A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities

Summary

This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.

Conditions

• Tobacco Use Cessation
• Cardiovascular Diseases
• Tobacco Use
• Smoking
• Smoking Cessation

Interventions

BEHAVIORAL

Longitudinal Proactive Outreach (LPO).

All participants will receive personalized invitation materials (in their preferred language) with messages culturally and linguistically tailored to BIPOC communities, guided by the literature on culturally adapting evidence-based interventions. The study team will tailor these resources in collaboration with the CE core. The tailored mailed packet will include an invitation letter and a brochure describing the types of tobacco treatment services available from their health system and from Quit Partner. One week after the written materials are sent, participants assigned to this condition will receive LPO by a MI-trained coach. The MI outreach call protocol will consist of 6 contact attempts over two weeks.The MI outreach call protocol will be repeated at 3, 6, and 9 months for a total of four outreach cycles because participants may not have quit or may have relapsed.

BEHAVIORAL

Ask-Advice-Connect (AAC)

Licensed Practical Nurses will be trained to ask all patients if they smoke, document smoking status in the EHR, advise patients to stop smoking, and complete an electronic referral to Quit Partner or the smoking cessation clinic. AAC will be designed to connect participants to Quit Partner Minnesota to receive tobacco cessation counseling. Quit Partner™ is a family of programs available to help Minnesota residents quit commercial tobacco, administered by the Minnesota Department of Health (MDH). Quit Partner programs are provided by National Jewish Health (NJH). Any Minnesota resident can access a free 2-week supply of Nicotine Replacement Therapy (NRT). Uninsured and underinsured residents can access the full Quit Partner programs, including free one-on- one coaching, more NRT, and additional supports. Quit Partner also offers four population- specific programs and calls are available in several languages.

Sponsors & Collaborators

• University of Minnesota

  lead OTHER

Principal Investigators

• Steven Fu, MD, MSCE · Minneapolis Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-05

Primary Completion

2027-03-31

Completion

2028-03-31

Countries

• United States

Study Locations