Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,080
- 试验地点
- 12
- 主要终点
- Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed
研究概览
简要总结
The main objective of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings.
详细描述
Task-shared mental health interventions are effective in low- and middle-income countries (LMICs), yet they remain underutilized, and the mental health treatment gap remains substantial. Innovative implementation strategies are needed to successfully integrate evidence-based mental health treatments into medical care in LMICs.
A common component of many implementation efforts is a "champion" strategy which identifies and empowers an on-the-ground staff member as the implementation champion, in charge of focusing their colleagues' efforts on implementation of the evidence-based treatment model. Yet a growing body of research, including our own work in Malawi and elsewhere, highlights that the champion's success is strongly influenced by the strength of support from their line manager and other up-the-chain organization leaders, who are critical in aligning the organization's climate and priorities in support of the implementation effort.
Approaches to influencing leadership engagement to change organizational climate and align priorities has been developed over decades in the field of organizational and industrial psychology but only relatively recently applied to implementation science health research and primarily to implementation in high-income countries. The Leadership and Organizational Change for Implementation (LOCI) is a recently developed multi-level leadership coaching implementation strategy that has demonstrated effectiveness in changing organizational climate, aligning priorities, and enhancing mental health treatment model integration in the US and Norway, but has not been adapted to or tested in low-income country settings. LOCI has significant potential to address the gaps identified in our current research by aligning leadership priorities to support champions in advancing mental health integration.
The overall aim of the proposed study is to evaluate the impact of the combined leadership alignment + champion implementation strategy compared to a champion strategy alone, on integration of an evidence-based mental health treatment model into multiple medical care settings via a cluster-randomized randomized control trial(RCT).
Leadership alignment strategies are an understudied but essential ingredient for successful mental health integration efforts. This project will make a major contribution to our understanding of the role of leadership alignment in advancing evidence-based mental health integration in LMICs.
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
- None
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
- •18 years old or older
- •Patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.
排除标准
- •<18 years old
- •Not currently a patient receiving medical care in participating district who screened positive for elevated common mental disorder symptoms that day or in the preceding month.
研究组 & 干预措施
Adapted LOCI leadership and climate alignment strategy plus champion strategy
Implementation of LOCI strategy (adapted for the Malawian context) plus the champion strategy (enhanced usual care- usual outpatient care enhanced with use of trained champions).
干预措施: Adapted LOCI leadership and climate alignment strategy plus champion strategy (Behavioral)
Champion strategy
Enhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions.
干预措施: Champion strategy (Behavioral)
结局指标
主要结局
Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed
时间窗: Over the 12 months of the randomized period
Fidelity of safety assessment will be defined as the proportion of patient visits with a PHQ-9 question 9 score \>0 that included a documented Suicide Risk Assessment result. This will be measured utilizing clinical administrative data abstraction.
Proportion of patients who were appropriately initiated on mental health treatment
时间窗: Over the 12 months of the randomized period
Fidelity of mental health treatment initiation will be defined as the proportion of patients eligible for mental health treatment who actually started either Friendship Bench counseling or medication within 30 days of identification. Eligibility for mental health treatment is defined as having a GAD-7 or PHQ-9 total score of 5 or above. This will be measured utilizing clinical administrative data abstraction.
Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines
时间窗: Over the 12 months of the randomized period
Fidelity of follow-up treatment will be defined as the proportion of follow-up appointments in the first three months of mental health treatment where the clinical treatment decision follows the mental health treatment guidelines. For Friendship Bench (FB) counseling, fidelity is achieved by continuing FB until completion or switching to medication. For medication, if the follow-up GAD-7/PHQ-9 score is \<5, fidelity is achieved by continuing treatment; if the follow-up GAD-7/PHQ-9 score is ≥5, fidelity is achieved by continuing treatment and increasing dose. This will be measured utilizing clinical administrative data abstraction.
Proportion of Counseling sessions meeting Fidelity Threshold
时间窗: Over the 12 months of the randomized period
Fidelity of Friendship Bench counseling will be defined as the proportion of Friendship Bench counseling sessions receiving a score of ≥3 (Satisfactory) on ≥8 of 10 fidelity checklist items.
Proportion of screening-eligible visits at which patients were screened for mental health
时间窗: Over the 12 months of the randomized period
Fidelity of mental health screening will be defined as the proportion of visits eligible for anxiety and depression screening that included the screening. Screening-eligible visits are visits where the patient is not currently receiving mental health treatment. Completion of anxiety and depression screening is defined as completing both the GAD-2 and the Patient Health Questionnaire-2 (PHQ-2), and, if one or both are ≥3, also completing the relevant longer instrument(s) - GAD-7 and PHQ-9. This will be measured utilizing clinical administrative data abstraction.
次要结局
- Proportion of patients achieving chronic condition control(6 months after participant enrollment)
- Proportion of patients achieving mental health remission(3 months after participant enrollment)