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Home-Based Mental Health Evaluation (HOME) (HOME)

Primary Purpose

Suicide and Self-harm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HOME
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide and Self-harm focused on measuring treatment engagement

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • VA Portland Health Care System
  • Philadelphia VA Medical Center
  • Michael E. DeBakey VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Treatment

E-CARE

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Treatment Engagement 1
Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to engage in treatment and or care more quickly. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).
Treatment Engagement 3
Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to attend more outpatient appointments. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).

Secondary Outcome Measures

Lower Suicidal Ideation scores
Compared to the E-CARE group, Veterans participating in the HOME program will report significantly lower suicidal ideation scores on the Scale for Suicidal Ideation. The Scale for Suicidal Ideation (SSI) will be used to measure this outcome.

Full Information

First Posted
November 15, 2017
Last Updated
April 13, 2018
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03347552
Brief Title
Home-Based Mental Health Evaluation (HOME)
Acronym
HOME
Official Title
Home-Based Mental Health Evaluation (HOME): A Multi-Site Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 29, 2014 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm
Keywords
treatment engagement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
Participants in the active arm will be enrolled in the HOME Program.
Arm Title
E-CARE
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HOME
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Engagement 1
Description
Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to engage in treatment and or care more quickly. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).
Time Frame
From discharge from the hospital through 90 days post discharge
Title
Treatment Engagement 3
Description
Access to participants' VA electronic medical record will be utilized to address the hypothesis that Veterans participating in the HOME program will be significantly more likely to attend more outpatient appointments. Data collection may be facilitated by VA's Compensation and Pension Record Interchange (CAPRI) and VA's Corporate Data Warehouse (CDW).
Time Frame
From discharge from the hospital through 90 days post discharge
Secondary Outcome Measure Information:
Title
Lower Suicidal Ideation scores
Description
Compared to the E-CARE group, Veterans participating in the HOME program will report significantly lower suicidal ideation scores on the Scale for Suicidal Ideation. The Scale for Suicidal Ideation (SSI) will be used to measure this outcome.
Time Frame
3 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 18-89 Able to provide a phone number and the location of a residence at which they can be reached Planned location of discharge is a safe environment for the HOME provider to visit* Agree to receive the HOME program intervention (active site participants only) Ability to adequately respond to questions regarding the informed consent procedure Exclusion Criteria: Receiving services from the Mental Health Intensive Case Management (MHICM) or Domiciliary program or being directly transferred to further inpatient or residential treatment 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 Current involvement in the criminal justice system as a prisoner or ward of the state.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridget B Matarazzo, PsyD
Organizational Affiliation
VA Rocky Mountain MIRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33523330
Citation
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.
Results Reference
derived

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Home-Based Mental Health Evaluation (HOME)

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