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Completed

NCT Number: NCT05128227

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pharm-SAVES

Behavioral

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.

Interactive video cases

Behavioral

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.

Primary outcomes

  1. Change in proportion of participants who ask about suicide.

    Time frame: 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 outcomes

  1. Change in proportion of participants who report they would call the National Suicide Prevention Lifeline.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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 (optional)

    Time frame: 1-month follow-up

    At 1-month follow-up, participants can choose to 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 SP 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Foundation for Suicide Prevention
  • US Department of Veterans Affairs

Registry information

Official study title

PHARM-S.A.V.E.S: Suicide Prevention Gatekeeper Training for Pharmacy Staff

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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