AAC + Longitudinal Proactive Outreach (LPO) for Cardiovascular Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cardiovascular Disease+4 MoreAsk-Advice-Connect (AAC) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Cardiovascular Disease
  • Quitting Smoking
  • Tobacco Use
  • Smoking
  • Smoking Cessation

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 6, 12, and 18 months

Month 18
Change in Overall Quality of Life
Change in Theory of Planned Behavior Questionnaire (TPB-Q) Score
18 months
7-day point-prevalence smoking abstinence at 18 months
Month 18
Change in Treatment utilization.

Trial Safety

Trial Design

2 Treatment Groups

Enhanced Usual Care: Ask-Advice-Connect (AAC)
1 of 2
AAC + Longitudinal Proactive Outreach (LPO)
1 of 2

Active Control

Experimental Treatment

2000 Total Participants · 2 Treatment Groups

Primary Treatment: AAC + Longitudinal Proactive Outreach (LPO) · No Placebo Group · N/A

AAC + Longitudinal Proactive Outreach (LPO)Experimental Group · 2 Interventions: Ask-Advice-Connect (AAC), Longitudinal Proactive Outreach (LPO). · Intervention Types: Behavioral, Behavioral
Enhanced Usual Care: Ask-Advice-Connect (AAC)
Behavioral
ActiveComparator Group · 1 Intervention: Ask-Advice-Connect (AAC) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6, 12, and 18 months

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,260 Previous Clinical Trials
1,483,141 Total Patients Enrolled
Steven Fu, MD, MSCEPrincipal InvestigatorMinneapolis Veterans Affairs Medical Center
1 Previous Clinical Trials
64 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an English or Spanish-speaking person of color (defined as any race other than White) who is receiving care at Hennepin Healthcare or MCHS
You have smoked more than one cigarette in the last 30 days.
You are required to possess an address or contact number recorded in the e-health registry.