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

NCT04689997 | Unknown DMC

• 1 other identifier: R44DA046262
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

substance use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Riding/driving risky behavior

  Change from Day 0 to 3 months

• Riding/driving risky behavior

  Change from Day 0 to 11.5 months

Study Arms (2)

computerized Substance Brief Intervention cSBI

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Standard care PCPs will screen using a standard SU tool and carry out their usual health supervision visits without additional decision support.

Interventions

cSBI BEHAVIORAL

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.

computerized Substance Brief Intervention cSBI

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking and reading

You may not qualify if:

• None

Sponsors & Collaborators

• Total Child Health, Inc.: lead
• Boston Children's Hospital: collaborator

Study Sites (1)

Total Child Health dba CHADIS, Inc.

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participating teens and parents will not know that their primary care provider has extra tools for their health supervision visit devoted to substance use prevention, reduction, or care. Statisticians will be blind to assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: We will employ a cluster randomized two-group pretest-posttest design, clustered at the provider level.

Study Record Dates

• First Submitted: December 25, 2020
• First Posted: December 30, 2020
• Study Start: February 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)