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临床试验/NCT05493254
NCT05493254招募中不适用

Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 672 人开始时间: 2022年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
672
试验地点
1
主要终点
Cigarettes smoking

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • current smoking, defined as 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
  • enrolled in MyChart or willing to enroll
  • possess a valid e-mail address that is checked daily
  • owner of an iOS or Android smartphone to provide remote CO
  • have a valid mailing address
  • English fluency

排除标准

  • 1) Use of an FDA-approved cessation medication in the last 7 days

研究组 & 干预措施

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.

干预措施: Smoking cessation e-visit (Behavioral)

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.

干预措施: Treatment As Usual (Behavioral)

结局指标

主要结局

Cigarettes smoking

时间窗: Month 6

Cigarettes per day reduction greater than 50%

Quit attempts

时间窗: Month 6

Quit attempts since last contact

Seven-day point prevalence abstinence

时间窗: Month 6

Participant has not had a cigarette in the past 7 days

Number of participants who utilized smoking cessation treatment

时间窗: Month 6

Number of participants who utilized smoking cessation treatment since last assessment.

E-visit Adoption

时间窗: Month 6

Patients prescribed a medication who obtain their medication

E-visit Acceptability

时间窗: Month 6

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.

Number of participants who utilized smoking cessation treatment

时间窗: Month 1

Number of participants who utilized smoking cessation treatment since last assessment.

Number of participants who utilized smoking cessation treatment

时间窗: Month 3

Number of participants who utilized smoking cessation treatment since last assessment.

Cigarettes smoking

时间窗: Month 1

Cigarettes per day reduction greater than 50%

Cigarettes smoking

时间窗: Month 3

Cigarettes per day reduction greater than 50%

Quit attempts

时间窗: Month 1

Quit attempts since last contact

Quit attempts

时间窗: Month 3

Quit attempts since last contact

Seven-day point prevalence abstinence

时间窗: Month 1

Participant has not had a cigarette in the past 7 days

Seven-day point prevalence abstinence

时间窗: Month 3

Participant has not had a cigarette in the past 7 days

E-visit Acceptability

时间窗: Month 1

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.

E-visit Acceptability

时间窗: Month 3

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.

E-visit Adoption

时间窗: Month 1

Patients prescribed a medication who obtain their medication

E-visit Adoption

时间窗: Month 3

Patients prescribed a medication who obtain their medication

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Dahne

Associate Professor

Medical University of South Carolina

研究点 (1)

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