Clinical trial NCT05671380: A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
Official title: A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Cardiovascular Diseases
Tobacco Use
Smoking
Smoking Cessation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 7-day point-prevalence smoking abstinence at 18 months
timeFrame: 18 months
Secondary outcomes:
measure: Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
timeFrame: 0, 6, 12, and 18 months
measure: Change in Treatment utilization.
timeFrame: 6, 12, and 18 months
measure: Change in Overall Quality of Life
timeFrame: 0, 6, 12, and 18 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Health System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Steven Fu, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: