Clinical trial NCT04612777: A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
Official title: A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders, Severe
Schizophrenia and Related Disorders
Bipolar Disorder
Depressive Disorder
Keywords: serious mental illness
community navigation
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2020-11-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized either to the intervention ("Opening Doors to Recovery") or standard treatment (Intensive Case Management or Case Management)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Able to speak/read English
* Clinical diagnosis of one of the following: psychotic disorder, bipolar disorder, or major depressive disorder
* Capacity to give informed consent
* Being discharged to one of seven counties served by Gateway Behavioral Health Services
* Being hospitalized on an adult, non-forensics unit at Georgia Regional Hospital at Savannah, the Gateway-Brunswick CSU, or the Savannah CSU (located at Coastal Harbor) for ≥2 nights
* At least one additional prior hospitalization or CSU stay of ≥2 nights within the past 12 months (our definition of "institutional recidivism")
* Inability to complete activities of daily living in at least two of the following areas despite support from caregiver or behavioral health staff (this is a criterion previously established for receiving ICM services):

  1. navigate and self-manage necessary services,
  2. maintain personal hygiene, meet nutritional needs,
  3. care for personal business affairs, obtain or maintain medical, legal, and housing services,
  4. recognize and avoid common dangers or hazards to self and possessions,
  5. perform daily living tasks,
  6. obtain or maintain employment at a self-sustaining level or consistently perform homemaker roles (meal preparation, washing clothes, budgeting, or childcare tasks and responsibilities),
  7. maintain safe living situation (evicted from housing/recent loss of housing/imminent risk of loss of housing)
* Requires assistance with one or more of the following as an indicator of demonstrated ownership and engagement with his/her own illness self-management (this also is a criterion previously established for receiving ICM services): a. Taking prescribed medications b. Following a crisis plan c. Maintaining community integration d. Keeping appointments with needed services which have resulted in the exhibition of specific behaviors that have led to two or more of the following within the past 18 months (hospitalization, incarcerations, homelessness, or use of other crisis services)

Exclusion Criteria:

* Known or suspected intellectual disability, mental retardation, or dementia
* Known or suspected autism-spectrum disorder, organic mental disorder, and/or traumatic brain injury
* Significant medical condition compromising ability to participate (e.g., short of breath, in pain)
* Having taken part in the initial ODR study or being enrolled in any other study.
* Being referred to ACT
* Not having the ability to provide informed consent for the study

Primary outcomes:
measure: Number of Inpatient Psychiatric Stays for Intervention and Control Participants
timeFrame: 12 months of study enrollment
measure: Number of Arrests for Intervention and Control Participants
timeFrame: 12 months of study enrollment
measure: Number of Days Hospitalized for Intervention and Control Participants
timeFrame: 12 months of study enrollment
Secondary outcomes:
measure: Scores on the Housing Instability Index (HII)
timeFrame: 12 months of study enrollment
measure: Scores on the Housing Satisfaction Scale (HSS)
timeFrame: 12 months of study enrollment
measure: Scores on the Multnomah Community Ability Scale (MCAS)
timeFrame: 12 months of study enrollment
measure: Scores on the Maryland Assessment of Recovery in People With Serious Mental Illness (MARS)
timeFrame: 12 months of study enrollment
measure: Scores on the Herth Hope Scale (HHS)
timeFrame: 12 months of study enrollment
measure: Scores on the Empowerment Scale
timeFrame: 12 months of study enrollment
measure: Scores on the Community Navigation Abilities Scale (CNAS)
timeFrame: 12 months of study enrollment
Other outcomes:
Locations:
Study officials:
References:
citation: Compton MT, Kelley ME, Anderson S, Ellis S, Graves J, Broussard B, Pauselli L, Zern A, Pope LG, Johnson M, Haynes NL. Opening Doors to Recovery: A Randomized Controlled Trial of a Recovery-Oriented Community Navigation Service for Individuals With Serious Mental Illnesses and Repeated Hospitalizations. J Clin Psychiatry. 2023 Jan 16;84(2):22m14498. doi: 10.4088/JCP.22m14498.