Addressing Rural Cancer Disparities via Proactive Smoking Cessation Treatment within Primary Care: A Hybrid Type 1 Effectiveness Implementation Trial of a Scalable Smoking Cessation Electronic Visit

Sponsor:

NIH

Sponsor Study ID:

R01CA258669

CTO #:

103807

NCT Number:

NCT05764759

Phase:

II

Protocol Type:

Prevention

Age Group:

Adults

Disease Sites:

Study Objectives:

We will conduct a Hybrid Type I effectiveness-implementation trial to comprehensively assess effectiveness of a proactive electronic visit (e-visit) for smoking cessation relative to treatment as usual (TAU) while simultaneously evaluating implementation when delivered across rural primary care settings. In Aim 1, we will conduct a stepped-wedge, cluster-randomized clinical trial (N=288) to examine the effectiveness of the smoking cessation e-visit vs. TAU for smoking cessation across seven rural (Rural-Urban Commuting Area codes 4-10) primary care practices in South Carolina. In Aim 2, we will evaluate e-visit implementation outcomes across rural South Carolina primary care settings at patient, provider, and organizational levels. Main outcomes include: 1) biochemically verified 7-day PPA (point prevalence of abstinence) at six-month follow-up, 2) reduction in cigarettes per day, and 3) evidence-based smoking cessation treatment utilization (medication, psychosocial cessation counseling). We hypothesize that rural smokers randomized to the e-visit condition will have significantly better cessation outcomes relative to TAU.

eConsent:

Not available

Study Documents:

Open Study Documents
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