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Smoking Cessation E-Visit
NA trial testing Smoking cessation e-visit in Smoking in 51 participants. Completed in 28 February 2020.
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 51 |
| Start date | 1 May 2019 |
| Primary completion | 31 October 2019 |
| Estimated completion | 28 February 2020 |
| Sites | 1 location across United States |
Medical University of South Carolina
18 and older, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants who utilized smoking cessation treatment since last assessment.
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 15 | |
| Treatment As Usual | 3 |
Number of participants who utilized smoking cessation treatment since last assessment.
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 14 | |
| Treatment As Usual | 4 |
Number of participants that completed the e-visit
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation E-visit (Electronic Visit) Group | 19 |
Cigarettes per day reduction greater than 50%
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 9 | |
| Treatment As Usual | 3 |
Cigarettes per day reduction greater than 50%
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 15 | |
| Treatment As Usual | 5 |
Quit attempts since last contact
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 16 | |
| Treatment As Usual | 5 |
Quit attempts since last contact
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 14 | |
| Treatment As Usual | 12 |
Quit attempt lasting 24 hours since last contact
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 11 | |
| Treatment As Usual | 4 |
Quit attempt lasting 24 hours since last contact
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 11 | |
| Treatment As Usual | 11 |
Participant has not had a cigarette in the past 7 days
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 3 | |
| Treatment As Usual | 0 |
Participant has not had a cigarette in the past 7 days
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 5 | |
| Treatment As Usual | 1 |
Participant has gone 7+ days without a cigarette since last contact.
| Group | Value | 95% CI |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 4 | |
| Treatment As Usual | 1 |
Time frame: 1 month and 3 month assessments (3 total months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Smoking Cessation Electron… | Treatment As Usual |
|---|---|---|---|
| Sleep problems | Psychiatric disorders | — | — |
| Headaches | Nervous system disorders | — | — |
| Insomnia/trouble sleeping | Psychiatric disorders | — | — |
| Depressed mood | Psychiatric disorders | — | — |
| Agitation/hostility | Social circumstances | — | — |
| Heartburn | Gastrointestinal disorders | — | — |
| Muscle pain | Musculoskeletal and connective tissue disorders | — | — |
| Nausea | Nervous system disorders | — | — |
| Appetite change | Gastrointestinal disorders | — | — |
| Weight loss/gain | Gastrointestinal disorders | — | — |
| Ringing in the ears | Ear and labyrinth disorders | — | — |
Data from ClinicalTrials.gov NCT04316260 adverse events section.
The goal of this study is to develop, refine, and complete preliminary feasibility testing of a smoking cessation electronic visit (e-visit) for implementation in primary care/family medicine. The investigators will conduct a feasibility RCT (N=51) of the smoking cessation e-visit as compared to treatment as usual (TAU), delivered via primary care, with primary objective to provide effect size estimates for a larger RCT. Primary outcomes cluster around: 1) treatment feasibility, 2) treatment acceptability, 3) treatment satisfaction, 4) evidence-based cessation treatment utilization, and 5) cessation-related outcomes (quit attempt incidence, abstinence). It is hypothesized that participants randomized to the e-visit condition as compared to those randomized to the TAU condition will have higher rates of cessation treatment utilization (medications, counseling) and superior cessation-related outcomes.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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