Clinical trial NCT02707367: Recovery Roadmap Phase II Small Business Innovation Research Grant
Official title: Recovery Roadmap Phase II: A Collaborative Multimedia Tool for Person-Centered Recovery Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Behavior Disorders
Lead sponsor: Center for Social Innovation, Massachusetts
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2016-03-14
Enrollment: 127
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: Recovery Roadmap: A Collaborative Multimedia Tool for Person-Centered Recovery Planning is a highly interactive web-based tool that provides guidance for providers and people in recovery, and promotes widespread implementation of Person-Centered Recovery Planning (PCRP). The Recovery Roadmap prototype was developed and tested by the Center for Social Innovation (C4), in partnership with Yale University's Program for Recovery and Community Health (PRCH), under a Phase I Small Business Innovative Research (SBIR) grant funded by the National Institute of Mental Health (NIMH) (1R43MH100712). Phase II refined the prototype Roadmap to streamline content, provide additional handouts and exercises for providers and clients to complete together, expand the audio/video vignettes and case studies, and add interactive online coaching and support for providers. Phase II also involved a robust evaluation of the Roadmap, using a quasi-experimental design in a fully powered trial. Approximately 30 practitioners and 90 clients (two to three clients per practitioner) were recruited from a total of five Community Support Programs in Connecticut. The programs were randomly selected into one of two intervention waves (Wave 1 and Wave 2). Survey data for Wave 1 included a total of four surveys: a pre-observation period, post-observation/pre-intervention, a midpoint survey (after completion of online curriculum), and a post survey (after completion of the entire intervention, including coaching calls). Surveys for the Wave 2 study participants included a pre-intervention, midpoint, and post survey. Qualitative interviews were also completed with interviews with practitioners and and administrators/clinical supervisors in each agency. State level client administrative client data were also collected and analyzed. Data examined changes in knowledge related to PCRP, person centered planning practices, practitioner/client relationship, and overall feedback on the intervention. our team also conducted a social network analysis to examine any changes in the size and strength of their networks related to person centered planning before and after the intervention. This phase will culminate with the dissemination of findings and preparation for Phase III commercialization.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Person-Centered Care Questionnaire
timeFrame: 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 outcomes:
measure: Recovery Knowledge Inventory
timeFrame: 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)
measure: Recovery Markers Questionnaire
timeFrame: 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)
measure: Helping Relationship Inventory
timeFrame: 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 outcomes:
measure: Change in Provider Online Sociometric Surveys
timeFrame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
measure: Qualitative Change in Provider Social Connectivity
timeFrame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
measure: Change in Provider Network Analytic Data
timeFrame: PreBaseline (pre-observation), Baseline (pre-intervention), and Time 1 (upon completion of the 6 month intervention)
Locations:
city: Needham
country: United States
facility: Center for Social Innovation
state: Massachusetts
Study officials:
affiliation: Center for Social Innovation
name: Kathleen Ferreira, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University Program for Recovery and Community Health
name: Janis Tondora, PsyD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Poulin J & Young T. Development of a helping relationship inventory for social work practice. Research on Social Work Practice 7: 463-489, 1997.
citation: 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.
citation: 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.