Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04689997 |
| Other study ID # |
R44DA046262 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2021 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
July 2023 |
| Source |
Total Child Health, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This Quality Improvement (QI) project for physician education will build on an existing
platform, CHADIS (Comprehensive Health and Decision Information System; www.CHADIS.com). We
plan to further develop and test innovations that will assist primary care providers (PCPs)
in addressing the serious morbidity of teen substance use during routine check-up visits and
follow up care using a new Module of CHADIS that facilitates guideline-based care. The CHADIS
c-SBI (computer-facilitated Substance screening and provider Brief Intervention) Module will
include pre-visit screening tools that cover substance use and strengths and goals. It will
also include reminders to the patient about their goals and commitments for change and a
teleprompter for interview hints for the PCP. These hints will be aimed at enhancing a
patient focused discussion of individual strengths and barriers related to the teens' goals
in a motivational interviewing style.
Description:
The primary goals of this project are to develop and test an innovative teen substance use
(SU) module in CHADIS integrating the cSBI questionnaire and decision support into CHADIS
along with teen strength and goal data to be called CHADIS-cSBI. The CHADIS-cSBI will
facilitate evidence-based SU screening, severity assessment and initiation of primary care
management and care coordination for any referrals to reduce morbidity, mortality and costs
of SU. Inclusion of strength and goal data is anticipated to foster the doctor-teen
relationship and make SU advice more effective.
Primary Research Questions
1. Of those who reported any substance use at their annual well-visit, is there a lower
rate of reported use at 3- and 12- months follow-up among those exposed to CHADIS-cSBI
as compared to those who received treatment as usual?
2. Of those who reported no substance use at their annual well-visit, is there a lower rate
of reported use at 3- and 12- months follow-up among those exposed to CHADIS-cSBI as
compared to those who received treatment as usual? Secondary Research Question
1) Among all patients, is there are lower rate of reported driving after using or riding with
a driver who has been using substances (risky driving/riding) at 3- and 12-months follow-up
among those exposed to CHADIS-cSBI as compared to those who received treatment as usual? We
will employ a cluster randomized two-group pre-test-post-test design, clustered at the
provider level. Given the nature of the enhanced care and the measurement it is not possible
to randomize at the patient level, and it is not necessary to randomize at the clinic level.
The use of a cluster-randomized design adds complexity, and generally requires larger samples
to achieve sufficient statistical power as compared to simple randomized control trials.
Sample size estimates consider the design effect resulting from a cluster randomized design
as well as other assumptions.
A total of 40 PCPs reporting at least 2 teen well visits per week, either in person or by
telemedicine visit, will be recruited and randomly assigned in equal numbers to the enhanced
care and standard care arms of the study. We will randomize clinicians stratified by whether
they have completed Adolescent Medicine fellowships, as those with Adolescent Medicine
training have been shown to have higher rates of addressing substance use in their practice.
The authors' prior experience showed that, in a trial where the patients were randomized,
individual PCPs being trained to deliver the counseling did not give similar levels of
counseling to intervention and control patients. Their studies also show wide variation in
patient-reported receipt of counseling across participating providers; e.g., within the
intervention group, there was a range from 65%-93% across providers within one site. Such
heterogeneity within a site reduces concern about contamination of practice across providers.
All 12-18 year old patients in the practice will complete pre-visit screens dependent on the
randomization of their own attributed PCP. While there are, in fact, three levels (i.e.,
patient -> practitioner -> practice), we confine the fundamental design herein to two levels
(i.e., patient -> practitioner). Intra-class correlations will be used to adjust sample size
estimates during power analyses, and also used to account for the covariance that is presumed
to exist wherein patients from the same cluster (i.e., PCP) are likely to be more similar to
each other than to patients from other clusters. The study design is depicted by the
following research design notation figure:
T0 T1 T2 T3 NR O X O O NR O O O
Each line represents the study timeline for an enhanced care group (i.e., first line
represents the CHADIS-cSBI group; second line represents the Standard CHADIS group using
CRAFFT), N: Indicates the groups are nonequivalent (i.e., subjects are not randomly assigned
to treatment).
R: Indicates the groups are derived from randomly assigned PCPs (i.e., the subjects are
treated by clinicians randomly assigned to a treatment protocol).
O: Indicates an observation timepoint (i.e., data collection). The first observation (T0)
represents baseline substance use for patients at their well-visit; the second and third
refer to follow-up assessments at 3 and 12 months post-visit.
X: Indicates the enhanced care (i.e., CHADIS-cSBI) that patients of enhanced care providers
will receive.
Finally, because this will be a Quality Improvement study, and practical utility of the
CHADIS-cSBI enhanced care applies at the practitioner level rather than the patient level, we
will conduct all analyses using Intent to Treat groups, retaining all patients initially
enrolled regardless of participation or compliance.
