NCT02697643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

March 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

February 22, 2016

Last Update Submit

August 9, 2018

Conditions

Substance Abuse

Keywords

clinical decision supportsubstance useopioid

Outcome Measures

Primary Outcomes (3)

  • 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.

    1-month, 3-month

  • Number of client treatment visits

    Total number of treatment and assessment visits throughout the field trial period.

    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.

    3-month

Study Arms (2)

BHCDS-based recommendations

EXPERIMENTAL

The Experimental condition will use the BH-CDS tool and receive tailored recommendations in addition to treatment as usual.

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.

Behavioral: Non-tailored recommendations

Interventions

BHCDS-based recommendationsBEHAVIORAL
Also known as: Behavioral Health Clinical Decision Support, BH-CDS
BHCDS-based recommendations
Non-tailored recommendationsBEHAVIORAL
Also known as: control condition
Non-tailored recommendations

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephen Butler

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Stephen F. Butler, PhD

    Inflexxion, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Vice-President & Chief Science Officer

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 3, 2016

Study Start

March 17, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(1)