- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06375551
K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions (K-ORCA)
Refining and Pilot Testing a Decision Support Intervention to Facilitate Adoption of Evidence-Based Programs to Improve Parent and Child Mental Health
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gracelyn Cruden, PhD
- Phone Number: 843-513-9928
- Email: gcruden@chestnut.org
Study Contact Backup
- Name: Kelli Wright
- Email: kwright@chestnut.org
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Recruiting
- Chestnut Health Systems
-
Contact:
- Gracelyn Cruden, PhD
- Phone Number: 309-451-7868
- Email: gcruden@chestnut.org
-
Contact:
- Jessica Harrison, MS
- Email: jlharrison@chestnut.org
-
Principal Investigator:
- Gracelyn Cruden, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ORCA-A
Decision Makers receiving automated facilitation to accompany ORCA
|
Participants will receive automated facilitation in the ORCA platform. This will entail prompts for group discussion based on group model building scripts and decision hygiene approaches proposed by Kahneman, Sibony, and Sunstein (2021). Participants will have the option of using these prompts to discuss ORCA results in group decision discussions. Optimizing Responses with Collaborative Assessments (ORCA) is a technical decision support tool based in multi-criteria decision analysis. Decision makers rate and compare evidence-based programs or other practices with ORCA, then prioritize practices for local implementation based on ORCA results. ORCA will be on a virtual platform to allow for web-based completion, automated analysis, and automated facilitation. |
|
Active Comparator: ORCA-L
Decision Makers receiving live facilitation to accompany ORCA
|
A facilitator will guide group decision discussions using group model building scripts and decision hygiene approaches proposed by Kahneman, Sibony, and Sunstein (2021). Facilitation will be either in-person or virtual, but occur "live" as in during real-time. Optimizing Responses with Collaborative Assessments (ORCA) is a technical decision support tool based in multi-criteria decision analysis. Decision makers rate and compare evidence-based programs or other practices with ORCA, then prioritize practices for local implementation based on ORCA results. ORCA will be on a virtual platform to allow for web-based completion, automated analysis, and automated facilitation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention
Time Frame: Baseline; Immediately Post-intervention
|
A two-item, quantitative measure will inquire about assumptions and goals in the decision to adopt an intervention.
This uses a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly Agree).
This outcome is part of Aim 2b: Decision quality based on intervention fit to local context.
|
Baseline; Immediately Post-intervention
|
|
Mean changes in decision experience quality pre-post intervention
Time Frame: Baseline; Immediately Post-intervention
|
This will be measured across five validated, quantitative sub-scales from a measure of community partnered research: Partner Values, Synergy, Conflict and Cooperation, Participation, Participatory decision-making.
Each scale has a range of 1 (Strongly Disagree) to 5 (Strongly Agree).
|
Baseline; Immediately Post-intervention
|
|
Mean changes in decision commitment pre-post intervention
Time Frame: Baseline; Immediately Post-intervention
|
A two-item, Likert-scale measure regarding the decision maker's confidence in and commitment to implementing the selected intervention(s) will be gathered using a two-item measure.
This uses a 5-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly Agree).
These scales relate to Aim 2a: decision experience quality.
|
Baseline; Immediately Post-intervention
|
|
Mean changes in perceived potential community health impact pre-post intervention
Time Frame: Baseline; Immediately Post-intervention; 12-month follow-up
|
This will be measured across a validated, quantitative sub-scale from a measure for community partnered research: Community Health Improvement.
This scale has a range of 1 (Strongly Disagree) to 5 (Strongly Agree).
This is part of Aim 2b: Decision quality.
|
Baseline; Immediately Post-intervention; 12-month follow-up
|
|
Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA)
Time Frame: Baseline; Immediately Post-intervention
|
Decision makers will rank interventions in an ordinal manner at baseline using a study-specific survey.
Rankings will be calculated post-intervention by ORCA as a function of completing the ORCA tool.
The number of ordinal rankings will depend on the number of interventions considered, to be determined by participants.
A rank of 1 = highest, followed by 2 ...n.
This is part of Aim 2c: Decision quality.
|
Baseline; Immediately Post-intervention
|
|
Qualitatively described rationale for program adoption from pre-post intervention
Time Frame: Baseline; Immediately Post-intervention
|
This is a study-specific, short, open-ended survey to understand decision makers' rationale for adopting programs during initial Family First Prevention Services Act decisions.
There is no scale for the items, given the qualitative, open-ended nature.
These are one survey of similar, but related constructs of intervention feasibility, acceptability, and appropriateness.
This is part of Aim 2c: Decision quality.
|
Baseline; Immediately Post-intervention
|
|
Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention
Time Frame: Baseline; Immediately Post-intervention; 12-month post-intervention
|
The validated, quantitative Feasibility of Intervention Measure (FIM) will be used to assess perceived implementation feasibility for each intervention considered with ORCA.
Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree).
This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.
|
Baseline; Immediately Post-intervention; 12-month post-intervention
|
|
Descriptive, mean group-level changes in perceived acceptability of intervention for implementation
Time Frame: Baseline; Immediately Post-intervention; 12-month post-intervention
|
The validated, quantitative Acceptability of Intervention Measure (AIM) will be used to assess perceived implementation feasibility for each intervention considered with ORCA.
Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree).
This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.
|
Baseline; Immediately Post-intervention; 12-month post-intervention
|
|
Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation
Time Frame: Baseline; Immediately Post-intervention; 12-month post-intervention
|
The validated, quantitative Intervention Appropriateness Measure (IAM) will be used to assess perceived acceptability for each intervention considered with ORCA.
Scale ranges from 1 (Completely Disagree) to 5 (Completely Agree).
This outcome is part of Aim 2b regarding decision quality operationalized as intervention fit to local context.
|
Baseline; Immediately Post-intervention; 12-month post-intervention
|
|
Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA
Time Frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
|
A validated measure of implementation activities across 8 stages and 3 phases will be used (Universal Stages of Implementation Completion).
Dates are recorded for each activity to be reported or as missing the date, but still being completed.
One of the results for the calculated scores is the proportion of activities completed.
A higher proportion of activities is generally positive.
|
Immediately Post-intervention; bi-weekly through 12-month post-intervention
|
|
Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA
Time Frame: Immediately Post-intervention; bi-weekly through 12-month post-intervention
|
A validated measure of implementation activities across 8 stages and 3 phases will be used (Universal Stages of Implementation Completion).
Dates are recorded for each activity to be reported or as missing the date, but still being completed.
One of the results for the calculated scores is the duration (time elapsed).
The ideal duration depends on the proportion score.
|
Immediately Post-intervention; bi-weekly through 12-month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative changes in decision reasoning pre- post-intervention
Time Frame: Baseline; Immediately Post-intervention
|
Group discussion transcripts will be analyzed using directed content analysis to identify themes.
At baseline and post-intervention, a single-item, study-specific questionnaire will ask participants to express their rationale for adopting the selected intervention(s).
|
Baseline; Immediately Post-intervention
|
|
Qualitative changes in decision goals pre- post-intervention
Time Frame: Baseline; Immediately Post-intervention
|
Group discussion transcripts will be analyzed using directed content analysis to identify themes.
At baseline and post-intervention, a single-item, study-specific questionnaire (the same as in Outcome 12) will ask participants to express their rationale for adopting the selected intervention(s).
|
Baseline; Immediately Post-intervention
|
|
Qualitative changes in decision consensus pre- post-intervention
Time Frame: Baseline; Immediately Post-intervention
|
Group discussion transcripts will be analyzed using directed content analysis to identify themes.
At baseline and post-intervention, a single-item, study-specific questionnaire (the same as in Outcome 12) will ask participants to express their rationale for adopting the selected intervention(s).
|
Baseline; Immediately Post-intervention
|
|
Time to adoption or re-adoption of interventions with ORCA
Time Frame: Baseline to adoption of an intervention for implementation, assessed for up to 24 months
|
Days elapsed from completing ORCA initial time to official decision regarding adopting or re-adopting an intervention.
This outcome relates to Aim 2a: decision process quality.
|
Baseline to adoption of an intervention for implementation, assessed for up to 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gracelyn Cruden, PhD, Chestnut Health Systems
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1171-0623
- K01MH128761 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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