C2DREAM #2

ClinicalTrials.gov link

Hybrid type 1 implementation-effectiveness study

Diseases or Conditions Being Studied
Cardiovascular disease

Communities of Focus
Rural and urban BIPOC communities

Region, Regional Partners, Stakeholders
Hennepin Healthcare and Mayo Clinic

Study Site
Hennepin Healthcare in Minneapolis​ and Mayo Clinic in Rochester & Mayo Clinic Health System clinics in southern Minnesota 

Study Objectives

• Conduct a hybrid type 1 implementation-effectiveness RCT to examine the direct effect of AAC+LPO vs. AAC on population-level smoking abstinence at 18 months and treatment utilization among 2000 BIPOC patients. ​

• Examine the moderating effects of structural racism and daily interpersonal discrimination on intervention effectiveness.​

• Use a mixed methods approach to evaluate implementation outcomes of appropriateness, acceptability, and feasibility of AAC and LPO for BIPOC patients.

Intervention or Treatment

• Ask-Advise-Connect (AAC)​

• AAC + Longitudinal Proactive Outreach (LPO)

Abstract

Tobacco use is a leading cause of cardiovascular disease and related chronic conditions (e.g., hypertension; CVD & RCC). According to the 2014 Surgeon General’s Report on smoking and health, cigarette smoking causes about 1 in 4 deaths from CVD. BIPOC communities experience higher prevalence of CVD & RCC compared to White communities due, in part, to disparities in tobacco exposure. Smoking can be effectively treated with guideline-recommended cessation counseling and medication, but such treatments are rarely used and are particularly unlikely to be offered to or used by BIPOC patients. Project 2 of C2DREAM tests the effect of adding an intervention to promote health equity among BIPOC patients: Longitudinal Proactive Outreach (LPO; 4 culturally tailored outreach call cycles over one year by a counselor trained in motivational interviewing to help connect patients to cessation counseling and medication) to the current standard of care, Ask-Advise-Connect (AAC; primary care providers asking all patients if they smoke, advising smokers to quit, and connecting smokers to the state quit line through an electronic referral).

Specific Aims

The proposed Project has 3 Aims:

• A1: Conduct a randomized controlled trial to examine the direct effect of AAC+LPO (a multilevel health system intervention) vs. AAC on population-level smoking abstinence at 18 months and treatment utilization among 2000 BIPOC adults.
• A2: Examine the moderating effects of structural racism and daily interpersonal discrimination on intervention effectiveness.
• A3: Use a mixed methods approach to evaluate implementation outcomes of appropriateness, acceptability, and feasibility of AAC and LPO for BIPOC patients. To test these aims, we will conduct a hybrid type 1 implementation-effectiveness trial where 2000 BIPOC patients who smoke across two urban and rural healthcare systems in Minnesota will be randomly assigned to BIPOC tailored LPO + AAC or AAC alone. Participants will be surveyed at 6, 12, and 18 months post-enrollment to assess outcomes.

The primary outcome is biochemically confirmed tobacco abstinence at 18 months. Potential treatment mechanisms include increased treatment utilization, perceived behavioral control and intention to quit. Potential moderators include structural racism in communities and personal experiences of racism. LPO promotes health equity by addressing barriers caused by structural racism, including access to care, care fragmentation, and provider racism, by systematically reaching out to all BIPOC patients who smoke. LPO improves health equity by ensuring that those most at risk for CVD & RCC are offered preventive care. LPO integrates individual-level treatment with public health approaches to increase treatment engagement. Further, LPO will be culturally tailored in collaboration with BIPOC communities in Minnesota to effectively reach and engage the target population.