Home-Based Mental Health Evaluation (HOME)

NCT ID: NCT03347552

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-29

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this project is to investigate the effectiveness of the Home-Based Mental Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide prevention intervention for Veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk.

Detailed Description

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The purpose of this project is to investigate the effectiveness of the Home-Based Mental Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide prevention intervention for Veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk. The research project employs a multi-site two-arm interventional trial design to study the effectiveness of the HOME program. Effectiveness of the treatment will be evaluated by comparing Veterans receiving the HOME program at two active treatment sites, Denver and Philadelphia Department of Veterans Affairs Medical Centers (VAMCs), to with those receiving care at two control sites, Houston and Portland VAMCs. The current protocol describes procedures as they will occur at all sites, including those completed locally at the Denver VAMC, which is the lead site for the study.

Conditions

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Suicide and Self-harm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The blind assessor will administer follow up measures. In order to keep the assessor blind to participant status (active vs. control), research staff will facilitate phone calls. To monitor blinding, the blind assessor will record if participants inadvertently un-blind themselves during the assessment and also record their guess to which treatment condition (active versus E-CARE)participants were allocated.

Study Groups

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Active Treatment

Participants in the active arm will be enrolled in the HOME Program.

Group Type EXPERIMENTAL

HOME

Intervention Type BEHAVIORAL

Prior to discharge from the inpatient unit, the HOME program provider or another member of the research team, will meet individually with the Veteran to provide further information regarding the HOME program intervention. Efforts are made to schedule the initial phone call and home visit that occur during the first week after discharge. Following the home visit, the HOME provider may continue to have weekly contact with the Veteran via the telephone or in person until he or she is disenrolled following engagement in outpatient care. "Engaged in care" is defined as attendance at two individual outpatient mental health appointments or engagement in equivalent or elevated care as determined by the PI. All clinical contacts with the Veteran may include the following: suicide risk assessment, review and modification of the Veteran's safety plan, review and modification of the discharge plan, involvement of the Veteran's support system, and facilitation of engagement in outpatient care.

E-CARE

Receiving enhanced care as usual. Participants at these sites are described as receiving "enhanced care as usual" or "E-CARE" because they will be recruited, enrolled and complete baseline and follow-up assessments in addition to care as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HOME

Prior to discharge from the inpatient unit, the HOME program provider or another member of the research team, will meet individually with the Veteran to provide further information regarding the HOME program intervention. Efforts are made to schedule the initial phone call and home visit that occur during the first week after discharge. Following the home visit, the HOME provider may continue to have weekly contact with the Veteran via the telephone or in person until he or she is disenrolled following engagement in outpatient care. "Engaged in care" is defined as attendance at two individual outpatient mental health appointments or engagement in equivalent or elevated care as determined by the PI. All clinical contacts with the Veteran may include the following: suicide risk assessment, review and modification of the Veteran's safety plan, review and modification of the discharge plan, involvement of the Veteran's support system, and facilitation of engagement in outpatient care.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age between 18-89
2. Able to provide a phone number and the location of a residence at which they can be reached
3. Planned location of discharge is a safe environment for the HOME provider to visit\*
4. Agree to receive the HOME program intervention (active site participants only)
5. Ability to adequately respond to questions regarding the informed consent procedure

Exclusion Criteria

1. Receiving services from the Mental Health Intensive Case Management (MHICM) or Domiciliary program or being directly transferred to further inpatient or residential treatment
2. Enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, until the subject has completed their participation in the other study
3. Current involvement in the criminal justice system as a prisoner or ward of the state.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bridget B Matarazzo, PsyD

Role: PRINCIPAL_INVESTIGATOR

VA Rocky Mountain MIRECC

Locations

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VA Portland Health Care System

Portland, Oregon, United States

Site Status

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Matarazzo BB, Gerard GR, Jankovsky MC, Oslin DW, Brenner LA. Feasibility and Acceptability of the HOME Program for Veterans Recently Discharged from a Psychiatric Hospitalization. Adm Policy Ment Health. 2021 Nov;48(6):974-982. doi: 10.1007/s10488-021-01109-7. Epub 2021 Feb 1.

Reference Type DERIVED
PMID: 33523330 (View on PubMed)

Other Identifiers

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13-2982

Identifier Type: -

Identifier Source: org_study_id

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