Trial Outcomes & Findings for Smoking Cessation E-Visit (NCT NCT04316260)
NCT ID: NCT04316260
Last Updated: 2020-12-08
Results Overview
Number of participants who utilized smoking cessation treatment since last assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Month 1
Results posted on
2020-12-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
17
|
|
Overall Study
COMPLETED
|
34
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation E-Visit
Baseline characteristics by cohort
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=34 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.21 years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
42.76 years
STANDARD_DEVIATION 11.22 • n=7 Participants
|
46.39 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
17 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Number of participants who utilized smoking cessation treatment since last assessment.
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
Number of Participants Who Utilized Smoking Cessation Treatment
|
15 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Number of participants who utilized smoking cessation treatment since last assessment.
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
Number of Participants Who Utilized Smoking Cessation Treatment
|
14 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Cigarettes per day reduction greater than 50%
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
Cigarettes Smoking
|
9 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Cigarettes per day reduction greater than 50%
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
Cigarettes Smoking
|
15 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Quit attempts since last contact
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
Quit Attempts
|
16 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Quit attempts since last contact
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
Quit Attempts
|
14 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Quit attempt lasting 24 hours since last contact
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
24-hour Quit Attempt
|
11 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Quit attempt lasting 24 hours since last contact
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
24-hour Quit Attempt
|
11 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Participant has not had a cigarette in the past 7 days
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
Seven-day Point Prevalence Abstinence
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Participant has not had a cigarette in the past 7 days
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
Seven-day Point Prevalence Abstinence
|
5 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Participant has gone 7+ days without a cigarette since last contact.
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=28 Participants
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
|
Treatment As Usual
n=17 Participants
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
|
|---|---|---|
|
Floating Abstinence
|
4 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Participant has gone 7+ days without a cigarette since last contact.
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=23 Participants
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
|
Treatment As Usual
n=16 Participants
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
|
|---|---|---|
|
Floating Abstinence
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Month 1Number of participants that completed the e-visit
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=34 Participants
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
|
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
|
|---|---|---|
|
E-visit Completion
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 1Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=34 Participants
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
|
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
|
|---|---|---|
|
Provider Fidelity
|
27 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 1Participants reported Agree or Strongly Agree to finding the e-visit easy to use question
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=34 Participants
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
|
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
|
|---|---|---|
|
E-visit Ease of Use
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 1Population: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.
Time (days) to complete the e-visit among participants that completed the e-visit.
Outcome measures
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=19 Participants
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
|
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
|
|---|---|---|
|
Time to Complete the E-visit
|
1.42 days
Standard Deviation 2.27
|
—
|
Adverse Events
Smoking Cessation Electronic Visit (E-visit)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment As Usual
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Smoking Cessation Electronic Visit (E-visit)
n=34 participants at risk
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
|
Treatment As Usual
n=17 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Headaches
|
5.9%
2/34 • Number of events 3 • 1 month and 3 month assessments (3 total months)
|
11.8%
2/17 • Number of events 3 • 1 month and 3 month assessments (3 total months)
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
2.9%
1/34 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
|
Psychiatric disorders
Insomnia/trouble sleeping
|
5.9%
2/34 • Number of events 3 • 1 month and 3 month assessments (3 total months)
|
11.8%
2/17 • Number of events 4 • 1 month and 3 month assessments (3 total months)
|
|
Nervous system disorders
Nausea
|
2.9%
1/34 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
|
Psychiatric disorders
Sleep problems
|
5.9%
2/34 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
17.6%
3/17 • Number of events 4 • 1 month and 3 month assessments (3 total months)
|
|
Psychiatric disorders
Depressed mood
|
5.9%
2/34 • Number of events 3 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
|
Gastrointestinal disorders
Appetite change
|
2.9%
1/34 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
|
Gastrointestinal disorders
Weight loss/gain
|
0.00%
0/34 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
|
Social circumstances
Agitation/hostility
|
5.9%
2/34 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
11.8%
2/17 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
|
Gastrointestinal disorders
Heartburn
|
5.9%
2/34 • Number of events 2 • 1 month and 3 month assessments (3 total months)
|
0.00%
0/17 • 1 month and 3 month assessments (3 total months)
|
|
Ear and labyrinth disorders
Ringing in the ears
|
0.00%
0/34 • 1 month and 3 month assessments (3 total months)
|
5.9%
1/17 • Number of events 1 • 1 month and 3 month assessments (3 total months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place