Randomized Controlled Trial of a Learning Collaborative to Implement Health Promotion in Mental Health
试验速览
- 阶段
- 不适用
- 入组人数
- 55
- 主要终点
- Change in Participant Weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Change in Participant Weight
时间窗: Baseline, quarterly through 24 months
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.
Change in Program Fidelity
时间窗: 6, 12, and 24 months
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.
Change in Program Participation
时间窗: 6, 12, 18, and 24 months
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.
次要结局
- 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 Program Sustainability defined as having a Health Mentor who meets with at least one InSHAPE participant(24 months)
- Change in Participant Dietary Behavior(Baseline, quarterly through 24 months)
- Change in Participant Physical Activity(Baseline, quarterly through 24 months)
- Change in Organizational Change that supports an organization's capacity to implement and sustain the InSHAPE program(3, 12, and 24 months)
- Change in VLC Adherence(Up to 18 months)
研究者
Stephen Bartels
Director, The Mongan Institute, James J. and Jean H. Mongan Chair in Health Policy and Community Health at MGH-Harvard
Massachusetts General Hospital