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

University of Pennsylvania

Status: Completed

Conditions: Implementation Science

Treatments: Behavioral: Implementation as Usual (IAU); Behavioral: Exposure Based Implementation Strategy (EBIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05172609

356336

Details and patient eligibility

About

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.

Full 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.

Aim 1 did not include data collection from study participants. Activities in this aim only included refinement with the advisory board members who were not considered study participants.

Data collected in Aim 2 was largely descriptive and qualitative to inform EBIS development and refinement activities.

We are reporting Aim 3 data which included pilot randomization with clinicians. Data was collected at the following timepoints: Time 1: baseline measures completed before the training; Time 2: immediately after completing the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Exposure Based Implementation Strategy (EBIS)

Experimental group

Description:

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.

Treatment:

Behavioral: Exposure Based Implementation Strategy (EBIS)

Implementation as Usual (IAU)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Implementation as Usual (IAU)