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INSPIRE: Investigating Novel Smoking Cessation Primary Care Interventions in Rural Environments

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05764759
Collaborator
National Cancer Institute (NCI) (NIH)
288
Enrollment
1
Location
2
Arms
53.5
Anticipated Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation across rural primary care settings. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smoking cessation e-visit
  • Behavioral: Treatment as usual
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Addressing Rural Cancer Disparities Via Proactive Smoking Cessation Treatment Within Primary Care: A Hybrid Type 1 Effectiveness-Implementation Trial of a Scalable Smoking Cessation Electronic Visit
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Feb 28, 2027
Anticipated Study Completion Date :
Aug 15, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Smoking cessation e-visit
electronic visits (e-visits) for smoking cessation
Active Comparator: Treatment as usual (TAU)

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Smoking Cessation [Month 1]

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

  2. Smoking Cessation [Month 3]

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

  3. Smoking Cessation [Month 6]

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

  4. Reduction in Cigarettes Per Day [Month 1]

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

  5. Reduction in Cigarettes Per Day [Month 3]

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

  6. Reduction in Cigarettes Per Day [Month 6]

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Current cigarette smoking, defined as smoking 5+ cigarettes per day, for 20+ days out of the last 30, for the last 6+ months

  • Age 18+

  • Enrolled in Epic's MyChart program or willing to enroll

  • Possess a valid e-mail address that is checked daily to access study assessments and MyChart messages

  • Owner of an iOS or Android compatible smartphone to provide remote CO readings

  • Have a valid address at which mail can be received (for mailing iCO™)

  • English fluency

Exclusion Criteria:
  • Current engagement in cessation treatment, defined as use of an FDA-approved cessation medication within the last 30 days

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of South Carolina Charleston South Carolina United States 29425

Sponsors and Collaborators

  • Medical University of South Carolina
  • National Cancer Institute (NCI)

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Jennifer Dahne, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05764759
Other Study ID Numbers:
  • Pro00121669
  • 1R01CA268023-01A1
First Posted:
Mar 13, 2023
Last Update Posted:
Mar 13, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 13, 2023