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

Primary Purpose

Suicide Prevention

Status
Recruiting
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Suicide Prevention Package
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Suicide Prevention

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dhulikhel HospitalRecruiting

Outcomes

Primary Outcome Measures

Feasibility assessed by recruitment
Recruitment defined as the percent of eligible participants that agree to participate
Feasibility assessed by treatment adherence
The percent of participants that completed one session with the intervention delivery agent
Feasibility assessed by treatment adherence- SuPP
Treatment adherence defined as the percent of participants who remain in SuPP
Feasibility assessed by retention
The percent of participants who completed all follow up measures
Feasibility assessed by retention- missing items
The percent of missing measure items per participant
Feasibility assessed by screening
The number of participants screened and referred
Percent enrolled
The percent of referred participants that enrolled
Median number of sessions completed
Median number of sessions completed

Secondary Outcome Measures

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.

Full Information

First Posted
October 13, 2023
Last Updated
October 16, 2023
Sponsor
Yale University
Collaborators
Dhulikhel Hospital, Kathmandu University School of Medical Sciences, American Foundation for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT06094959
Brief Title
Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
Official Title
Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Dhulikhel Hospital, Kathmandu University School of Medical Sciences, American Foundation for Suicide Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: What is the feasibility of implementing the SuPP open clinical trial? What is the degree to which SuPP was implemented correctly 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Hagaman, PhD
Phone
2487908954
Email
ashley.hagaman@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Hagaman, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhulikhel Hospital
City
Dhulikhel
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Hagaman, PhD
Phone
2487908954
Email
ashley.hagaman@yale.edu
First Name & Middle Initial & Last Name & Degree
Renu Shakya, MA
Phone
+977-011-490497
Email
shakyarenu69@dhulikhelhospital.org
First Name & Middle Initial & Last Name & Degree
Ajay Risal, MD PhD
First Name & Middle Initial & Last Name & Degree
Roshana Shrestha, MD
First Name & Middle Initial & Last Name & Degree
Anmol Shrestha, MD
First Name & Middle Initial & Last Name & Degree
Ashley Hagaman, PhD
First Name & Middle Initial & Last Name & Degree
Subasna Shrestha, MSN

12. IPD Sharing Statement

Plan to Share IPD
No

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

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