search
Back to results

Recovery Bridge: A Peer Facilitated Intervention to Help Bridge the Transition From Psychiatric Inpatient Hospitalized to Living in the Community

Primary Purpose

Mental Illness

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Bridge
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Illness focused on measuring Veteran, In-patient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Recovery Bridge

Arm Description

Open trial single arm pilot study

Outcomes

Primary Outcome Measures

Feasibility 1: Recruitment Benchmark
Recruitment (number consented divided by number approached)
Feasibility 2: Intervention Engagement
Percentage of sample that completes at least 3 intervention sessions-with one of the three occurring inpatient
Feasibility 3: Drop out rate
Percent that do not complete post-intervention assessment
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)
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)

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
October 4, 2023
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT05758376
Brief Title
Recovery Bridge: A Peer Facilitated Intervention to Help Bridge the Transition From Psychiatric Inpatient Hospitalized to Living in the Community
Official Title
Recovery Bridge: A Peer Facilitated Intervention to Help Bridge the Transition From Psychiatric Inpatient Hospitalized to Living in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Veteran, In-patient

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open Pilot Trial (n=15) to examine feasibility, fidelity, and acceptability of study intervention (called Recovery Bridge)
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recovery Bridge
Arm Type
Experimental
Arm Description
Open trial single arm pilot study
Intervention Type
Behavioral
Intervention Name(s)
Recovery Bridge
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility 1: Recruitment Benchmark
Description
Recruitment (number consented divided by number approached)
Time Frame
6 months
Title
Feasibility 2: Intervention Engagement
Description
Percentage of sample that completes at least 3 intervention sessions-with one of the three occurring inpatient
Time Frame
6 months
Title
Feasibility 3: Drop out rate
Description
Percent that do not complete post-intervention assessment
Time Frame
6 months
Title
Fidelity
Description
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)
Time Frame
6 months
Title
Acceptability
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard W Goldberg, PhD
Phone
(410) 637-1863
Email
Richard.Goldberg@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sera Havrilla, MA
Phone
(410) 637-1850
Email
Sera.Havrilla@VA.GOV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Goldberg, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederick M Ivey, PhD
Phone
410-605-7000
Ext
56510
Email
Frederick.Ivey@va.gov
First Name & Middle Initial & Last Name & Degree
Richard W Goldberg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Recovery Bridge: A Peer Facilitated Intervention to Help Bridge the Transition From Psychiatric Inpatient Hospitalized to Living in the Community

We'll reach out to this number within 24 hrs