Clinical trial NCT03132753: Developing SUPPORT, a Community-Driven, Recovery-Oriented System of Care
Official title: Developing SUPPORT, a Community-Driven, Recovery-Oriented System of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators seek to develop and assess the effectiveness of Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT), a community-driven recovery-oriented system of care for individuals recently released from prison. SUPPORT is modeled after Indiana Access to Recovery (ATR), a program that operated between October 2007 and December 2014. ATR, a national initiative funded by the Substance Abuse and Mental Health Services Administration (SAMHSA), provided comprehensive, flexible, recovery-oriented services for substance use disorder (SUD). The investigators' local evaluation of this program demonstrated significant improvement in a number of recovery-related outcomes (e.g., substance use, employment, income, involvement in the criminal justice system, and emotional well-being) for clients between intake and discharge. Additionally, qualitative findings from this evaluation demonstrated ATR was well liked among clients and providers. While Indiana ATR did serve a wider range of clients, the investigators have focused SUPPORT on returning inmates because (a) this was the largest group served by the program and (b) there is significant need for evidence-based SUD interventions for this population.

The investigators' primary long-term goal is to establish an effective and scalable recovery-oriented system of care for SUD within the reentry population. The investigators will conduct a pilot test comparing SUPPORT clients to clients receiving usual treatment. The investigators will collect quantitative data for both groups at multiple time points to understand the intervention's impact on recovery capital and outcomes and will collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences.

Detailed description: The investigators will conduct the pilot at Public Advocates in Community Re-Entry (PACE), a nonprofit that provides services to individuals with felony convictions in Marion County Indiana. PACE has provided re-entry services in Marion County, IN for 55 years. PACE's services are divided into four distinct categories: transitional, employment, addiction, and pre-release services. It is the only former ATR agency in Marion County specializing in a re-entry population, and our evaluation of Indiana's program demonstrated they had significantly lower rates of recidivism than any other Marion County agency. In 2015, PACE served 1,703 new clients.

The investigators will recruit 100 clients for participation in the pilot, half (50) will be assigned to SUPPORT and half (50) to treatment as usual. SUPPORT clients will be offered 12 months of support service with a PACE recovery coach. The recovery coach will guide the SUPPORT client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The SUPPORT program will provide SUPPORT clients with $1,000 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover similar support services as the previous Access to Recovery (ATR) program, such as housing (permanent, transitional), employment services (training, placement, readiness), substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Clients will NOT be responsible for keeping track of their vouchers, but rather, his/her assigned recovery coach will track all voucher funding/spending. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion.

Clients in the treatment as usual group will have significantly reduced choices in services compared to SUPPORT clients. These clients will not receive vouchers to access support services such as transportation and housing and will only receive standard case management, which is more prescriptive and less intensive than the recovery consultant services provided through SUPPORT.

All PACE clients who are over the age of 18, have a SUD, are no longer incarcerated (in a prison, jail, or work release facility), are within 3 months from their release from prison, jail, or work release, and are unable to access the previously mentioned Recovery Works program, will be eligible for study participation. For both parolees and probationers the risk of recidivism is highest in the first year of release; therefore, the investigators will be connecting with clients during the initial months following releases. The investigators will also be excluding sex offenders from the pilot, as they face greater barriers to community integration and experience higher levels of supervision while on parole, which have the potential to confound results during a small-scale pilot. Once a potential client is released from incarceration and enrolled at PACE, if eligible, an intake worker will inform them of the opportunity to participate in the pilot study and describe the SUPPORT program services. If the client agrees to participate in the pilot, they will sign a consent form and be randomly assigned to either SUPPORT or a treatment as usual condition. If a participant in either the SUPPORT or treatment as usual group is re-incarcerated during the study period, the investigators will not engage them while under correctional supervision to collect data and the investigators will replace them with a new participant. However, if a participant is re-incarcerated but released back into the community during the study period, and reengages with PACE, they will continue to be a part of the study and the investigators will continue to collect data and offer them SUPPORT services. In short, for the purposes of this pilot, the investigators will not be collecting data from clients while incarcerated.

Quantitative:

PACE will hire and assign two recovery coaches to provide SUPPORT services for the pilot. Once hired, the recovery coaches will complete all required IRB training and receive training on data collection and the informed consent procedures. The names of these recovery coaches will be added to the IRB protocol through an IRB amendment, having completed all required training, before interacting with subjects.

In addition to providing the support services, recovery coaches will 1) go over the statement of informed consent and Authorization form and have willing participants provide their signature, 2) conduct an initial interview with all clients after they have provided informed consent (to be included at the beginning of the electronic data collection) and have been assigned to the SUPPORT or comparison group, and 3) collect electronic data using REDCap system at the designated time points. Recovery consultants will collect data through a computer assisted personal interview (CAPI) (i.e., individual interviews assisted by computer technology.) Consultants will conduct interviews in a private room, away from other individuals so that others may not overhear what is discussed. Each consultant will have a tablet computer through which they will access the REDCap system. After the consultant has collected all necessary service or background data, the REDCap system will instruct them to hand the tablet over to the client to allow them to answer the remaining questions (regarding Self Determination, Treatment Motivation, Self Efficacy, Stages of Change, Substance Use, and Quality of Life) independently. The recovery coach will hand the tablet to the client and move so they cannot see their responses. Instructions will appear on the tablet telling the client to ask questions should they need assistance with either the tablet or answering a question. Should the client need assistance using the tablet or answering a question, the recovery coach will be available to help. During the screening process (i.e. client enrollment), client illiteracy will be picked up. Should a client be illiterate, they will still be invited to participate, but a recovery coach will read the questions rather than asking them to answer the questions independently.

CAPI interviews will be conducted with all clients (SUPPORT and non-SUPPORT) at baseline and 6 and 12 months to understand change in outcomes overtime. Consultants will also conduct a CAPI interview at 15 months with SUPPORT clients only to understand retention of treatment effects three months post discharge. Based on our previous experience conducting CAPI interviews, the investigators expect this process to take between 60 and 90 minutes.

CAPI Data collection measures include: demographic and background information on all clients at baseline; including: date of birth, gender, race, ethnicity, sexual orientation, housing history, education, employment history, and past involvement in addiction recovery and treatment. The investigators will also collect a number of measures, including (1) agency/self-determination, (2) recovery capital (i.e. treatment motivation, social support/networks, and self-efficacy), and (3) recovery-related outcomes (frequency of substance use and abstinence, incremental progress towards recovery, quality of life, recidivism, and administrative data on housing status, education, employment, income, physical and mental health status, and attendance at self-report self-help groups.)

Additionally, IU researchers will conduct structured social network interviews within one week of the client's entrance in the study and at 12 months. Social support is a proven influential factor on recovery. Having relationships and social networks that provide support, friendship, love, and hope through the process of recovery improves outcomes. The recovery coaches that work in the SUPPORT program will work with the clients to utilize their recovery support services to strengthen the individual's place in the community as a productive community member, family member, and worker, and, ideally, improve the quality of clients' interpersonal relationships and likelihood of positive recovery outcomes. This study will measure social support as a recovery-related outcome to see if the program is able to positively impact the social support in clients' lives over the course of 12 months. The total data collection time for these interviews will be between 30 and 60 minutes depending on the number of individuals in the client's network. At the time of the second network interview, the investigators will also collect qualitative data on SUPPORT client's overall program experience. During these interviews, the client will be asked for the first names and last initial of people who provide certain types of social support in his/her life.

Qualitative:

IU researchers will also collect qualitative data from both group through semi-structured interviews. The purpose of the interviews is to develop an understanding of client's treatment experience and how the SUPPORT program may have assisted them in overcoming barriers to recovery. These interviews are expected to take between 45 and 60 minutes. Guiding questions for the interview include: "Describe what you liked/did not like about the SUPPORT program (probe: client-centeredness, self-determination)."; "How was your relationship with your recover consultant?"; "Overall, how has the program helped you in your recovery? (probe: motivation; social capital; quality of life; elimination of barriers)"; "Are there specific things the program helped you with that you would not have been able to do on your own?"; "How did the program help you not return to jail (for those who did not recidivate)/How could the program have assisted your better so you would not have returned to jail (for those who did recidivate)?"; "If you experienced a relapse in the program, how did the program help you through that?"; "If you could change anything about SUPPORT, what would it be? Why?" (Attachment: Qualitative Interview Questions)

Also, researchers will conduct focus groups with SUPPORT clients after their 15-month CAPI interview. The researchers will conduct between 5 and 8 focus groups with 5-10 participants each. The researchers will attempt to recruit all SUPPORT clients for focus groups. Focus groups will last between 60 and 90 minutes and will be audio recorded.

Eligibility criteria: Inclusion Criteria:

* All PACE clients who are over the age of 18, have a SUD, are no longer incarcerated (in a prison, jail, or work release facility), are within 3 months of release from prison, jail, or work release, and are unable to access the previously mentioned Recovery Works program will be eligible for study participation.

Exclusion Criteria:

* Any individual that is not a PACE client, has not been released from prison, over the age of 18, or does not have a substance abuse disorder will not be included in the study.

Also, sex offenders will be excluded from this study because of the additional integration barriers faced by this population and their increased parole supervision, as these may confounding variables in such a small pilot.

Primary outcomes:
measure: Number of Participants Reporting Substance Use
timeFrame: Baseline
measure: Number of Participants Reporting Substance Use
timeFrame: 6 months
measure: Number of Participants Reporting Substance Use
timeFrame: 12 months
measure: Difference in the Number of Days That Participants Reported Substance Use
timeFrame: Baseline- 6 months
measure: Difference in the Number of Days That Participants Reported Substance Use
timeFrame: 6 months - 12 months
measure: Difference in the Number of Days That Participants Reported Substance Use
timeFrame: Baseline - 12 months
measure: Difference in Readiness to Change
timeFrame: Baseline - 6 months
measure: Difference in Readiness to Change
timeFrame: 6 months - 12 months
measure: Difference in Readiness to Change
timeFrame: Baseline - 12 months
measure: Difference in Quality of Life: Perceived General Health
timeFrame: Baseline - 6 months
measure: Difference in Quality of Life: Perceived General Health
timeFrame: 6 months - 12 months
measure: Difference in Quality of Life: Perceived General Health
timeFrame: Baseline - 12 months
measure: Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health
timeFrame: Baseline - 6 months
measure: Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health
timeFrame: 6 months - 12 months
measure: Difference in Quality of Life: Unhealthy Days or Days Limited by Poor Health
timeFrame: Baseline - 12 months
measure: Frequency of Incarceration
timeFrame: 6 months
measure: Frequency of Incarceration
timeFrame: 12 months
Secondary outcomes:
measure: Difference in Self Determination
timeFrame: Baseline - 6 months
measure: Difference in Self Determination
timeFrame: 6 months - 12 months
measure: Difference in Self Determination
timeFrame: Baseline - 12 months
measure: Difference in Self Efficacy
timeFrame: Baseline - 6 months
measure: Difference in Self Efficacy
timeFrame: 6 months - 12 months
measure: Difference in Self Efficacy
timeFrame: Baseline - 12 months
measure: Difference in Number of Alters That Participants Identified in Their Social Network
timeFrame: Baseline - 6 months
measure: Difference in Number of Alters That Participants Identified in Their Social Network
timeFrame: Baseline - 12 months
measure: Difference in the Fraction of Network That Are Close to Subject
timeFrame: Baseline - 6 months
measure: Difference in the Fraction of Network That Are Close to Subject
timeFrame: Baseline - 12 months
measure: Difference in the Network Closeness Sum
timeFrame: Baseline - 6 months
measure: Difference in the Network Closeness Sum
timeFrame: Baseline - 12 months
measure: Difference in the Network Closeness Average
timeFrame: Baseline - 6 months
measure: Difference in the Network Closeness Average
timeFrame: Baseline - 12 months
measure: Difference in the Network Closeness Density
timeFrame: Baseline - 6 months
measure: Difference in the Network Closeness Density
timeFrame: Baseline - 12 months
measure: Difference in the Fraction of Network Communicating With Subject
timeFrame: Baseline - 6 months
measure: Difference in the Fraction of Network Communicating With Subject
timeFrame: Baseline - 12 months
measure: Difference in the Fraction of Network Providing Support to the Subject
timeFrame: Baseline - 6 months
measure: Difference in the Fraction of Network Providing Support to the Subject
timeFrame: Baseline - 12 months
measure: Difference in the Fraction of Network Causing Subject Problems
timeFrame: Baseline - 6 months
measure: Difference in the Fraction of Network Causing Subject Problems
timeFrame: Baseline - 12 months
measure: Difference in the Fraction of Network Using Substance(s)
timeFrame: Baseline - 6 months
measure: Difference in the Fraction of Network Using Substance(s)
timeFrame: Baseline - 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Public Advocates in Community Re-Entry (PACE)
state: Indiana
Study officials:
References:
citation: Watson DP, Ray B, Robison L, Xu H, Edwards R, Salyers MP, Hill J, Shue S. Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Dec 15;3:73. doi: 10.1186/s40814-017-0212-1. eCollection 2017.