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临床试验/NCT02376062
NCT02376062Unknown不适用

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

Possible2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2016年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
225
试验地点
2
主要终点
Cost assessment of bundled intervention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Bundled Intervention (Other)

结局指标

主要结局

Cost assessment of bundled intervention

时间窗: 3 years

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.

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

时间窗: 3 years

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.

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

时间窗: 3 years

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?".

次要结局

未报告次要终点

研究者

发起方
Possible
申办方类型
Other
责任方
Sponsor

研究点 (2)

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