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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking cessation electronic visit (e-visit) | Experimental | 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. |
|
| Treatment As Usual | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation e-visit | Behavioral | electronic visits (e-visits) for smoking cessation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Utilized Smoking Cessation Treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 1 |
| Number of Participants Who Utilized Smoking Cessation Treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 3 |
| Cigarettes Smoking | Cigarettes per day reduction greater than 50% | Month 1 |
| Cigarettes Smoking | Cigarettes per day reduction greater than 50% | Month 3 |
| Quit Attempts | Quit attempts since last contact | Month 1 |
| Quit Attempts | Quit attempts since last contact | Month 3 |
| 24-hour Quit Attempt | Quit attempt lasting 24 hours since last contact | Month 1 |
| 24-hour Quit Attempt | Quit attempt lasting 24 hours since last contact | Month 3 |
| Seven-day Point Prevalence Abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| E-visit Completion | Number of participants that completed the e-visit | Month 1 |
| Provider Fidelity | Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33085578 | Derived | Dahne J, Player M, Carpenter MJ, Ford DW, Diaz VA. Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Telemed J E Health. 2021 Mar;27(3):347-354. doi: 10.1089/tmj.2020.0167. Epub 2020 Oct 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Utilized Smoking Cessation Treatment | Number of participants who utilized smoking cessation treatment since last assessment. | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
1 month and 3 month assessments (3 total months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noelle Natale | Medical University of South Carolina | 843-876-2426 | natalen@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2018 | Dec 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment As Usual | Behavioral | 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 |
|
Participant has not had a cigarette in the past 7 days |
| Month 1 |
| Seven-day Point Prevalence Abstinence | Participant has not had a cigarette in the past 7 days | Month 3 |
| Floating Abstinence | Participant has gone 7+ days without a cigarette since last contact. | Month 1 |
| Floating Abstinence | Participant has gone 7+ days without a cigarette since last contact. | Month 3 |
| Month 1 |
| E-visit Ease of Use | Participants reported Agree or Strongly Agree to finding the e-visit easy to use question | Month 1 |
| Time to Complete the E-visit | Time (days) to complete the e-visit among participants that completed the e-visit. | Month 1 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| Primary | Number of Participants Who Utilized Smoking Cessation Treatment | Number of participants who utilized smoking cessation treatment since last assessment. | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Secondary | E-visit Completion | Number of participants that completed the e-visit | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | Cigarettes Smoking | Cigarettes per day reduction greater than 50% | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | Cigarettes Smoking | Cigarettes per day reduction greater than 50% | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Primary | Quit Attempts | Quit attempts since last contact | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | Quit Attempts | Quit attempts since last contact | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Primary | 24-hour Quit Attempt | Quit attempt lasting 24 hours since last contact | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | 24-hour Quit Attempt | Quit attempt lasting 24 hours since last contact | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Primary | Seven-day Point Prevalence Abstinence | Participant has not had a cigarette in the past 7 days | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | Seven-day Point Prevalence Abstinence | Participant has not had a cigarette in the past 7 days | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Primary | Floating Abstinence | Participant has gone 7+ days without a cigarette since last contact. | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Primary | Floating Abstinence | Participant has gone 7+ days without a cigarette since last contact. | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Count of Participants | Participants | Month 3 |
|
|
|
| Secondary | Provider Fidelity | Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Secondary | E-visit Ease of Use | Participants reported Agree or Strongly Agree to finding the e-visit easy to use question | Posted | Count of Participants | Participants | Month 1 |
|
|
|
| Secondary | Time to Complete the E-visit | Time (days) to complete the e-visit among participants that completed the e-visit. | The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information. | Posted | Mean | Standard Deviation | days | Month 1 |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 4 |
| 34 |
| EG001 | 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 | 0 | 17 | 0 | 17 | 3 | 17 |
| Muscle pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Insomnia/trouble sleeping | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea | Nervous system disorders | Non-systematic Assessment |
|
| Sleep problems | Psychiatric disorders | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
|
| Appetite change | Gastrointestinal disorders | Non-systematic Assessment |
|
| Weight loss/gain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Agitation/hostility | Social circumstances | Non-systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| Ringing in the ears | Ear and labyrinth disorders | Non-systematic Assessment |
|
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