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A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared decision-making with pharmacists
Standard care from primary care providers
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Toluca Lake Health Center
  • 100 Medical Plaza Primary Care Suites 455 & 490
  • Internal Medicine Women's Health Clinic Suites 250 & 290
  • UCLA Internal Medicine Family Westwood Suite 465
  • UCLA Internal Medicine Geriatrics Suite 365 & 420
  • CPN Brentwood
  • CPN West Washington Internal Medicine
  • Pacific Palisades
  • 12th Street Clinic
  • Wilshire Office
  • CPN Santa Monica 15th Street Family Medicine Practice
  • CPN/Santa Monica Parkside
  • Santa Moica Bay Physicians/20th Street 10th Floor
  • Santa Monica Bay Physicians Plaza
  • Santa Monica Bay Physicians/20th Street 3rd Floor
  • Santa Monica Internal Medicine
  • UCLA Family Health Clinic
  • Santa Moica Bay Physicians Ocean Park
  • Jack H. Skirball Health Center
  • CPN Woodland Hills Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Usual Care

Arm Description

Pharmacist-coordinated shared decision making about treatment for pre-diabetes (lifestyle change and/or metformin), using a decision tool

Usual care for patients with a diagnosis of pre-diabetes

Outcomes

Primary Outcome Measures

Uptake of evidence-based diabetes prevention (lifestyle change or metformin)
Either attending 4/16 or 9/16 lifestyle change sessions, or taking metformin

Secondary Outcome Measures

Weight change
Change in A1c
Change in systolic blood pressure

Full Information

First Posted
March 4, 2015
Last Updated
September 26, 2019
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02384109
Brief Title
A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program
Official Title
A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pharmacist-coordinated shared decision making about treatment for pre-diabetes (lifestyle change and/or metformin), using a decision tool
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual care for patients with a diagnosis of pre-diabetes
Intervention Type
Behavioral
Intervention Name(s)
Shared decision-making with pharmacists
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care from primary care providers
Intervention Description
Primary care providers address pre-diabetes as part of usual care, which may involve no action, referrals, or treatment with medications.
Primary Outcome Measure Information:
Title
Uptake of evidence-based diabetes prevention (lifestyle change or metformin)
Description
Either attending 4/16 or 9/16 lifestyle change sessions, or taking metformin
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Weight change
Time Frame
12 months
Title
Change in A1c
Time Frame
12 months
Title
Change in systolic blood pressure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenrik Duru, MD, MSHS
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toluca Lake Health Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
100 Medical Plaza Primary Care Suites 455 & 490
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Internal Medicine Women's Health Clinic Suites 250 & 290
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Internal Medicine Family Westwood Suite 465
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Internal Medicine Geriatrics Suite 365 & 420
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
CPN Brentwood
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
Facility Name
CPN West Washington Internal Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90066
Country
United States
Facility Name
Pacific Palisades
City
Pacific Palisades
State/Province
California
ZIP/Postal Code
90272
Country
United States
Facility Name
12th Street Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
Wilshire Office
City
Santa Monica
State/Province
California
ZIP/Postal Code
90401
Country
United States
Facility Name
CPN Santa Monica 15th Street Family Medicine Practice
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
CPN/Santa Monica Parkside
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Moica Bay Physicians/20th Street 10th Floor
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Bay Physicians Plaza
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Bay Physicians/20th Street 3rd Floor
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Monica Internal Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UCLA Family Health Clinic
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Santa Moica Bay Physicians Ocean Park
City
Santa Monica
State/Province
California
ZIP/Postal Code
90405
Country
United States
Facility Name
Jack H. Skirball Health Center
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91364
Country
United States
Facility Name
CPN Woodland Hills Practice
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31471729
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.
Results Reference
derived

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A Pharmacist-Coordinated Implementation of the Diabetes Prevention Program

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