PHARM-S.A.V.E.S: Suicide Prevention Training
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharm-SAVES
Interactive video cases
Sponsored by
About this trial
This is an interventional health services research trial for Suicide focused on measuring community pharmacy, communication, gatekeeper training, suicide prevention, pharmacy
Eligibility Criteria
Inclusion Criteria:
Staff must:
- be at least 18 years of age;
- read and speak English; and
- be employed as a pharmacist or pharmacy technician
Exclusion Criteria:
- Individuals will be excluded if they hold floater status (non-staff pharmacists or technicians).
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pharm-SAVES
Interactive video case
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05128227
First Posted
October 28, 2021
Last Updated
June 20, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Foundation for Suicide Prevention, US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT05128227
Brief Title
PHARM-S.A.V.E.S: Suicide Prevention Training
Official Title
PHARM-S.A.V.E.S: Suicide Prevention Gatekeeper Training for Pharmacy Staff
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Foundation for Suicide Prevention, US Department of Veterans Affairs
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
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
community pharmacy, communication, gatekeeper training, suicide prevention, pharmacy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharm-SAVES
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Interactive video case
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pharm-SAVES
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interactive video cases
Intervention Description
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 Outcome Measure Information:
Title
Change in proportion of participants who ask about suicide.
Description
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.
Time Frame
Baseline and immediately post-intervention
Secondary Outcome Measure Information:
Title
Change in proportion of participants who report they would call the National Suicide Prevention Lifeline.
Description
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.
Time Frame
Baseline and immediately post-intervention
Title
Change in suicide prevention knowledge score from baseline to immediate post-intervention.
Description
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.
Time Frame
Baseline and immediately post-intervention
Title
Change in mean suicide prevention self-efficacy score from baseline to immediate post-intervention.
Description
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.
Time Frame
Baseline and immediately post-intervention
Title
Change in mean suicide prevention self-efficacy score from baseline to 1-month follow-up
Description
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.
Time Frame
Baseline and 1-month follow-up
Title
Change in mean suicide prevention preparedness score from baseline to immediate post-intervention.
Description
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.
Time Frame
Baseline and immediately post-intervention
Title
Change in mean suicide prevention preparedness score from baseline to 1-month follow-up.
Description
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.
Time Frame
Baseline and 1-month follow-up
Title
Proportion of participants who ask about suicide (optional)
Description
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.
Time Frame
1-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delesha M Carpenter, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill E Lavigne, PhD
Organizational Affiliation
US Department of Veterans Affairs
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
18229988
Citation
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.
Results Reference
background
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PHARM-S.A.V.E.S: Suicide Prevention Training
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