Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05128227
Other study ID # 21-1062
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date June 1, 2023

Study information

Verified date June 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 119
Est. completion date June 1, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT04127292 - Impact of Clinician Virtual Human Interaction Training in Emotional Self-Awareness on Patients Suicidal Ideation and Suicide Crisis Syndrome N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Recruiting NCT05423483 - Developing an Intervention to Promote Lethal Means Safety in Suicidal Adolescents Phase 2
Completed NCT03272048 - Identifying Effective Approaches to Counseling on Firearm Safety N/A
Completed NCT05514587 - Meaning of Life Questionnaire (MLQ) in Patients Admitted to the Crisis Centre (MSVCAC)
Enrolling by invitation NCT05639426 - Preventing Youth Violence Through Building Equitable Communities N/A
Completed NCT03703128 - Suicide in People Aged 45-60: A Case-control Psychological Autopsy Study
Completed NCT03646903 - Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk N/A
Not yet recruiting NCT05558332 - Youth Nominated Support Team N/A
Not yet recruiting NCT06349915 - A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents N/A
Completed NCT02718248 - Ottawa Suicide Prevention in Men Pilot Study N/A
Completed NCT02094898 - Ketamine for Depression and Suicide Risk Phase 2
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT01594138 - Linguistic Characteristics of Suicidal Patients in the Emergency Department N/A
Completed NCT02228044 - Alcohol, Suicide and HIV Prevention for Teens in Mental Health Treatment N/A
Completed NCT00604097 - Preventing Youth Suicide in Primary Care: A Family Model Phase 3
Completed NCT00387855 - An Evaluation of the SOS (Suicide Prevention) Program N/A
Recruiting NCT03519802 - Evaluation of Cognitive Function in a Suicidal Crisis
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Recruiting NCT03030924 - Wearable Suicidal Early Warning System for Adolescents