A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
1 other identifier
interventional
700
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedStudy Start
First participant enrolled
May 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
April 13, 2026
April 1, 2026
3.9 years
January 2, 2023
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
7-day point-prevalence smoking abstinence at 18 months
7-day point prevalence abstinence from combustible tobacco will be verified at 18 months post-enrollment. Surveys to self-report abstinence will be provided at 6, 12, and 18 months. Self-reported smoking abstinence will be verified using expired carbon monoxide as the primary method with salivary cotinine as an alternative method at the 18-month follow-up. Participants with a CO of \< 6 ppm will be considered abstinent. Participants with a salivary cotinine \< 10 ng/ml will be considered abstinent.
18 months
Secondary Outcomes (3)
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
0, 6, 12, and 18 months
Change in Treatment utilization.
6, 12, and 18 months
Change in Overall Quality of Life
0, 6, 12, and 18 months
Study Arms (2)
Enhanced Usual Care: Ask-Advice-Connect (AAC)
ACTIVE COMPARATORAAC 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.
AAC + Longitudinal Proactive Outreach (LPO)
EXPERIMENTALAAC+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.
Interventions
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.
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 Partnerâ„¢ 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Electronic health record documented cognitive impairment or legal guardianship
- Patients who have opted out of reserach studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hennepin Healthcare
Minneapolis, Minnesota, 55415, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Health System
Rochester, Minnesota, 55902, United States
Related Publications (1)
Fu SS, Hammett P, Nelson D, Busch A, McKinney W, Sharma P, Patten CA, Gutierrez Sacasa N, Andreae L, Japuntich S. Evaluating chronic disease approaches to ameliorate tobacco-related health disparities: Study protocol of a hybrid type 1 implementation-effectiveness trial. Contemp Clin Trials Commun. 2024 Oct 16;42:101380. doi: 10.1016/j.conctc.2024.101380. eCollection 2024 Dec.
PMID: 39498443DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Fu, MD, MSCE
Minneapolis Veterans Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
May 5, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share