Integrating a Suicide Prevention Package of Strategies Into Decentralized Primary Health Care Systems: an Implementation Pilot Study in Rural Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Mean Beck Scale for Suicide Ideation (BSSI) score
研究概览
简要总结
Suicide remains a major contributor to global mortality, with particularly high and persistent rates in low-resourced settings such as South Asia. In Nepal, ongoing integration of mental health services into primary care provides a critical opportunity to strengthen suicide risk assessment and management. Despite the scale-up of mhGAP training for primary care providers (PCPs), gaps remain in the systematic detection, referral, and follow-up of individuals at risk for suicide. There is an urgent need to enhance mhGAP implementation with strategies that address provider workload, stigma, and inequities within the health workforce.
Using experience-based co-design principles and RE-AIM this study will assess the feasibility and acceptability of integrating an implementation strategy package to optimize mhGAP suicide prevention delivery in Nepal's decentralized primary healthcare system. This clinical trial leverages deep collaboration with a community advisory board of individuals with lived experience of suicide throughout the trials' design, delivery and analysis.
This R34 will generate critical preliminary evidence on the feasibility, acceptability, and implementation of an integrated suicide prevention package within government primary care facilities in Nepal. The findings will inform the design and parameters of a future fully powered effectiveness trial, while aligning with Nepal's national suicide prevention strategy and advancing WHO and NIMH global mental health priorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Care Providers
- •Health workers with a prescribing license employed in government health facilities in Bagmati Province.
- •Are between 21-65 years, per government health system criteria.
- •Participants will be required to have competency in Nepali, be actively engaged in care provision within their health facility
- •Patient lives in the study site
- •Is under the care of a PCP at a facility site.
- •Patient meets any level of suicide risk based on mhGAP 2.0 criteria.
- •Patients who have been treated for mental illness before or presently (expected in both groups).
- •Speaks Nepali.
- •Levels of Suicide Risk (as defined by mhGAP 2.0)
排除标准
- •Primary Care Providers
- •Healthcare workers without proper government credentials will be excluded.
- •Health workers who plan to migrate or who do not intend to stay in the study area for at least a year.
- •Patient requiring immediate hospitalization
- •Unable to consent as determined by the diminished capacity tool.
研究组 & 干预措施
Treatment As Usual
PCPs will receive standard or refresher mhGAP training. The training follows Nepal's district mental health plan for primary care workers with prescribing credentials. Paramedical staff are included because most primary healthcare facilities lack doctors, making them the primary frontline primary care providers. The training is based on the WHO mhGAP Intervention Guide and focuses on five priority conditions in Nepal: depression, psychosis, epilepsy, alcohol use disorder, and suicide. Training is delivered over 5 days by a Nepali psychiatrist with government issued credentials to facilitate mhGap training and subsequent ongoing supervision. After training, PCPs receive psychiatric supervision approximately every three months as per the Nepal government mhGap protocol. Patient participants in the TAU arm will receive the services based on mhGAP treatment protocols.
TAU+Suicide Prevention Package (PSuPP)
PCPs will receive all components of TAU. In addition, they receive an implementation package to optimize mhGAP siucide prevention delivery. The implementation package includes: [assessment optimization] systematic assessment training using systematized screening questions, an embedded decision-support tool, [risk management optimization] culturally adapted safety planning, and [follow up care optimization] a collaborative care protocol with Community Health Workers (CHWs) to support patient follow-up uptake and continued care. Participants in the PSuPP arm will receive all TAU services with aforementioned implementation strategies.
干预措施: Suicide Prevention Package (PSuPP) (Behavioral)
结局指标
主要结局
Mean Beck Scale for Suicide Ideation (BSSI) score
时间窗: Baseline; 3 months; 6 months
Suicide ideation severity measured with BSSI. BSSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during the past week. The first 19 items consist of three options graded are on a 3-point scale ranging from 0 to 2. These items are then summed to yield a total score, which ranges from 0 to 36. Higher scores indicate higher severity of suicide ideation. Assessed in patients only.
Percent intervention arm uptake to assess feasibility
时间窗: 6 months
Percent primary care providers (PCPs) that attend the implementation training. Feasibility will be defined as 70% or more uptake.
Percentage of interviews that hold themes
时间窗: 6 months
Qualitative feasibility acceptability data will be deemed acceptable if it demonstrates provider and patient perceptions of P-SuPP benefits to clinical care and mhGAP implementation and the absence of themes that suggest -SuPP is disruptive, unlikeable, and unacceptable. Acceptability will be assessed as the percentage of interviews that hold themes suggesting SuPP is disruptive, unlikeable, and unacceptable.
Percent retention to assess feasibility
时间窗: 6 months
Percent participants enrolled (PCPs and Patients) who complete the study of all enrolled. Feasibility is established as retention of at least 65% completion of 6 month follow up of patients and PCPs.
Structured checklist to assess fidelity
时间窗: 6 months
18-item structured checklist assessed in a standardized behavioral rehearsal to assess fidelity to the mhGAP suicide module protocol
Percent successful allocation procedures
时间窗: 6 months
Percent successful allocation procedures followed
Percent adherence to the randomization protocol
时间窗: 6 months
Percent adherence to the randomization protocol
Percent deviations to the randomization protocol
时间窗: 6 months
Percent deviations to the randomization protocol
Percent participants who completed all follow up measures
时间窗: 6 months
Percent participants who completed all follow up measures
Percent missing measure items per participant
时间窗: 6 months
Percent missing measure items per participant
次要结局
- Suicide Prevention Knowledge survey(Baseline, 3 months; 6 months)
- Mean Self-Efficacy in Mental Health Care survey score(Baseline; 3 month; 6 month)
- Mean Clinical Competency and Communication Skills (ENACT) score(Baseline; 6 months)
- Columbia Suicide Severity Rating Scale(Baseline; 3 months; 6 months)
- Mean Patient Health Questionnaire (PHQ-9) score(Baseline; 3 months; 6 months)
- Mean Suicide Cognitions Scale (SCS) score(Baseline; 3 months; 6 months)
- Suicide-Related Coping Scale (SRCS) - Internal Coping Skills(Baseline; 3 months; 6 months)
- Suicide-Related Coping Scale (SRCS) - External Coping Skills(Baseline; 3 months; 6 months)
- Mean Generalized Anxiety Disorder (GAD-7) score(Baseline; 3 months; 6 months)
- Mean Social Connectedness Scale score(Baseline; 3 months; 6 months)
- Client Service Receipt Inventory to assess health service uptake(Baseline; 3 months; 6 months)