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Comparative effectiveness of significant other-enhanced office-based opioid treatment (OBOT) in primary care
Investigator (PI): Osilla, Karen
Performing Organization (PO): (Current): RAND Corporation / (310) 393-0411
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2024
Record Source/Award ID: PCORI/ OBOT-2018C2-12876
Funding: Total Award Amount: $5,149,648
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of problem: Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment dropout are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Methods: We propose a study to recruit 500 patient and SP pairs in community health clinics throughout northern and southern California. We will recruit patients who are starting OUD medication treatment and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment as usual. We will then interview patients and SPs three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve. Outcomes: We will follow patient and SPs for a year and assess patient retention in OUD treatment. We will also assess patient opioid use, SP health, relationship, and quality of life. We will assess for which patient subgroups CRAFT is most helpful, and we will survey staff to understand the best ways to make CRAFT available to other clinics in the future. Importance to patients: This study is important to patients with OUD because treatment dropout is linked to a substantially greater risk of opioid relapse and overdose. Thus, finding ways to keep patients in treatment is essential. Stakeholder engagement: Our team consists of patients, SPs, clinic staff, psychologists, psychiatrists, statisticians, payers, and other qualified individuals who have dedicated their lives and careers to improving the wellbeing of those affected by opioid and other substance use. We have assembled clinic, patient, and payer/health board stakeholder advisory panels who will guide us in planning and conducting the study and disseminating study results. We will meet with each panel regularly, using a community engagement process that emphasizes joint leadership, open communication, and two-way knowledge exchange. In doing so, we want to create a project that is relevant and meaningful to the community that can be successfully completed. The proposed study not only fills critical gaps in what we know about CRAFT and OUD treatment, but also provides data to inform a much-needed new way to address the opioid epidemic.
MeSH Terms:
  • Ambulatory Care /organization & administration
  • California
  • Communication
  • Community Mental Health Services /*organization & administration
  • Comparative Effectiveness Research
  • Drug Overdose /prevention & control
  • Family Health
  • Friends
  • Humans
  • Mental Health Services /organization & administration
  • Multicenter Studies as Topic
  • Opioid-Related Disorders /*therapy
  • Opioids /*adverse effects
  • Outcome Assessment (Health Care)
  • Outpatients
  • Primary Care /*organization & administration
  • Program Development
  • Quality of Life
  • Relapse
  • Social Support
  • Spouses
Country: United States
State: Massachusetts
Zip Code: 90401
UI: 20202349
CTgovId: NCT04239235
Project Status: Ongoing