Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed |
This primary outcome is measured at the level of the clinician-patient visit out of all clinic visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is not already engaged in depression treatment (denominator) and number of visits for which the patient is screened for depression (numerator) on each clinic day at each facility. Completion of depression screening (successful outcome) is defined as the clinician completing the Patient Health Questionnaire-2 (PHQ-2), and, if the PHQ-2 score is >0, also completing the PHQ-9 with the patient. |
Measured based on data from clinic visits on each clinic day throughout study period |
|
Primary |
Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification |
This primary outcome is measured at the level of the clinician-patient visit out of all treatment-eligible visits during the intervention period, including visits with both consented and non-consented patients. The outcome is based on aggregate clinic process data including number of visits for which the patient is eligible for depression treatment (denominator) and number of visits for which the patient initiates depression treatment (numerator) on each clinic day at each facility. Eligible for depression treatment is defined as PHQ-9 total score of 5 or above. Initiating depression treatment is defined as prescription of antidepressant medication or referral to Friendship Bench psychosocial counselors within 30 days of positive screen. |
Measured based on data from clinic visits on each clinic day throughout study period |
|
Primary |
Fidelity in Following the Depression Treatment Algorithm: Number of Treatment Follow-up Appointments in the First Three Months of Depression Treatment for Which the Clinical Treatment Decision Follows the Depression Treatment Guidelines |
This primary outcome is measured at the level of the clinician-patient visit out of all eligible visits during the intervention period. Eligible visits are clinical visits by consented participants within the first 90 days after initiating depression treatment. The outcome is based on clinic process data including number of clinic visits for which the participant is already engaged in depression treatment (denominator) and number of visits where the treatment decision follows the treatment algorithm (numerator) on each clinic day at each facility. Following the algorithm (positive outcome) is defined as: (1) if the participant has completed 6 counseling sessions, any action is acceptable; (2) otherwise, if the participant started counseling, either continuing counseling or starting medication; (3) if the participant started medication and PHQ-9 score <10, continuing medication; (4) if the participant started medication and PHQ-9 score >=10, continuing medication and increasing dose. |
Within the first three months of follow-up after initiating depression treatment |
|
Secondary |
Number of Participants Achieving Depression Remission at 3 Months |
This secondary outcome is measured at the level of the consented participant. Depressive severity is determined using the Patient Health Questionnaire-9 (PHQ-9; range 0-27). The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27, with 0-4 indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 severe depression. Depression remission is defined as a score <5. |
Three months post enrollment |
|
Secondary |
Number of Participants With Well Controlled NCD at 3 Months |
This secondary outcome is measured at the level of the consented participant. Hypertension is measured by research assistants at each study visit while fasting blood glucose is measured as part of routine clinical care and will be abstracted. Well-controlled non-communicable disease (NCD) will be defined for hypertension patients as systolic blood pressure (BP) <140 mmHg AND diastolic blood pressure <90 mmHg, and for diabetes patients as fasting blood glucose <130 mg/dl, following the Malawi Clinical Guidelines for the Management of NCDs. |
Three months post enrollment |
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