- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05758376
Recovery Bridge: A Peer Facilitated Intervention to Help Bridge the Transition From Psychiatric Inpatient Hospitalized to Living in the Community
Study Overview
Detailed Description
Background: The time following discharge from psychiatric hospitalization is a high-risk period and has been associated with a range of negative outcomes, including high rates of hospital readmission and suicide (1). Because the evidence for transitional discharge interventions with bridging components is mixed and limited in terms of how Peer Specialists (PS) can help support such interventions, additional research is needed. This proposal calls for the development and preliminary evaluation of a PS facilitated technology-supported intervention based on the existing and frequently used My Recovery Plan program. However, to date, no studies have examined use of this tool to improve post-hospital discharge outcomes. Given the importance of the problem for the VA, and the fact that the VA has both a large PS infrastructure that is valued by both professional providers and Veterans, the investigators' work offers sound justification and the unique opportunity to test the proposed intervention in a single integrated system of inpatient and outpatient services.
Significance: The significance of this project lies in its ability to actively address an important gap in the research, namely PS interventions focused on reducing readmission and supporting recovery-oriented outcomes in Veterans. Further relating to important HSR&D priorities the project is designed to advance scientific knowledge and clinical practice in the areas of access to care, mental health, and suicide prevention.
Innovation and Impact: A key innovation of the proposed research is the potential to efficiently optimize existing resources to target the widespread challenges associated with transitioning out of acute inpatient settings and effectively connect Veterans to preferred services (in this case peer support) in order to prevent re-admission, and improve utilization of VA outpatient mental health services. Finally, in relationship to impact, Recovery Bridge has potential to result in improvement across multiple clinical and functional outcomes that are applicable to a broad Veteran population (rather than only in small select diagnostically specific subpopulations).
Specific Aim 1: Integrate the My Recovery Plan tool and existing PS tools and strategies to develop a manualized intervention called Recovery Bridge for use by VA PS working to help Veterans make the transition from acute inpatient psychiatric hospitalization to community living.
Specific Aim 2: Complete an open pilot trial (n=15) to examine the feasibility, fidelity, and acceptability of the Recovery Bridge intervention in relation to well specified benchmarks supporting continued and expanded investigation.
[Specific Aim 3: As part of the open pilot trial: 1) explore the impact of the intervention on readmission rates (at 30 and 90 days), and connection to outpatient care compared to a control group (n=15) identified from administrative data, and; 2) explore the change in recovery and Quality of Life measures over time in the intervention participants].
Methodology: Source documents described in the proposal will be used to create the Recovery Bridge intervention (as Specified in Aim 1). Quantitative, qualitative, and administrative services data the investigators will be used to complete an open trial of the intervention (as specified in Aim 2 and Aim 3).
Next Steps: Benchmarks across the domains of feasibility, fidelity, and acceptability; as well as exploratory outcomes specified in Aim 3, will be used to inform next steps including a larger effectiveness trial followed by a possible hybrid-I effectiveness/implementation trial to inform future dissemination and implementation of the intervention more broadly across the VA.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Richard W Goldberg, PhD
- Phone Number: (410) 637-1863
- Email: Richard.Goldberg@va.gov
Study Contact Backup
- Name: Sera Havrilla, MA
- Phone Number: (410) 637-1850
- Email: Sera.Havrilla@VA.GOV
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
-
Principal Investigator:
- Richard W Goldberg, PhD
-
Contact:
- Frederick M Ivey, PhD
- Phone Number: 56510 410-605-7000
- Email: Frederick.Ivey@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion Criteria for active sample:
- 18 years of age or older
- enrolled in the inpatient program
- planned discharge to the community
Exclusion Criteria:
- Inability to provide consent
- No access to either a computer or a telephone after discharge (as at least one of these will be needed should the Veteran and PS interventionist decide to continue to meet remotely)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Recovery Bridge
Open trial single arm pilot study
|
Recovery Bridge is a Peer Specialist facilitated intervention designed to help Veterans being discharged from an inpatient psychiatric hospitalization bridge the gap to outpatient care and community living
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility 1: Recruitment Benchmark
Time Frame: 6 months
|
Recruitment (number consented divided by number approached)
|
6 months
|
Feasibility 2: Intervention Engagement
Time Frame: 6 months
|
Percentage of sample that completes at least 3 intervention sessions-with one of the three occurring inpatient
|
6 months
|
Feasibility 3: Drop out rate
Time Frame: 6 months
|
Percent that do not complete post-intervention assessment
|
6 months
|
Fidelity
Time Frame: 6 months
|
Greater than 90% of all Adherence and Competence Items Rated as Acceptable or Higher ...(higher ratings of acceptability are considered to be the better outcome)
|
6 months
|
Acceptability
Time Frame: 6 months
|
Average score of 26 percent or higher on Patient Satisfaction Questionnaire (scale ranges from 8-32)-Higher scores are associated with "better outcome" (i.e. higher satisfaction)
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard W Goldberg, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 22-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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