Clinical trial NCT06375551: K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions
Official title: Refining and Pilot Testing a Decision Support Intervention to Facilitate Adoption of Evidence-Based Programs to Improve Parent and Child Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Abuse
Decision Making
Child Welfare
Decision Making, Shared
Decision Support Technique
Social Facilitation
Implementation Science
Policy
Organizations
Consensus
Mental Health
Family
Lead sponsor: Chestnut Health Systems
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-04-19
Enrollment: 80
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: This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention.

Detailed description: Over 268,000 children entered foster care in the United States during fiscal year 2019 despite the existence of Maltevidence-based programs (EBPs) that can successfully prevent child maltreatment. Evidence-informed decision-making (EIDM) can lead to the adoption of EBPs that are likely to be successfully implemented and result in the intended impacts. Despite the existence of EBPs to prevent child maltreatment, EBPs are underutilized in child welfare. Proposed study activities in this career development award respond to NIMH Objective 4.2.c by developing, refining, and piloting an implementation strategy to increase EIDM when decision makers are adopting EBPs to improve mental health and child welfare services. Activities leverage an unprecedented federal policy opportunity to prevent child maltreatment and test implementation decision support strategies in the real world: The Family First Prevention Services Act (FFPSA). FFPSA aims to prevent child maltreatment and foster care entries by providing federal funding to states for implementing EBPs that support child and parent mental health, reduce parental substance misuse, and improve parenting skills. This project engages decision makers from four states implementing FFPSA to extend the candidate's prior work developing an innovative EIDM tool to support EBP adoption: Optimizing Responses through Collaborative Assessments (ORCA). ORCA is based in multi-criteria decision analysis, which provides a structured approach to reach quality, evidence-informed group decisions. Given that group decisions with tools such as ORCA benefit from facilitation, this study will develop and test two facilitation modalities to accompany ORCA: automated (ORCA-A) and live (ORCA-L). In addition, a web-based platform to host the ORCA tool and the ORCA-A facilitation strategy will be developed with decision makers' input (Aim 1). The impact of ORCA-A and ORCA-L on quality of decision experiences, processes, and outcomes then will be tested (Aim 2). Implementation process quality for each EBP adopted with ORCA-A and ORCA-L will be monitored (Aim 3). To enhance her strong foundation in the implementation, decision, and systems sciences, the candidate, Dr. Gracelyn Cruden, will leverage these research activities and training activities to expand her skillset to include: leading implementation studies in service systems, employing a continuum of methods for engaging community members, leveraging interdisciplinary approaches for eliciting members' preferences, conducting advanced simulation model testing, and using advanced statistics for multilevel, longitudinal studies. Cruden will be mentored by an outstanding team led by Primary Mentor Dr. Lisa Saldana, who is accompanied by Mentors Dr. Jason Chapman, Dr. Lindsey Zimmerman, Dr. R. Christopher Sheldrick, Dr. Jonathan Purtle, and Consultants Dr. David Vanness, and Ms. Clare Anderson. Upon completion of these activities, Cruden will be equipped to lead an interdisciplinary research team that will support quality mental health and child welfare services by increasing decision makers' use of EIDM.

Eligibility criteria: Inclusion Criteria:

* Non-institutionalized
* Adults (18 years or older).
* English-Speaking

Aim 1:

* Involved in initial state decision-making related to Family First Prevention Services Act.
* Willing to participate in two data collection occasions.

Aim 2:

* Non-institutionalized
* Adults (18 years or older). English-Speaking.
* Involved in ongoing state decision-making related to Family First Prevention Services Act.
* Willing to participate in three measurement occasions.

Aim 3:

-Willing to participate in multiple (bi-weekly up to two years) measurement occasions.

Exclusion Criteria:

-Not involved in or potentially influencing child welfare intervention decisions

Primary outcomes:
measure: Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Mean changes in decision experience quality pre-post intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Mean changes in decision commitment pre-post intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Mean changes in perceived potential community health impact pre-post intervention
timeFrame: Baseline; Immediately Post-intervention; 12-month follow-up
measure: Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA)
timeFrame: Baseline; Immediately Post-intervention
measure: Qualitatively described rationale for program adoption from pre-post intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention
timeFrame: Baseline; Immediately Post-intervention; 12-month post-intervention
measure: Descriptive, mean group-level changes in perceived acceptability of intervention for implementation
timeFrame: Baseline; Immediately Post-intervention; 12-month post-intervention
measure: Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation
timeFrame: Baseline; Immediately Post-intervention; 12-month post-intervention
measure: Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA
timeFrame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
measure: Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA
timeFrame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
Secondary outcomes:
measure: Qualitative changes in decision reasoning pre- post-intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Qualitative changes in decision goals pre- post-intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Qualitative changes in decision consensus pre- post-intervention
timeFrame: Baseline; Immediately Post-intervention
measure: Time to adoption or re-adoption of interventions with ORCA
timeFrame: Baseline to adoption of an intervention for implementation, assessed for up to 24 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Chestnut Health Systems
state: Oregon
Study officials:
affiliation: Chestnut Health Systems
name: Gracelyn Cruden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alley ZM, Chapman JE, Schaper H, Saldana L. The relative value of Pre-Implementation stages for successful implementation of evidence-informed programs. Implement Sci. 2023 Jul 21;18(1):30. doi: 10.1186/s13012-023-01285-0.
citation: Oetzel JG, Wallerstein N, Duran B, Sanchez-Youngman S, Nguyen T, Woo K, Wang J, Schulz A, Keawe'aimoku Kaholokula J, Israel B, Alegria M. Impact of Participatory Health Research: A Test of the Community-Based Participatory Research Conceptual Model. Biomed Res Int. 2018 Apr 24;2018:7281405. doi: 10.1155/2018/7281405. eCollection 2018.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
citation: Cruden G, Frerichs L, Powell BJ, Lanier P, Brown CH, Lich KH. Developing a Multi-Criteria Decision Analysis Tool to Support the Adoption of Evidence-Based Child Maltreatment Prevention Programs. Prev Sci. 2020 Nov;21(8):1059-1064. doi: 10.1007/s11121-020-01174-8. Epub 2020 Oct 11.