Substance AbuseBHCDSNCT02697643
A Clinical Decision Support Tool for Electronic Health Records
A study testing BHCDS-based recommendations and Non-tailored recommendations in people with Substance Abuse, run by Inflexxion, Inc. at 1 site in United States.
Trial summary
For behavioral health clinicians who are interested in getting tailored treatment and level of care recommendations, "BH-CDS" is a desktop/tablet web-based application that provides clinicians with data and a rationale for better decision-making to improve patient care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- BHCDS-based recommendations and Non-tailored recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2016to 31 Mar 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
For behavioral health clinicians who are interested in getting tailored treatment and level of care recommendations, "BH-CDS" is a desktop/tablet web-based application that provides clinicians with data and a rationale for better decision-making to improve patient care.
Few Clinical Decision Support (CDS) systems are available for Behavioral Health, and unlike existing CDS this product will compile relevant patient data and organize these data into general treatment recommendations linked to the patient's presenting circumstances, symptoms and substance use issues.
The BH-CDS solution shall factor patient characteristics into a Latent Class Analysis (LCA) that will group patients according to their responses with other patients with similar responses (i.e., a subgroup or "class"). Once patients have been assigned to a class, the solution shall present recommendations to counselors that use the software.
Read the detailed description
Summary of the specific aims and impact on public health of the Phase II. Substance abuse treatment is often complicated by a client's family, employment, psychiatric, or legal problems. When these co-existing issues are addressed with evidence-based practices (EBPs), outcomes improve. The inclusion of behavioral health evidence-based practices to enhance Medication-Assisted Treatment (MAT) is the subject of a number of federal and state treatment initiatives. However, the integration of such evidence-based practices into clinical settings continues to lag, despite extensive efforts to educate clinicians through training. Since it is often difficult to integrate EBPs into the clinical workflow, clinicians rely on established (and often ineffective) patterns of care. This grant proposed to (1) use electronic health record data on patients with a diagnosis of opioid use disorder to create profiles of patient groups using latent class analysis (LCA) analysis and determine, for each class, which combination of services are empirically associated with positive outcomes; (2) develop clinical decision support (CDS) software to help counselors classify patients and match them to appropriate services, and (3) conduct a field trial (randomized controlled trial or RCT) to test the impact of the CDS software on clinical practice.
Provide a succinct account of published and unpublished results, indicating progress toward achievement of the originally stated aims.
Latent Class Analysis: The first aim (using electronic health record data on patients with a diagnosis of opioid use disorder to create profiles of patient groups using LCA and determining which combinations of services are empirically associated with positive outcomes for each class of opioid users) was successfully achieved, as discussed in previous progress reports.
Four classes were identified: Class 1: Individuals in this class tend to have relatively high medical and mental health problems, be taking psychiatric medications and tend to experience control problems with their temper. Class 2: Individuals in this class tend to have mental health problems, but are not taking psychiatric medications. They do not generally snort or inject opiates and tend not to have serious medical problems. Class 3: Individuals in this class tend to have medical and mental health problems and are taking psychiatric medications. They have a tendency to snort or inject opiates and may have some problems controlling their temper. Class 4: Individuals in this class tend to have a high tendency to snort or inject opiates. They have medium medical problems and low mental health issues.
Software Development: Based on the LCA results, CDS software was developed to help counselors classify patients and match them to appropriate services.
Field Trial: The purpose of this field trial was to evaluate the effectiveness of this new CDS software when compared to clinical care as usual or treatment-as-usual (TAU), and to gather information about feasibility and perceived usefulness of the CDS software from the counselor's perspective. It was anticipated that when compared to TAU, clients in the experimental condition would (1) have significantly greater matched evidenced-based and wraparound services, (2) have greater engagement in treatment, (3) have less frequent use of substances, (4) have greater biopsychosocial functioning, and (5) have greater cost effectiveness (i.e., less cost to achieve successful outcomes).
- Conditions
- Substance Abuse
- Being tested
- BHCDS-based recommendations, Non-tailored recommendations
- Keywords
- clinical decision support, substance use, opioid
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHCDS-based recommendationsBehavioural
Also called Behavioral Health Clinical Decision Support, BH-CDS
Non-tailored recommendationsBehavioural
Also called control condition
| Study group | Role | What they receive |
|---|---|---|
| BHCDS-based recommendations | Experimental | The Experimental condition will use the BH-CDS tool and receive tailored recommendations in addition to treatment as usual. Receives: Behavioral: BHCDS-based recommendations |
| Non-tailored recommendations | Placebo comparator | The Control condition will use the BH-CDS tool and receive non-tailored recommendations in addition to treatment as usual. Receives: Behavioral: Non-tailored recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clients' past 30-day substance use and psychosocial functioning at 1 month and 3 months post-baseline as measured by ASI-MV composite scores
Measured through ASI-MV composite scores at each time point. Composite Scores for the Addiction Severity Index - Multimedia Version (ASI-MV) are generated from a number of answered questions in each domain that refer to client behavior over the last 30 days. Therefore, they are useful for identifying changes in problem status and can be used in research and outcome evaluation.
For more information, please see:
Butler, S. F., Budman, S. H., Goldman, R. J., Newman, F. J., Beckley, K. E., Trottier, D., \& Cacciola, J. S. (2001). Initial validation of a computer-administered Addiction Severity Index: The ASI-MV. Psychology of Addictive Behaviors, 15(1), 4.
Measured: 1-month, 3-month
Number of client treatment visits
Total number of treatment and assessment visits throughout the field trial period.
Measured: 3-month
Number of services each client receives or is referred to
Total number of services (including wraparound services, such as housing support or medical consultation) the client received or was referred to throughout the field trial period.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study start17 Mar 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflexxion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Stephen F Butler, PhD, Inflexxion, Inc.
- Investigators
- Stephen F. Butler, PhD, Principal investigator, Inflexxion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697643
- Sponsor's protocol ID
- 19015.13
- Acronym
- BHCDS
- Status last verified
- Aug 2018
- First submitted
- 22 Feb 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Decision Support Tool for Electronic Health Records
- ClinicalTrials.gov ID
- NCT02697643
- Acronym / sponsor ID
- BHCDS / 19015.13
- Conditions
- Substance Abuse
- Keywords
- clinical decision support, substance use, opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inflexxion, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 3 Mar 2016 (estimated)
- 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.
For behavioral health clinicians who are interested in getting tailored treatment and level of care recommendations, "BH-CDS" is a desktop/tablet web-based application that provides clinicians with data and a rationale for better decision-making to improve patient care.
Few Clinical Decision Support (CDS) systems are available for Behavioral Health, and unlike existing CDS this product will compile relevant patient data and organize these data into general treatment recommendations linked to the patient's presenting circumstances, symptoms and substance use issues.
The BH-CDS solution shall factor patient characteristics into a Latent Class Analysis (LCA) that will group patients according to their responses with other patients with similar responses (i.e., a subgroup or "class"). Once patients have been assigned to a class, the solution shall present recommendations to counselors that use the software.
Detailed description
Summary of the specific aims and impact on public health of the Phase II. Substance abuse treatment is often complicated by a client's family, employment, psychiatric, or legal problems. When these co-existing issues are addressed with evidence-based practices (EBPs), outcomes improve. The inclusion of behavioral health evidence-based practices to enhance Medication-Assisted Treatment (MAT) is the subject of a number of federal and state treatment initiatives. However, the integration of such evidence-based practices into clinical settings continues to lag, despite extensive efforts to educate clinicians through training. Since it is often difficult to integrate EBPs into the clinical workflow, clinicians rely on established (and often ineffective) patterns of care. This grant proposed to (1) use electronic health record data on patients with a diagnosis of opioid use disorder to create profiles of patient groups using latent class analysis (LCA) analysis and determine, for each class, which combination of services are empirically associated with positive outcomes; (2) develop clinical decision support (CDS) software to help counselors classify patients and match them to appropriate services, and (3) conduct a field trial (randomized controlled trial or RCT) to test the impact of the CDS software on clinical practice.
Provide a succinct account of published and unpublished results, indicating progress toward achievement of the originally stated aims.
Latent Class Analysis: The first aim (using electronic health record data on patients with a diagnosis of opioid use disorder to create profiles of patient groups using LCA and determining which combinations of services are empirically associated with positive outcomes for each class of opioid users) was successfully achieved, as discussed in previous progress reports.
Four classes were identified: Class 1: Individuals in this class tend to have relatively high medical and mental health problems, be taking psychiatric medications and tend to experience control problems with their temper. Class 2: Individuals in this class tend to have mental health problems, but are not taking psychiatric medications. They do not generally snort or inject opiates and tend not to have serious medical problems. Class 3: Individuals in this class tend to have medical and mental health problems and are taking psychiatric medications. They have a tendency to snort or inject opiates and may have some problems controlling their temper. Class 4: Individuals in this class tend to have a high tendency to snort or inject opiates. They have medium medical problems and low mental health issues.
Software Development: Based on the LCA results, CDS software was developed to help counselors classify patients and match them to appropriate services.
Field Trial: The purpose of this field trial was to evaluate the effectiveness of this new CDS software when compared to clinical care as usual or treatment-as-usual (TAU), and to gather information about feasibility and perceived usefulness of the CDS software from the counselor's perspective. It was anticipated that when compared to TAU, clients in the experimental condition would (1) have significantly greater matched evidenced-based and wraparound services, (2) have greater engagement in treatment, (3) have less frequent use of substances, (4) have greater biopsychosocial functioning, and (5) have greater cost effectiveness (i.e., less cost to achieve successful outcomes).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHCDS-based recommendations | Experimental | Behavioral: BHCDS-based recommendationsThe Experimental condition will use the BH-CDS tool and receive tailored recommendations in addition to treatment as usual. |
| Non-tailored recommendations | Placebo comparator | Behavioral: Non-tailored recommendationsThe Control condition will use the BH-CDS tool and receive non-tailored recommendations in addition to treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| BHCDS-based recommendationsAlso: Behavioral Health Clinical Decision Support, BH-CDS | Behavioural | BHCDS-based recommendations |
| Non-tailored recommendationsAlso: control condition | Behavioural | Non-tailored recommendations |
Primary outcome
Change in clients' past 30-day substance use and psychosocial functioning at 1 month and 3 months post-baseline as measured by ASI-MV composite scores
Time frame: 1-month, 3-month
Measured through ASI-MV composite scores at each time point. Composite Scores for the Addiction Severity Index - Multimedia Version (ASI-MV) are generated from a number of answered questions in each domain that refer to client behavior over the last 30 days. Therefore, they are useful for identifying changes in problem status and can be used in research and outcome evaluation. For more information, please see: Butler, S. F., Budman, S. H., Goldman, R. J., Newman, F. J., Beckley, K. E., Trottier, D., \& Cacciola, J. S. (2001). Initial validation of a computer-administered Addiction Severity Index: The ASI-MV. Psychology of Addictive Behaviors, 15(1), 4.
Number of client treatment visits
Time frame: 3-month
Total number of treatment and assessment visits throughout the field trial period.
Number of services each client receives or is referred to
Time frame: 3-month
Total number of services (including wraparound services, such as housing support or medical consultation) the client received or was referred to throughout the field trial period.
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 13 Aug 2018.
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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.
Stephen F. Butler, PhD principal investigator
Inflexxion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BHCDS-based recommendations and Non-tailored recommendations in people with Substance Abuse, run by Inflexxion, Inc. at 1 site 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 0 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: finished, as of the sponsor's last update on 13 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 1 site 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. Some participants in this study may receive a placebo. 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?
Change in clients' past 30-day substance use and psychosocial functioning at 1 month and 3 months post-baseline as measured by ASI-MV composite scores (time frame: 1-month, 3-month). The study lists 3 primary outcomes in all. 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 13 Aug 2018.