Suicide and Self-harmHOMENCT03347552
Home-Based Mental Health Evaluation (HOME)
A study testing HOME in people with Suicide and Self-harm, run by University of Colorado, Denver at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- HOME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2014to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
VA Portland Health Care System
Portland, Oregon, 97239
About this study
Official title: Home-Based Mental Health Evaluation (HOME): A Multi-Site Trial
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.
- Conditions
- Suicide and Self-harm
- Being tested
- HOME
- Keywords
- treatment engagement
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Participants in the active arm will be enrolled in the HOME Program. Receives: Behavioral: HOME |
| E-CARE | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From discharge from the hospital through 90 days post discharge
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).
Measured: 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.
Measured: 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start29 Apr 2014
- Primary completion1 Sep 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Bridget B Matarazzo, PsyD, Principal investigator, VA Rocky Mountain MIRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347552
- Sponsor's protocol ID
- 13-2982
- Acronym
- HOME
- Status last verified
- Apr 2018
- First submitted
- 15 Nov 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Mental Health Evaluation (HOME): A Multi-Site Trial
- ClinicalTrials.gov ID
- NCT03347552
- Acronym / sponsor ID
- HOME / 13-2982
- Conditions
- Suicide and Self-harm
- Keywords
- treatment engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Behavioral: HOMEParticipants in the active arm will be enrolled in the HOME Program. |
| E-CARE | No intervention | –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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOMEPrior 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. | Behavioural | Active Treatment |
Primary outcome
Treatment Engagement 1
Time frame: 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
Time frame: 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).
1 secondary outcome
Lower Suicidal Ideation scores
Time frame: 3 months post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 33523330Matarazzo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bridget B Matarazzo, PsyD principal investigator
VA Rocky Mountain MIRECC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME in people with Suicide and Self-harm, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Engagement 1 (time frame: From discharge from the hospital through 90 days post discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03347552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.