Menu
Enrolling by invitation NCT06236347

Rural COPD E-Visit Study

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking cessation e-visit, Treatment as usual.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Smoking Cessation [Time frame: Month 1]
  • Smoking Cessation [Time frame: Month 3]
  • Smoking Cessation [Time frame: Month 6]
  • Reduction in Cigarettes Per Day [Time frame: Month 1]
  • Reduction in Cigarettes Per Day [Time frame: Month 3]
  • Reduction in Cigarettes Per Day [Time frame: Month 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT06236347 · Pro00132325 · 6 U66RH31458-05-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗