Clinical trial NCT04689997: Online System for Primary Care to Prevent and Address Teen Substance Use
Official title: Online System for Primary Care to Prevent and Address Teen Substance Use
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Keywords: substance use
Lead sponsor: Total Child Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston Children's Hospital
First posted: 2020-12-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will employ a cluster randomized two-group pretest-posttest design, clustered at the provider level.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* English speaking and reading

Exclusion Criteria:

* None

Primary outcomes:
measure: Substance use level
timeFrame: Change from Day 0 to 3 months
measure: Substance use at one year
timeFrame: Change from Day 0 to 11.5 months
Secondary outcomes:
measure: Riding/driving risky behavior
timeFrame: Change from Day 0 to 3 months
measure: Riding/driving risky behavior
timeFrame: Change from Day 0 to 11.5 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Total Child Health dba CHADIS, Inc.
state: Maryland
Study officials:
affiliation: CHADIS aka Total Child Health
name: Barbara J Howard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Promotion of Child Devlopment
name: Raymond Sturner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Sion Harris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Lydia Shrier, MD
role: PRINCIPAL_INVESTIGATOR
References: