Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Champion strategy, Adapted LOCI leadership and climate alignment strategy plus champion strategy.
- Who it may be relevant to
- Registry conditions: Anxiety, Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
Overview
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.
Detailed description
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.
Interventions
- Behavioral Champion strategy
The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision. - Behavioral Adapted LOCI leadership and climate alignment strategy plus champion strategy
The LOCI strategy involves engaging with district health leadership through data and feedback, leadership development trainings, coaching, and alignment strategy activities to align leadership and climate in support of implementing the evidence-based mental health package. The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.
Primary outcome measures
- Proportion of screening-eligible visits at which patients were screened for mental health [Time frame: Over the 12 months of the randomized period]
- Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed [Time frame: Over the 12 months of the randomized period]
- Proportion of patients who were appropriately initiated on mental health treatment [Time frame: Over the 12 months of the randomized period]
- Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines [Time frame: Over the 12 months of the randomized period]
- Proportion of Counseling sessions meeting Fidelity Threshold [Time frame: Over the 12 months of the randomized period]
Secondary outcome measures (2)
- Proportion of patients achieving mental health remission [Time frame: 3 months after participant enrollment]
- Proportion of patients achieving chronic condition control [Time frame: 6 months after participant enrollment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- <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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Malawi · 12 centers
- Chiradzulu District Hospital — Chiradzulu
- Dedza District Hospital — Dedza
- Kasungu District Hospital — Kasungu
- Machinga District Hospital — Machinga
- Mangochi District Hospital — Mangochi
- Mchinji District Hospital — Mchinji
- Mulanje District Hospital — Mulanje
- Mzimba South District Hospital — Mzimba
- … and 4 more centers
Identifiers
NCT: NCT06399991 · 23-2722 · R01MH133028