Implementing and Sustaining a Sleep Treatment to Improve Community Mental Health Part 3: Sustainment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 20
- 主要终点
- Adaptations to Evidence-Based Practices Scale
研究概览
简要总结
Research on the sustainment of implemented evidence-based psychological treatments in routine practice settings, such as community mental health centers, is limited. The goal of this study is to test sustainment predictors, mechanisms, and outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in community mental health centers after implementation efforts have ended. CMHC providers have been trained to deliver a "Standard" or "Adapted" version of TranS-C. Researchers will compare these two groups to evaluate differences--and possible mechanisms--with respect to sustainment outcomes.
详细描述
More research on the sustainment of implemented evidence-based treatments in routine practice settings, such as community mental health centers (CMHCs), is needed. This study is the third and final phase-i.e., the Sustainment Phase-of a cluster-randomized controlled trial and focuses on CMHC providers' sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C). The Sustainment Phase seeks to build on the two earlier phases of the trial-the Implementation Phase (NCT04154631) and Train-the-Trainer Phase (NCT05805657)-during which TranS-C was adapted to fit the CMHC context, and ten CMHCs were cluster-randomized to implement Standard TranS-C or Adapted TranS-C via facilitation and train-the-trainer. Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended. Note that in this study, sustainment is operationalized per Shediac-Rizkallah and Bone's framework (1998) and defined as continued (a) activities, (b) benefits, and (c) capacity of an intervention after implementation efforts have ended.
Aim 1: Report the sustainment outcomes of TranS-C after implementation support has ended.
Aim 2: Evaluate whether manipulating fit to context predicts sustainment outcomes. It is hypothesized that providers in Adapted TranS-C will report better sustainment outcomes (i.e., activities, benefits, and capacity) relative to Standard TranS-C.
Aim 3: Test whether provider perceptions of fit-operationalized as acceptability, appropriateness, and feasibility-mediate the relation between treatment condition (Standard versus Adapted TranS-C) and sustainment outcomes. It is hypothesized that Adapted TranS-C, compared to Standard TranS-C, will predict better sustainment outcomes (i.e., activities, benefits, and capacity) indirectly through better provider perceptions of fit.
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 (Participant)
盲法说明
CMHC providers (i.e., the study participants) are blind to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria for CMHCs are:
- •Publicly funded adult mental health outpatient services
- •Support from CMHC leadership
- •The inclusion criteria for CMHC providers are:
- •Employed, able to deliver, or have delivered patient-facing services to patients within a CMHC
- •Have attended a TranS-C training
- •CMHC site of employment has been in a period of sustainment (i.e., implementation activities have ended) for at least three months
- •volunteer to participate and formally consent to participate
排除标准
- 未提供
结局指标
主要结局
Adaptations to Evidence-Based Practices Scale
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses provider adaptations to TranS-C via six self-report items that are rated on scale from 1 (not at all) to 4 (very great extent) such that higher scores indicate greater use of adaptations.
Provider Report of Sustainment Scale
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' continued delivery of TranS-C via three self-report items that are rated on a scale from 0 (not at all) to 4 (to a very great extent) such that higher scores indicate more sustainment.
Skills Subscale from the Determinants of Implementation Behavior Questionnaire
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers perceptions of their skills to deliver TranS-C using three self-report items rated on a scale from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate perceptions of greater skills.
Organizational Resources Subscale from the Implementation Potential Scales
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' perceptions of whether they have the resources, support, and time needed to deliver TranS-C. Three items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), where higher ratings indicate more perceived resources, support, and time.
Penetration of TranS-C in Provider Caseload
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Two self-report items are used to derive the proportion of eligible patients with whom the provider has used TranS-C (i.e., number of eligible patients with whom provider has used TranS-C / the number of providers' patients with sleep problems), with higher scores indicating more penetration.
Outcomes and Effectiveness Scale
时间窗: Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.
Assesses providers' perceptions of TranS-C's health benefits using five self-report items rated on a scale from 0 (to little or no extent) to 7 (to a very great extent) such that higher scores indicate more perceived benefits.
次要结局
- Percentage of TranS-C Strategies Used(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Number of Sessions with TranS-C(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Administrator Support Subscale from the Implementation Potential Scales(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Use of Provider Manual and Patient Workbook(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- TranS-C Provider Checklist(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Adaptations Checklist from the Framework for Reporting Adaptations and Modification - Expanded(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- TranS-C Delivery Relative to Pre-Sustainment(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Creation of Sleep Treatment Materials(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- Knowledge of TranS-C(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)
- TranS-C as Integrated or Standalone Treatment(Once during the Sustainment Phase, at least 3 months after implementation efforts have ended.)