Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts

Suicide Prevention Clinical Trial

Official title:

Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06094959
• Other study ID #: 2000029480
• Secondary ID: No NIH funding
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Ashley Hagaman, PhD
• Phone: 2487908954
• Email: ashley.hagaman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to assess the feasibility and acceptability of implementing a co-designed suicide prevention package of implementation strategies (SuPP) in a pilot open, non-randomized, clinical trial. The main questions it aims to answer are:

1. What is the feasibility of implementing the SuPP open clinical trial?

2. What is the degree to which SuPP was implemented correctly

3. What is the perceived acceptability of SuPP among providers and patients?

Participants will include healthcare providers and patients at risk for suicide. Providers will identify and provide culturally adapted safety planning and contact follow up to at-risk patients over a period of six months. Patients will receive an initial culturally adapted patient-centered safety plan and receive a tapered series of contacts (phone calls) over the course of six months from health providers.

Description:

Low and middle income countries (LMIC) hold 75% of the world's suicides. Suicide disproportionately affects those living in poverty and in adverse conditions and, in LMIC settings, up to 20% of maternal deaths are due to suicide. In Nepal, suicide is a leading cause of death among women of reproductive age. Despite the disproportionate burden, systematic suicide detection and prevention mechanisms are nearly non-existent. Deaths are only a fraction of the burden, where evidence from Nepal reports between 5 and 27% of individuals have current thoughts of suicide. Suicidal behavior remains under-reported and is difficult for clinicians to properly identify and monitor, especially in limited health systems. This calls for improved understanding of how to identify and monitor individuals at risk for suicidal behavior. Therefore, this study seeks to integrate existing hospital healthcare providers into suicide prevention, contributing much needed evidence for multi-pronged, accessible strategies to reduce a leading cause of death worldwide.

This study's purpose is to adapt and pilot the implementation of packaged suicide prevention strategies in a low-resource setting. The impact involves informing an implementation plan to test in a fully powered future trial. Findings will contribute to the evidence of systems-integrated suicide prevention strategies and result in a multi-level package for mental health service integration that can be utilized around the world. Ultimately, this project will save lives and improve under-resourced health systems. The pilot trial is not powered for statistical analysis, but data will be monitored monthly and continuously analyzed to facilitate iterative revision, then finalization of the protocol.

The implementation package to be tested (the Suicide Prevention Package, SuPP) will include a culturally adapted suicide crisis response plan and a series of contacts via phone call from a hospital healthcare provider. This is a small open, non-randomized, pilot trial to assess the feasibility and acceptability of SuPP within the existing health system. The investigators will select delivery agents, an implementation strategy, and complete SuPP training. The investigators will train the selected delivery agents and their supervisory team (e.g., hospital nurses, physicians, and department heads) in SuPP (detection, safety planning, brief contact follow up). Participants will be recruited through the hospital's emergency department. Following suicide risk detection (e.g., suicide attempt in the past 6 months), 24 at-risk patients will be enrolled in the open trial and given the full SuPP package. All participants will receive standard of care, the SuPP package is in addition. In accordance with recommendations for pilot trial studies, The investigators have established qualitative and quantitative indicators to guide decisions about what procedures to carry through to the full trial and when modifications should be made. Each patient will be provided contact and suicide crisis response planning (weekly, then tapering to monthly) for at least 6 months. SuPP feasibility and acceptability will be determined by the following criteria: delivery agent fidelity to SuPP elements at 75% or greater; retention of at least 70% of participants through 6 months of SuPP; fewer than 15% missing items on outcome measures across all assessments; 80% of delivery agents and patients finding SuPP acceptable. In domains where criteria are met, the investigators will retain the procedure for a future full trial. In domains where criteria are not met, the investigators will modify procedures for the future full trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria (healthcare workers):

• Be older than 18 at the time of recruitment

• Speak Nepali fluently

• Be actively employed by Dhulikhel Hospital/KUSMS

• Have a valid certificate of practice from the Ministry of Health and Population

Exclusion Criteria (healthcare workers)

• Have less than 3 months of experience in current position

• Be planning to remain in the study area or current position for less than six months

• Be unable to provide voluntary informed consent for any reason

Inclusion Criteria (trial patients):

• Speak Nepali fluently

• Be older than 18 at the time of recruitment

• Be actively receiving care from a KUDH clinician

• Permanently reside in Dhulikhel District

• Have access to a cell phone

• Screen positive for suicide risk

Exclusion Criteria (trial patients):

• Reside outside of the catchment area

• Be planning to leave relocate their residence in the next 6 months

• Unable to provide voluntary informed consent for any reason

• Unable to provide a mobile phone number for contact

• Present evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research

Related Conditions & MeSH terms

• Suicide
• Suicide Prevention

Intervention

Other:
• Suicide Prevention Package
The implementation package consists of co-designed and culturally adapted suicide prevention elements including suicide crisis response planning, contact follow up phone calls, and healthcare provider support mechanisms to optimize implementation.

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital	Dhulikhel

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	American Foundation for Suicide Prevention, Dhulikhel Hospital, Kathmandu University School of Medical Sciences

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility assessed by recruitment	Recruitment defined as the percent of eligible participants that agree to participate	6 months post intervention
Primary	Feasibility assessed by treatment adherence	The percent of participants that completed one session with the intervention delivery agent	6 months post intervention
Primary	Feasibility assessed by treatment adherence- SuPP	Treatment adherence defined as the percent of participants who remain in SuPP	6 months post intervention
Primary	Feasibility assessed by retention	The percent of participants who completed all follow up measures	6 months post intervention
Primary	Feasibility assessed by retention- missing items	The percent of missing measure items per participant	6 months post intervention
Primary	Feasibility assessed by screening	The number of participants screened and referred	6 months post intervention
Primary	Percent enrolled	The percent of referred participants that enrolled	6 months post intervention
Primary	Median number of sessions completed	Median number of sessions completed	6 months post intervention
Secondary	Acceptability assessed by Consolidated Framework for Implementation Research (CFIR) qualitative interviews	CFIR interviews are qualitative interviews that will be thematically analyzed with qualitative analysis guided by the CFIR framework and taxonomy.	6 months post intervention