Learn, Engage, Act, Process (LEAP) for MOVE!
1 other identifier
interventional
137
1 country
1
Brief Summary
The overall goal of this project is to test whether the Learn. Engage. Act. Process (LEAP) intervention helps teams within the Veterans Health Administration's (VHA) local MOVE! group weight management programs be more in line with guidance. Forty-eight sites will be randomized to the LEAP intervention, which is a virtually delivered program that relies on the Institute for Healthcare Improvement (IHI) Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool. The LEAP intervention will be compared to active support that is provided to all VA MOVE! programs by the National Center for Health Promotion and Disease Prevention (NCP). The investigators will compare whether participation in LEAP results in engaging more Veterans in the MOVE! weight management program compared to facilities not participating in LEAP. The investigators will also collect information to understand what components of LEAP worked best and how to scale up so more teams can participate in LEAP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Oct 2016
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
July 7, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedResults Posted
Study results publicly available
October 12, 2020
CompletedJuly 27, 2023
July 1, 2023
3 years
May 12, 2016
September 16, 2020
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of MOVE! Visits Per 1000 Candidate Veterans
Rate is calculated as aggregate number of MOVE! group visits per facility divided by aggregate count of candidate Veterans living w/in 40 miles multiplied by 1000. This will include facility level aggregated number of MOVE! group visits at rolling prospective 6 month time periods after the end of each stepped-wedge cohort timeframe. Time periods are rolling based on stepped-wedge trial design. Data will be extracted from the Corporate Data Warehouse (CDW).
6 months
Study Arms (2)
Enhanced NCP Support
ACTIVE COMPARATORTeams at facilities who expressed interest in being in the trial but who are not randomly assigned to the experimental arm will be in the active comparator arm. These facilities will receive enhanced support from NCP.
LEAP Intervention
EXPERIMENTALCohorts of 6 facilities, who expressed interest in being in the trial, will be randomly selected each quarter, as guided by the stepped-wedge trial design protocol, to participate in LEAP. These facilities will also receive the same enhanced NCP support as received by the active comparator arm.
Interventions
NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool
The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool.
Eligibility Criteria
You may qualify if:
- Unit of randomization is facility.
- MOVE! group program in a VA Medical Center.
- MOVE! coordinators at medical centers who express interest in participating in the trial prior to the first cohort randomization.
You may not qualify if:
- Unit of randomization is facility.
- Facilities that are not a medical center e.g., community-based outpatient clinic, Veteran service center
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a pragmatic trial. Our main outcome measure relied on administratively collected data. Additionally, the causal pathway that leads from LEAP coaching to reach outcomes is likely impacted by unmeasured influences.
Results Point of Contact
- Title
- Laura Damschroder
- Organization
- VA Center for Clinical Management Research
Study Officials
- PRINCIPAL INVESTIGATOR
Laura J. Damschroder, MPH
VA Ann Arbor Healthcare System, Ann Arbor, MI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
July 7, 2016
Study Start
October 1, 2016
Primary Completion
September 30, 2019
Study Completion
September 30, 2020
Last Updated
July 27, 2023
Results First Posted
October 12, 2020
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
Primary outcome is based on data aggregated to the facility level. Thus, this question is N/A.