A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

Study Overview
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Brief Summary
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This proposed project will translate evidence-based strategies for diabetes prevention within the framework of an existing and highly utilized pharmacist-led diabetes care program. Our team includes investigators and practitioners with experience in implementing the DPP (Diabetes Prevention Program) as well as in community-based research. This proposal represents an opportunity to rapidly implement an innovative project addressing a critical area of significant unmet need, as the required key health system and community infrastructure are already in place. The intended outcome is the creation of a practical, effective and sustainable approach to increase evidence-based diabetes prevention strategies that can readily be adopted in other systems.

Detailed Description
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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: 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): Uptake of intensive lifestyle change and/or metformin at 4 months (primary outcome) Proportion of patients who achieve >5% weight loss at 4 and 12 months Adjusted mean weight loss at 4 and 12 months, as a percentage of body weight at baseline Adjusted change in A1c at 12 months Adjusted change in systolic blood pressure at 12 months To evaluate characteristics that will influence long-term sustainability of this intervention, among those in the intervention arm the investigators will measure: Acceptability to patients, physicians, pharmacists, clinic staff, and community partners including the YMCA Patient-reported psychosocial impact of their prediabetes, both positive and negative, stratified by the treatment selected Uptake of intensive lifestyle change and/or metformin at 4 months, by age (< 60 vs. 60+), gender, and race/ethnicity The incremental cost of program implementation per participant who successfully initiates lifestyle change and/or metformin. I

Official Title
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A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

Conditions
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Prediabetic State

Intervention / Treatment
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* Behavioral: Shared decision-making with pharmacists
* Other: Standard care from primary care providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pharmacist-coordinated shared decision making about treatment for pre-diabetes (lifestyle change and/or metformin), using a decision tool | Behavioral: Shared decision-making with pharmacists<br>* Pharmacist will engage patient using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change with a goal of 7% weight loss or metformin. Patients interested in lifestyle change will be referred to a CDC (Center for Disease Control and Prevention)-approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.<br>|
| Placebo Comparator: Usual Care<br>Usual care for patients with a diagnosis of pre-diabetes | Other: Standard care from primary care providers<br>* Primary care providers address pre-diabetes as part of usual care, which may involve no action, referrals, or treatment with medications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of evidence-based diabetes prevention (lifestyle change or metformin) | Either attending 4/16 or 9/16 lifestyle change sessions, or taking metformin | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 12 months | 
| Change in A1c |  | 12 months | 
| Change in systolic blood pressure |  | 12 months |