Smoking
Conditions
Brief summary
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.
Interventions
BEHAVIORALSmoking cessation e-visit
electronic visits (e-visits) for smoking cessation
BEHAVIORALTreatment 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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ months 2. age 18+ 3. enrolled in Epic's MyChart program or willing to sign up for MyChart 4. possess a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages 5. English fluency
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Floating Abstinence | Month 1 | Participant has gone 7+ days without a cigarette since last contact. |
| Cigarettes Smoking | Month 1 | Cigarettes per day reduction greater than 50% |
| Quit Attempts | Month 1 | Quit attempts since last contact |
| 24-hour Quit Attempt | Month 1 | Quit attempt lasting 24 hours since last contact |
| Seven-day Point Prevalence Abstinence | Month 1 | Participant has not had a cigarette in the past 7 days |
| Number of Participants Who Utilized Smoking Cessation Treatment | Month 1 | Number of participants who utilized smoking cessation treatment since last assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Fidelity | Month 1 | Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations |
| E-visit Ease of Use | Month 1 | Participants reported Agree or Strongly Agree to finding the e-visit easy to use question |
| Time to Complete the E-visit | Month 1 | Time (days) to complete the e-visit among participants that completed the e-visit. |
| E-visit Completion | Month 1 | Number of participants that completed the e-visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.
Smoking cessation e-visit: electronic visits (e-visits) for smoking cessation | 34 |
| Treatment As Usual 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 | 17 |
| Total | 51 |
Baseline characteristics
| Characteristic | Smoking Cessation Electronic Visit (E-visit) | Total | Treatment As Usual |
|---|---|---|---|
| Age, Continuous | 48.21 years STANDARD_DEVIATION 13.42 | 46.39 years STANDARD_DEVIATION 12.88 | 42.76 years STANDARD_DEVIATION 11.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 50 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 17 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 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 | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 22 Participants | 30 Participants | 8 Participants |
| Region of Enrollment United States | 34 participants | 51 participants | 17 participants |
| Sex: Female, Male Female | 23 Participants | 35 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 17 |
| other Total, other adverse events | 4 / 34 | 3 / 17 |
| serious Total, serious adverse events | 0 / 34 | 0 / 17 |
Outcome results
Primary
24-hour Quit Attempt
Quit attempt lasting 24 hours since last contact
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 24-hour Quit Attempt | 11 Participants |
| Treatment As Usual | 24-hour Quit Attempt | 11 Participants |
Primary
24-hour Quit Attempt
Quit attempt lasting 24 hours since last contact
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | 24-hour Quit Attempt | 11 Participants |
| Treatment As Usual | 24-hour Quit Attempt | 4 Participants |
Primary
Cigarettes Smoking
Cigarettes per day reduction greater than 50%
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Cigarettes Smoking | 9 Participants |
| Treatment As Usual | Cigarettes Smoking | 3 Participants |
Primary
Cigarettes Smoking
Cigarettes per day reduction greater than 50%
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Cigarettes Smoking | 15 Participants |
| Treatment As Usual | Cigarettes Smoking | 5 Participants |
Primary
Floating Abstinence
Participant has gone 7+ days without a cigarette since last contact.
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Floating Abstinence | 7 Participants |
| Treatment As Usual | Floating Abstinence | 4 Participants |
Primary
Floating Abstinence
Participant has gone 7+ days without a cigarette since last contact.
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Floating Abstinence | 4 Participants |
| Treatment As Usual | Floating Abstinence | 1 Participants |
Primary
Number of Participants Who Utilized Smoking Cessation Treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Number of Participants Who Utilized Smoking Cessation Treatment | 15 Participants |
| Treatment As Usual | Number of Participants Who Utilized Smoking Cessation Treatment | 3 Participants |
Primary
Number of Participants Who Utilized Smoking Cessation Treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Number of Participants Who Utilized Smoking Cessation Treatment | 14 Participants |
| Treatment As Usual | Number of Participants Who Utilized Smoking Cessation Treatment | 4 Participants |
Primary
Quit Attempts
Quit attempts since last contact
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Quit Attempts | 14 Participants |
| Treatment As Usual | Quit Attempts | 12 Participants |
Primary
Quit Attempts
Quit attempts since last contact
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Quit Attempts | 16 Participants |
| Treatment As Usual | Quit Attempts | 5 Participants |
Primary
Seven-day Point Prevalence Abstinence
Participant has not had a cigarette in the past 7 days
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Seven-day Point Prevalence Abstinence | 3 Participants |
| Treatment As Usual | Seven-day Point Prevalence Abstinence | 0 Participants |
Primary
Seven-day Point Prevalence Abstinence
Participant has not had a cigarette in the past 7 days
Time frame: Month 3
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Seven-day Point Prevalence Abstinence | 5 Participants |
| Treatment As Usual | Seven-day Point Prevalence Abstinence | 1 Participants |
Secondary
E-visit Completion
Number of participants that completed the e-visit
Time frame: Month 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | E-visit Completion | 19 Participants |
Secondary
E-visit Ease of Use
Participants reported Agree or Strongly Agree to finding the e-visit easy to use question
Time frame: Month 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | E-visit Ease of Use | 25 Participants |
Secondary
Provider Fidelity
Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations
Time frame: Month 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Provider Fidelity | 27 Participants |
Secondary
Time to Complete the E-visit
Time (days) to complete the e-visit among participants that completed the e-visit.
Time frame: Month 1
Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smoking Cessation Electronic Visit (E-visit) | Time to Complete the E-visit | 1.42 days | Standard Deviation 2.27 |