Trial Title:
Investigating Novel Smoking Cessation Primary Care Interventions in Rural Environments
NCT ID:
NCT05764759
Condition:
Smoking Cessation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Smoking cessation e-visit
Description:
electronic visits (e-visits) for smoking cessation
Arm group label:
Smoking cessation electronic visit (e-visit)
Intervention type:
Behavioral
Intervention name:
Treatment as usual
Description:
Information about the state quitline and about the importance of quitting smoking and a
recommendation to contact one's PCP to schedule a medical visit to discuss quitting
smoking.
Arm group label:
Treatment as usual (TAU)
Summary:
The purpose of this research study is to evaluate an electronic visit (e-visit) for
smoking cessation across rural primary care settings. Participants will be randomly
assigned to receive either the smoking cessation e-visit or not. The e-visit will look
similar to an online questionnaire asking about smoking history, motivation to quit, and
preferences for medications for quitting smoking. Participants may receive a prescription
for a smoking cessation medication as an outcome of the e-visit, if randomized to the
e-visit group, but there is no requirement to take any medication. This study consists of
questionnaires and breath samples provided at 4 separate time points throughout the
study. Participation in this study will take about 24 weeks.
Detailed description:
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.
This Hybrid Type I trial is designed to optimize external validity while assessing
implementation. A stepped-wedge, cluster-randomized clinical trial (N=288) will test
e-visit effectiveness vs. TAU. This trial will involve three clinical divisions
(Florence, Marion, Lancaster) and thus three wedges. At trial outset, divisions will be
randomized to active intervention (e-visit) start as first, second, or third. All
divisions will begin the trial assigned to TAU and will transition to e-visit according
to randomization order. Individual clinics (seven total) will be assigned to treatments
based on their divisional affiliation. Participants will be recruited within clinics.
After completing consent, participants will complete baseline assessments and receive the
intervention currently assigned to their clinic/division (based on their last primary
care visit). All participants will complete follow-up research assessments at 1-, 3-, and
6-months post-enrollment. We will require that participants complete follow-ups via their
smartphone so that CO collection is seamlessly integrated with assessments. Assessments
are estimated at 20 minutes. Participants will be compensated $20 in electronic gift
codes for completion of each, $20 for submission of CO at each follow-up timepoint, and
will receive a $100 bonus if all follow-up assessments are completed. Procedures for
remote remuneration are well-established through our prior trials. At baseline,
participants will self-report basic demographics including home address which will be
used to determine degree of rurality. Experience using technology and internet access
(home broadband, access via mobile device) will be assessed via questions from Pew
Research Center's technology adoption survey. Digital literacy will be assessed at
baseline via the Mobile Device Proficiency Questionnaire (MDPQ-16) and the Computer
Proficiency Questionnaire (CPQ-12). Both questionnaires are valid, reliable measures of
device (mobile, computer) proficiency and have been used to facilitate digital literacy
training within research contexts. Cigarette smoking, use of other tobacco products
(e.g., e-cigarettes), and quit attempts/quit duration will be assessed at each follow-up
using a timeline followback for the last 6-months at baseline and since prior follow-up
for each subsequent assessment. Nicotine dependence will be assessed at baseline via the
Fagerström Test of Nicotine Dependence. Participants will report motivation to quit and
confidence in quitting using a modified Contemplation Ladder. Self-reported smoking will
be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4ppm.
Self-report and CO data will be utilized together to determine 7-day PPA. Treatment
utilization will be assessed via self-report and EHR data. At each follow-up, all
participants regardless of intervention will be queried for: 1) use of a cessation
treatment (medication or psychosocial counseling) since the last assessment, 2) how the
medication was obtained, and 3) receipt of the 5As from their PCP. Self-report data will
be supplemented with treatment utilization data pulled from the EHR coinciding with each
follow-up. Specifically, we will capture: 1) cessation medication prescriptions, 2) if
prescribed, whether cessation medications were filled, 3) whether the participant was
referred to counseling, and 4) whether the participant attended a counseling session.
Confounders of CO including combustible cannabis use, secondhand smoke exposure, and
environmental CO exposure within the last 24 hours will be assessed at all timepoints to
account for factors that may falsely inflate CO. Additional data from the EHR will be
captured to describe the sample including information on: 1) medical and psychiatric
comorbidities, 2) medications, 3) tobacco-related billing codes, and 4) insurance type.
Because the e-visit will be delivered remotely and the trial will be conducted remotely,
biochemical verification of smoking must also be completed remotely for all participants.
Following enrollment, participants will be mailed an iCO™ Smokerlyzer (personal breath CO
monitor). Prior to mailing, all iCO™ devices will be tested against a fixed concentration
CO cannister and only devices that test within the manufacturer's stated accuracy range
(within 15%) will be sent to participants. All participants will receive their iCO™ prior
to their 1-month follow-up, and we anticipate having CO readings for all follow-ups. To
capture CO, after completing self-reports, participants will be instructed to sync their
iCO™ via Bluetooth with their smartphone and provide CO (all in REDCap). These procedures
have been developed and refined in Dr. Dahne's NCI R21. Identity will be video confirmed,
and all videos will be stored in REDCap with date and time stamps.
Implementation Evaluation: We will use mixed methods to assess implementation during our
effectiveness trial at patient, provider, and organizational levels. Our framework is
guided by the Consolidated Framework for Implementation Research (CFIR), which provides a
comprehensive, pragmatic approach to understand implementation barriers, facilitators and
processes. The goal is to provide an in-depth understanding of implementation
acceptability, adoption, and capacity for sustainability. Specific implementation
outcomes will be assessed according to Proctor's guidance, which has recently been
adapted by Hermes et al. for digital intervention evaluation. These models suggest the
evaluation of key implementation factors including: acceptability, adoption, fidelity,
cost, penetration, and sustainability. All self-report assessments will be administered
to patients in the e-visit condition during the 3-month research assessment, following
completion of baseline and 1-month e-visits. Provider questionnaires will be administered
via REDCap to MUSC RHN PCPs affiliated with the rural clinics involved in the trial who
have at least one patient enrolled in the e-visit condition. Provider questionnaires will
be sent at 6 weeks following each site's start in the e-visit arm and again at the end of
Year 4. Drs. Zebian and McCutcheon, CMOs for the RHN, will aid our team to ensure high
response (see support letters). Systems-level evaluation will utilize aggregate analytics
supplemented with qualitative data. After the implementation period, a set of key
informant interviews will be conducted with patients, PCPs, and stakeholders to enhance
quantitative data. No studies to our knowledge have specifically examined implementation
outcomes of proactive EHR-facilitated cessation treatments. As such, for each
implementation factor, we have identified benchmarks that we believe would be indicative
of meaningful uptake. These benchmarks have been selected based on prior documented rates
of cessation treatment acceptance and medication receipt within primary care, Healthy
People 2020's goals for cessation treatment in ambulatory settings, and prior uptake
rates in response to proactive, automated cessation intervention delivery in primary
care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Current cigarette smoking, defined as smoking 5+ cigarettes per day, for 20+ days
out of the last 30, for the last 6+ months
- Age 18+
- Enrolled in Epic's MyChart program or willing to enroll
- Possess a valid e-mail address that is checked daily to access study assessments and
MyChart messages
- Owner of an iOS or Android compatible smartphone to provide remote CO readings
- Have a valid address at which mail can be received (for mailing iCO™)
- English fluency
Exclusion Criteria:
- Current engagement in cessation treatment, defined as use of an FDA-approved
cessation medication within the last 7 days
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Medical University of South Carolina
Address:
City:
Charleston
Zip:
29425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Noelle E Natale
Phone:
843-876-9457
Email:
natalen@musc.edu
Investigator:
Last name:
Jennifer Dahne, PhD
Email:
Principal Investigator
Start date:
March 7, 2023
Completion date:
August 15, 2027
Lead sponsor:
Agency:
Medical University of South Carolina
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Medical University of South Carolina
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764759
