Online System for Primary Care to Prevent and Address Teen Substance Use (Substance)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: cSBI

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.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raymond Sturner, MD

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21210
      • Total Child Health dba CHADIS, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking and reading

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: computerized Substance Brief Intervention cSBI; Enhanced care PCPs will address the serious morbidity of teen substance use during routine check-up visits using cSBI and follow up care using a new Module of CHADIS that facilitates guideline-based care. The CHADIS c-SBI Module will include pre-visit screening tools and embedded education that cover substance use and strengths and goals. It will also include reminders to the patient about their goals and commitments for change and teleprompted 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.	Behavioral: cSBI; The standard CRAFFT SU screen has additional questions about reasons to use or not use, SU expectancies of effect and embedded education. The teens of enhanced care PCPs will also complete a Strengths and Goals tool. Data from both will be used by the PCP in counseling regarding continued abstention, reduction or cessation of SU or referral. Teens will also get monthly text messages about goals.
No Intervention: Standard care; Standard care PCPs will screen using a standard SU tool and carry out their usual health supervision visits without additional decision support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance use level	Repeated CRAFFT screens at 3 months documenting SU level.	Change from Day 0 to 3 months
Substance use at one year	Repeated CRAFFT screens at 3 months documenting SU level.	Change from Day 0 to 11.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Riding/driving risky behavior	rate of reported driving after using or riding with a driver who has been using substances	Change from Day 0 to 3 months
Riding/driving risky behavior	rate of reported driving after using or riding with a driver who has been using substances	Change from Day 0 to 11.5 months

Collaborators and Investigators

• Sponsor: Total Child Health, Inc.
• Collaborators: Boston Children's Hospital
• Investigators: Principal Investigator: Barbara J Howard, MD, CHADIS aka Total Child Health; Principal Investigator: Raymond Sturner, MD, Center for Promotion of Child Devlopment; Principal Investigator: Sion Harris, PhD, Boston Children's Hospital; Principal Investigator: Lydia Shrier, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: substance use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: R44DA046262 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only group deidentified data will be shared to qualified researchers after the study results have been reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No