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

Primary Purpose

Implementation Science

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exposure Based Implementation Strategy (EBIS)
Implementation as Usual (IAU)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • University of Pennsylvania Department of PsychiatryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exposure Based Implementation Strategy (EBIS)

Implementation as Usual (IAU)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Clinician perception of EBIS acceptability for clinical practice
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.
Clinician perception of EBIS feasibility and utility for clinical practice
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.
EBIS feasibility as assessed by clinician retention statistics
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

Clinician Anxiety
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.
Clinician Self-Efficacy Questionnaire
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).
Screening use
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.
Safety Planning Intervention Use
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.

Full Information

First Posted
August 25, 2021
Last Updated
May 8, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05172609
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implementation Science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure Based Implementation Strategy (EBIS)
Arm Type
Experimental
Arm 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.
Arm Title
Implementation as Usual (IAU)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Based Implementation Strategy (EBIS)
Intervention Description
EBIS will include psychoeducation, assessment/hierarchy building. guided practice, and guidance for application to clinical practice.
Intervention Type
Behavioral
Intervention Name(s)
Implementation as Usual (IAU)
Intervention Description
IAU will consist of standard didactic training and ongoing consultation activities for enrolled clinicians
Primary Outcome Measure Information:
Title
Clinician perception of EBIS acceptability for clinical practice
Description
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.
Time Frame
end of trial period (12 weeks)
Title
Clinician perception of EBIS feasibility and utility for clinical practice
Description
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.
Time Frame
end of trial period (12 weeks)
Title
EBIS feasibility as assessed by clinician retention statistics
Description
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)
Time Frame
through study completion, an average of 12 weeks
Secondary Outcome Measure Information:
Title
Clinician Anxiety
Description
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.
Time Frame
baseline, immediately post-intervention, two week follow up, and 12 week follow up
Title
Clinician Self-Efficacy Questionnaire
Description
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).
Time Frame
baseline, immediately post-intervention, two week follow up, and 12 week follow up
Title
Screening use
Description
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.
Time Frame
baseline, immediately post-intervention, two week follow up, and 12 week follow up
Title
Safety Planning Intervention Use
Description
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.
Time Frame
baseline, immediately post-intervention, two week follow up, and 12 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily M Becker-Haimes, PhD
Phone
215-573-5614
Email
emily.haimes@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Brady, B.A.
Email
mhquire@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania Department of Psychiatry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily M Becker-Haimes, PhD
Phone
215-573-5614
Email
emily.haimes@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Megan Brady, BA
Email
mhquire@pennmedicine.upenn.edu

12. IPD Sharing Statement

Learn more about this trial

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

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