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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02697643
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : February 28, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : May 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

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 identifier (NCT number): NCT02697643

United States, Massachusetts
Newton, Massachusetts, United States, 02464
Sponsors and Collaborators
Inflexxion, Inc.
Principal Investigator: Stephen F. Butler, PhD Inflexxion, Inc.

Responsible Party: Stephen F Butler, PhD, Senior Vice-President & Chief Science Officer, Inflexxion, Inc. Identifier: NCT02697643     History of Changes
Other Study ID Numbers: 19015.13
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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

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