PHARM-S.A.V.E.S: Suicide Prevention Training

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT05128227
Collaborator
American Foundation for Suicide Prevention (Other), US Department of Veterans Affairs (U.S. Fed)
150
1
2
12.7
11.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pharm-SAVES
  • Behavioral: Interactive video cases
N/A

Detailed Description

This is a prospective pilot RCT that will evaluate the impact of suicide prevention gatekeeper training (Pharm-SAVES) on 150 pharmacy staff member communication behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 1-month follow up. Data sources include simulated patient observations (to rate quality of communication) and survey data (for self-reports of knowledge, self-efficacy, and referral behaviors).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
PHARM-S.A.V.E.S: Suicide Prevention Gatekeeper Training for Pharmacy Staff
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pharm-SAVES

This an approximately 30-minute self-guided online module that covers basic information about suicide prevention gatekeeper skills training that is relevant to community pharmacists.

Behavioral: Pharm-SAVES
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.

Experimental: Interactive video case

An 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.

Behavioral: Pharm-SAVES
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.

Behavioral: Interactive video cases
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.

Outcome Measures

Primary Outcome Measures

  1. Change in proportion of participants who ask about suicide. [Baseline and immediately post-intervention]

    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.

Secondary Outcome Measures

  1. Change in proportion of participants who report they would call the National Suicide Prevention Lifeline. [Baseline and immediately post-intervention]

    An online survey will include a written case with an open-ended question that asks if, and where, participants would refer a patient who has expressed verbal suicide warning sign(s). Blinded coders will review the open-ended response to determine whether the participant reported they would call the National Suicide Prevention Lifeline. The responses will be coded as no=0 and yes=1.

  2. Change in suicide prevention knowledge score from baseline to immediate post-intervention. [Baseline and immediately post-intervention]

    An online survey including 5 multiple choice and 5 true-false questions will assess participants suicide prevention knowledge based on the content of Pharm-SAVES.A summary score that assesses the total number of correct answers (range: 0-10) will be created, with higher scores reflecting higher knowledge.

  3. Change in mean suicide prevention self-efficacy score from baseline to immediate post-intervention. [Baseline and immediately post-intervention]

    A 6-item scale will be used to assess gatekeeper efficacy, or how confident trainees are that they can perform various suicide prevention tasks, including identifying signs of suicide and making a referral. Response options range from 1=not at all confident to 5=extremely confident. Item responses for each individual will be averaged to create a mean score, with higher scores indicating higher gatekeeper efficacy. Scores will range from 1 to 5.

  4. Change in mean suicide prevention self-efficacy score from baseline to 1-month follow-up [Baseline and 1-month follow-up]

    A 6-item scale to will be used assess gatekeeper efficacy, or how confident trainees are that they can perform various suicide prevention tasks, including identifying signs of suicide and making a referral. Response options range from 1=not at all confident to 5=extremely confident. Item responses for each individual will be averaged to create a mean score, with higher scores indicating higher gatekeeper efficacy. Scores will range from 1 to 5.

  5. Change in mean suicide prevention preparedness score from baseline to immediate post-intervention. [Baseline and immediately post-intervention]

    Six items from a validated scale will be used to assess gatekeeper preparedness, or how well-prepared trainees feel they are to perform gatekeeper activities, including to "ask appropriate questions about suicide." Response options range from 1=not prepared to 7=quite well-prepared. Item responses for each individual will be averaged, and higher scores will indicate higher levels of gatekeeper preparedness. Scores will range from 1 to 7.

  6. Change in mean suicide prevention preparedness score from baseline to 1-month follow-up. [Baseline and 1-month follow-up]

    Six items from a validated scale will be used to assess gatekeeper preparedness, or how well-prepared trainees feel they are to perform gatekeeper activities, including to "ask appropriate questions about suicide." Response options range from 1=not prepared to 7=quite well-prepared. Item responses for each individual will be averaged, and higher scores will indicate higher levels of gatekeeper preparedness. Scores will range from 1 to 7.

  7. Proportion of participants who ask about suicide [1-month follow-up]

    At 1-month follow-up, participants will complete a video-recorded standardized patient assessment via Zoom. One live standardized patient will enact a scenario in which they express verbal suicide warnings signs. After completion of the live standardized patient (SP) assessment, the participant will watch a pre-recorded video of a second standardized patient who also expressed suicide warning signs. The live standardized patient will then ask the participant how they would respond to the person depicted in the pre-recorded video. Using an observation guide, two masked coders will independently view the videos from each SP scenario and document whether the participant asked a direct question about suicide (yes/no). Examples of direct questions are provided in the observation guide. Scores for asking will range from 0 to 2.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Staff must:
  • be at least 18 years of age;

  • read and speak English; and

  • be employed as a pharmacist or pharmacy technician with Ingles.

Exclusion Criteria:
  • Individuals will be excluded if they hold floater status (non-staff pharmacists or technicians).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • American Foundation for Suicide Prevention
  • US Department of Veterans Affairs

Investigators

  • Principal Investigator: Delesha M Carpenter, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Jill E Lavigne, PhD, US Department of Veterans Affairs

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT05128227
Other Study ID Numbers:
  • 21-1062
First Posted:
Nov 19, 2021
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022