A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

The staggering number of Americans with prediabetes, now 1 in 3 adults,(1, 2) reinforces the
urgency of implementing effective action to prevent incident diabetes. Several randomized
controlled trials (RCTs) including the Diabetes Prevention Program (DPP) have demonstrated
that both intensive lifestyle change and metformin significantly reduce the risk of
progression to diabetes compared to placebo.(3-5) Prior efforts to disseminate treatment with
lifestyle into practice have resulted in variable uptake and very limited population
reach,(6) and their has been minimal to virtually no uptake of metformin for the treatment of
prediabetes.

Within the University of California, Los Angeles (UCLA) Health System, the investigators have
developed a program that embeds pharmacists in ambulatory clinics to co-manage patients with
primary care physicians. The program, called Managing your Medications for Education and
Daily Support (MyMEDS), has enrolled and treated almost 250 patients with diabetes and
poorly-controlled cardiovascular risk factors in 14 primary care clinics over the last
12-months. Because of its effectiveness, leadership at UCLA Health has disseminated this
program to all 28 primary care clinics in the system, and covers program-related costs
including the pharmacists' salaries and appointment scheduling. The MyMEDS program is now
part of routine clinical operations and represents a promising resource that could be
mobilized to improve care for patients with prediabetes.

The investigators propose to implement a novel and pragmatic diabetes prevention intervention
leveraging and extending the existing MyMEDS infrastructure. Within 10 of 20 randomly
selected intervention clinics, the investigators will facilitate appointments for patients
with prediabetes to the MyMEDS pharmacists. The pharmacists will educate patients about the
DPP and engage them in shared decision-making about diabetes prevention, using a decision aid
developed by HealthWise©. They will jointly develop a plan of care that includes intensive
lifestyle change (preferred strategy since it has the greatest probability of reducing
incident diabetes mellitus (DM)) and/or metformin, or take no immediate action and the
pharmacist will communicate this decision to the primary care physician via our electronic
health record (EHR). For participants who select lifestyle change, the investigators will
partner with the YMCA (Young Men's Christian Association) of Metropolitan Los Angeles, which
offers the DPP at multiple locations at sliding-scale rates. The YMCA will track attendance
and participation in 16 weekly lifestyle change sessions and report this data to the
pharmacists and study team (see Appendix 1 for letter of support). Patients can also
participate in the UCLA DPP which is a separate DPP delivered on the UCLA campus. For
patients who also select metformin, pharmacists will prescribe the medication as permitted
under California law SB 493.(7) Pharmacists will see patients with prediabetes in routine
follow-up to reinforce the care plan. This will be a pragmatic trial, and research funds will
not be used to support delivery of the intervention. Rather than measuring the impact of
lifestyle and/or metformin on incident diabetes or other clinical parameters, our primary
endpoint will measure improvements in active engagement of treatment for prediabetes. The
Specific Aims are as follows:

1. In a practice level, cluster-randomized, intention-to-treat trial, to test the
effectiveness of using pharmacists to implement diabetes prevention strategies among
patients with prediabetes, as compared to patients receiving usual care, on several
outcomes with pre-planned stratification of a-e by age (<60 vs > 60 years):

1. Uptake of intensive lifestyle change and/or metformin at 4 months (primary outcome)

2. Proportion of patients who achieve >5% weight loss at 4 and 12 months

3. Adjusted mean weight loss at 4 and 12 months, as a percentage of body weight at
baseline

4. Adjusted change in A1c at 12 months

5. Adjusted change in systolic blood pressure at 12 months

2. To evaluate characteristics that will influence long-term sustainability of this
intervention, among those in the intervention arm the investigators will measure:

1. Acceptability to patients, physicians, pharmacists, clinic staff, and community
partners including the YMCA

2. Patient-reported psychosocial impact of their prediabetes, both positive and
negative, stratified by the treatment selected

3. Uptake of intensive lifestyle change and/or metformin at 4 months, by age (< 60 vs.
60+), gender, and race/ethnicity

4. The incremental cost of program implementation per participant who successfully
initiates lifestyle change and/or metformin.

I

Inclusion Criteria:

- BMI (Body Mass Index) of >=24 (>=22 for Asians)

- Prediabetes based on A1c values of 5.7-6.4%

Exclusion Criteria:

- Any recorded A1c values of >6.5%

- ICD-9 billing codes of 250.xx

- Use of any antiglycemic medication

- Current or past participation in the Diabetes Prevention Program prior to providing
informed consent