Study of a Learning Collaborative to Implement Health Promotion in Mental Health
NCT ID: NCT03891368
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
55 participants
INTERVENTIONAL
2014-11-26
2022-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim 1 (Service Outcomes): Compare the effectiveness of VLC to TA with respect to Program Participation as measured by the proportion of enrolled individuals who received an adequate exposure to the evidence-based practice, as defined by attending at least 50% of the InSHAPE Health Mentor sessions over 6 months.
(H1) Hypothesis: VLC compared to TA will be associated with greater Program Participation.
Aim 2 (Implementation Outcomes): Compare VLC to TA with respect to Program Fidelity as measured by the InSHAPE Fidelity Scale.
(H2) Hypothesis: VLC compared to TA will be associated with greater Program Fidelity.
Aim 3 (Participant Outcomes): Compare VLC to TA with respect to adult participants with SMI enrolled in the InSHAPE program achieving clinically significant weight loss (≥5% weight loss).
(H3) Hypothesis: VLC compared to TA will be associated with a greater proportion of InSHAPE participants achieving clinically significant weight loss.
Secondary aims:
The investigators will also examine the following exploratory hypotheses: VLC compared to TA will result in (E1) more rapid Full Program Operation; (E2) greater Program Uptake; (E3) significantly improved participant health behaviors of physical activity and nutrition; and (E4) greater likelihood of Program Sustainability at 24 months. The investigators will also explore (E5) the effect of Organizational Change and VLC fidelity on Program Participation, and (E6) agency participation and adherence to the core elements of a Learning Collaborative as a predictor of InSHAPE program participation, InSHAPE program fidelity, and participant weight outcomes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Virtual Learning Collaborative
The virtual learning collaborative (VLC) is an 18-month intensive training, skill building, and structured implementation process focused on reinforcing fidelity to the InSHAPE model.
Virtual Learning Collaborative
InSHAPE teams consisting of health mentors, supervisors, and senior leaders from each mental health agency randomized to the VLC will be invited to attend an in-person initial kick-off meeting followed by once per month 90-minute VLC sessions. The VLC is organized into three stages: Prework, Action, and Continuous Improvement. VLC faculty, including interventionists with expertise in implementation science, quality improvement, and subject matter (i.e., InSHAPE) experts, will facilitate VLC sessions following a structured protocol to standardize the planning and execution of the VLC across three cohorts enrolled in the study.
Technical Assistance
The technical assistance (TA) condition includes four scheduled conference calls between an InSHAPE expert TA "coach" and the agency's InSHAPE team, with the option for sites to request additional calls as needed through 18-months post-randomization.
Technical Assistance
Scheduled calls will occur at 1 month, 2 months, 8 months, and 14 months following their participation in initial InSHAPE training following randomization and follow a structured protocol. At the end of each scheduled conference call, the coach will schedule the next call with the site.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Virtual Learning Collaborative
InSHAPE teams consisting of health mentors, supervisors, and senior leaders from each mental health agency randomized to the VLC will be invited to attend an in-person initial kick-off meeting followed by once per month 90-minute VLC sessions. The VLC is organized into three stages: Prework, Action, and Continuous Improvement. VLC faculty, including interventionists with expertise in implementation science, quality improvement, and subject matter (i.e., InSHAPE) experts, will facilitate VLC sessions following a structured protocol to standardize the planning and execution of the VLC across three cohorts enrolled in the study.
Technical Assistance
Scheduled calls will occur at 1 month, 2 months, 8 months, and 14 months following their participation in initial InSHAPE training following randomization and follow a structured protocol. At the end of each scheduled conference call, the coach will schedule the next call with the site.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Agree to study procedures including a commitment by CEO or designee to: (a) participate over the full program, including randomization to VLC or TA; (b) engage (if randomized to VLC) in monthly web-based meetings with other VLC members, including sharing implementation outcome data and performance evaluations; (c) collect and submit aggregate participant-level data, including demographics, weight/BMI, physical fitness as measured by a 6-minute walk test, waist circumference, frequency of physical activity, and self-reported changes in nutrition; and (d) participate in phone-based organizational change and implementation assessments, including organization leadership, middle management, and InSHAPE staff.
* Age 18 or older
* SMI as defined by primary DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder or any other state-certified SMI diagnosis (e.g., post-traumatic stress disorder)
* Verbal permission from participant to share de-identified data with the research team
* Overweight or obesity as indicated by BMI of 25 kg/m2 or greater
* Medical clearance for participation in an exercise and dietary medication program by a physician, physician assistant, or nurse practitioner.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Dartmouth College
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stephen Bartels
Director, The Mongan Institute, James J. and Jean H. Mongan Chair in Health Policy and Community Health at MGH-Harvard
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen Bartels, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
References
Explore related publications, articles, or registry entries linked to this study.
Aschbrenner KA, Pratt SI, Bond GR, Zubkoff L, Naslund JA, Jue K, Williams G, Kinney A, Cohen MJ, Godfrey MM, Bartels SJ. A virtual learning collaborative to implement health promotion in routine mental health settings: Protocol for a cluster randomized trial. Contemp Clin Trials. 2019 Sep;84:105816. doi: 10.1016/j.cct.2019.105816. Epub 2019 Jul 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.