Depression
Conditions
Brief summary
This is a 10-site cluster-randomized implementation science trial that compares two clinic-level implementation strategies to facilitate ongoing Ministry of Health efforts to scale up depression treatment within non-communicable diseases clinics in Malawi. Primary outcomes are clinical care indicators measured at the level of the visit (patient screened yes/no; depression treatment initiated if indicated yes/no; depression treatment algorithm followed at follow-up yes/no). Secondary outcomes are patient health outcomes measured at the level of the participant.
Detailed description
This 10-site cluster-randomized implementation science trial compares the success of two clinic-level strategies in achieving high-quality integration of depression treatment into 10 non-communicable diseases (NCD) clinics in Malawi. Clinics are randomized 1:1 to one of two clinic-level implementation strategies: a basic strategy involving an internal coordinator, and an enhanced strategy combining the internal coordinator with an external quality assurance monitoring and supervision team. During a pre-randomization run-in period (months 1-5), all clinics receive the basic strategy. During a post-randomization intervention period (months 6-38), half of the clinics continue to receive the basic strategy and half receive the enhanced strategy. Visit-level data (for primary outcomes) and participant enrollment and follow-up (for secondary outcomes) are collected from all 10 clinics during the run-in and intervention periods.
Interventions
The basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.
The enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
Sponsors
Study design
Masking description
As randomization is at the clinic level and cannot be masked, participants, care providers, and investigators will not be masked to allocation. Outcome assessors do not need to know study arm, but it will be operationally difficult to blind them to whether a clinic is receiving the basic or enhanced implementation package.
Intervention model description
10 clinics will be randomized 1:1 to either a basic or enhanced implementation package to support integration of evidence-based depression treatment.
Eligibility
Inclusion criteria
Patients who meet the following eligibility criteria will be invited to participate: * Ages 18-65 years (antidepressant treatment considerations differ for those \<18 or \>65 years, and these age groups are expected to be very rare in the target clinics), * Current or new patient receiving care for either hypertension or diabetes from a participating NCD clinic * Elevated depressive symptoms (PHQ-9 score ≥5)
Exclusion criteria
Patients will be excluded if they have * a history of bipolar or psychotic disorder, or show emergent threat of self-harm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed | Measured based on data from clinic visits on each clinic day throughout study period | 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. |
| Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification | Measured based on data from clinic visits on each clinic day throughout study period | 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. |
| 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 | Within the first three months of follow-up after initiating depression treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Depression Remission at 3 Months | Three months post enrollment | 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. |
| Number of Participants With Well Controlled NCD at 3 Months | Three months post enrollment | 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. |
Countries
Malawi
Participant flow
Recruitment details
Ten clinics began the pre-randomization run-in period. All ten continued into the randomized intervention period. Primary outcomes (clinical care indicators) are measured at the level of the visit; visits do not overlap between the run-in and intervention periods. Secondary outcomes are measured at the level of the enrolled participant over 12 months of follow-up; enrolled participants do not overlap between the run-in and intervention periods. The numbers below represent participants.
Pre-assignment details
357 participants were enrolled during the run-in period before randomization. These participants are reported according to the arm to which their clinic was later assigned. 589 participants were enrolled during the intervention period post-randomization. By protocol, participants completed the study at 12 months post-consent. However, for logistical reasons the decision was made to conclude the study early and so the final 91 participants completed the study at 6 months.
Participants by arm
| Arm | Count |
|---|---|
| Basic Implementation Package The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities. | 469 |
| Basic Implementation Package The basic implementation package is a clinic-level strategy that involves identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities. | 27,187 |
| Enhanced Implementation Package The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence. | 477 |
| Enhanced Implementation Package The enhanced implementation package is a clinic-level strategy that combines the internal coordinator (basic arm) with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence. | 33,587 |
| Total | 61,720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1: Recruited in Study Months 1-5 | Death | 7 | 1 |
| Period 1: Recruited in Study Months 1-5 | Lost to Follow-up | 13 | 4 |
| Period 1: Recruited in Study Months 1-5 | Withdrawal by Subject | 0 | 1 |
| Period 1: Recruited in Study Months 6-32 | Death | 5 | 4 |
| Period 1: Recruited in Study Months 6-32 | Lost to Follow-up | 17 | 21 |
| Period 1: Recruited in Study Months 6-32 | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Basic Implementation Package | Enhanced Implementation Package | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical >=65 years | 10 Participants | 15 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 456 Participants | 462 Participants | 918 Participants |
| Age, Continuous | 51.1 years STANDARD_DEVIATION 9.9 | 50.5 years STANDARD_DEVIATION 9.8 | 50.8 years STANDARD_DEVIATION 9.8 |
| Race/Ethnicity, Customized Black African non-Hispanic | 469 Participants | 477 Participants | 946 Participants |
| Region of Enrollment Malawi | 469 Participants | 477 Participants | 946 Participants |
| Sex: Female, Male Female | 366 Participants | 392 Participants | 758 Participants |
| Sex: Female, Male Male | 103 Participants | 85 Participants | 188 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 469 | 5 / 477 |
| other Total, other adverse events | 54 / 469 | 90 / 477 |
| serious Total, serious adverse events | 31 / 469 | 11 / 477 |
Outcome results
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.
Time frame: Measured based on data from clinic visits on each clinic day throughout study period
Population: The population for this outcome is all screening-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a small portion of all captured visits (n=27,187 and 33,587), but non-consented patients (who are not uniquely identified) represent a large portion.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Basic Implementation Package | Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed | 14712 Visits |
| Enhanced Implementation Package | Fidelity in Depression Screening: Number of Screening-eligible Visits at Which Depression Screening is Completed | 15888 Visits |
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.
Time frame: Measured based on data from clinic visits on each clinic day throughout study period
Population: The population for this outcome is all depression treatment-eligible clinician-patient visits during the study period, not patient participants. Aggregate data are captured for visits with both consented and non-consented patients. The enrolled participants (n=301 and 288) constitute a portion of all captured visits for this outcome (n=610 and 545), but non-consented patients (who are not uniquely identified) represent an additional portion.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Basic Implementation Package | Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification | 601 Visits |
| Enhanced Implementation Package | Fidelity in Depression Treatment Initiation: Number of Treatment-eligible Visits for Which Depression Treatment Actually Starts Within 30 Days of Identification | 538 Visits |
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.
Time frame: Within the first three months of follow-up after initiating depression treatment
Population: Population: all clinic visits for consented participants in the first 3 months after starting depression treatment. Analysis is restricted to consented participants because the clinic visit must be linked to information from the initial visit to define whether the treatment decision follows the algorithm. Participants may have multiple clinic visits during the three months. These are routine clinic visits and are not the 3-month research assessment referenced in the participant flow.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Basic Implementation Package | 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 | 14 Visits |
| Enhanced Implementation Package | 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 | 69 Visits |
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.
Time frame: Three months post enrollment
Population: All participants who completed the 3-month assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Package | Number of Participants Achieving Depression Remission at 3 Months | 98 Participants |
| Enhanced Implementation Package | Number of Participants Achieving Depression Remission at 3 Months | 138 Participants |
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.
Time frame: Three months post enrollment
Population: Analysis population restricted to those (1) completing 3-month assessment (n=275;264); (2) hypertension diagnosis at baseline (n=221;234); (3) completing 3-month in person (n=59;90). Item 2 above is to exclude participants who only had a diabetes diagnosis at baseline because blood glucose measures were not consistently available from clinical records. Item 3 above is because with COVID, most follow-ups moved to phone in which case BP was no longer collected.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Basic Implementation Package | Number of Participants With Well Controlled NCD at 3 Months | 35 Participants |
| Enhanced Implementation Package | Number of Participants With Well Controlled NCD at 3 Months | 51 Participants |