Rural COPD E-Visit Study

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06236347
• Other study ID #: Pro00132325
• Secondary ID: 6 U66RH31458-05-
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 19, 2024
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 144
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Smoking cessation e-visit
Electronic visits (e-visits) for smoking cessation
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 1
Primary	Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 3
Primary	Reduction in Cigarettes Per Day	Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.	Month 6