Clinical trial NCT03347552: Home-Based Mental Health Evaluation (HOME)
Official title: Home-Based Mental Health Evaluation (HOME): A Multi-Site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide and Self-harm
Keywords: treatment engagement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-11-20
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Engagement 1
timeFrame: From discharge from the hospital through 90 days post discharge
measure: Treatment Engagement 3
timeFrame: From discharge from the hospital through 90 days post discharge
Secondary outcomes:
measure: Lower Suicidal Ideation scores
timeFrame: 3 months post-discharge
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: VA Rocky Mountain MIRECC
name: Bridget B Matarazzo, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
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.