Clinical trial NCT05172609: An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention
Official title: An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety About Delivering Suicide Prevention Evidence-Based Practices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implementation Science
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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).

Primary outcomes:
measure: Clinician perception of EBIS acceptability for clinical practice
timeFrame: end of trial period (12 weeks)
measure: Clinician perception of EBIS feasibility and utility for clinical practice
timeFrame: end of trial period (12 weeks)
measure: EBIS feasibility as assessed by clinician retention statistics
timeFrame: through study completion, an average of 12 weeks
Secondary outcomes:
measure: Clinician Anxiety
timeFrame: baseline, immediately post-intervention, two week follow up, and 12 week follow up
measure: Clinician Self-Efficacy Questionnaire
timeFrame: baseline, immediately post-intervention, two week follow up, and 12 week follow up
measure: Screening use
timeFrame: baseline, immediately post-intervention, two week follow up, and 12 week follow up
measure: Safety Planning Intervention Use
timeFrame: baseline, immediately post-intervention, two week follow up, and 12 week follow up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Department of Psychiatry
state: Pennsylvania
Study officials:
References: