Trial Outcomes & Findings for Learn, Engage, Act, Process (LEAP) for MOVE! (NCT NCT02825680)

NCT ID: NCT02825680

Last Updated: 2023-07-27

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

137 participants

Primary outcome timeframe

6 months

Results posted on

2023-07-27

Participant Flow

Participant milestones

Participant milestones
Measure
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 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
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. 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.
Overall Study
STARTED
82
55
Overall Study
COMPLETED
82
39
Overall Study
NOT COMPLETED
0
16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Learn, Engage, Act, Process (LEAP) for MOVE!

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Enhanced NCP Support
n=82 Participants
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
LEAP Intervention
n=55 Participants
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
Rate of MOVE! Visits Per 1000 Candidate Veterans
Before LEAP
4.504 Rate of MOVE! Visits per 1000 Candidate
Interval 4.267 to 4.742
4.853 Rate of MOVE! Visits per 1000 Candidate
Interval 4.555 to 5.15
Rate of MOVE! Visits Per 1000 Candidate Veterans
After LEAP
4.824 Rate of MOVE! Visits per 1000 Candidate
Interval 4.414 to 5.233
5.061 Rate of MOVE! Visits per 1000 Candidate
Interval 4.677 to 5.445

Adverse Events

Enhanced NCP Support

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

LEAP Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Damschroder

VA Center for Clinical Management Research

Phone: 734-845-3603

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place