Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 4:12 PM
Study NCT ID:
NCT03891368
Status:
UNKNOWN
Last Update Posted:
2021-10-18
First Post:
2019-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Learning Collaborative to Implement Health Promotion in Mental Health
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). The investigators hypothesize that VLC compared to TA will be associated with greater Program Participation, Program Fidelity, and a greater proportion of participants achieving clinically significant weight loss.
Detailed Description:
Despite the existence of a variety of evidence-based health promotion practices, it is not well documented how to effectively transform community mental health organizations to embrace wellness as central to their mission and services. Healthcare organizations have increasingly formed quality-improvement Learning Collaboratives to improve care for specific populations; however, there are few data on the effectiveness of this strategy compared to conventional training approaches. The primary aim of this cluster randomized implementation trial is to evaluate the effectiveness of a virtual learning collaborative (VLC) in the implementation of a lifestyle intervention for persons with serious mental illness (SMI) in routine mental health settings, compared to typical implementation consisting of site training and one-on-one individual technical assistance (TA). Forty-eight mental health provider organizations from across the United States providing behavioral health services to people with SMI will be recruited to participate in collaboration with the National Council for Behavioral Health. The evidence-based practice to be implemented is the InSHAPE health coaching intervention for persons with SMI. Sites will be stratified by size and randomized to receive an 18-month intensive group-based VLC with monthly learning sessions or individual technical assistance with four scheduled conference calls over 18 months. Sites will be enrolled in three blocks of 16 sites each. The investigators will compare implementation VLC to TA with respect to service outcomes, implementation outcomes, and participant outcomes:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MH102325 | NIH | None | https://reporter.nih.gov/quic… | View |
| STUDY00028067 | OTHER | Dartmouth College | View |