An interventional study of Opening Doors to Recovery and Case Management in Mental Disorders, Severe, Schizophrenia and Related Disorders and Bipolar Disorder, sponsored by New York State Psychiatric Institute. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Health services research
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.
2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.
This study's enrollment of 240 is above the median of 96 across 1,607 interventional studies indexed under Mental Disorders.
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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):
Exclusion Criteria:
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
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 · Behavioral: Intensive Case Management
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.
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.
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).
Number of Inpatient Psychiatric Stays 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 inpatient psychiatric stays during a 12-month period compared to participants in ICM/CM.
Time frame: 12 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.
Time frame: 12 months of study enrollment
Number of Days Hospitalized for Intervention and Control Participants
Data on inpatient psychiatric days 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 A2: ODR participants will have fewer inpatient psychiatric hospital days during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
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, and 12-months. It contains 10 items. The measure was scaled on a scale of 0 to 10 with higher scores indicating greater housing instability. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis C1a: ODR participants will have lesser housing instability during a 12-month period compared to participants in ICM/CM.
Time frame: 12 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, and 12-months. It contains 19 items covering choice, safety, privacy, and proximity. The measure was scaled on a scale of 1 to 5, with higher scores indicate lesser housing satisfaction. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis C1b: ODR participants will have greater housing satisfaction during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
Scores on the Multnomah Community Ability Scale (MCAS)
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Multnomah Community Adjustment Scale .It contains 17 items that measure social and community functioning; 5 other items were added. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater community abilities. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). 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.
Time frame: 12 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, and 12-months, participants will respond to the Maryland Assessment of Recovery in People with Serious Mental Illness. It contains 25 items that measure recovery experiences. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater recovery. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1b: ODR participants will have greater recovery, based on the MARS scale, during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
Scores on the Herth Hope Scale (HHS)
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Herth Hope Scale (HHS). It contains 30 items that measure hope. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater hope. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1c: ODR participants will have greater recovery, based on the HHS, during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
Scores on the Empowerment Scale
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Empowerment Scale. It contains 28 items that measure self-esteem, perceived power, optimism/control over the future, and related constructs. The measure was scaled on a scale of 1 to 4, with higher scores indicate greater empowerment. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1d: ODR participants will have greater recovery, based on the Empowerment Scale, during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
Scores on the Community Navigation Abilities Scale (CNAS)
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Community Navigation Abilities Scale (CNAS). It contains 21 items that measure community navigation abilities. The measure was scaled on a scale of 1 to 7, with higher scores indicate greater community navigation abilities. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1e: ODR participants will have greater recovery, based on the CNAS, during a 12-month period compared to participants in ICM/CM.
Time frame: 12 months of study enrollment
| Milestone | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Started | 117 | 123 |
| 4 months | 109 | 109 |
| 8 months | 106 | 106 |
| Completed | 100 | 100 |
| Not completed | 17 | 23 |
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 inpatient psychiatric stays during a 12-month period compared to participants in ICM/CM.
| Hospitalizations | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Number of Inpatient Psychiatric Stays for Intervention and Control Participants | 1.9 ± 1.5 | 2.3 ± 1.8 |
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.
| number of arrests | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Number of Arrests for Intervention and Control Participants | 1.7 ± 1.1 | 2.0 ± 1.3 |
Data on inpatient psychiatric days 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 A2: ODR participants will have fewer inpatient psychiatric hospital days during a 12-month period compared to participants in ICM/CM.
| days hospitalized | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Number of Days Hospitalized for Intervention and Control Participants | 18.0 ± 15.1 | 20.7 ± 27.0 |
The Housing Instability Index will be administered orally to all study participants during the routine follow-up assessments at 4-months, 8-months, and 12-months. It contains 10 items. The measure was scaled on a scale of 0 to 10 with higher scores indicating greater housing instability. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis C1a: ODR participants will have lesser housing instability during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Housing Instability Index (HII) | -2.97 ± 0.27 | -2.48 ± 0.30 |
The Housing Satisfaction Scale (HSS) will be administered orally to all study participants during the routine follow-up assessments at 4-months, 8-months, and 12-months. It contains 19 items covering choice, safety, privacy, and proximity. The measure was scaled on a scale of 1 to 5, with higher scores indicate lesser housing satisfaction. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis C1b: ODR participants will have greater housing satisfaction during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Housing Satisfaction Scale (HSS) | -0.88 ± 0.09 | -0.52 ± 0.10 |
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Multnomah Community Adjustment Scale .It contains 17 items that measure social and community functioning; 5 other items were added. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater community abilities. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). 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.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Multnomah Community Ability Scale (MCAS) | 0.47 ± 0.07 | 0.32 ± 0.08 |
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Maryland Assessment of Recovery in People with Serious Mental Illness. It contains 25 items that measure recovery experiences. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater recovery. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1b: ODR participants will have greater recovery, based on the MARS scale, during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Maryland Assessment of Recovery in People With Serious Mental Illness (MARS) | 0.22 ± 0.08 | 0.05 ± 0.09 |
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Herth Hope Scale (HHS). It contains 30 items that measure hope. The measure was scaled on a scale of 1 to 5, with higher scores indicate greater hope. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1c: ODR participants will have greater recovery, based on the HHS, during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Herth Hope Scale (HHS) | 0.24 ± 0.06 | 0.14 ± 0.06 |
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Empowerment Scale. It contains 28 items that measure self-esteem, perceived power, optimism/control over the future, and related constructs. The measure was scaled on a scale of 1 to 4, with higher scores indicate greater empowerment. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1d: ODR participants will have greater recovery, based on the Empowerment Scale, during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Empowerment Scale | 0.11 ± 0.03 | 0.00 ± 0.03 |
At each routine follow-up assessments at 4-months, 8-months, and 12-months, participants will respond to the Community Navigation Abilities Scale (CNAS). It contains 21 items that measure community navigation abilities. The measure was scaled on a scale of 1 to 7, with higher scores indicate greater community navigation abilities. We computed a "change score" representing the participant's change in scores from baseline to 12-months. Group effects are shown as the mean difference (Δ) from baseline to 12 months per group, but estimates are derived from fitted linear slope of change over all data (baseline, 4 months, 8 months, and 12 months). Hypothesis D1e: ODR participants will have greater recovery, based on the CNAS, during a 12-month period compared to participants in ICM/CM.
| units on a scale | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Scores on the Community Navigation Abilities Scale (CNAS) | 1.15 ± 0.13 | 0.75 ± 0.14 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opening Doors to Recovery | 0/117 (0%) | 1/117 (0.9%) | 0/117 (0%) |
| Intensive Case Management or Case Management | 3/123 (2.4%) | 1/123 (0.8%) | 0/123 (0%) |
| Event | Opening Doors to Recovery | Intensive Case Management or Case Management |
|---|---|---|
| Psychiatric symptom exacerbationPsychiatric disorders | 1/117 | 1/123 |
| Age, Categorical(Participants) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 117 | 123 | 240 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| Mean | 35.8 ± 11.8 | 36.0 ± 11.4 | 35.9 ± 11.6 |
| Sex: Female, Male(Participants) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| Female | 36 | 49 | 85 |
| Male | 81 | 74 | 155 |
| Ethnicity (NIH/OMB)(Participants) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 7 | 12 |
| Not Hispanic or Latino | 106 | 112 | 218 |
| Unknown or Not Reported | 6 | 4 | 10 |
| Race (NIH/OMB)(Participants) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 56 | 58 | 114 |
| White | 55 | 61 | 116 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 4 | 10 |
| Region of Enrollment(Participants) | Opening Doors to Recovery | Intensive Case Management or Case Management | Total |
|---|---|---|---|
| United States | 117 | 123 | 240 |
No study locations are listed for this record.
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Plan to share: No
Ran from Jun 2014 to primary completion in Dec 2019, 65 months.
Results were first posted in Oct 2024, 4 years 10 months after primary completion.
Of 841 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's 65 months is above that.
Counting every sponsor, half of 856 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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