Cigarette Smoking, Pulmonary Disease, Chronic Obstructive, Telemedicine
Conditions
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.
Interventions
BEHAVIORALsmoking cessation, early COPD detection, electronic visit
electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
OTHERTreatment 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
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence-based Cessation Treatment Utilization | Baseline through Month 3 | participants in both groups will be queried for use of a smoking cessation medication since the last assessment |
| Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | Baseline through Month 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| E-visit Acceptability and Feasibility | Baseline through Month 3 | the percentage of patients who complete the initial and follow-up e-visits |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COPD/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, 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.
smoking cessation, early COPD detection, electronic visit: electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD) | 85 |
| 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.
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 | 40 |
| Total | 125 |
Baseline characteristics
| Characteristic | Treatment as Usual (TAU) | Total | COPD/Smoking Cessation Electronic Visit (E-visit) |
|---|---|---|---|
| Age, Continuous | 51.93 years STANDARD_DEVIATION 8.52 | 53.42 years STANDARD_DEVIATION 9.4 | 54.12 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 121 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 27 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 28 Participants | 87 Participants | 59 Participants |
| Sex: Female, Male Female | 22 Participants | 74 Participants | 52 Participants |
| Sex: Female, Male Male | 18 Participants | 51 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 40 |
| other Total, other adverse events | 0 / 85 | 0 / 40 |
| serious Total, serious adverse events | 0 / 85 | 0 / 40 |
Outcome results
Primary
Evidence-based Cessation Treatment Utilization
participants in both groups will be queried for use of a smoking cessation medication since the last assessment
Time frame: Baseline through Month 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COPD/Smoking Cessation Electronic Visit (E-visit) | Evidence-based Cessation Treatment Utilization | Month 1 | 44 Participants |
| COPD/Smoking Cessation Electronic Visit (E-visit) | Evidence-based Cessation Treatment Utilization | Month 3 | 51 Participants |
| Treatment as Usual (TAU) | Evidence-based Cessation Treatment Utilization | Month 1 | 10 Participants |
| Treatment as Usual (TAU) | Evidence-based Cessation Treatment Utilization | Month 3 | 11 Participants |
Primary
Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| COPD/Smoking Cessation Electronic Visit (E-visit) | Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | Month 1 | 20 Participants |
| COPD/Smoking Cessation Electronic Visit (E-visit) | Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | Month 3 | 24 Participants |
| Treatment as Usual (TAU) | Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | Month 3 | 13 Participants |
| Treatment as Usual (TAU) | Number of Participants at Month 1 and Month 3 With At Least 1 Quit Attempt | Month 1 | 6 Participants |
Secondary
E-visit Acceptability and Feasibility
the percentage of patients who complete the initial and follow-up e-visits
Time frame: Baseline through Month 3