Clinical trial NCT03891368: Study of a Learning Collaborative to Implement Health Promotion in Mental Health
Official title: Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Promotion
Obesity
Organizational Innovation
Mental Health Services
Keywords: Learning collaborative
Technical assistance
Serious mental illness
Organizational change
InSHAPE
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Dartmouth-Hitchcock Medical Center
name: Dartmouth College
First posted: 2019-03-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Mental Health Provider Organizations Inclusion Criteria:

* Provide outpatient behavioral health services to people with SMI as defined by primary DSM-V Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder or any other state-certified serious mental illness diagnosis (e.g., post-traumatic stress disorder)
* 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.

InSHAPE Participant Inclusion Criteria:

* 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:

• None

Primary outcomes:
measure: Change in Program Participation
timeFrame: 6, 12, 18, and 24 months
measure: Change in Program Fidelity
timeFrame: 6, 12, and 24 months
measure: Change in Participant Weight
timeFrame: Baseline, quarterly through 24 months
Secondary outcomes:
measure: Change in Full Program Operation defined as a 1.0 FTE Health Mentor with a caseload of 20 participants
timeFrame: 12 and 24 months
measure: Change in Program Uptake defined as the number of 1.0 FTE Health Mentors
timeFrame: 12 and 24 months
measure: Change in Participant Cardiorespiratory Fitness
timeFrame: Baseline, quarterly through 24 months
measure: Change in Participant Dietary Behavior
timeFrame: Baseline, quarterly through 24 months
measure: Change in Participant Physical Activity
timeFrame: Baseline, quarterly through 24 months
measure: Change in Program Sustainability defined as having a Health Mentor who meets with at least one InSHAPE participant
timeFrame: 24 months
measure: Change in Organizational Change that supports an organization's capacity to implement and sustain the InSHAPE program
timeFrame: 3, 12, and 24 months
measure: Change in VLC Adherence
timeFrame: Up to 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Stephen Bartels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.