An Exposure-Based Implementation Strategy to Decrease Clinician Anxiety Around Suicide Prevention
- Conditions
- Implementation Science
- Registration Number
- NCT05172609
- Lead Sponsor
- University of Pennsylvania
- 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinician Perception of EBIS Acceptability for Clinical Practice at Time 4, 12 Weeks After Completing Training Time 4: 12 weeks after completing training Acceptability of EBIS was measured with 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.
Clinician Perception of EBIS Feasibility and Utility for Clinical Practice at Time 4, 12 Weeks After Completing Training Time 4: 12 weeks after completing training Feasibility of EBIS was measured 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.
- Secondary Outcome Measures
Name Time Method Clinician Self-Efficacy Questionnaire at 4 Timepoints Across 12 Weeks 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 Self-efficacy was 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 was assessed separately for clinician self-efficacy for suicide screening and for use of the Safety Planning Intervention. Higher scores indicate greater self-efficacy. Scores were averaged for analysis (Range = 1 - 7).
Screening Use at 3 Timepoints Across 12 Weeks Time 1: baseline measures completed before the training; Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training Use of clinician routine suicide screening in all patient encounters was 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 reviewed the clinician's deidentified caseload with them for the past clinic week. For each patient seen that week, the researcher asked brief questions related to the clinicians' suicide-related practices around screening for suicide risk. Results below report the proportion of patients clinicians screened for suicide out of the total number of patients seen on one clinical day.
Clinician Anxiety at 4 Timepoints Across 12 Weeks 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. Clinician anxiety was 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. Clinicians rated their anxiety on screening and safety planning separately.
Safety Planning Intervention Use (Fidelity) at Time 3 (Two Weeks After Completing the Training) and Time 4 (12 Weeks After Completing the Training) Time 3: two weeks after completing the training; Time 4: 12 weeks after completing the training SPI Fidelity was indexed at Time 3 and Time 4 through case vignettes and standardized role play methodology. Participants received a vignette and prepare for a 45-60-minute role play, during which they were asked to complete an SPI with a patient who was determined to be at-risk for suicide following Columbia Suicide Severity Rating Scale (CSSRS) administration. Role plays were audio-recorded and coded for competence with the Safety Planning Intervention Rating Scale (SPIRS), developed by INSPIRE MPI G. Brown. This observational scale include 6 items on general safety plan intervention skills and 6 items which mapped onto the safety plan steps on a 4-point scale (0=not present to 3=excellent). Total scores were calculated by summing the 12 items with higher scores indicating greater SPI fidelity.
Trial Locations
- Locations (1)
University of Pennsylvania Department of Psychiatry
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Department of Psychiatry🇺🇸Philadelphia, Pennsylvania, United States