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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02996344
Other study ID # 00061161
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2016
Est. completion date June 7, 2018

Study information

Verified date February 2020
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. The study 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date June 7, 2018
Est. primary completion date June 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- trainee in family medicine residency, pediatrics residency, or nurse practitioner program at URMC.

- speaks/writes English.

Exclusion Criteria:

- on academic probation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Didactic training
Six online training modules pertaining to suicide prevention in primary care.
Standardized patient interaction
Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (1)

Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Aiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.

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. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Mean score using the Commitment to Living: Primary Care Observational Rating form 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
Secondary Changes in suicide prevention knowledge Participants will complete a 17-item knowledge questionnaire prior to and following the online didactic training. Number of correct responses will be compared. 1 day following enrollment and 15 days from enrollment
Secondary Changes in suicide prevention self-efficacy 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. 1 day following enrollment and 15 days from enrollment
Secondary Changes in suicide prevention knowledge Participants will complete a 17-item knowledge questionnaire following the online didactic training and end of study. Number of correct responses will be compared. 15 days from enrollment and through study completion, an average of 6 months
Secondary Number of participants intending to transfer training to practice 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. 15 days from enrollment and through study completion, an average of 6 months
Secondary Changes in suicide prevention self-efficacy 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. 15 days from enrollment and through study completion, an average of 6 months
Secondary Use of suicide prevention skills 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. through study completion, an average of 6 months
Secondary Feedback on training Participants will provide feedback on their experience with suicide prevention training on 15 items using a 5-point likert scale. through study completion, an average of 6 months
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