A Pragmatic Trial of Chronic Disease Approaches to Ameliorate Tobacco Related Cardiovascular Disease Health Disparities
- Conditions
- Cardiovascular DiseasesSmoking CessationTobacco Use CessationTobacco UseSmoking
- Interventions
- Behavioral: Longitudinal Proactive Outreach (LPO).Behavioral: Ask-Advice-Connect (AAC)
- Registration Number
- NCT05671380
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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
- Electronic health record documented cognitive impairment or legal guardianship
- Patients who have opted out of reserach studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AAC + Longitudinal Proactive Outreach (LPO) Ask-Advice-Connect (AAC) 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. Enhanced Usual Care: Ask-Advice-Connect (AAC) Ask-Advice-Connect (AAC) 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. AAC + Longitudinal Proactive Outreach (LPO) Longitudinal Proactive Outreach (LPO). 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.
- Primary Outcome Measures
Name Time Method 7-day point-prevalence smoking abstinence at 18 months 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.
- Secondary Outcome Measures
Name Time Method Change in Overall Quality of Life 0, 6, 12, and 18 months Overall quality of life will be assessed using a single-item numerical linear analogue self-assessment from 0 (as bad as it can be) to 10 (as good as it can be) via survey through 18 months post-enrollment.
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score 0, 6, 12, and 18 months The TPB-Q is a commonly used and thoroughly validated instrument that maps onto the three predictors of health behavior change in the Theory of Planned Behavior: attitudes about the behavior, perceived subjective norms about the behavior, and perceived control over the behavior. The TPB-Q items have common wording tapping into those three domains, but the scale was developed such that the items are customized to the specific behavioral goal of an intervention, and thus still comparable across behaviors.
Change in Treatment utilization. 6, 12, and 18 months Self-reported utilization of evidence-based cessation treatment (EBCT) will be assessed during the 18-month follow-up from any source. The main treatment outcome will be initiation of counseling with Quit Partner or the participant's healthcare provider, combined with medication treatment utilization. Initiation of counseling treatment with the Quit Partner will be defined as completion of a warm transfer or electronic referral to the quitline. Initiation of medication treatment will be defined as using one or more tobacco dependence medications (e.g., NRT, bupropion or varenicline) in the 18-month follow-up period. Additional treatment utilization outcomes include individual use of counseling or medication and use of any form of EBCT.
Trial Locations
- Locations (3)
Hennepin Healthcare
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Health System
🇺🇸Rochester, Minnesota, United States