Learn, Engage, Act, Process (LEAP) for MOVE!
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The Veterans Affairs (VA) National Center for Health Promotion and Disease Prevention (NCP) first disseminated MOVE! weight management program guidance in 2006. Program guidance was updated in 2014, which is expected to increase engagement and improve outcomes. However, variation in local programs is high. The overall goal of this project is to test the Learn. Engage. Act. Process (LEAP) intervention to work with teams virtually, to build skills in implementing program improvements. Forty-eight sites will be randomized to the LEAP intervention using a stepped-wedge trial design. LEAP is a virtually delivered program that relies 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. The LEAP intervention will be compared to active support provided by NCP to all local VA MOVE! teams. The investigators will compare whether teams participating in LEAP have MOVE! programs that engage more Veterans compared to facilities not participating in LEAP. The investigators will also collect information to understand which components of LEAP worked best and how to scale up and implement LEAP more broadly. The project aims are:
Aim 1: To develop three core products to enhance NCP support to Veterans Affairs Medical Centers (VAMCs) and to pilot LEAP in three VAMCs.
H1: Dissemination of products to enhance NCP support will improve MOVE! outcomes.
Aim 2: To determine effectiveness of LEAP plus enhanced NCP support (LEAP+NCP) versus enhanced NCP support alone.
H2: VAMCs with LEAP+NCP will have better MOVE! group outcomes than VAMCs with enhanced NCP support alone.
Aim 3: To conduct formative and cost evaluations to refine design of LEAP and inform future scaling-up of LEAP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Enhanced NCP Support Teams 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. |
Other: Enhanced NCP Support
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
|
| Experimental: LEAP Intervention Cohorts 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. |
Other: Enhanced NCP Support
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
Other: LEAP
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.
|
Outcome Measures
Primary Outcome Measures
- Rate of MOVE! Visits Per 1000 Candidate Veterans [6 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
Unit of randomization is facility.
-
Facilities that are not a medical center e.g., community-based outpatient clinic, Veteran service center
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | United States | 48105 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Laura J. Damschroder, MPH, VA Ann Arbor Healthcare System, Ann Arbor, MI
Study Documents (Full-Text)
More Information
Publications
None provided.- QUX 16-004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Enhanced NCP Support | LEAP Intervention |
|---|---|---|
| Arm/Group Description | Teams 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 the National Center for Health Promotion and Disease Prevention (NCP). Enhanced NCP Support: 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 | Cohorts 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. Enhanced NCP Support: 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 LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based 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. |
| Period Title: Overall Study | ||
| STARTED | 82 | 55 |
| COMPLETED | 82 | 39 |
| NOT COMPLETED | 0 | 16 |
Baseline Characteristics
| Arm/Group Title | Enhanced NCP Support | LEAP Intervention | Total |
|---|---|---|---|
| Arm/Group Description | Teams 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 the National Center for Health Promotion and Disease Prevention (NCP). Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls, online tools and resources, and technical assistance. Facilities will also have access to a customized "cube" of administrative data including sessions delivered, weight outcomes, and levels of participation for all Veterans Health Administration (VHA) MOVE! programs. | Cohorts 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. Enhanced NCP Support: NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls, online tools and resources, and technical assistance. Facilities will also have access to a customized "cube" of administrative data including sessions delivered, weight outcomes, and levels of participation for all VHA MOVE! programs. LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based 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. | Total of all reporting groups |
| Overall Participants | 0 | 0 | 0 |
| Age (years) [] | |||
| Sex: Female, Male () [] | |||
| Female | |||
| Male | |||
| Race and Ethnicity Not Collected () [] | |||
Outcome Measures
| Title | Rate of MOVE! Visits Per 1000 Candidate Veterans |
|---|---|
| Description | 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). |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Enhanced NCP Support | LEAP Intervention |
|---|---|---|
| Arm/Group Description | Teams 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. Enhanced NCP Support: 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 | Cohorts 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. Enhanced NCP Support: 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 LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model of Change, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool |
| Measure Participants | 82 | 55 |
| Before LEAP |
4.504
|
4.853
|
| After LEAP |
4.824
|
5.061
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Enhanced NCP Support, LEAP Intervention |
|---|---|---|
| Comments | This analysis compares reach within the pre-intervention timeframe versus the post-intervention timeframe for each LEAP (intervention) and control case. Intention to treat analysis was used; all participating facilities randomized to the LEAP (intervention) arm were included whether or not they completed the intervention. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .011 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Adverse Events
| Time Frame | This study did not collect data about individual patients. The unit of randomization for this study was VA Medical Centers. Participants in this study were a team of healthcare providers from the group MOVE! weight management program at each participating VA Medical Center. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Participants for this study were VA facilities and not individual patients. | |||
| Arm/Group Title | Enhanced NCP Support | LEAP Intervention | ||
| Arm/Group Description | Teams 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. Enhanced NCP Support: 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 | Cohorts 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. Enhanced NCP Support: 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 LEAP: The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model of Change, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool | ||
All Cause Mortality |
||||
| Enhanced NCP Support | LEAP Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
| Enhanced NCP Support | LEAP Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Enhanced NCP Support | LEAP Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | ||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Laura Damschroder |
|---|---|
| Organization | VA Center for Clinical Management Research |
| Phone | 734-845-3603 |
| Laura.Damschroder@va.gov |
- QUX 16-004