ence (Atlanta, GA, 6–7 April 2000).
References
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Japanese patients with non-insulin-de-
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3. UK Prospective Diabetes Study Group:
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9. Gruesser M, Bott U, Ellermann P, Krons-
bein P, Joergens V: Evaluation of a struc-
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RB, Freemantle N, Harvey EL: Audit and
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47:S55–S62, 1998
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Risk stratification improves diabetes outcomes
1086 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001

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EVIDENCE-BASED CARESHEETAuthorsHillary Mennella, DNP
 

A Systematic Approach to Diabetes Risk Stratification and Intervention Improves Outcomes

  • 1. A Systematic Approach to Risk Stratification and Intervention Within a Managed Care Environment Improves Diabetes Outcomes and Patient Satisfaction CHARLES M. CLARK, JR., MD 1 JAMES W. SNYDER, MD 2 ROBERT L. MEEK, MS 3 LINDA M. STUTZ, RN, MBA 4 CHRISTOPHER G. PARKIN, MS 5 OBJECTIVE — To determine whether a comprehensive diabetes management program that included risk stratification and social marketing would improve clinical outcomes and patient satisfaction within a managed care organization (MCO). RESEARCH DESIGN AND METHODS — The 12-month prospective trial was con- ducted at primary care clinics within a MCO and involved 370 adults with diabetes. Measure- ments included 1) the frequency of dilated eye and foot examinations, microalbuminuria assessment, blood pressure measurement, lipid profile, and HbA1c measurement; 2) changes in blood pressure, lipid levels, and HbA1c levels; and 3) changes in patient satisfaction. RESULTS — Complete data are reported for the 193 patients who had been enrolled for 12 months; life table analysis is reported for all patients who remained enrolled at the study’s end as well as for a comparative control group of 623 patients. For the 193 patients for whom 12-month data were available, the number of patients in the low-risk category (HbA1c Ͻ7%) increased by 51.1%. A total of 97.4% of patients with an HbA1c Ͼ8% at baseline had a change in treatment regimen. Patients at the highest risk for coronary heart disease (LDL Ͼ130 mg/dl) decreased from 25.4% at baseline to 20.2%. Patients with a blood pressure Ͻ130/85 mmHg increased from 23.8 to 44.6%. Of these patients, 63.0% had changes in medication. Patients and providers expressed significant increases in satisfaction with the program. CONCLUSIONS — The program was successful in initiating the recommended changes in the diabetic therapeutic regimen, resulting in improved glycemic control, increased monitoring/ management of diabetic complications, and greater patient and provider satisfaction. These results should have great significance in the design of future programs in MCOs aimed at improving the care of people with diabetes and other chronic diseases. Diabetes Care 24:1079–1086, 2001 S tudies have shown that control of glycemia, hypertension, and hyper- lipidemia significantly reduces the risk of microvascular and cardiovascular complications in patients with diabetes (1–4). Nevertheless, diabetes remains poorly controlled in the U.S., with Ͻ2% of adult diabetic patients receiving opti- mal quality of care as defined by the Clin- ical Practice Recommendations of the American Diabetes Association (ADA) (5,6). This study incorporated the findings of several previous studies suggesting that to improve patient outcomes, it is neces- sary for the patient to interact with a prac- tice team prepared with the appropriate information, skills, and resources (7–11). The comprehensive approach used was based on processes of social marketing to influence physician behaviors (12–19) (Table 1). The study was predicated on the utilization of previously agreed-upon protocols that could be acted on as a re- sult of the patient interview and the data obtained. The purpose of this study was to de- termine whether improvements could be made in clinical outcomes, patient/provider compliance, and patient/provider satis- faction within a managed care organiza- tion (MCO) through an assessment and intervention initiative. The program ad- dressed the needs of diabetes care within the primary care setting, bringing to- gether a team with the patient as a central and empowered participant. An en- hanced data management system was de- vised to facilitate communication and practice-initiated follow-up. Outputs al- lowed for both risk stratification to iden- tify patients in the greatest need of medical intervention and reports that prompted providers with suggested inter- ventions and care plans. They also al- lowed for the systematic allocation of personnel resources (i.e., primary care ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● From 1 Indiana University, Indianapolis, Indiana; the 2 VA Southern Nevada Healthcare System, Las Vegas, Nevada; the 3 Roche Diagnostics Corporation; the 4 Meszzia Corporation; and 5 CGParkin Communications, Indianapolis, Indiana. Address correspondence and reprint requests to Charles M. Clark, Jr. MD, Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202. E-mail: Chclark@iupui.edu. Received for publication 29 June 2000 and accepted in revised form 23 February 2001. J.W.S. served on the advisory panel of Sierra Health Services, which helped conduct the study and received grant funding. L.M.S. was employed by Roche Diagnostics during the implementation of this study. Abbreviations: ADA, American Diabetes Association; DQIP, Diabetes Quality Improvement Project; HEDIS, Health Plan Employer Data and Information Set; HMO, health maintenance organization; MAU, microalbumin; MCO, managed care organization; PAID, Problem Areas In Diabetes; SMBG, self-monitoring of blood glucose. A table elsewhere in this issue shows conventional and Syste`me International (SI) units and conversion factors for many substances. E p i d e m i o l o g y / H e a l t h S e r v i c e s / P s y c h o s o c i a l R e s e a r c h O R I G I N A L A R T I C L E DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1079
  • 2. physicians, extenders, diabetes educa- tors, and administrative staff) to optimize the function and value of each provider. The objectives of the study were to: 1) improve compliance with Health Plan Employer Data and Information Set (HEDIS) 1999 Diabetes Quality Improve- ment Project (DQIP) measures (20) (i.e., following defined guidelines for fre- quency of dilated eye examinations, foot examinations, urinary microalbumin [MAU] assessment, blood pressure mea- surement, lipid profile, and HbA1c mea- surement); 2) improve patient outcomes as measured by HbA1c levels, blood pres- sure, and lipid levels; 3) improve patient satisfaction with the services provided; 4) improve patient understanding and com- pliance with therapeutic regimens; and 5) improve provider satisfaction. This study was conducted at an MCO based in Las Vegas, Nevada. This report describes study objectives, protocol, and 12-month results for 193 patients who participated in the program. RESEARCH DESIGN AND METHODS Clinical setting The MCO studied has Ͼ180,000 health maintenance organization (HMO) mem- bers. Most (ϳ70%) of the HMO members obtain primary care services at the MCO- owned clinics, with the balance of mem- bers receiving care at network clinics. The MCO has Ͼ8,500 members with diabe- tes. A majority of these members are Medicare Risk enrollees. The two clinics studied were staff- model primary care clinics. Each provid- er had his/her own panel of patients. Clinic 1 had nine providers. Clinic 2 had seven providers. Data from 623 members at a third clinic were analyzed to identify secular trends over the 12-month study period. Participants Patient selection. Using a computerized database from the MCO, 1,121 subjects were identified. Letters were sent to all 1,121 subjects, inviting them to partici- pate in the study. We then randomly se- lected 655 patients for telephone follow- up; we were able to contact 555 (85%) patients. Of the 555 patients contacted, 431 met the study criteria. The study ex- cluded members who were Ͻ21 or Ͼ75 years of age; had end-stage renal disease; were on dialysis; had cancer, blindness, drug or alcohol addiction, or stage III or IV congestive heart failure; were in another clinical trial; had gestational dia- betes or were pregnant; or were institu- tionalized or unable to provide self-care. Of the 431 eligible patients, 370 (86%) were included in the study. At the study’s end, 315 patients remained en- rolled. This represents 85% of the pa- tients who were initially enrolled in the study. We have 12-month data for 193 subjects, which are herein reported. An overview of the selection and enrollment process is presented in Fig. 1. Although no data are available re- garding the reasons for patient with- drawal (14.9%), it should be noted that the annual patient turnover rate within the MCO studied averaged ϳ26%. Patient demographics. The average age of the subjects enrolled was 64.0 years; the average duration of diabetes was 10.7 years. Of the patients enrolled, 76% were Caucasian, 14% were African- American, 7% were Hispanic, and 2% were Asian. Median annual income was $10,000–20,000; 70% had a median an- nual income of Ͻ$40,000. There were no significant differences between the con- trol and study groups with regard to age, duration of diabetes, race, or income. Treatment modalities. At baseline, sub- jects controlled their diabetes with an in- sulin–oral therapy combination (11.4%), Figure 1—Enrollment process. Table 1—Changing practitioner behavior: what works? Intervention Description/Findings Audit and feedback Particularly effective for prescribing and diagnostic testing Reminders Prompts the provider to perform clinical action Outreach visits Meetings with providers in practice settings to provide information and feedback Patient-mediated interventions Educating and informing patients – particularly useful when combined with outreach Visits Opinion leaders Providers explicitly nominated by their colleagues to be “educationally influential” Conferences Need to be explicit and related to the practice environment Marketing Use of interviews, focus groups, or surveys to identify barriers Multifaceted The use of a variety of interventions is most effective Summary: there must be agreement that there is a problem and that the solution agreed-upon is the solution to the problem, combined with a system of information and feedback necessary to resolve the problem. Risk stratification improves diabetes outcomes 1080 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
  • 3. insulin (14.0%), oral medications (59.6%), or diet and exercise (15.0%). The control group used similar treatment modalities. Comorbidities. At baseline, 1.0% sub- jects self-reported having kidney disease; the subjects also reported having diabetic foot disease (12.8%), diabetic eye disease (15.1%), heart disease (31.6%), and dia- betic neuropathy (35.4%). High blood pressure and high cholesterol occurred in 67.2 and 57.8% of the subjects, respec- tively. Comorbidities were similar in the control group. Protocol The program was implemented in the fol- lowing phases: 1) enrollment; 2) initial encounter; 3) risk stratification and action planning; 4) intervention; 5) patient edu- cation; 6) interim visits; and 7) follow-up visits. Program personnel included a team care coordinator, who was responsible for administrative tasks, maintaining contact with patients, data management, and scheduling. Program personnel also in- cluded a team care leader, who was a reg- istered nurse who implemented the orders and assumed responsibilities for care as directed by the patients’ primary care providers. In addition to these indi- viduals, each clinic had available diabetes educators, nutritionists, advanced prac- tice nurses, and physician assistants; these people, with the physicians, com- prised the health care team. Enrollment. Potential subjects were identified by diagnosis (ICD-9 250.xx) through patient records, and their data were downloaded into the software. Pa- tients were eligible if they were continu- ously enrolled in the health plan for at least 2 years and had at least two clinical encounters coded specifically for diabetes procedure/diagnostic codes. Patients re- ceived letters of invitation from their pro- vider. Patients were asked to complete a questionnaire enclosed with the letter, obtain necessary lab tests, and call the team care coordinator to schedule an ini- tial visit. The questionnaire (administered pre- and postintervention) solicited de- mographic information, self-reported co- morbidities, current healthcare practices and medical therapies, self-assessment of current status of diabetes control, and overall satisfaction with the healthcare plan, healthcare staff, and level of knowl- edge about diabetes care. Patients were instructed to bring the completed ques- tionnaire to the first clinic visit, along with their current blood glucose meter and medications. An overview of the enroll- ment process is presented in Fig. 1. Initial encounter. At the first visit, the team care coordinator measured blood pressure, height, and weight; conducted a foot examination (pedal pulses, deformi- ties, 10 gm monofilament test); and mea- sured microalbuminuria using the Micral test (Roche Diagnostics, Indianapolis, IN). Patients were also instructed in the self-monitoring of blood glucose (SMBG) and were provided with a blood glucose Accu-Chek Advantage blood glucose meter (Roche Diagnostics) and supplies. Risk stratification and action planning. Laboratory tests and data from completed patient questionnaires were entered into the software. Risk profiles were generated using stratification algorithms and clini- cal intervention guidelines based on the ADA Clinical Practice Recommendations. Patients were stratified into high-, mod- erate-, or low-risk groups in seven categories: 1) glycemic control, 2) cardio- vascular disease, 3) nephropathy, 4) reti- nopathy, 5) hyper/hypoglycemia, 6) amputation, and 7) psychosocial disorders. Interventions. Interventions were based on previously agreed-upon standing or- ders (protocols) after approval from the primary care physician. The team care co- ordinator printed risk profile reports (physician and patient versions) and en- tered data elements into patient trending flowcharts. The team care coordinator and team care leader met to review the reports and develop action plans. The team care leader then met with primary care providers to review risk stratification reports and approve action plans. The appropriate follow-up action was deter- mined by the healthcare team based on the degree of medical intervention deemed necessary. For example, if fol- low-up was needed, the team care coor- dinator scheduled the patient for nurse consultation and/or a provider visit. If no immediate follow-up was needed, a tele- phone call to the patient may have been sufficient to update the patient on his/her status or to make a minor medication change, followed by a mailing of the pa- tient’s report. The patient reports con- tained information about the patient’s level of risk in each category and provided self-care recommendations for improving his/her diabetes (Fig. 2). Patient education. All patients attended three educational programs (2 h each) and received educational materials. Edu- cational programs focused on adult learn- ing principles and actively engaged the patients in their care. As a result, when patients presented for physician office vis- its, they were knowledgeable about their risk status and what actions would be necessary. Patients also were invited to attend optional support groups. Interim visits. Interim visits were scheduled at 3 and 6 months after the ini- tial encounter. The team care coordinator verified that patients were performing SMBG at least twice per day and recording test-strip usage. If patients were not per- forming SMBG at the minimal frequency, the team care coordinator worked with patients to identify barriers and propose solutions. Other potential self-care barri- ers related to meal-planning adherence, exercise, smoking cessation, medication administration, and so forth were identi- fied, and solutions were explored with the patient. At these visits, patients com- pleted an interim survey regarding their health care utilization. Follow-up visits. The team care coordi- nator reviewed patient records monthly (via an internet application) to monitor patient compliance; this was facilitated by an automated reminder function pro- vided by the software. The team care co- ordinator made reminder telephone calls to patients, answered questions, and re- ferred patients to the team care leader when appropriate. Statistical and analytical methods Methods/technologies used to assess complications. The patients’ blood work was performed by a local certified laboratory contracted by the MCO. HbA1c determinations were performed using a high-performance liquid chromatogra- phy method. Foot examinations included the use of the Semmes-Weinstein 5.07 monofilament (21) to test cutaneous sen- sitivity. Eye examinations were obtained by referral to optometrists supervised by ophthalmologists at several MCO practice locations. Lipid panels included a calcu- lated LDL cholesterol. Random urine dip- sticks using Micral were used to obtain a MAU result. MAU results Ͼ100 mg/l were sent to a local laboratory for quantitative evaluation. Design/validity of questionnaires used to assess patient satisfaction and statis- Clark and Associates DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1081
  • 4. tical analysis of all data. Metabolic, clinical lab, and patient survey response data were extracted from the database based on a priori hypotheses established for the statistical analyses. For DQIP (20) analysis, measures (e.g., lab HbA1c or metabolic blood pressure group values) were categorized by DQIP criteria; changes over time were tested for statisti- cal significance using McNemar’s test (22). The diabetes-specific patient satisfac- tion survey tool, which incorporates a five-point Likert-response scale, was de- veloped by a research group at the Office of Health Policy and Clinical Outcomes, Thomas Jefferson University (Philadel- phia, PA). Changes over time for the sat- isfaction multiple-response items were tested using Agresti’s test of marginal ho- mogeneity for ordinal data (23). This sta- tistical significance test is based on the generalization of the McNemar test; it ap- plies for more than two response catego- ries and takes advantage of the ordered responses of the questions. All analyses were performed using SAS software, ver- sion 6.12 for MacIntosh (SAS Institute, Cary, NC). RESULTS — At 12 months, data from 193 patients were available to assess met- abolic outcomes, which were evaluated by changes in HbA1c, blood pressure, and lipids. Additionally, an assessment was made of provider adherence to care guidelines with regard to frequency of HbA1c measurements, blood pressure readings, lipid panel utilization, foot ex- aminations, and dilated eye examinations (Table 2). Assessments were also made re- garding the number of patients who re- ceived diabetes self-management education, nutrition counseling, and smoking cessation counseling. Patient satisfaction with the health care services provided and patient understanding and compliance with the therapeutic regimen were evaluated by questionnaire. Data showed a significant improve- ment in glycemic control as measured by HbA1c (Fig. 3). During the 12-month pe- riod, the number of patients in the low- risk category (HbA1c Ͻ7%) increased by 51.1%, from 47 members at baseline to 71 after 12 months. The number of pa- tients in the moderate category (7 to Ͻ8%) increased 2.5%. The number of pa- tients in the high-risk category (Ն8.0%) decreased by 58.3%, from 76 to 48 par- ticipants. Furthermore, of those patients with HbA1c levels Ն8% at baseline, 97.4% had a change in treatment regimen during the 12 months in the program. In addition to analyzing the HbA1c data for the 193 patients for whom 12- month data were available, we also ana- lyzed the time course of 356 patients from the experimental group (which included Figure 2—Example of a risk stratification report generated from the application server. Risk stratification improves diabetes outcomes 1082 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
  • 5. data from the 315 patients who were still enrolled and the 41 patients who had dropped out of the study) and 623 pa- tients from the control group. These data are summarized in Fig. 4. The control group remained essentially unchanged, whereas significant decreases in HbA1c in the experimental group were seen at the first interval at which it was measured. The change remained constant through- out the remainder of the study. A reduction in hypertension was also seen at 12 months. The percentage of pa- tients with blood pressure readings Ͻ140/90 mmHg, an accountability mea- sure for HEDIS accreditation, increased from 38.9% at baseline to 66.8% at 12 months (Fig. 5). The percentage of pa- tients with blood pressure readings Ͻ130/85 mmHg (our pilot clinical deci- sion threshold for hypertension) in- creased from 23.8 to 44.6%. Of those patients with blood pressure readings Ͼ130/85 mmHg at baseline, 63.0% had a change in medication within 12 months in the program. The percentage of patients receiving lipid profile tests increased from 66% at baseline to 100% at 12 months, and mi- croalbuminuria testing increased from 17 to 100%, respectively (Table 2). The per- centage of patients at the highest risk for coronary heart disease (LDL Ͼ130 mg/dl) decreased from 25.4% at baseline to 20.2% at 12 months. Of those patients identified at the highest risk for nephrop- athy, 76.7% had a change in medication within the 12 months of program partic- ipation after the initial visit. In addition, at the end of 12 months, the percentage of patients who had received a dilated eye examination increased from 53.9 to 80.3%, and documented foot examina- tions increased from 0 to 100%. Improvements were also observed in patient and provider satisfaction scores (Table 3 and Fig. 6). Patients expressed a significant increase in satisfaction with the program and staff performance. Of the 70% of providers that responded to the survey, 100% indicated that they were “very satisfied” with the program, 100% believed that their patients’ diabetes was better controlled as a result of the diabetes management program, and 93% believed the program saved them time on patient visits. In addition, 100% of the providers said they would recommend the use of this program to other physicians. CONCLUSIONS — In our program, it was necessary to convert the ADA’s Clinical Practice Recommendations into concrete actions that could be carried out by the care team, supported by a interre- lated set of practice enhancements. The most significant of these enhancements was to translate the protocols into a data system that stratified each patient into risk categories based on his/her data. Therapeutic recommendations were then generated in an easy-to-follow format that could be quickly reviewed and signed by the provider and then implemented with guidance from the team care leader. The provider and the patient received an illustrated summary of the data and the resultant recommendations, allowing a productive discussion at the time of the patient visit on how to act upon the data. Based on data from the provider survey, this process resulted in more efficient vis- its and improved use of both the provid- er’s and the patient’s time. The patient survey data showed that in combination with the educational programs, it also re- sulted in improved patient satisfaction be- cause the patient understood a priori the changes necessary and the rationale. Whereas the program is simple to de- scribe, it was complex to initiate for sev- eral reasons. First, the providers had to be involved from the start to assure that the standards and their recommended ac- tions were consistent with the practitio- ners’ views. Perhaps even more important than creating provider buy-in to this pro- gram was creating awareness that there were significant gaps in performance. In several instances, this involved interactive discussion with the practitioners as well as nonpunitive provider-specific feed- back on prior performance. This feedback was provided by the authors (C.M.C. and Figure 3—Change in glycemic control risk (% HbA1c) for the treatment cohort. Ⅺ, Low (HbA1c Ͻ7.0%); u, moderate (HbA1c 7–8%); f, high (HbA1c Ͼ8.0%). Table 2—Summary of changes in clinical outcomes and provider adherence at 12 months Baseline 12 Months Clinical outcome measures High-risk glycohemoglobin, HbA1c Ͼ9.5% 10.9 3.1 Members with drop in HbA1c Ն0.5% — 45.6 Blood pressure Ͻ140/90 mmHg 38.9 66.8 Provider adherence measures Lipid profile testing within the last 2 years 66 100 Microalbuminuria within the last year 17 100 Retinal eye exam within the last year 53.9 80.3 Foot exam with monofilament test within the last year N/A 100 Data are %. Clark and Associates DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1083
  • 6. J.W.S.) reviewing the scientific basis for both the recommendation and the accep- tance of the need for change in the ap- proach to diabetes care. These educational sessions and the presentation of data on prior performance were viewed as critical links in the process of prompting the recognition that a change in the way care is delivered could have positive consequences. However, it was also critical to devise a process that included the necessary support and resources to enable providers to achieve results without being overburdened. Al- though the clinic structure was left intact, patient flow was altered, and tasks were delegated to the team care coordinator and team care leader. The team care coor- dinator and leader assured that the data were available before the patient’s visit with the provider and that the appropri- ate patient education occurred before that visit. The patients were involved in edu- cation programs from the start of the pro- gram and received a printout (in condensed form) of their data and risk status (Fig. 2). Thus, they were prepared for the visit and the discussion about how they might improve their health-risk status. The providers saw this process as improving effectiveness and productivity, which greatly facilitated ongoing partici- pation and support of the program within their clinics. Another enhancement in the program was the initiation at the onset of a psycho- social evaluation using the Problem Areas In Diabetes (PAID) questionnaire devel- oped and validated by Polonsky et al. (24). This was viewed as an important part of the initial assessment because a large percentage of adult patients with di- abetes have significant psychological co- morbidities, usually depression or anxiety disorders (25,26). Patients with abnormal PAID scores were identified to the practi- tioners for appropriate action. Educa- tional courses by the clinic psychologist were conducted with all providers to as- sist them in managing such patients. Thus, before recommendations were made for changes in therapy, it was nec- essary to address those comorbidities. Finally, it was necessary to develop a system that collated the data and pre- sented it in a format that was immediately understandable by (and useful to) the pa- tient and the provider. Thus, the data needed to be summarized in such a fash- ion as to be clear and accurate, yet of suf- ficient brevity that it could be the basis of discussion by the patient and provider. The system developed also had two addi- tional important features. First, it gener- ated a set of orders for the clinicians to review and initiate, making the recom- mended changes easy, yet permitting in- dividualization as needed. Visual graphic and analytical reporting components were shared between the patient and pro- vider report formats, facilitating the com- munication between the patient and the healthcare team. Second, it generated a reminder list for the team care coordina- tor, providing a fail-safe system to ensure that recommended actions were not over- looked or omitted. For example, if an eye exam was recommended, the system would repeatedly remind the team care coordinator until the exam took place. The success of the program in initiat- ing the recommended changes in the diabetes therapeutic regimen was the most striking; 95.8% of the patients out- side of the recommended therapeutic range had a prescribed change in therapy. These data suggest that the program was successful in convincing both patients and providers that the goals were of value and that changes were necessary to reach those goals. As the number of therapeutic choices available to treat diabetes ex- Figure 4—Time trend in average HbA1c value for Diabetes Advantage Program treatment and control groups. Average HbA1c is shown at 3-month intervals for the 12-month periods before and after enrollment. Note that the treatment group includes patients who dropped out of the program. F, Control (n ϭ 623); Ⅺ, treatment (n ϭ 356). Figure 5—Reduction in hypertension risk for treatment cohort. Risk stratification improves diabetes outcomes 1084 DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001
  • 7. pands, the metabolic success of the pro- gram should increase. It is also important to note that based on provider surveys at the completion of the study, the program did not add work to the already “overbur- dened” physician. In fact, the program served to improve workflow efficiencies for both providers and staff. The noted improvements demonstrated that excel- lent diabetes care can be achieved through enhancements in the primary care setting and that “carve-outs,” or sep- arate systems of care involving mass refer- rals of patients with diabetes to specialty clinics, are not necessary. In addition, the success of the pro- gram in initiating new therapies and im- proving patient outcomes did not come at the expense of patient satisfaction. Quite the contrary, the most striking finding of the study was the improvement in patient satisfaction that accompanied the program. Whereas the striking results of the study could have been attributable to some unique features of the patients se- lected, there are several reasons why we do not feel this is the case. Although only 193 of the patients had complete 12- month data at the completion of the study, Ͼ85% of the patients entered into the study remained in the study at its end. The data over time for the compete co- hort revealed a significant fall in HbA1c by 3 months that persisted through- out the study, whereas the HbA1c levels of a comparative control group remained constant. We believe the program was success- ful because it effectively capitalized on an array of interventions based on social marketing that have been shown to change physician behavior. Our overall strategy was to provide necessary infor- mation regarding diabetes management to care providers while removing obsta- cles that have traditionally inhibited the delivery of quality diabetes care. To this end, we developed interventions to ad- dress each of the areas previously demon- strated to influence physician behaviors, as summarized in Table 1. For example, with regard to audit and feedback, ex- plicit standards were agreed upon by the practitioners, and feedback was provided. Furthermore, once these standards were inputted into the system, they were im- plemented automatically; there was no deviation or partial compliance with the established protocols. With regard to the “opinion leader” involvement, both pri- mary care leadership and endocrine lead- ership were enthusiastic and supportive of the program. Additionally, an auto- matic system of risk stratification and re- minders was put into place. Through these interventions and others previously described, we created an environment that was supportive of comprehensive di- abetes management. Regarding the economic benefits of the intervention, this study did not ad- dress the financial implications of im- proved diabetes control. However, two recent publications suggest that there are significant and immediate economic ad- vantages to improving glycemic control and treatment of diabetes risk factors (27,28). The intervention studied was com- prehensive, and we are unable to tease out the relative role of the various interven- tions. Additionally, the study was con- ducted in a staff-model MCO and may not be applicable to other types of delivery systems. Despite these limitations, we feel that the results provide a sound basis for Figure 6—Staff provider responses to satisfaction survey. f, Yes; Ⅺ, no. Table 3—Results from patient satisfaction survey Category/question Responses Baseline 12 months Knowledge and information “In the past 3 months, how satisfied have you been with your knowledge of your diabetes?” 49.2 81.3 “How helpful is the information that you received from your health plan about taking care of your diabetes?” 82.4 96.9 Program staff “How satisfied are you with the way the staff in the diabetes program treated you?” 63.8 97.4 “How satisfied are you with the number of times that the diabetes program staff talked with you?” 51.3 96.9 Program recommendation “Overall, how satisfied are you with your health plan’s diabetes program?” 57.5 94.3 “How likely are you to recommend your health plan’s diabetes program to someone else who has your kind of diabetes?” 56.4 94.8 Data are %. Responses column refers to the percentage of patients responding “very” and “slightly” satisfied, “helpful,” or “likely” to the questions on the survey. Clark and Associates DIABETES CARE, VOLUME 24, NUMBER 6, JUNE 2001 1085
  • 8. the design of future programs within MCOs directed at improving the care of patients with diabetes and other chronic diseases. To determine whether these protocols can be adapted to other care set- tings, we have developed a CD-ROM– based continuing medical education program that targets primary care physi- cians; we are now in the process of eval- uating this program (29). Acknowledgments— Funding for the pro- gram was made possible by an educational grant from Roche Diagnostics Corporation. The authors thank the following people and institutions who participated in the develop- ment and implementation of this program: Southwest Medical Associates (B. Mitchell, R. Parr, C. Belle, P. Sparks, C. DelRosario, J. Mar- tin, and R. Appelt), Sierra Health Services (Y. Riggan and G. Teeter), Indiana University (C. Clark), Stanford University (G. Singh), AvailTek (R. Bogue), HCIA (G. Lenhart and T. Reinsch), the Clinical Education Group (K. Swenson), and Roche Diagnostics Corpora- tion (D. Burgh, S. Earl, L. Halcomb, L. Hen- derson, R. Peyton, J.M. Quach, M. Schafer, K. Schmelig, L. Stutz, and R. Wishnowsky). We also thank Elizabeth Warren-Boulton (Roche Diagnostics), upon whose literature review Table 1 is based. Part of the data included in this article was presented previously in ab- stract form at the Building Bridges VI Confer- ence (Atlanta, GA, 6–7 April 2000). References 1. Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complica- tions in insulin–dependent diabetes mel- litus. N Engl J Med 329:977–986, 1993 2. Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Fu- ruyoshi N, Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-de- pendent diabetes mellitus: a randomized prospective 6-year study. 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