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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05758376
Other study ID # PPO 22-004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source VA Office of Research and Development
Contact Richard W Goldberg, PhD
Phone (410) 637-1863
Email Richard.Goldberg@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. The purpose of this proposal is to: 1) create a Peer Specialist facilitated intervention, called Recovery Bridge, designed to facilitate the transition from inpatient psychiatric hospitalization to community living; 2) examine feasibility, fidelity, and acceptability; and preliminarily explore the impact of the intervention on: a) readmission rates and connection to outpatient care compared to a control group identified from administrative data; and b) change in recovery and quality of life measures over time in the intervention participants. Results from the proposed open pilot trial will set the stage for 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Recovery Bridge
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

Locations

Country Name City State
United States Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility 1: Recruitment Benchmark Recruitment (number consented divided by number approached) 6 months
Primary Feasibility 2: Intervention Engagement Percentage of sample that completes at least 3 intervention sessions-with one of the three occurring inpatient 6 months
Primary Feasibility 3: Drop out rate Percent that do not complete post-intervention assessment 6 months
Primary Fidelity 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
Primary Acceptability 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
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