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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02010866
Other study ID # IRB 00009003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date October 2030

Study information

Verified date April 2024
Source Oregon Health and Science University
Contact Marie V Soller, MD
Phone 503-494-9000
Email soller@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. The screening and ability to interact online with a clinician anonymously are hypothesized to increase willingness to come for counseling in person. Suicide risk factors are expected to be lower once the distressed medical trainee or faculty member receives treatment.


Description:

According to theories such as motivational interviewing and stages of change, individuals change health behaviors when the benefits (e.g., being less stressed) outweigh the risks (e.g., concerns about confidentiality of treatment). Prior research suggests that educational programming to promote the benefits and counter the perceived risks of counseling increases adults' motivation to get professional help. Distressed physicians' motivation to seek help following an educational intervention has not been evaluated but organizations such as the American Foundation for Suicide Prevention, Association for the Accreditation of Graduate Medical Education, and the American Medical Association have developed policies and programming to educate physicians about the importance of treating depression and reducing suicide risk in themselves and their colleagues. A "best practices" suicide prevention program in 50+ US universities, the American Foundation for Suicide Prevention's Interactive Screening Program (ISP), was identified by the Oregon Health and Science University (OHSU) Resident and Faculty Wellness Program (RFWP) clinicians as a possible avenue by which to reach distressed OHSU trainees and faculty and encourage them to get help. The "Stress and Depression Questionnaire" is an anonymous, online screening tool for stress, depression, substance abuse, eating disorders, and suicide risk. Responses are scored and ranked according to level of distress and risk with Tier 1 representing "high risk, high distress" and Tier 2 "moderate distress, less risk" and Tier 3 "low or no distress or risk". RFWP clinicians will monitor responses, provide prompt communication back to the participants with information about how they scored, resources available to them, address any questions/concerns they might have and invite them to set up an appointment at the RFWP (if distressed). Moutier and her colleagues at a similar size academic medical center to OHSU, University of California at San Diego (UCSD), administered this survey to all medical students, residents, fellows, and faculty (13% completed it) and the majority eventually seen by clinicians indicated that they never would have sought help if they had not received feedback on the ISP and been encouraged to come in for evaluation/treatment. Being able to anonymously dialogue with a clinician about their specific situation and questions appeared to persuade some participants to come in for an evaluation or accept a referral. This academic medical center did not have an in-house counseling program for residents and faculty like the OHSU RFWP-UCSD trainees received an initial evaluation from a clinician and then were provided with community referrals. Their participation rate of 13% is similar to rates of participation in the ISP in undergraduate populations. In the present study, it is hypothesized that a highly visible and utilized RFWP may lead to a higher ISP participation rate among the residents, fellows, and faculty. Although the ultimate goal is to save lives (i.e., reduce the rate of suicide among medical trainees and faculty), the low base rate of suicide in a population makes it difficult to evaluate whether the implementation of the ISP at OHSU will lead to a drop in suicide rates at this institution. Even using patient suicidal ideation and attempts as outcomes is problematic as this information can be difficult to gather unless the patient is actively involved in treatment at the time. Rather in the present study the effectiveness of this suicide prevention program will be measured by examining related variables to suicide risk-increases in protective factors and decreases in risk factors. Specifically, these researchers seek to decrease known risk factors (e.g., identify and intervene with untreated depression, substance abuse, high level of stress) and increase protective factors (e.g., promote self-awareness, receipt of support and resources and delivery of mental health services if needed). Present study aims are to: - reduce known risk factors of untreated psychological distress (e.g., depression, high stress level, substance abuse) by encouraging all residents, fellows, and School of Medicine (SOM) faculty to complete a self-assessment of their level of stress and risk using the ISP and then offer professional help through a personalized message/dialogue that directly addresses any concerns/barriers about seeking help at the RFWP and offers resources for better coping; - increase self-awareness in mildly/moderately distressed trainees and faculty who fill out the ISP and offer preventive/early intervention educational resources via the ISP on topics that are relevant to them (based on their responses); - evaluate whether all RFWP patients (ones who come to the program via ISP and other referral sources) report decreased psychological distress, burnout, and risk of suicide across treatment; - assess levels of distress and flourishing among RFWP participants over time - assess level of satisfaction with the RFWP educational outreach workshops, consultation to department leaders (and referral of their trainees and/or faculty), and clinical services provided to distressed trainees and faculty.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date October 2030
Est. primary completion date October 2030
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - OHSU medical residents, fellows, and full-time School of Medicine faculty Exclusion Criteria: - individuals not meeting the above inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
counseling
in-person counseling through RFWP offered to distressed respondents on the ISP and others who seek counseling (due to other reasons for referral)

Locations

Country Name City State
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ISP levels of distress seen with medical trainees and faculty online, anonymous Interactive Screening Program (ISP) measures stress, depression, anxiety, substance abuse, and suicidal ideation--participants fill out survey at different points and may or may not come in for counseling Time survey is completed by trainee or faculty member at baseline
Primary Demographics of residents and faculty physicians who seek counseling through in house program Demographics of residents, faculty at time of intake for counseling at Resident and Faculty Wellness Program at enrollment for treatment (intake appointment)
Primary Who responds to treatment--level of distress % of participants in counseling services through Resident and Faculty Wellness who show change in psychological distress on ACORN from baseline to end of treatment time of intake (baseline) to participants' end of treatment or 6 months since last seen
Primary Who responds to treatment-level of burnout participants at Resident and Faculty Wellness Program who show significant decline in burnout on MBI screening items (emotional exhaustion and depersonalization items) from baseline (time of intake) to end of treatment time of intake to participants' end of treatment or 6 months since last seen
Primary Who responds to treatment-clinician rating of suicide risk participants of Resident and Faculty Wellness Program who show change in clinician rating of suicide risk during treatment time of intake (baseline) to participants end of treatment or 6 months since last seen
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