Back to resultsE-Visit for COPD and Smoking Cessation
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Cigarette Smoking, Telemedicine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smoking cessation, early COPD detection, electronic visit
Treatment As Usual
Sponsored by
About this trial
This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- current cigarette smoker,
- enrolled in MUSC's Epic MyChart program or willing to sign up for MyChart,
- possess a valid e-mail address that is checked daily,
- English fluency, and
- owner of an iOS or Android-compatible smartphone and a webcam-enabled device
Exclusion Criteria:
- COPD on a patient's problem list within Epic.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COPD/smoking cessation electronic visit (e-visit)
Treatment as Usual (TAU)
Arm Description
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
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.
Outcomes
Primary Outcome Measures
Evidence-based cessation treatment utilization
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Quit attempts
quit attempts 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
Secondary Outcome Measures
E-visit acceptability and feasibility
the percentage of patients who complete the initial and follow-up e-visits
Full Information
NCT ID
NCT04155073
First Posted
November 1, 2019
Last Updated
May 13, 2021
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04155073
Brief Title
E-Visit for COPD and Smoking Cessation
Official Title
Development and Testing of an Electronic Visit for COPD Early Detection and Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this work is to develop, refine, and pilot test an electronic visit (e-visit) to: 1) deliver smoking cessation treatment to adults at risk for COPD and 2) to improve rates of COPD early detection and accurate diagnosis. The investigators will conduct a pilot RCT of the COPD/smoking cessation e-visit as compared to treatment as usual (TAU), with primary objective to provide effect size estimates for a larger RCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Cigarette Smoking, Telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD/smoking cessation electronic visit (e-visit)
Arm Type
Experimental
Arm Description
This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking, quitting smoking, and respiratory symptoms, 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit, and if needed, 3) a home spirometry test with instructions on how to video themselves completing a lung functioning test via the device within an additional e-visit.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation, early COPD detection, electronic visit
Intervention Description
electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention 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
Primary Outcome Measure Information:
Title
Evidence-based cessation treatment utilization
Description
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Time Frame
Baseline through Month 3
Title
Quit attempts
Description
quit attempts 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
Time Frame
Baseline through Month 3
Secondary Outcome Measure Information:
Title
E-visit acceptability and feasibility
Description
the percentage of patients who complete the initial and follow-up e-visits
Time Frame
Baseline through Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
current cigarette smoker,
enrolled in MUSC's Epic MyChart program or willing to sign up for MyChart,
possess a valid e-mail address that is checked daily,
English fluency, and
owner of an iOS or Android-compatible smartphone and a webcam-enabled device
Exclusion Criteria:
COPD on a patient's problem list within Epic.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36040766
Citation
Dahne J, Player MS, Strange C, Carpenter MJ, Ford DW, King K, Miller S, Kruis R, Hawes E, Hidalgo JE, Diaz VA. Proactive Electronic Visits for Smoking Cessation and Chronic Obstructive Pulmonary Disease Screening in Primary Care: Randomized Controlled Trial of Feasibility, Acceptability, and Efficacy. J Med Internet Res. 2022 Aug 30;24(8):e38663. doi: 10.2196/38663.
Results Reference
derived
Learn more about this trial
E-Visit for COPD and Smoking Cessation
We'll reach out to this number within 24 hrs