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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Champion strategy
BehavioralThe 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
BehavioralThe 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
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
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.
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.
Sponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator