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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Pharm-SAVES
* Behavioral: Interactive video cases


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharm-SAVES<br>This 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. | Behavioral: Pharm-SAVES<br>* 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.<br>|
| Experimental: Interactive video case<br>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<br>* 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.<br>Behavioral: Interactive video cases<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of participants who report they would call the National Suicide Prevention Lifeline. | 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. | Baseline and immediately post-intervention | 
| Change in suicide prevention knowledge score from baseline to immediate 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. | Baseline and immediately post-intervention | 
| Change in mean suicide prevention self-efficacy score from baseline to immediate 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. | Baseline and immediately post-intervention | 
| Change in mean suicide prevention self-efficacy score from baseline to 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. | Baseline and 1-month follow-up | 
| Change in mean suicide prevention preparedness score from baseline to immediate 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. | Baseline and immediately post-intervention | 
| Change in mean suicide prevention preparedness score from baseline to 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. | Baseline and 1-month follow-up | 
| Proportion of participants who ask about suicide (optional) | 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. | 1-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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community pharmacy, communication, gatekeeper training, suicide prevention, pharmacy