Aligning Facility Leadership and Climate to Advance Mental Health Services Integration in Malawi

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

<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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Champion strategy

    Behavioral

    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

    Behavioral

    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.

Treatment groups

1,080 Participants
are divided into 2 treatment groups
Group A: Adapted LOCI leadership and climate alignment strategy plus champion strategyExperimental treatment 1 intervention
Group B: Champion strategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of screening-eligible visits at which patients were screened for mental health

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.

Time frame
Over the 12 months of the randomized period
2

Proportion of visits at which patients endorsed suicidal ideation at which a suicide risk assessment was completed

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.

Time frame
Over the 12 months of the randomized period
3

Proportion of patients who were appropriately initiated on mental health treatment

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.

Time frame
Over the 12 months of the randomized period
4

Proportion of follow-up visits at which clinical decisions followed mental health treatment guidelines

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.

Time frame
Over the 12 months of the randomized period

Secondary outcomes

1

Proportion of patients achieving mental health remission

Mental health remission will be defined as the proportion of patients who achieve depression and anxiety remission at 3 months. Anxiety severity is determined using the Generalized Anxiety Disorder scale-7 (GAD-7) which is a seven-item diagnostic tool with total scores ranging from 0 to 21 where higher scores indicate greater self-reported anxiety. Anxiety remission is defined as a score \<5. Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9) which is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression with scores ranging from 0 to 27 where higher scores indicate greater self-reported depression. Depression remission is defined as a score \<5. Overall remission is defined as both a GAD-7 score \<5 and a PHQ-9 score \<5, regardless of which score or scores was elevated at baseline.

Time frame
3 months after participant enrollment
2

Proportion of patients achieving chronic condition control

Chronic condition control will be defined as the proportion of patients whose chronic condition biomarker indicates good control. Patients from the HIV clinic will complete a viral load. Patients from the Non-Communicable Diseases (NCD) clinic will complete a blood pressure measure (hypertension) or HbA1c measure (diabetes). Patients from the Tuberculosis (TB) clinic will complete a sputum smear. Control will be defined for HIV as HIV RNA viral load \<1000 c/mL; for hypertension patients as systolic blood pressure \<140 mmHg AND diastolic blood pressure \<90 mmHg, for diabetes patients as HbA1c \< 7.0%; and for TB patients as sputum smear negative.

Time frame
6 months after participant enrollment

Other outcomes

Sponsors and contacts

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University of North Carolina, Chapel Hill

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator