Bundled Intervention Integrating Mental Health Services in Nepal

NCT02376062 | Unknown

• 1 other identifier: MHCMEnyaya
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief Summary

Globally, access to mental healthcare is often non-existent in rural, resource-deprived communities despite the pervasive need for services, particularly in post-conflict and post-disaster settings. We are developing and piloting will develop and pilot a culturally appropriate training model for non-specialist providers (NSPs) to deliver high-quality mental health care over a period of 24 months in a primary care hospital in a rural district in Nepal. We will employ a mixed methods framework to evaluate change in skills, knowledge, and attitude in NSP's, identify key mechanisms for continuum of mental healthcare delivery, and efficacy and cost-effectiveness in care delivery through a government hospital, clinics, and a network of community health workers. This integrated approach will introduce a bundled intervention that includes: both an on-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu, weekly case conferences, and surveys of NSP's and clinical supervisors every six months during the study period. To learn about the acceptability, feasibility and challenges in the program we will also conduct Focus Group Discussions among the PCPs. In the last one year of the research in Achham District we have seen increase in knowledge efficacy and skills among the NSPs and also improved mental health care services at Bayalpata Hospital. Our experience in Achham motivated us to develop a similar program for Charikot Primary Health Center in Dolakha District. Outcomes of this study will focus on efficacy of this model to appropriately identify, counsel, and treat patients with depression, psychosis, and post-traumatic stress disorder (PTSD) through an integrated rural mental healthcare delivery intervention as a model for rural healthcare delivery.

Conditions

Mental Health

Keywords

Continuing Medical Education; Chronic Diseases; Nepal; Implementation Research

Outcome Measures

Primary Outcomes (3)

• Changes in knowledge, attitudes, practices, and self-efficacy of Primary Care Providers

  To measure retention of knowledge, and change in attitudes, practices, and self-efficacy among primary care providers who take part in the integrated mental health care delivery intervention. The primary outcome will be reported as change in scores for all pre-and post-tests will be scored with a total score of 100 on each module. Self-efficacy will be assessed on a Likert Scale. Change in knowledge and self-efficacy before and after the intervention will be compared with wilcoxon rank sum tests, assuming lack of normal distribution and given the small sample size. Trainee's rating of the module will be on a Likert scale from 1-5 and these will be presented as means with standard deviation.

  3 years

• Longitudinal clinical outcomes for patients with depression, post-traumatic stress disorder, and patient self-reported medication adherence

  To analyze the longitudinal clinical outcomes related to a decrease in acute symptoms as measured by PHQ-9 and PCL, regular adherence to medication and counseling as appropriate. The primary outcome will be reported as the difference in means of the PHQ-9 scores (depression) or PCL scores (post-traumatic stress disorder) before and after the length of the intervention. For patients who are lost of follow-up, the last observation will be carried forward. For patient self-reported medication adherence, the primary outcome will be patient self reported rates of medication adherence, based on a "Yes" response to the question "Have you been able to take your medications as prescribed almost all the time?".

  3 years

• Cost assessment of bundled intervention

  To assess the costs and scalability of the bundled intervention through mixed quantitative and qualitative methods. We will include the following expenses aggregated to per patient per year psychotropic medications, time effort for PCPs, psychosocial counselors, consultant psychiatrist and nurses, and laboratory and other diagnostic tools.

  3 years

Study Arms (1)

Bundled Intervention

EXPERIMENTAL

* On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu * Weekly case conferences * Surveys of clinicians and clinical supervisors in accordance with CME curriculum

Other: Bundled Intervention

Interventions

Bundled Intervention OTHER

The authors have designed continuing medical education curriculum to improve clinical capacity and competency about mental health for Nepali Primary Care Providers. Specifically: * On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu * Weekly case conferences * Surveys of clinicians and clinical supervisors in accordance with CME curriculum

Bundled Intervention

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary Care Provider (MBBS-level physician or Health Assistant)
• Current staff at healthcare facility in Achham, Bajura, or Doti Districts.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Possible: lead
• University of California, San Francisco: collaborator
• Harvard Medical School Center for Global Health Delivery-Dubai: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Bayalpata Hospital

Sanfebagar, Achham, Nepal

Location

Charikot Primary Health Center

Bhimeshwor, Dolakha, Nepal

Location

Related Links

• Possible
• Healthcare Systems Design Group

MeSH Terms

Conditions

Psychological Well-Being; Chronic Disease

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Citrin, PhD, MPH

  Possible

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: March 3, 2015
• Study Start: February 6, 2016
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

NE (2)