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

University of Minnesota (UMN)

Status: Active, not recruiting

Conditions: Tobacco Use Cessation; Cardiovascular Diseases; Smoking; Smoking Cessation; Tobacco Use

Treatments: Behavioral: Longitudinal Proactive Outreach (LPO).; Behavioral: Ask-Advice-Connect (AAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05671380

STUDY00013870

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English or Spanish-speaking BIPOC patients within the Hennepin Healthcare or MCHS system. BIPOC patients are any patients with a chart identified race that is not White, and will be verified by self-report from the baseline survey.
• Currently smoke >1 cigarette over the past 30 days
• Must have address or telephone number in the electronic health record

Exclusion criteria

• Electronic health record documented cognitive impairment or legal guardianship
• Patients who have opted out of reserach studies

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Enhanced Usual Care: Ask-Advice-Connect (AAC)

Active Comparator group

Description:

AAC participants will receive care through their primary care provider as usual (with the caveat that providers in the clinics will be trained to provide AAC). AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.

Treatment:

Behavioral: Ask-Advice-Connect (AAC)

AAC + Longitudinal Proactive Outreach (LPO)

Experimental group

Description:

AAC+LPO participants will receive AAC plus an MI tailored outreach call at baseline and at 3, 6, and 9 months post-enrollment. AAC includes enhanced access to State Quitline and Nicotine Replacement Therapy.

Treatment:

Behavioral: Ask-Advice-Connect (AAC)

Behavioral: Longitudinal Proactive Outreach (LPO).