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

Study Overview
=================
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.

Official Title
-----------------
A Trial of Opening Doors to Recovery for Persons With Serious Mental Illnesses

Conditions
-----------------
Mental Disorders, Severe, Schizophrenia and Related Disorders, Bipolar Disorder, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Opening Doors to Recovery
* Behavioral: Case Management
* Behavioral: Intensive Case Management


Participation Criteria
=================
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): navigate and self-manage necessary services, maintain personal hygiene, meet nutritional needs, care for personal business affairs, obtain or maintain medical, legal, and housing services, recognize and avoid common dangers or hazards to self and possessions, perform daily living tasks, obtain or maintain employment at a self-sustaining level or consistently perform homemaker roles (meal preparation, washing clothes, budgeting, or childcare tasks and responsibilities), 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized either to the intervention (Opening Doors to Recovery) or standard treatment (Intensive Case Management or Case Management)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opening Doors to Recovery<br>Participants will receive services from the team of three ODR navigators: one professional social worker, one navigator who is a family member of someone with SMI, and one peer navigator with lived experience. | Behavioral: Opening Doors to Recovery<br>* 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.<br>|
| Active Comparator: Intensive Case Management or Case Management<br>Participants randomized to the control group will either receive standard services of Intensive Case Management or Case Management, depending on the services that are available in their county. | Behavioral: Case Management<br>* 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.<br>Behavioral: Intensive Case Management<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inpatient psychiatric stays and days for intervention and control participants | Data on inpatient psychiatric stays will be collected from the Georgia Department of Behavioral Health and Developmental Disabilities, Gateway Behavioral Health Services Crisis Stabilization Unit in Brunswick, Georgia, and Coastal Harbor Crisis Stabilization Unit in Savannah, Georgia. Hypothesis A1: ODR participants will have fewer total days in inpatient psychiatric settings during a 12-month period compared to participants in ICM/CM. Hypothesis A2: Effects on hospital recidivism will persist at 18 months (6 months after being transitioned out of ODR). | 18 months of study enrollment | 
| Number of arrests for intervention and control participants | Participants' Record of Arrest and Prosecution (RAP) sheets will be collected from the Georgia Bureau of Investigation, and data on each participant's arrests during the study period will be extracted. Hypothesis B1: ODR participants will have fewer arrests during a 12-month period compared to participants in ICM/CM. Hypothesis B2: Effects on arrests will persist at 18 months. | 18 months of study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on the Housing Instability Index (HII) | The Housing Instability Index will be administered orally to all study participants during the routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months. Hypothesis C1a: ODR participants will have lesser housing instability during a 12-month period compared to participants in ICM/CM. Hypothesis C2a: Effects on housing instability will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Housing Satisfaction Scale (HSS) | The Housing Satisfaction Scale (HSS) will be administered orally to all study participants during the routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months. Hypothesis C1b: ODR participants will have greater housing satisfaction during a 12-month period compared to participants in ICM/CM. Hypothesis C2b: Effects on housing satisfaction will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Multnomah Community Adjustment Scale (MCAS) | At each routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months, participants will respond to the Multnomah Community Adjustment Scale. Hypothesis D1a: ODR participants will have greater recovery, based on the scale of community adjustment, during a 12-month period compared to participants in ICM/CM. Hypothesis D2a: Effects on recovery will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Maryland Assessment of Recovery in People with Serious Mental Illness (MARS) | At each routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months, participants will respond to the Maryland Assessment of Recovery in People with Serious Mental Illness. Hypothesis D1b: ODR participants will have greater recovery, based on the MARS scale, during a 12-month period compared to participants in ICM/CM. Hypothesis D2b: Effects on recovery will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Herth Hope Scale (HHS) | At each routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months, participants will respond to the Herth Hope Scale (HHS). Hypothesis D1c: ODR participants will have greater recovery, based on the HHS, during a 12-month period compared to participants in ICM/CM. Hypothesis D2c: Effects on recovery will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Empowerment Scale | At each routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months, participants will respond to the Empowerment Scale. Hypothesis D1d: ODR participants will have greater recovery, based on the Empowerment Scale, during a 12-month period compared to participants in ICM/CM. Hypothesis D2d: Effects on recovery will persist at 18 months. | 18 months of study enrollment | 
| Scores on the Community Navigation Abilities Scale (CNAS) | At each routine follow-up assessments at 4-months, 8-months, 12-months, and 18-months, participants will respond to the Community Navigation Abilities Scale (CNAS). Hypothesis D1e: ODR participants will have greater recovery, based on the CNAS, during a 12-month period compared to participants in ICM/CM. Hypothesis D2e: Effects on recovery will persist at 18 months. | 18 months of study enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serious mental illness, community navigation