Study of a Learning Collaborative to Implement Health Promotion in Mental Health

NCT03891368 | Unknown

• 2 other identifiers: R01MH102325STUDY00028067
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Promotion; Obesity; Organizational Innovation; Mental Health Services

Keywords

Learning collaborative; Technical assistance; Serious mental illness; Organizational change; InSHAPE

Outcome Measures

Primary Outcomes (3)

• Change in Program Participation

  Program Participation will be measured as the proportion of InHAPE participants who have been enrolled and have received adequate exposure to the intervention, defined by attending at least 50% of health mentor sessions over 6 months.

  6, 12, 18, and 24 months

• Change in Program Fidelity

  Program Fidelity will be measured using the 22-item InSHAPE Fidelity Scale which assesses structural elements of program implementation in the domains of staffing, organization, and services. Items are rated on a 5-point behaviorally-anchored scale ranging from 1 (not implemented) to 5 (fully implemented) (e.g., weekly review of exercise objectives is scored 5 if 90-100% of required exercise logs are completed, a score of 1 represents 0-24%). The 22 items give a total score ranging from 22 to 110, with a higher score indicating stronger fidelity to the InSHAPE model.

  6, 12, and 24 months

• Change in Participant Weight

  Participant Weight will be defined as clinically significant weight loss of ≥5% body weight since baseline, and weight will be measured to the tenth of a pound on a digital bathroom scale.

  Baseline, quarterly through 24 months

Secondary Outcomes (8)

• Change in Full Program Operation defined as a 1.0 FTE Health Mentor with a caseload of 20 participants

  12 and 24 months

• Change in Program Uptake defined as the number of 1.0 FTE Health Mentors

  12 and 24 months

• Change in Participant Cardiorespiratory Fitness

  Baseline, quarterly through 24 months

• Change in Participant Dietary Behavior

  Baseline, quarterly through 24 months

• Change in Participant Physical Activity

  Baseline, quarterly through 24 months

Study Arms (2)

Virtual Learning Collaborative

EXPERIMENTAL

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.

Other: Virtual Learning Collaborative

Technical Assistance

ACTIVE COMPARATOR

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.

Other: Technical Assistance

Interventions

Virtual Learning Collaborative OTHER

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.

Virtual Learning Collaborative

Technical Assistance OTHER

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.

Technical Assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Dartmouth College: collaborator

Related Publications (1)

• 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.

  PMID: 31344520 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Health Planning Technical Assistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations

Study Officials

• Stephen Bartels, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, The Mongan Institute, James J. and Jean H. Mongan Chair in Health Policy and Community Health at MGH-Harvard

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 27, 2019
• Study Start: November 26, 2014
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-08