Trial Outcomes & Findings for A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses (NCT NCT04612777)
NCT ID: NCT04612777
Last Updated: 2024-10-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
12 months of study enrollment
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
Opening Doors to Recovery
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.
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.
|
Intensive Case Management or Case Management
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
123
|
|
Overall Study
4 Months
|
109
|
109
|
|
Overall Study
8 Months
|
106
|
106
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
17
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of "Opening Doors to Recovery" for Persons With Serious Mental Illnesses
Baseline characteristics by cohort
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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). These interventions include assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (4) coordinating services identified on the IRP, and (5) ensuring continued adequacy of the IRP to meet their ongoing and changing needs. Contact must be made with the individual ≥2 times per month, and at least once in-person, in a non-clinic setting.
Intensive Case Management (ICM) is similar to CM, but 4 in-person visits are required monthly. Additional contacts may be in-person or telephonic. At least 60% of total contacts must be in-person with the individual, and at least 50% must be delivered in non-clinic settings. An ICM team includes 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
117 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.8 Years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
36.0 Years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
35.9 Years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
106 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
117 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months of study enrollmentData 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload 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
|
1.9 Hospitalizations
Standard Deviation 1.5
|
2.3 Hospitalizations
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 12 months of study enrollmentParticipants' 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Number of Arrests for Intervention and Control Participants
|
1.7 number of arrests
Standard Deviation 1.1
|
2.0 number of arrests
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 12 months of study enrollmentData 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Number of Days Hospitalized for Intervention and Control Participants
|
18.0 days hospitalized
Standard Deviation 15.1
|
20.7 days hospitalized
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentThe 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Scores on the Housing Instability Index (HII)
|
-2.97 units on a scale
Standard Error 0.27
|
-2.48 units on a scale
Standard Error 0.30
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentThe 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Scores on the Housing Satisfaction Scale (HSS)
|
-0.88 units on a scale
Standard Error 0.09
|
-0.52 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentAt 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Scores on the Multnomah Community Ability Scale (MCAS)
|
0.47 units on a scale
Standard Error 0.07
|
0.32 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentAt 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Scores on the Maryland Assessment of Recovery in People With Serious Mental Illness (MARS)
|
0.22 units on a scale
Standard Error 0.08
|
0.05 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentAt 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
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Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
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|---|---|---|
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Scores on the Herth Hope Scale (HHS)
|
0.24 units on a scale
Standard Error 0.06
|
0.14 units on a scale
Standard Error 0.06
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentAt 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
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|---|---|---|
|
Scores on the Empowerment Scale
|
0.11 units on a scale
Standard Error 0.03
|
0.00 units on a scale
Standard Error 0.03
|
SECONDARY outcome
Timeframe: 12 months of study enrollmentAt 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.
Outcome measures
| Measure |
Opening Doors to Recovery
n=117 Participants
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.
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.
|
Intensive Case Management or Case Management
n=123 Participants
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Scores on the Community Navigation Abilities Scale (CNAS)
|
1.15 units on a scale
Standard Error 0.13
|
0.75 units on a scale
Standard Error 0.14
|
Adverse Events
Opening Doors to Recovery
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Intensive Case Management or Case Management
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Opening Doors to Recovery
n=117 participants at risk
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.
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.
|
Intensive Case Management or Case Management
n=123 participants at risk
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.
Case Management (CM) services 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 includes assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) connecting them to services and resources, (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 4 in-person visits are required monthly. At least 60% of contacts must be face-to-face, and at least 50% must be delivered in non-clinic settings. ICM teams include 9 professionals: a licensed clinician, 4 masters-level clinicians, 2 bachelors-level clinicians, and 2 paraprofessionals. The team's maximum caseload is 200 in rural settings and 300 in urban settings (22-33 per team member).
|
|---|---|---|
|
Psychiatric disorders
Psychiatric symptom exacerbation
|
0.85%
1/117 • Number of events 1 • 1 year
Consistent with clinicicaltrials.gov definitions.
|
0.81%
1/123 • Number of events 1 • 1 year
Consistent with clinicicaltrials.gov definitions.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place