mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care

Summary

The QUIT-Mobile study proposes to use mobile phone self-monitoring and feedback to enhance and sustain over 12-months the impacts of the Quit Using Drugs Intervention Trial (QUIT), an effective screening and brief intervention (SBI) previously successful in reducing risky drug use (i.e., moderate use) in low-income, diverse patients over a 3-month follow up. The investigators will conduct the QUIT-Mobile study for patients who receive care in clinics of federally qualified health centers (FQHC) in Southern California over 12-months follow up. The study is an Effectiveness-Implementation Hybrid Type 1 design consisting of a single-blind, 3-arm, RCT with adult, mostly Latino FQHC primary care patients with risky drug use (ASSIST score 4-26), randomized to 3 conditions (n=200/arm, n=600 total): 1) QUIT-Mobile; 2) standard QUIT; 3) Usual Care. Qualitative data on implementation facilitators and barriers will inform future scale-up and sustainability, in addition to cost data analyses. The aims are to examine effectiveness in reducing risky drug use and cost-effectiveness comparing the three arms over 3-, 6- and 12-months. Drug use measures include self-reports for past 30-days and urine drug screen validation for underreporting (acknowledging that people with moderate risk drug use have sporadic drug use patterns requiring longer self-report recalls for drug use that urine screens may not detect). The 3-arm study enables testing of the independent and synergistic effects of QUIT-Mobile compared to QUIT and both to Usual Care. The 12-month timeline reflects annual primary care visits when screening and brief intervention would be repeated routinely. The QUIT intervention contains 3 primary components: 1) patient screening with the WHO ASSIST, 2) brief clinician advice (\<3 minutes) including opioid overdose prevention education, and 3) 2- and 6-week telephone drug-use health coaching sessions utilizing motivational interviewing and cognitive behavioral techniques, delivered by paraprofessional health coaches. QUIT-Mobile tests the addition of mobile phone self-monitoring, automated feedback, and coach monitoring dashboard to enhance and sustain QUIT\'s drug use reductions using mobile-web app, text-messaging (SMS), or interactive voice response (IVR).

Conditions

• Drug Use

Interventions

BEHAVIORAL

Usual Care

Usual Care participants will receive their standard medical care as usual and all study assessments. Providers will not receive information about their drug use. To reduce Hawthorne effect biases and to mask the study's purpose, RAs will provide the Usual Care arm patients with a cancer screening booklet and have them view a cancer screening Video Doctor. Participants will receive re-contact calls (5 min) to provide attentional control for the Usual Care arm, motivate continued trial participation by reminding next research assessment and study incentives, update contact information, and address participation barriers, but do not provide intervention. At study end, Usual Care will receive the QUIT video doctor and drug use reduction booklet materials including overdose prevention materials and a list of clinic/community resources to help them reduce substance use.

BEHAVIORAL

QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks)

QUIT's core components include: 1. patient screening with the WHO Alcohol Smoking and Substance Involvement Screening Test (ASSIST, score 4-26); 2. face-to-face brief clinician advice on reducing drug use (2-3 minutes); 3. video doctor reinforcing the clinician message; 4. drug use reduction brochure; 5. 2- and 6-week telephone health coaching sessions to enhance self-efficacy in reducing drug use, via motivational interviewing and cognitive behavior therapy (CBT) techniques (20-30 minutes).

BEHAVIORAL

QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months)

The QUIT-Mobile intervention includes QUIT's core components and adds: 1. SMS/IVR/mobile-app self-monitoring survey prompts twice-weekly during the QUIT coaching through 6 weeks, and then weekly self-monitoring and automated feedback via SMS/IVR/app through 12-months. 2. Web-based dashboards will be used by coaches for monitoring of patients' self-monitoring data to enhance 2- and 6-week coaching sessions and for monitoring during the post-coaching self-management and monitoring period from 7-weeks to 12-months and intervening accordingly. The mobile platform will provide the same intervention functions (self-monitoring surveys and feedback messages) and robust data transfer protocols across three mobile technology platforms.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Arkansas

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Lillian Gelberg, MD, MSPH · University of California, Los Angeles

• Dallas Swendeman, PhD, MPH · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• United States

Study Locations