NCT04612777

A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Insufficient community-based support after inpatient discharge for persons with serious mental illnesses (SMI) may lead to re-hospitalization, excessive criminal justice involvement, homelessness, and an inability to embrace recovery. In fact, many of these especially vulnerable persons find themselves in a cycle of repeated hospital stays, arrests, and even homelessness, with little support for real recovery. Public mental health systems are struggling to address these problems. Evidence-based, comparatively inexpensive, time-limited community support models are needed to reduce institutional recidivism and facilitate recovery. The Georgia chapter of the National Alliance on Mental Illness (NAMI-GA) developed Opening Doors to Recovery (ODR), and we have collected extensive preliminary data on it. ODR is now being tested in a randomized controlled trial (RCT) taking place in southeast Georgia where ODR was first developed. The primary goals of ODR are to prevent institutional recidivism (i.e., going back into the hospital) and to promote recovery among persons with SMI like schizophrenia and bipolar disorder. The ODR intervention is comprised of several components that work together to address barriers to successful integration into the community among individuals with SMI and repeated inpatient hospitalizations. A team of 3 specially trained "Community Navigation Specialists" (CNSs, also called Navigators) provides intensive, mobile, community support to persons with SMI with a defined history of inpatient recidivism (i.e., repeated hospital stays). We are carrying out a fully powered trial of ODR in a 7-county catchment area in southeast Georgia, which is an ideal real-world location to carry out the study. During the 5-year study period, we will randomize 240 persons with SMI and a history of ≥2 inpatient stays in the past 12 months to ODR (n=120, followed for 12 months, with a maximum CNS caseload of 40) versus community care in traditional intensive case management or case management (ICM/CM, n=120). Assessments are conducted at baseline (just before hospital discharge), and at 4, 8, 12, and 18 months.

Conditions

• Mental Disorders, Severe
• Schizophrenia and Related Disorders
• Bipolar Disorder
• Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Opening Doors to Recovery	Opening Doors to Recovery (ODR) was created by a large, collaborative group in southeast Georgia as a recovery-oriented approach that navigates clients into services that may in some cases be fragmented and seemingly inaccessible. The team of three Community Navigation Specialists (CNSs) strives to help clients reduce institutional (e.g., hospital, jail) recidivism and embrace recovery. Their process of community navigation is a broader function than traditional case management as it includes mapping out and connecting clients to all available local resources, which requires being embedded in the community. The work of the CNSs benefits from commitments of diverse collaborative ODR partners, including local treatment providers, law enforcement, employers, and housing programs. Each CNS was expected to meet with the client at home or in community settings at least monthly, with the client having contact with at least one CNS weekly.
BEHAVIORAL	Case Management	Case Management (CM) services, as defined by the State mental health agency, consist of providing essential environmental support and care coordination to assist the individual with improving his/her functioning, gaining access to necessary services, and creating an environment that promotes recovery as identified in his/her Individual Recovery Plan (IRP). The focus of interventions include assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) referring and linking to services and resources identified through the service planning process, (4) coordinating services identified on the IRP to maximize service integration and minimize service gaps, and (5) ensuring continued adequacy of the IRP to meet his/her ongoing and changing needs. Contact must be made with the individual ≥2 times per month, at least one of which must be in-person, in a non-clinic setting.
BEHAVIORAL	Intensive Case Management	Intensive Case Management (ICM) is very similar to CM, but four in-person visits are required monthly. Additional contacts may be either face-to-face or via telephone, depending on the individual's needs. At least 60% of total contacts must be face-to-face with the individual, and at least 50% must be delivered in non-clinic/community-based settings. An ICM team includes nine professionals: a licensed clinician, four masters-level clinicians, two bachelors-level clinicians, and two paraprofessionals. The team's maximum case load is 200 in rural settings and 300 in urban settings (22-33 per team member).

Timeline

• Start date: 2014-06-15
• Primary completion: 2019-12-05
• Completion: 2020-05-31
• First posted: 2020-11-03
• Last updated: 2024-10-18
• Results posted: 2024-10-18