Bundled Intervention Integrating Mental Health Services in Nepal

Mental Health Clinical Trial

Official title:

Bundled Intervention Integrating Mental Health Service Into Rural Primary Care in Nepal: Implementation Research Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02376062
• Other study ID #: MHCMEnyaya
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 31, 2014
• Last updated: December 4, 2017
• Start date: February 6, 2016
• Est. completion date: July 30, 2019

Study information

• Verified date: December 2017
• Source: Possible
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Primary Care Provider (MBBS-level physician or Health Assistant)

• Current staff at healthcare facility in Achham, Bajura, or Doti Districts.

Exclusion Criteria:

Related Conditions & MeSH terms

• Mental Health

Intervention

Other:
• Bundled Intervention
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

Locations

Country	Name	City	State
Nepal	Charikot Primary Health Center	Bhimeshwor	Dolakha
Nepal	Bayalpata Hospital	Sanfebagar	Achham

Sponsors (5)

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

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Healthcare Systems Design Group
•   Possible