ClinicalTrials.gg
CompletedNCT03347552HOMEUpdated Apr 17, 2018

Home-Based Mental Health Evaluation (HOME)

An interventional study of HOME in Suicide and Self-harm, sponsored by University of Colorado, Denver. Completed at 3 sites in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Apr 2014, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
323
Allocation
Non-randomized
Ages
18 Years to 89 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 386 studies in Suicide with a site in United States — 99 open to participants now, 113 under way, 2 of them phase 3. Suicide · United States.

Enrollment
71st of 348
323 · median 91
Started
2014
with 15 others
No phase
288 of 386
80 open now
Registered
126th of 386
by date

Among the 386 studies in Suicide with a site in United States, this one is the 71st largest by enrollment of the 348 interventional ones, is one of 16 that started in 2014, is one of 288 with no phase, and was the 126th registered.

By phase

386 studies; the count open now beside each. This study's row is marked.

No phasethis study288 · 80 open
Observational36 · 5 open
Phase 218 · 7 open
Phase 116 · 3 open
Phase 411 · 0 open
Phase 1/27 · 3 open
Phase 2/35 · 1 open
Phase 35 · 0 open

By the year they started

First in 1990; this study’s year is marked. 16 started in 2014.

Size and results

Median enrollment 91 across the 348 interventional studies, 172 across the 36 observational. Of the 251 that completed or were terminated, 103 (41%) have results posted.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Suicide and Self-harm

Keywords

  • treatment engagement
04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 procedure

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
323 participants (actual)

Study arms

  • Experimental
    Active Treatment

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

    Behavioral: HOME

  • No intervention
    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.

Interventions

  • BehavioralHOME

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From discharge from the hospital through 90 days post discharge

  2. 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).

    Time frame: From discharge from the hospital through 90 days post discharge

Secondary outcomes

  1. 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.

    Time frame: 3 months post-discharge

07

Study locations

3 sites
  • VA Portland Health Care System
    Portland, Oregon 97239, United States
  • Philadelphia VA Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • Michael E. DeBakey VA Medical Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • 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. PubMed 33523330 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2014 to primary completion in Sep 2016, 28 months.

Of 308 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's 28 months is close to that.

Counting every sponsor, half of 319 studies reached it within 30 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2017
First posted
Nov 20, 2017
StartActual
Apr 29, 2014
Primary completionActual
Sep 1, 2016
CompletionActual
Nov 30, 2016
Last update
Apr 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03347552
Collaborators
United States Department of Defense
Responsible party
Sponsor
First posted
Nov 20, 2017
Start date
Apr 29, 2014
Primary completion
Sep 1, 2016
Completion
Nov 30, 2016
Last update
Apr 17, 2018

Study contacts

Bridget B Matarazzo, PsyD
principal investigator · VA Rocky Mountain MIRECC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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