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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA258669 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.
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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. |
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| Treatment as usual (TAU) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation e-visit | Behavioral | electronic visits (e-visits) for smoking cessation |
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| 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 |
| Number of participants who utilized smoking cessation treatment | Number of participants who utilized smoking cessation treatment since last assessment. | Month 6 |
| Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 1 |
| Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 3 |
| Cigarettes smoking | Cigarettes per day reduction greater than 50% | Month 6 |
| Quit attempts | Quit attempts since last contact | Month 1 |
| Quit attempts | Quit attempts since last contact | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
1) Use of an FDA-approved cessation medication in the last 7 days
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noelle E Natale | Contact | 843-876-2426 | natalen@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38030991 | Derived | Fahey MC, Wahlquist AE, Diaz VA, Player MS, Natale N, Sterba KR, Chen BK, Hermes EDA, Carpenter MJ, Dahne J. Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial. BMC Prim Care. 2023 Nov 29;24(1):254. doi: 10.1186/s12875-023-02205-3. |
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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 | Jul 25, 2022 | Aug 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 29, 2022 | Aug 3, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| 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. |
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| Quit attempts | Quit attempts since last contact | Month 6 |
| Seven-day point prevalence abstinence | 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 |
| Seven-day point prevalence abstinence | Participant has not had a cigarette in the past 7 days | Month 6 |
| E-visit Acceptability | The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4. | Month 1 |
| E-visit Acceptability | The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4. | Month 3 |
| E-visit Acceptability | The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4. | Month 6 |
| E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 1 |
| E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 3 |
| E-visit Adoption | Patients prescribed a medication who obtain their medication | Month 6 |