Integrating Behavioral HealthNCT03351374
Web Platform to Integrate Behavioral Health
An observational study of Integrating Behavioral Health, run by Medical Decision Logic, Inc. at 2 sites in United States.
Trial summary
Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155, the Contractor will create an integrated multi-module system of web software tools to aid in behavioral health screening, prevention, triage, and tracking in medical, school, and mental health settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Integrating Behavioral Health
- What is being tested?
- Software
- How many people
- 16,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2018to 25 Sep 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients that enter the health system through primary care clinics, academic medical and behavioral health centers, hospitals, or rural health clinics.
Who may be able to join
- Potential Mental Health issue
Who cannot join
- Not Willing to be Screened for mental health issues
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fayette Regional
Connersville, Indiana, 47331
Port Richmond Family Medicine
Philadelphia, Pennsylvania, 19134
About this study
Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155, the Contractor will create an integrated multi-module system of web software tools to aid in behavioral health screening, prevention, triage, and tracking in medical, school, and mental health settings.
Read the detailed description
Health care systems experience problems with lack of tools, lack of knowledge, process variation, and system fragmentation in addressing behavioral health. As an ongoing science-based process for improving care and lowering costs, robust increases in translational capability are needed to re-tool health delivery systems for behavioral health integration. A logic linking translational capability to behavioral health integration as an ongoing shared information process, founded on the core belief that enabling human action with new information technology tools can grow knowledge, is the most powerful way to solve problems and improve health care.
Given these connected and interacting issues and obstacles, the Contractor has developed a solution strategy, building on four tiers of prior innovation and validation:
- The Behavioral Health Screen (BHS);
- BH-Works: the web software delivery of the BHS and new production features from Phase I;
- BH-Works Portal: new production software features from Phase I; and
- BH-Works Services: expertise and professional services to help primary care providers and healthcare systems integrate behavioral health into their organizations and workflows.
- Conditions
- Integrating Behavioral Health
- Being tested
- Software
- Keywords
- behavioral health, software, integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftwareOther
multi-module system of web software tools
| Study group | Role | What they receive |
|---|---|---|
| Temple Physicians Incorporated | A community-based provider, operating 32 primary care sites Receives: Other: Software | |
| WhiteBark | For profit entity created by the Indiana Rural Health Association Receives: Other: Software | |
| Drexel Family Intervention Science | Academic center that developed and deployed Attachment Based Family Therapy (ABFT) assessment, treatment, and prevention models with an interest in adolescents struggling with substance abuse, depression, trauma, and suicidality. Receives: Other: Software | |
| Bon Secours Health System | A primary care clinic in Baltimore that provides care services to a population in a lower socioeconomic status in downtown Baltimore. Receives: Other: Software | |
| Howard University Hospital CARES | A project provides free outpatient medical, dental, mental health, nutrition and social services for HIV positive uninsured and underinsured residents of the District of Columbia. Receives: Other: Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase Provider Integration
Increase collaboration between Primary Care Physician and mental health series.
Measured: 2 Years
Secondary outcomes (2)
Increase Screening
Increase identification rates of adults with depression and substance abuse problems.
Measured: 2 Years
Increase Referrals
Increase successful referrals to mental health services.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start25 Sep 2018 (estimated)
- Primary completion25 Sep 2019 (estimated)
- Study completion25 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrating Behavioral HealthStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Decision Logic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Tien, MD, Principal investigator, Medical Decision Logic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351374
- Sponsor's protocol ID
- N44DA-17-5679
- Status last verified
- Aug 2018
- First submitted
- 20 Nov 2017
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web Platform to Integrate Behavioral Health
- ClinicalTrials.gov ID
- NCT03351374
- Acronym / sponsor ID
- N44DA-17-5679
- Conditions
- Integrating Behavioral Health
- Keywords
- behavioral health, software, integration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Medical Decision Logic, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2018 (estimated)
- Primary completion
- 25 Sep 2019 (estimated)
- Study completion
- 25 Sep 2019 (estimated)
- First posted
- 22 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.
Under this Small Business Innovation Research (SBIR) Phase II project, Research Topic 155, the Contractor will create an integrated multi-module system of web software tools to aid in behavioral health screening, prevention, triage, and tracking in medical, school, and mental health settings.
Detailed description
Health care systems experience problems with lack of tools, lack of knowledge, process variation, and system fragmentation in addressing behavioral health. As an ongoing science-based process for improving care and lowering costs, robust increases in translational capability are needed to re-tool health delivery systems for behavioral health integration. A logic linking translational capability to behavioral health integration as an ongoing shared information process, founded on the core belief that enabling human action with new information technology tools can grow knowledge, is the most powerful way to solve problems and improve health care.
Given these connected and interacting issues and obstacles, the Contractor has developed a solution strategy, building on four tiers of prior innovation and validation:
- The Behavioral Health Screen (BHS);
- BH-Works: the web software delivery of the BHS and new production features from Phase I;
- BH-Works Portal: new production software features from Phase I; and
- BH-Works Services: expertise and professional services to help primary care providers and healthcare systems integrate behavioral health into their organizations and workflows.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Temple Physicians Incorporated | – | Other: SoftwareA community-based provider, operating 32 primary care sites |
| WhiteBark | – | Other: SoftwareFor profit entity created by the Indiana Rural Health Association |
| Drexel Family Intervention Science | – | Other: SoftwareAcademic center that developed and deployed Attachment Based Family Therapy (ABFT) assessment, treatment, and prevention models with an interest in adolescents struggling with substance abuse, depression, trauma, and suicidality. |
| Bon Secours Health System | – | Other: SoftwareA primary care clinic in Baltimore that provides care services to a population in a lower socioeconomic status in downtown Baltimore. |
| Howard University Hospital CARES | – | Other: SoftwareA project provides free outpatient medical, dental, mental health, nutrition and social services for HIV positive uninsured and underinsured residents of the District of Columbia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that enter the health system through primary care clinics, academic medical and behavioral health centers, hospitals, or rural health clinics.
Key inclusion criteria (1 listed)
- Potential Mental Health issue
Key exclusion criteria (1 listed)
- Not Willing to be Screened for mental health issues
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 |
|---|---|---|
| Softwaremulti-module system of web software tools | Other | Bon Secours Health System, Drexel Family Intervention Science, Howard University Hospital CARES, Temple Physicians Incorporated, WhiteBark |
Primary outcome
Increase Provider Integration
Time frame: 2 Years
Increase collaboration between Primary Care Physician and mental health series.
2 secondary outcomes
Increase Screening
Time frame: 2 Years
Increase Referrals
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Allen Tien, MD principal investigator
Medical Decision Logic, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Integrating Behavioral Health, run by Medical Decision Logic, Inc. at 2 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
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?
Increase Provider Integration (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018.