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A Clinical Decision Support Tool for Electronic Health Records (BHCDS)

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ClinicalTrials.gov Identifier: NCT02697643
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Stephen F Butler, PhD, Inflexxion, Inc.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Substance Abuse Behavioral: BHCDS-based recommendations Behavioral: Non-tailored recommendations Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Clinical Decision Support Tool for Electronic Health Records
Actual Study Start Date : March 17, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

Arm Intervention/treatment
Experimental: BHCDS-based recommendations
The Experimental condition will use the BH-CDS tool and receive tailored recommendations in addition to treatment as usual.
Behavioral: BHCDS-based recommendations
Other Name: Behavioral Health Clinical Decision Support, BH-CDS

Placebo Comparator: Non-tailored recommendations
The Control condition will use the BH-CDS tool and receive non-tailored recommendations in addition to treatment as usual.
Behavioral: Non-tailored recommendations
Other Name: control condition




Primary Outcome Measures :
  1. 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.


  2. Number of client treatment visits [ Time Frame: 3-month ]
    Total number of treatment and assessment visits throughout the field trial period.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Counselor Inclusion Criteria:

  • full or part-time counselors
  • English speaking
  • Treat clients with opioid use problems
  • Have an active e-mail account

Client Inclusion Criteria:

  • Currently meet with a counselor in the study at least once a month
  • able to read and speak English
  • in treatment for an opioid use problem
  • completed detox, if it was necessary

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697643


Locations
United States, Massachusetts
Stephen Butler
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Inflexxion, Inc.
Investigators
Principal Investigator: Stephen F. Butler, PhD Inflexxion, Inc.
  Study Documents (Full-Text)

Documents provided by Stephen F Butler, PhD, Inflexxion, Inc.:
Statistical Analysis Plan  [PDF] August 9, 2018


Responsible Party: Stephen F Butler, PhD, Senior Vice-President & Chief Science Officer, Inflexxion, Inc.
ClinicalTrials.gov Identifier: NCT02697643     History of Changes
Other Study ID Numbers: 19015.13
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Keywords provided by Stephen F Butler, PhD, Inflexxion, Inc.:
clinical decision support
substance use
opioid

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders