Rural COPD E-Visit Study

Scale and Evaluate Smoking Cessation and COPD Screening E-Visits to Rural Health Clinics

The purpose of this study is to evaluate an electronic visit (e-visit) for COPD screening and for quitting smoking. 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, preferences for cessation medications, and chronic COPD symptoms. 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Treatment as usual; Behavioral: Smoking cessation e-visit

Detailed Description

More than 16 million Americans have COPD and millions more suffer from COPD but have not yet been diagnosed or treated1. COPD is now concentrated within rural communities and those who reside in rural areas as compared to those who reside in large metropolitan areas have both higher COPD incidence (8% vs. 5%) and higher COPD-related death rates (55 per 100,000 vs. 32 per 100,000)2. Telehealth strategies to implement evidence-based best practice for COPD may be particularly impactful among rural communities as such treatment modalities can extend the reach of traditional COPD prevention, diagnosis, and treatment strategies.

In light of the significant public health impact of COPD, the National Heart Lung, and Blood Institute (NHLBI) issued a COPD National Action Plan in 2017. A key goal within this national action plan is to improve the diagnosis, prevention, treatment, and management of COPD by improving the quality of care delivered across the health care continuum. Because COPD is most commonly caused by cigarette smoking, investigators focus work herein on COPD early detection among cigarette smokers and on leveraging telehealth to extend the reach of evidence-based smoking cessation treatment (i.e., medications and counseling for smoking cessation) for those at risk for COPD. This work will build upon and extend our team's ongoing efforts to develop a smoking cessation electronic visit (e-visit) that can be proactively delivered to all adult MUSC patients who have been identified via the electronic health record as cigarette smokers. E-visits are embedded into the most common electronic health record (EHR) systems (e.g., Epic, Allscripts, and others) and offer a secure platform through which patients can remotely supply providers with health information. Providers in turn can deliver personalized instructions and/or treatment to the patient. Herein, investigators will leverage this proactive, scalable platform to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) improve rates of COPD early detection and accurate diagnosis. The ultimate goal of this line of work is to improve the quality of care and associated outcomes among patients at risk for COPD. investigators focus specifically on residents of rural areas given considerably higher smoking prevalence in the most rural parts of South Carolina.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Current cigarette smoking, defined as smoking 1+ cigarettes per day, for 20+ days out of the last 30, for the last 6+ months
• Age 40+
• 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:

• COPD on their problem list within Epic or prior diagnosis of COPD noted elsewhere within the EHR

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking cessation electronic visit (e-visit); This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.	Behavioral: Smoking cessation e-visit; Electronic visits (e-visits) for smoking cessation
Active Comparator: Treatment as usual (TAU); This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.	Behavioral: Treatment as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.	Month 1
Smoking Cessation	Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.	Month 3
Smoking Cessation	Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.	Month 6
Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 1
Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 3
Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 6

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Therapeutics
• Other Study ID Numbers: Pro00132325; 6 U66RH31458-05-01 (Other Grant/Funding Number: Telehealth Center of Excellence)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes