Clinical trial NCT02384109: A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program
Official title: A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-03-10
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of evidence-based diabetes prevention (lifestyle change or metformin)
timeFrame: 4 months
Secondary outcomes:
measure: Weight change
timeFrame: 12 months
measure: Change in A1c
timeFrame: 12 months
measure: Change in systolic blood pressure
timeFrame: 12 months
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Toluca Lake Health Center
state: California
city: Los Angeles
country: United States
facility: 100 Medical Plaza Primary Care Suites 455 & 490
state: California
city: Los Angeles
country: United States
facility: Internal Medicine Women's Health Clinic Suites 250 & 290
state: California
city: Los Angeles
country: United States
facility: UCLA Internal Medicine Family Westwood Suite 465
state: California
city: Los Angeles
country: United States
facility: UCLA Internal Medicine Geriatrics Suite 365 & 420
state: California
city: Los Angeles
country: United States
facility: CPN Brentwood
state: California
city: Los Angeles
country: United States
facility: CPN West Washington Internal Medicine
state: California
city: Pacific Palisades
country: United States
facility: Pacific Palisades
state: California
city: Santa Monica
country: United States
facility: 12th Street Clinic
state: California
city: Santa Monica
country: United States
facility: Wilshire Office
state: California
city: Santa Monica
country: United States
facility: CPN Santa Monica 15th Street Family Medicine Practice
state: California
city: Santa Monica
country: United States
facility: CPN/Santa Monica Parkside
state: California
city: Santa Monica
country: United States
facility: Santa Moica Bay Physicians/20th Street 10th Floor
state: California
city: Santa Monica
country: United States
facility: Santa Monica Bay Physicians Plaza
state: California
city: Santa Monica
country: United States
facility: Santa Monica Bay Physicians/20th Street 3rd Floor
state: California
city: Santa Monica
country: United States
facility: Santa Monica Internal Medicine
state: California
city: Santa Monica
country: United States
facility: UCLA Family Health Clinic
state: California
city: Santa Monica
country: United States
facility: Santa Moica Bay Physicians Ocean Park
state: California
city: Woodland Hills
country: United States
facility: Jack H. Skirball Health Center
state: California
city: Woodland Hills
country: United States
facility: CPN Woodland Hills Practice
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kenrik Duru, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moin T, Duru OK, Turk N, Chon JS, Frosch DL, Martin JM, Jeffers KS, Castellon-Lopez Y, Tseng CH, Norris K, Mangione CM. Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial. J Gen Intern Med. 2019 Nov;34(11):2652-2659. doi: 10.1007/s11606-019-05238-6. Epub 2019 Aug 30.