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

We will conduct a stepped-wedge, cluster-randomized clinical trial to comprehensively evaluate effectiveness of the smoking cessation e-visit within rural South Carolina primary care clinics. Consistent with a Type I Hybrid effectiveness-implementation design, we will assess implementation concurrently with effectiveness. Adult smokers will be recruited proactively across rural MUSC RHN clinics and assigned based on their clinic division's current step to either e-visit or TAU. Implementation will be assessed consistent with an adaptation of Proctor's framework proposed by Hermes et al. for digital interventions.

Effectiveness Trial: Participants will be recruited from rural South Carolina primary care clinics affiliated with MUSC's Regional Health Network (RHN). The RHN is divided into four divisions: 1) Florence, 2) Marion, 3) Lancaster, and 4) Chester. Across divisions, the RHN includes 16 primary care clinics distributed across South Carolina. Seven clinics are located in rural areas, defined as RUCA codes of 4-10. Among these seven clinics, three are affiliated with the Florence division, three with Marion, and one with Lancaster (no rural clinics are affiliated with Chester). All seven rural clinics will participate in this trial. These clinics treat 3,262 adult smokers annually. RHN clinics utilize MUSC's EHR (i.e., Epic), which supports use of the e-visit developed in our pilot. As of April 2020, all PCPs affiliated with RHN clinics can provide services via e-visits. Drs. Zebian and McCutcheon are the Chief Medical Officers for the RHN, are clinical partners on this proposal, and support recruitment efforts (see letters of support). Drs. Diaz and Player are MUSC PCPs and have leadership roles as Medical Directors for Care Coordination and Primary Care Telehealth respectively. Drs. Diaz and Player, in partnership with Drs. Zebian and McCutcheon, will serve as primary liaisons between the study and clinics, ensuring that our partnering rural clinics will contribute meaningfully to recruitment, intervention delivery, and implementation evaluation.

Study enrollment will begin in month 4 and will continue for a total of 44 months, ending at the end of Year 4. Final assessments will occur between months 48-54. With planned enrollment of 288 for the effectiveness RCT, we fully expect to enroll 6-7 participants per month (~2 per week) and recruit our full sample within 44 months. In our prior work, 20% of study invitations resulted in an enrolled participant and engagement rates were similar across rural and urban patients. As such, we will send 35 study invitations per month (35 * 0.2 = 7 enrolled participants) and 1,540 study invitations in total to meet recruitment milestones. Study invitations will be equally distributed across divisions with ~12 study invitations sent per division per month. Within divisions, study invitations will be sent proportional to the total patient volume of each individual clinic. Enrollment will be capped at 24 patients per division per step and each step will last 11 months.

Recruitment will occur proactively and remotely via the EHR using the same procedures utilized within our e-visit pilot. We will conduct an automated EHR search for all patients treated in participating clinics during the past 12 months who: 1) smoke, 2) are age 18+, and 3) have activated MyChart accounts (this search was used for Research Strategy Table 2). These patients will be sent an e-mail via MyChart from the study on behalf of their primary care team inviting them to participate in a study. MUSC is an opt-out research institution. Thus, all MUSC patients, including RHN patients, are eligible to be contacted for research unless they have specifically opted out of research contact in MyChart. Less than 5% of MUSC patients have opted out of research contact, thus we expect to have access to nearly all smokers from the rural RHN clinics.

Following the initial study invitation, if the patient does not complete the screening within 72-hours, our team will contact the patient via automated phone calls and/or text messages (based on preferences in the EHR; these procedures are currently IRB approved across three protocols). We do not view these repeated contacts as an impediment to scalability as organizations often send automated reminders to patients for a variety of reasons, and these reminders can be sent via patients' preferred communication channels. If interested, participants will complete an online screening within REDCap to determine eligibility. After determination of eligibility, a study team member will complete remote electronic informed consent (e-consent) with the participant via REDCap. Participants will receive a link to an electronic consent form, available via REDCap, that they can review and sign. Review of the consent form will be paired with a phone call with a member of the research team to ensure that all questions are answered prior to enrollment. This remote consent procedure is currently utilized by Dr. Dahne in both her K23 and R21 awards and has been used with success with smokers residing in rural areas. As smartphone ownership is an inclusion criterion (to provide remote CO), all participants will have internet access and thus access to the electronic consent form.