Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi
NCT ID: NCT06399991
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1080 participants
INTERVENTIONAL
2025-04-08
2027-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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).
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.
Champion strategy
Enhanced usual care. Continue with usual outpatient care, enhanced with use of trained champions.
Champion strategy
The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.
Interventions
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Champion strategy
The champion strategy involves identifying champions within each district who are trained and supported as change agents through training and supervision.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Brian Pence
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Chiradzulu District Hospital
Chiradzulu, , Malawi
Dedza District Hospital
Dedza, , Malawi
Kasungu District Hospital
Kasungu, , Malawi
Machinga District Hospital
Machinga, , Malawi
Mangochi District Hospital
Mangochi, , Malawi
Mchinji District Hospital
Mchinji, , Malawi
Mulanje District Hospital
Mulanje, , Malawi
Mzimba South District Hospital
Mzimba, , Malawi
Nkhata Bay District Hospital
Nkhata Bay, , Malawi
Ntcheu District Hospital
Ntcheu, , Malawi
Phalombe District Hospital
Phalombe, , Malawi
Salima District Hospital
Salima, , Malawi
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-2722
Identifier Type: -
Identifier Source: org_study_id
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