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

NCT ID: NCT05264792

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2023-12-31

Brief 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.

Detailed Description

Evidence-based clinical interventions exist for depression; however, the gap between those who need treatment and those who receive it (i.e., the care gap) is alarming, with upwards of 90% of individuals not having access to care in India. Integrating evidence-based treatments into primary care is essential for ensuring access to mental health services, and ultimately, bridging the care gap. In India, many of these barriers to implementation have emerged from prior efforts to integrate evidence-based depression care into primary care, such as suboptimal organization and planning, and demands for training of staff on evidence-based interventions.

Implementation research seeks to improve the integration of evidence-based treatments into routine practice through the use of "Implementation Strategies". In a recent review by Wagenaar et al (2020) on implementation strategies for depression care in low- and middle-income countries, it was found that approximately half of these studies were focused on testing revised professional roles, or task-shifting, for depression intervention implementation. In this review, six studies from India examined the integration, acceptability, feasibility and cost of integrating depression care in routine primary care settings, but only one of these studies had a randomized controlled trial design. There is a need to conduct studies with pragmatic designs to examine the effectiveness and cost-effectiveness of integrating evidence-based depression interventions into routine primary care. Moreover, the reviewed studies have scarcely reported on 'adoption' and initial implementation of depression interventions.

This trial aims to address the treatment gap and the structural and contextual factors affecting the optimal implementation of a collaborative care package for depression in primary care settings in Madhya Pradesh, India. Specifically, this study will employ a cluster-randomized controlled design to evaluate whether a 'remote coaching implementation support strategy' compared to 'routine implementation support' can increase rates of screening for depression (i.e., primary implementation outcome). The trial will also assess the successful implementation of the collaborative depression care package via facility-level indicators, including the following secondary implementation outcomes: 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, including the proportion of patients who achieve remission (defined as PHQ-9<5) at 3-month follow up, given that this reflects a clinically meaningful treatment target. Additional patient-level outcomes include symptoms of anxiety and functioning.

The trial will explore health facility 'readiness' and its relationship with the adoption of the depression care package. Importantly, this trial will employ the routine health facility cadres, such as the auxiliary nurse midwife (ANM) and nurses, primarily for depression screening, and the medical officer (MO) for diagnosis, treatment and referral of cases, and employ routine data collection and management systems. This trial builds on recent health system-level changes in India where screening and management of non-communicable disorders has already been integrated into primary care, creating a template for the integration of evidence-based depression care.

Conditions

Depression; Depressive Disorder; Psychological; Noncommunicable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Routine Implementation Support

All 14 health facilities will continue to receive existing routine implementation support. The facilities allocated to the control arm (n=7) will receive routine implementation support only.

Group Type: ACTIVE_COMPARATOR

Routine Implementation Support

Intervention Type: OTHER

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.

Enhanced Implementation Support

In addition to routine support, Enhanced Implementation Support will be provided to 7 facilities allocated to the 'intervention arm'.

Group Type: EXPERIMENTAL

Enhanced Implementation Support

Intervention Type: OTHER

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.

Routine Implementation Support

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Facilities must be primary health centers in Sehore district, Madhya Pradesh, which have been upgraded to "Health and Wellness Center" status offering services for non-communicable disease care, and that have an Accredited Social Health Activist (ASHA) worker linked to the Health and Wellness Center to ensure access to the brief psychological treatment for depression
• Patients must be outpatients seen at these facilities, and must be adults of any gender age ≥18 years
• Patients must screen positive for depression by the ANM/nurse defined as having a PHQ-2 score ≥3.

Exclusion Criteria

• Facilities that have not been upgraded to Health and Wellness Center and that do not have a linked ASHA worker
• Patients that have significant speech, hearing, language or cognitive impairment impacting their ability to provide informed consent and complete study assessments
• Patients in need of urgent medical or psychiatric attention (e.g., emergency treatment or in-patient admission)
• Patients who do not plan to stay in the study catchment area for at least three months at the time of consent
• Patients who do not understand Hindi

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sangath

OTHER

Sponsor Role: collaborator

Ministry of Health & Family Welfare, India

OTHER_GOV

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: lead

Responsible Party

John A. Naslund

Instructor of Global Health and Social Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deepak Tugnawat

Role: STUDY_DIRECTOR

Sangath

Anant Bhan, MD

Role: PRINCIPAL_INVESTIGATOR

Sangath

Locations

Sangath

Bhopal, Madhya Pradesh, India

Countries

India

References

Bondre AP, Singh A, Tugnawat D, Chandke D, Khan A, Shrivastava R, Lu C, Ramaswamy R, Patel V, Bhan A, Naslund JA. Remote coaching for supporting the implementation of treatment for depression in primary care in Madhya Pradesh, India: protocol for a cluster randomized controlled trial. Front Health Serv. 2024 Sep 24;4:1477444. doi: 10.3389/frhs.2024.1477444. eCollection 2024.

Reference Type: BACKGROUND

PMID: 39381591 (View on PubMed)

Tugnawat D, Singh A, Anand A, Bondre A, Chandke D, Dhurve P, Joshi U, Khan A, Muke S, Negi B, Nikhare K, Rathore D, Ramaswamy R, Haney JR, Sen Y, Sharma K, Shrivastava R, Verma N, Vishwakarma R, Vishwakarma D, Vorapanya V, Patel V, Bhan A, Naslund JA. ESSENCE: An Implementation Research Program to Scale Up Depression Care in Rural Communities. Psychiatr Serv. 2024 Feb 1;75(2):167-177. doi: 10.1176/appi.ps.202100223. Epub 2023 Oct 31.

Reference Type: BACKGROUND

PMID: 37904491 (View on PubMed)

Other Identifiers

U19MH113211

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U19MH113211-IT

Identifier Type: -

Identifier Source: org_study_id