Home-Based Mental Health Evaluation (HOME)

Not Applicable

Completed

• Conditions: Suicide and Self-harm
• Interventions: Behavioral: HOME

• Registration Number: NCT03347552
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2014-04-29
• Primary Completion: 2016-09-01
• Study Completion: 2016-11-30
• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 323

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	HOME	Participants in the active arm will be enrolled in the HOME Program.

Primary Outcome Measures

Name	Time	Method
Treatment Engagement 1	From discharge from the hospital through 90 days post discharge	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	From discharge from the hospital through 90 days post discharge	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

Name	Time	Method
Lower Suicidal Ideation scores	3 months post-discharge	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.

Trial Locations

Locations (3)

Philadelphia VA Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States