PHARM-S.A.V.E.S: Suicide Prevention Training
1 other identifier
interventional
119
1 country
1
Brief Summary
This is a pilot Randomized Controlled Trial (RCT) in which 150 pharmacy staff members will be randomized to an experimental or control group and data on suicide prevention communication and secondary outcomes will be collected over the course of the RCT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 23, 2023
June 1, 2023
1.1 years
October 28, 2021
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in proportion of participants who ask about suicide.
An online survey will include a written case that asks participants what they would say to a patient who has expressed verbal suicide warning sign(s). Blinded coders will review the open-ended response to determine whether the participant asks about suicide. The responses will be coded as no=0 and yes=1.
Baseline and immediately post-intervention
Secondary Outcomes (7)
Change in proportion of participants who report they would call the National Suicide Prevention Lifeline.
Baseline and immediately post-intervention
Change in suicide prevention knowledge score from baseline to immediate post-intervention.
Baseline and immediately post-intervention
Change in mean suicide prevention self-efficacy score from baseline to immediate post-intervention.
Baseline and immediately post-intervention
Change in mean suicide prevention self-efficacy score from baseline to 1-month follow-up
Baseline and 1-month follow-up
Change in mean suicide prevention preparedness score from baseline to immediate post-intervention.
Baseline and immediately post-intervention
- +2 more secondary outcomes
Study Arms (2)
Pharm-SAVES
ACTIVE COMPARATORThis is an approximately 30-minute self-guided online module that covers basic information about suicide prevention gatekeeper skills training that is relevant to community pharmacists.
Interactive video case
EXPERIMENTALAn approximately 30-minute self-guided online suicide prevention gatekeeper skills training module, plus two approximately 5-minute interactive video cases in which participants are asked to respond to patients who exhibit suicidal warning signs.
Interventions
A 30 minute long online module with videos and didactic content that covers the following topics: warning signs of suicide, how to ask a patient if they are contemplating suicide, and how to refer a patient to the Crisis Line. Three videos model patient scenarios of suicidal behavior in pharmacy settings including the pharmacy drive through, over the phone, and in person. Participants will receive continuing education credits (CEUs) (0.1 CEUs) for completing the course.
Two video interactive cases (approximately 10-minutes combined total) ask participants to complete open and close-ended questions about patients who exhibit suicidal behavior at the pharmacy. Participants will receive continuing education credits (0.1 CEUs) for completing the course.
Eligibility Criteria
You may qualify if:
- Staff must:
- be at least 18 years of age;
- read and speak English; and
- be currently employed as a pharmacist or pharmacy technician at a community pharmacy
You may not qualify if:
- Individuals will be excluded if they hold floater status (non-staff pharmacists or technicians).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Wyman PA, Brown CH, Inman J, Cross W, Schmeelk-Cone K, Guo J, Pena JB. Randomized trial of a gatekeeper program for suicide prevention: 1-year impact on secondary school staff. J Consult Clin Psychol. 2008 Feb;76(1):104-15. doi: 10.1037/0022-006X.76.1.104.
PMID: 18229988BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delesha M Carpenter, PhD
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Jill E Lavigne, PhD
US Department of Veterans Affairs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 19, 2021
Study Start
April 15, 2022
Primary Completion
May 31, 2023
Study Completion
June 1, 2023
Last Updated
June 23, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.