- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707367
Recovery Roadmap Phase II Small Business Innovation Research Grant
Recovery Roadmap Phase II: A Collaborative Multimedia Tool for Person-Centered Recovery Planning
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Person-Centered Recovery Planning (PCRP; also referred to as Patient-Centered Care Planning) is a field-tested intervention designed to maximize consumer choice and ownership of the treatment and recovery process. In Phase I of Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning, the research team developed a prototype online tool to train providers and persons in recovery to understand and implement PCRP. The tool provided in-depth information and included interactive components (e.g., videos, fillable forms, case studies) to prepare users to partner effectively. The tool was pilot tested in two sites (one received the Recovery Roadmap only; the other received the tool plus a two-day in-person training) to obtain feedback about the Roadmap and determine its impact. The purpose of this Phase II SBIR study is to expand the Recovery Roadmap and conduct a fully powered study to determine the tool's effectiveness in training providers and supporting people in recovery in the PCRP process.
This proposed Phase II study design:
We propose a randomized stepped wedge design in which we will recruit a total of 30 practitioners and 90 persons in recovery (PIRs), 3-4 from each participating practitioner. Per the power analysis, 90 PIRs will have enough power to show statistical significance. We will:
- Randomize the sample into two intervention waves, Wave 1 and Wave 2.
- Do a T1 assessment with all practitioners and PIRs and then immediately begin the first 2-month component of Wave 1 Recovery Roadmap Intervention, i.e., the 5-unit, online PCRP curriculum, with both PIRs and practitioners (for Wave 1, T1 will be a Baseline assessment; for Wave 2, T1 will be a Pre-Baseline assessment). Total of 3 months, including assessment and completion of the curriculum, while Wave 2 completes an observation period.
- Do a T2 assessment (practitioners and PIRs) with both waves and launch the first component of intervention with Wave 2 (RR on-line training units only) while Wave 1 launches the second component of the RR intervention, i.e., practitioners (only) receiving 3 months of twice monthly coaching calls and an on-line Community of Practice. The series of web-based technical assistance (coaching) sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice (COP). Wave 2 will have a total of 3 months, including its Baseline assessment and completion of the online curriculum. Wave 1 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T3 Assessment (practitioners and PIRs). This will be, for Wave 1, a post-intervention assessment for PIRs and practitioners. For Wave 2, it will include a mid-point intervention assessment for PIRs and practitioners, with Wave 2 immediately beginning a second component of the intervention (3 months of twice monthly coaching calls and an online COP for practitioners). The series of web-based technical assistance sessions are designed to reinforce PCRP key principles and practices as taught in the Recovery Roadmap and to optimize practitioners' use of/benefit from the web-based Community of Practice. Wave 1 will have a total of 3 months, including assessments and a 2-month observation period. Wave 2 will have a total of 4 months, including the mid-point assessment for PIRs and practitioners and completion of coaching calls and COP for practitioners.
- Do a T4 Assessment (practitioners and PIRs) after Wave 2 has completed the COP. This is post intervention for Wave 2 and follow-up for Wave 1.
Hypotheses (for Aims 1 and 2):
H1: Providers in the RR condition will show statistically significant improvements in PCRP knowledge, skills, and provider-client relationships.
H2: Clients served by providers in the RR condition will show statistically significant improvements in treatment engagement and progress toward goals.
H3: Providers with higher levels of connectivity with their peers online will report sustained PCRP practices, compared with those with lower connectivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Needham, Massachusetts, United States, 02494
- Center for Social Innovation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clients:
- Age of majority
- Receipt of mental health services within the participating program;
- Directly work with a provider participating in the study
- The ability to participate in the activities as determined by the client's clinical team
- Willing and able to engage in a six month PCRP intervention and participate in follow-up research activities (24 months total including follow up assessments).
Providers: Providers must meet the following inclusion criteria:
- Age of majority
- Directly work with clients willing to participate in the study;
- Have access to and basic navigation skills for using the Internet (for online coaching
- Work for a participating program
- Have a willingness to engage in a six-month PCRP intervention and participate in follow-up research activities (24 months total).
Administrators: Inclusion criteria for administrators participating in key informant semi-structured interviews include:
- Age of majority
- Being administrator of a program participating in the study or umbrella organization
- Have access to a computer to view tool components
- Knowledge about the market for this type of product for use in adult mental health. The team will develop a screening tool for administrators to ensure they meet basic criteria for the study.
Exclusion Criteria:
Clients:
- Non-English speakers
- Clients who are unable to participate in study activities (per clinical team determination) and individuals who are unable to understand the informed consent process (per the Quiz of Understanding for Informed Consent) will be excluded from the study.
Providers:
- Non-English speakers
- Providers who have prior experience with RR tools will be excluded from the study.
Administrators:
• Non-English speakers
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 |
|---|---|
|
Experimental: Recovery Roadmap (RR) Wave 1
All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design.
Data collection in Wave 1 will include two pre-tests and two post-tests, building in an observation period that is not present in Wave 2.
|
A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
|
|
Experimental: Recovery Roadmap (RR) Wave 2
All participants, in both Wave 1 and Wave 2, will act as their own comparator in a randomized stepped wedge design.
Data collection in Wave 1 will include one pre-test and three post-tests.
|
A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Person-Centered Care Questionnaire
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Change in PCRP knowledge and skills using the Person-Centered Care Questionnaire (Provider Version) for providers and the Person-Centered Care Questionnaire (Person in Recovery (PIR) Version) for clients (Tondora & Miller, 2009).
The provider and client/PIR versions allow providers and clients/PIR to respond to slightly different items, but each study participant will have one reported PCCQ value at each time point.
|
PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery Knowledge Inventory
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Change in provider participant knowledge and attitude data on four domains: roles and responsibilities in recovery, non-linearity of the recovery process, roles of self definition and peers in recovery, and expectations regarding recovery (Bedregal et al., 2006).
|
PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
|
Recovery Markers Questionnaire
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Change in client progress toward recovery (Ridgeway & Press, 2004).
|
PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
|
Helping Relationship Inventory
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Change in the relationship between the provider and client using the Helping Relationship Inventory-Worker for providers and the Helping Relationship Inventory-Client for clients (Poulin & Young, 1997).
Provider and client versions allow participants to respond to slightly different Helping Relationship Inventory (HRI) items, but each study participant will have one reported HRI value at each time point.
|
PreBaseline (pre-observation), Baseline (pre-intervention), Time 1 (upon completion of the 6 month intervention), Time 2 (6 month follow-up), Time 3 (12 month follow-up)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Provider Online Sociometric Surveys
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
|
Online Sociometric Surveys will contribute to a mixed methods approach of mapping provider social networks and social connectivity.
|
PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
|
|
Qualitative Change in Provider Social Connectivity
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
|
Semi-structured qualitative interviews will contribute to a mixed methods approach of mapping provider social networks and social connectivity.
|
PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
|
|
Change in Provider Network Analytic Data
Time Frame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
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Social network analytics will contribute to a mixed methods approach of mapping provider social networks and social connectivity.
|
PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kathleen Ferreira, Ph.D., Center for Social Innovation
- Principal Investigator: Janis Tondora, PsyD., Yale University Program for Recovery and Community Health
Publications and helpful links
General Publications
- Bedregal LE, O'Connell M, Davidson L. The Recovery Knowledge Inventory: assessment of mental health staff knowledge and attitudes about recovery. Psychiatr Rehabil J. 2006 Fall;30(2):96-103. doi: 10.2975/30.2006.96.103.
- Poulin J & Young T. Development of a helping relationship inventory for social work practice. Research on Social Work Practice 7: 463-489, 1997.
- Ridgway P & Press A. Assessing the recovery-orientation of your mental health program: A user's guide for the Recovery-Enhancing Environment scale (REE) (version 1). Lawrence, Kansas: University of Kansas, School of Social Welfare, Office of Mental Health Training and Research. 2004.
- Tondora J & Miller R. The PCCQ: Person-centered care questionnaire: A tool for supervision and quality monitoring. Yale Program for Recovery & Community Health: New Haven, CT. 2009.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
- 2R44MH100712-03 (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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