- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02996344
Suicide Prevention Training for PC Providers-in-training
Suicide Prevention Training for Primary Care Providers-in-training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Suicide is a national public health crisis and a critical patient safety issue. Suicide is the 10th leading cause of death overall and, shockingly, the 2nd leading cause of death in adolescents and young adults (15-34 years old). 1 A recent U.S. study of suicide reported that 45% of individuals who died by suicide had contact with primary care services within one month before their death. 2 Another study found that 80% of youth who died by suicide saw their primary care provider within the year of their death. 3 Patient safety is compromised when primary care providers lack the knowledge and skills to assess and respond to patients at risk for suicide.
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. 4 We will test the effectiveness of suicide prevention education for providers-in-training by comparing two conditions: 1) A Control learning group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online via brief videos, and 2) An Experimental learning group: includes didactics plus two standardized patient (SP) interactions. One Experimental learning group SP interaction will be in person and the other will be conducted remotely using a secure webcam service (OoVoo). All SP interactions will be recorded. Both groups will be compared in terms of their suicide prevention skills using an SP 'test case' at 6-month follow up. The primary research question is to learn about the impact of practice (though SP simulation) over and above didactics alone. The hypotheses are as follows:
H1: All subjects will demonstrate improved suicide prevention knowledge from pre to post didactics and maintain improvement 6 months after didactics.
H2: Subjects in the experimental learning group will report greater satisfaction with the training, greater self-efficacy in identifying and responding to patients at risk for suicide, greater intention to use, as well as use of suicide prevention skills.
H3: Subjects in the experimental learning group will also be more skillful in responding to patients at risk for suicide (in an SP interview, measured by objective observed ratings) compared to the control learning group 6 months after didactics.
Exploratory Aims: We will examine moderators of outcomes, differences among SP simulations (i.e., face-to-face vs. telehealth modalities), and if there is growth in improved skills observed over multiple SP experiences in the experimental learning group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- trainee in family medicine residency, pediatrics residency, or nurse practitioner program at URMC.
- speaks/writes English.
Exclusion Criteria:
- on academic probation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Didactic training
Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos.
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Six online training modules pertaining to suicide prevention in primary care.
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Experimental: Didactics and standardized patients
Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos plus two practice standardized patient interactions.
|
Six online training modules pertaining to suicide prevention in primary care.
Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean score using the Commitment to Living: Primary Care Observational Rating form
Time Frame: through study completion, an average of 6 months
|
Each participant will be evaluated via standardized patient interactions which are video taped and reliably coded using the Commitment to Living: Primary Care Observational Rating form.
Score will range from 0 - 32.
|
through study completion, an average of 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in suicide prevention knowledge
Time Frame: 1 day following enrollment and 15 days from enrollment
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Participants will complete a 17-item knowledge questionnaire prior to and following the online didactic training.
Number of correct responses will be compared.
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1 day following enrollment and 15 days from enrollment
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Changes in suicide prevention self-efficacy
Time Frame: 1 day following enrollment and 15 days from enrollment
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Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire prior to and following the online didactic training.
Average responses will be compared.
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1 day following enrollment and 15 days from enrollment
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Changes in suicide prevention knowledge
Time Frame: 15 days from enrollment and through study completion, an average of 6 months
|
Participants will complete a 17-item knowledge questionnaire following the online didactic training and end of study.
Number of correct responses will be compared.
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15 days from enrollment and through study completion, an average of 6 months
|
Number of participants intending to transfer training to practice
Time Frame: 15 days from enrollment and through study completion, an average of 6 months
|
Participants will complete a 8-item intentions to use training in practice on a 5-item likert scale questionnaire following the online didactic training and end of study.
Number of participants who report positive intentions to use the training in practice will be compared.
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15 days from enrollment and through study completion, an average of 6 months
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Changes in suicide prevention self-efficacy
Time Frame: 15 days from enrollment and through study completion, an average of 6 months
|
Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire following the online didactic training and end of study.
Average responses will be compared.
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15 days from enrollment and through study completion, an average of 6 months
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Use of suicide prevention skills
Time Frame: through study completion, an average of 6 months
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Participants will self-report whether they used suicide prevention skills in practice on 0-4 point likert scale, with 0 defined as no use and 4 as frequently used.
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through study completion, an average of 6 months
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Feedback on training
Time Frame: through study completion, an average of 6 months
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Participants will provide feedback on their experience with suicide prevention training on 15 items using a 5-point likert scale.
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through study completion, an average of 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wendi F Cross, PhD, Associate Professor of Psychiatry (Psychology) and Pediatrics
Publications and helpful links
General Publications
- Aiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.
- Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
- Bridge JA, Horowitz LM, Fontanella CA, Grupp-Phelan J, Campo JV. Prioritizing research to reduce youth suicide and suicidal behavior. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S229-34. doi: 10.1016/j.amepre.2014.06.001.
- Wei LJ. An application of an urn model to the design of sequential controlled trials. Journal of the American Statistical Association. 1978;73(363):559-563.
- Pisani AR, Cross WF, Watts A, Conner K. Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk. Crisis. 2012 Jan 1;33(1):30-8. doi: 10.1027/0227-5910/a000099.
- Cross WF, West JC, Pisani AR, Crean HF, Nielsen JL, Kay AH, Caine ED. A randomized controlled trial of suicide prevention training for primary care providers: a study protocol. BMC Med Educ. 2019 Feb 14;19(1):58. doi: 10.1186/s12909-019-1482-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00061161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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