Remote Coaching for Supporting the Implementation of Depression Care in Primary Care in Rural India

Summary

This cluster-randomized hybrid type-II implementation superiority trial will include 14 rural primary care facilities in Madhya Pradesh, which will implement a collaborative depression care packaged based on the WHO mhGAP program. These 14 facilities will be randomized to receive either 'Enhanced Implementation Support' or the existing 'Routine Implementation Support' control condition to determine if Enhanced Implementation Support is superior to Routine Implementation Support for ensuring successful implementation of the depression care package.

Enhanced Implementation Support consists of remote coaching support and technical assistance. The primary implementation outcome is the proportion of outpatients screened on the PHQ-2 by facility staff. Secondary implementation outcomes will also be collected, including the number of depression cases identified, number of patients with depression referred to the medical officer, number of patients referred to an accepted treatment intervention (i.e., either antidepressant medication or brief psychological intervention), and number of patients who successfully complete treatment at follow up. Secondary patient outcomes will also be collected from patients enrolled in each arm. Patient-level outcomes include the proportion of patients who achieve remission (defined as PHQ-9\<5) at 3-month follow up. Additional patient-level outcomes include symptoms of anxiety and functioning.

This trial will develop and test an Enhanced Implementation Support strategy for integrating evidence-based mental health services into primary care facilities. Findings from the trial will inform the need to have external coaching for primary care facilities to meet their depression screening and treatment goals, or if they can achieve these goals via routine system support. This is crucial to inform policymakers, due to severe constraints on mental health budgets for programs in India. Findings can generate insights to inform the scale-up of depression care across other districts in Madhya Pradesh and in India.

Conditions

• Depression
• Depressive Disorder
• Psychological
• Noncommunicable Diseases

Interventions

OTHER

Enhanced Implementation Support

This support package will include: 1. one-on-one remote (phone/web-based) technical assistance sessions (every two weeks) between the facility team and the study team Implementation Support Coaches. These sessions will involve a discussion on successes and challenges in integrating depression screening with routine care and developing strategies to improve screening, using the PDSA (Plan Do Study Act) cycle model. 2. remote peer learning community (peers include ANMs and Nurses who administer screening) through a cross-facility WhatsApp group moderated by the study team Coaching Support Team. 3. virtual peer learning network conferences (quarterly) moderated by the Coaching Support Team focused on lessons learned in improving depression screening. The 9-month intervention duration is informed by the Institute of Healthcare Improvement's Breakthrough Series guidelines.

OTHER

Routine Implementation Support

This support package will include weekly meetings between District and facility teams, to review and discuss mental health performance indicators, such as depression screening rate, refusal rate for PHQ-2 screening, proportion of referrals of screened positive patients from auxiliary nurse midwife (ANM) to Medical Officer, and rates of diagnosis and initiation of treatment of depression. These indicators will be collated and reviewed by the district team as part of existing non-communicable disease (NCD) care indicators. Monthly performance data will be then emailed by the district team to the facilities, in addition to further data submission reminders. Note that these weekly interactions between the district and facility teams does not include the additional PDSA cycle-based coaching support.

Sponsors & Collaborators

• Sangath

  collaborator OTHER

• Ministry of Health & Family Welfare, India

  collaborator OTHER_GOV

• Harvard Medical School (HMS and HSDM)

  lead OTHER

Principal Investigators

• Deepak Tugnawat · Sangath

• Anant Bhan, MD · Sangath

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-06

Primary Completion

2023-10-05

Completion

2023-12-31

Countries

• India

Study Locations