An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention

• ClinicalTrials.gov Identifier: NCT05172609
• Recruitment Status: Recruiting
• First Posted: December 29, 2021
• Last Update Posted: May 10, 2023
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

Brief Summary:

Study objectives are to design and pilot test a novel, exposure-based implementation strategy (EBIS) directly targeting clinician anxiety and low self-efficacy for use of evidence-based suicide screening, assessment, and intervention (SSAI) strategies with patients at risk for suicide in community settings. Early phases of this study will develop the EBIS in partnership with community clinicians (n = 15). The last phase of this study is a pilot clinical trial in which 40 community mental health clinicians will be randomized to receive either implementation as usual (IAU) or IAU+EBIS.

Condition or disease	Intervention/treatment	Phase
Implementation Science	Behavioral: Exposure Based Implementation Strategy (EBIS); Behavioral: Implementation as Usual (IAU)	Not Applicable

Detailed Description:

This exploratory project brings together an interdisciplinary team to design and pilot-test an exposure-based implementation strategy (EBIS) to target clinician-level anxiety about suicide screening, assessment, and intervention (SSAI) use. We will test the effect of EBIS as an implementation strategy to augment Implementation as Usual (IAU) to enhance SSAI implementation in community mental health settings. Specifically, this study first will use participatory design methods to develop and refine EBIS in collaboration with a stakeholder advisory board of clinicians, administrators, and content experts. This study then will further iteratively refine EBIS with up to 15 clinicians in a pilot field test, using rapid cycle prototyping, in collaboration with the INSPIRE Methods Core. Clinicians in Aim 2 will also provide qualitative feedback on EBIS' ability to mitigate anxiety and increase self-efficacy to deliver SSAIs to optimize our ability to engage target mechanisms of clinician anxiety. In the final phase, this study will test the refined EBIS in a pilot implementation trial in which 40 community mental health clinicians will be randomized to receive either IAU or EBIS+IAU. Primary clinical trial dependent variables are EBIS acceptability and feasibility, measured through questionnaires, interviews, and recruitment and retention statistics; this pilot trial is not intended to be powered to detect effects. Secondary outcomes are preliminary effectiveness of EBIS on clinician-level implementation outcomes (SSAI adoption), and engagement of target implementation mechanisms (clinician anxiety and self-efficacy related to SSAI use), assessed via mixed methods.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety About Delivering Suicide Prevention Evidence-Based Practices
• Actual Study Start Date: March 29, 2023
• Estimated Primary Completion Date: February 28, 2025
• Estimated Study Completion Date: August 31, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exposure Based Implementation Strategy (EBIS); EBIS is informed by the latest science in exposure theory, borrowing heavily from brief exposure-based treatments that can be delivered in a single session. We anticipate that EBIS will occur in four phases that map on to standard exposure therapy practice for patients with anxiety disorders: psychoeducation, assessment, practice, and relapse prevention; however, the final version will depend on the outcomes of the preparatory phases of this study. Clinicians assigned to the EBIS arm will also receive all elements of IAU.	Behavioral: Exposure Based Implementation Strategy (EBIS); EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.
Active Comparator: Implementation as Usual (IAU); Gold-standard IAU for SSAIs typically comprises pre-implementation preparation, didactic training, knowledge tests, experiential role plays, ongoing expert consultation, and providing certification status to clinicians who attain established benchmarks. Pre-implementation preparation will include provision of materials. Didactic training will occur in two parts: (1) suicide screening and assessment, and (2) Safety Planning Intervention (SPI) use. Part one will consist of materials we previously developed based on community clinician feedback. Part two will follow established SPI guidelines, including didactic training about SPI rationale and evidence base and experiential practice. IAU also will include supports for electronic health record integration (e.g., previously developed templates). After training, clinicians will receive 8 weeks of expert consultation to discuss implementation barriers and receive more role play practice.	Behavioral: Implementation as Usual (IAU); IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians

Outcome Measures

Primary Outcome Measures :

1. Clinician perception of EBIS acceptability for clinical practice [ Time Frame: end of trial period (12 weeks) ]
   Acceptability of EBIS will be measured via qualitative interviews with participants as well as the Acceptability of Intervention Measure (AIM), a 4-item, psychometrically-validated measure that indexes the extent to which stakeholders believe an implementation strategy is acceptable. Items on the AIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability.
2. Clinician perception of EBIS feasibility and utility for clinical practice [ Time Frame: end of trial period (12 weeks) ]
   Feasibility of EBIS will with the Feasibility of Intervention Measure (FIM), a 4-item measure that indexes the extent to which an implementation strategy is perceived as feasible. Items on the FIM are rated on a 5-point Likert scale (Range = 4-20) and higher scores indicate greater acceptability.
3. EBIS feasibility as assessed by clinician retention statistics [ Time Frame: through study completion, an average of 12 weeks ]
   Feasibility statistics for study retention (e.g., the proportion of recruited clinicians that agrees to be randomized to EBIS, he proportion of randomized clinicians that completes EBIS)

Secondary Outcome Measures :

1. Clinician Anxiety [ Time Frame: baseline, immediately post-intervention, two week follow up, and 12 week follow up ]
   Clinician anxiety will be assessed via 10-point Subjective Units of Distress (SUDS), a 10-point Likert rating of subjective distress where 1 = Not at all Distressed and 10 = Very Distressed.
2. Clinician Self-Efficacy Questionnaire [ Time Frame: baseline, immediately post-intervention, two week follow up, and 12 week follow up ]
   Self-efficacy will be measured via responses to two statements on a 7-point scale measuring clinicians' self-efficacy to use SSAIs, using established question stems from behavioral science (e.g., "If I really wanted to, I could screen every patient I see for suicide risk"). Self-efficacy will be assessed separately for clinician self-efficacy for suicide screening and for use of the Safety Planning Intervention. Higher scores indicate greater self-efficacy. Scores will be averaged for analysis (Range = 1 - 7).
3. Screening use [ Time Frame: baseline, immediately post-intervention, two week follow up, and 12 week follow up ]
   Use of clinician routine suicide screening in all patient encounters will be indexed via chart-stimulated recall (CSR). CSR is an established technique for examining clinician decision-making and clinical processes beyond what can be determined from chart review or self-report alone. A research team member will review the clinician's deidentified caseload with them for the past clinic week. For each patient seen that week, the researcher will ask brief questions related to the clinicians' suicide-related practices around screening for suicide risk.
4. Safety Planning Intervention Use [ Time Frame: baseline, immediately post-intervention, two week follow up, and 12 week follow up ]
   Clinician use of the Safety Planning Intervention when indicated (i.e., patient screens positive for suicide risk) will be indexed via chart-stimulated recall. CSR is an established technique for examining clinician decision-making and clinical processes beyond what can be determined from chart review or self-report alone. A research team member will review the clinician's caseload with them for the past clinic week. For each patient seen that week for which the clinician reports screening for suicide risk, the researcher will ask brief questions (no more than 5 minutes) related to the clinicians' follow up intervention to assess clinician use of the Safety Planning Intervention.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Practicing mental health clinicians who provide direct mental health services to a treatment-seeking population
• Proficient in the English language
• Have access to a computer with internet connectivity

Exclusion Criteria:

• Participants will be excluded if they do not see any mental health patients that are at risk for suicide (e.g., they screen out high-risk patients for their individual practice).

Contacts and Locations

Contacts

Contact: Emily M Becker-Haimes, PhD; 215-573-5614; emily.haimes@pennmedicine.upenn.edu

Contact: Megan Brady, B.A.; mhquire@pennmedicine.upenn.edu

Locations

United States, Pennsylvania

University of Pennsylvania Department of Psychiatry; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Emily M Becker-Haimes, PhD 215-573-5614 emily.haimes@pennmedicine.upenn.edu

Contact: Megan Brady, BA mhquire@pennmedicine.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

More Information

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05172609
• Other Study ID Numbers: 356336
• First Posted: December 29, 2021
• Last Update Posted: May 10, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicide; Suicide Prevention; Self-Injurious Behavior; Behavioral Symptoms