Clinical trial NCT06399991: Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi
Official title: Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi (ALIGN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-05-06
Enrollment: 1080
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Primary outcomes:
measure: Proportion of screening-eligible visits at which patients were screened for mental health
timeFrame: Over the 12 months of the randomized period
measure: Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed
timeFrame: Over the 12 months of the randomized period
measure: Proportion of patients who were appropriately initiated on mental health treatment
timeFrame: Over the 12 months of the randomized period
measure: Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines
timeFrame: Over the 12 months of the randomized period
measure: Proportion of Counseling sessions meeting Fidelity Threshold
timeFrame: Over the 12 months of the randomized period
Secondary outcomes:
measure: Proportion of patients achieving mental health remission
timeFrame: 3 months after participant enrollment
measure: Proportion of patients achieving chronic condition control
timeFrame: 6 months after participant enrollment
Other outcomes:
Locations:
city: Chiradzulu
country: Malawi
facility: Chiradzulu District Hospital
city: Dedza
country: Malawi
facility: Dedza District Hospital
city: Kasungu
country: Malawi
facility: Kasungu District Hospital
city: Machinga
country: Malawi
facility: Machinga District Hospital
city: Mangochi
country: Malawi
facility: Mangochi District Hospital
city: Mchinji
country: Malawi
facility: Mchinji District Hospital
city: Mulanje
country: Malawi
facility: Mulanje District Hospital
city: Mzimba
country: Malawi
facility: Mzimba South District Hospital
city: Nkhata Bay
country: Malawi
facility: Nkhata Bay District Hospital
city: Ntcheu
country: Malawi
facility: Ntcheu District Hospital
city: Phalombe
country: Malawi
facility: Phalombe District Hospital
city: Salima
country: Malawi
facility: Salima District Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pence
role: PRINCIPAL_INVESTIGATOR
References: