Mental Disorders, SevereODRNCT04612777
A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
A study testing Opening Doors to Recovery, Case Management and Intensive Case Management in people with Mental Disorders, Severe and Schizophrenia and Related Disorders, run by New York State Psychiatric Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorders, Severe, Schizophrenia and Related Disorders, Bipolar Disorder
- What is being tested?
- Opening Doors to Recovery, Case Management and Intensive Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2014to 31 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
Show all 15Show fewer
- 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)
Who cannot join
- 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
About this study
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
- Being tested
- Opening Doors to Recovery, Case Management, Intensive Case Management
- Keywords
- serious mental illness, community navigation
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opening Doors to RecoveryBehavioural
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 ManagementBehavioural
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 ManagementBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Opening Doors to Recovery | Experimental | 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. Receives: Behavioral: Opening Doors to Recovery |
| Intensive Case Management or Case Management | Active comparator | 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. Receives: Behavioral: Case Management; Behavioral: Intensive Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months of study enrollment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Jun 2014
- Primary completion5 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Disorders, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Michael Compton, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612777
- Sponsor's protocol ID
- 7419
- Acronym
- ODR
- Status last verified
- Jul 2024
- First submitted
- 21 Oct 2020
- Last updated
- 18 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36652687
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
- ClinicalTrials.gov ID
- NCT04612777
- Acronym / sponsor ID
- ODR / 7419
- Conditions
- Mental Disorders, Severe, Schizophrenia and Related Disorders, Bipolar Disorder, Depressive Disorder
- Keywords
- serious mental illness, community navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Emory University
- Study start
- 15 Jun 2014 (actual)
- Primary completion
- 5 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Posted 18 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized either to the intervention ("Opening Doors to Recovery") or standard treatment (Intensive Case Management or Case Management)
| Arm | Type | Receives |
|---|---|---|
| Opening Doors to Recovery | Experimental | Behavioral: Opening Doors to RecoveryParticipants 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. |
| Intensive Case Management or Case Management | Active comparator | Behavioral: Case Management, Behavioral: Intensive Case ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opening Doors to RecoveryOpening 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. | Behavioural | Opening Doors to Recovery |
| Case ManagementCase 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. | Behavioural | Intensive Case Management or Case Management |
| Intensive Case ManagementIntensive 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). | Behavioural | Intensive Case Management or Case Management |
Primary outcome
Number of Inpatient Psychiatric Stays for Intervention and Control Participants
Time frame: 12 months of study enrollment
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.
Number of Arrests for Intervention and Control Participants
Time frame: 12 months of study enrollment
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 Days Hospitalized for Intervention and Control Participants
Time frame: 12 months of study enrollment
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.
7 secondary outcomes
Scores on the Housing Instability Index (HII)
Time frame: 12 months of study enrollment
Scores on the Housing Satisfaction Scale (HSS)
Time frame: 12 months of study enrollment
Scores on the Multnomah Community Ability Scale (MCAS)
Time frame: 12 months of study enrollment
Scores on the Maryland Assessment of Recovery in People With Serious Mental Illness (MARS)
Time frame: 12 months of study enrollment
Scores on the Herth Hope Scale (HHS)
Time frame: 12 months of study enrollment
Scores on the Empowerment Scale
Time frame: 12 months of study enrollment
Scores on the Community Navigation Abilities Scale (CNAS)
Time frame: 12 months of study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36652687Compton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Opening Doors to Recovery, Case Management and Intensive Case Management in people with Mental Disorders, Severe and Schizophrenia and Related Disorders, run by New York State Psychiatric Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Inpatient Psychiatric Stays for Intervention and Control Participants (time frame: 12 months of study enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04612777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.