Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,200
- 试验地点
- 1
- 主要终点
- The proportion of adult participants who engage in any evidence-based tobacco use treatments
研究概览
简要总结
The goal of this clinical trial is to compare the reach and effectiveness of the Refer2Quit intervention for increasing tobacco use treatment and quit rates among household members who smoke versus a treatment as usual group. This clinical trial also aims to study household member and pediatric patient characteristics that are associated with reach and effectiveness of Refer2Quit.
详细描述
This study aims to evaluate a proactive and population health-based approach that leverages a clinical decision support (CDS) system embedded in the electronic health record (EHR) to identify household members who smoke but did not complete the smoking survey at the visit, and remotely engage them in tobacco use treatment.
Participants will be recruited through up to 32 outpatient primary care practice from the Children's Hospital of Philadelphia's (CHOP) Pediatric Research Consortium (PeRC). Potential participants will be identified from the cohort of referrals for tobacco cessation treatment. Randomization of adult participants into either the intervention or control group will occur after the participants have consented to partake in the study and completed enrollment. The investigators will deploy a remote recruitment strategy (via phone and/or text) to outreach to eligible adult participants to maximize recruitment efforts.
After the initial referral of the household member who smokes, a study team member will reach out to them, explain the reason they are being contacted and confirm their smoking status and age. All participants will complete the enrollment step with data collection including: adult participant demographics, nicotine dependence and quitting motivation.
Only the intervention arm will receive the opportunity to be automatically connected by the study team to four evidence-based tobacco treatment options: varenicline, nicotine replacement therapy (NRT), quitline, and/or smokefreeTXT. Adult intervention arm participants will also receive brief motivational counseling by the study team.
Adult control arm participants will receive treatment as usual which consistent of a handout of evidence tobacco treatment resources which the adult participant must connect with on their own
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Only adult participants will be blinded during the study. Child participants do not need to be blinded because they will not be engaging in study procedures. Study staff will be aware of the assigned treatment arms. To maintain the blinding of adult participants, study staff will not disclose the treatment assignment to the adult participants at any point during the study. The recruit and consent procedures will describe the study, but not provide the adult participants with details that would reveal their treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Intervention Subject Inclusion Criteria
- •Males or females ages ≥18 years in age
- •Self-identify as a current combustible tobacco user
- •Have a valid cell phone number
- •Child Intervention Subject Inclusion Criteria
- •Must be a CHOP patient
- •Adult Intervention Subject
排除标准
- •<18 years in age.
- •Indicates no combustible tobacco smoking
- •Child Intervention Subject Exclusion Criteria
- •Not a CHOP patient
- •Adult Control Subject Inclusion Criteria
- •Males or females ages ≥18 years in age
- •Self-identify as a current combustible tobacco user
- •Have a valid cell phone number
- •Child Control Subject Inclusion Criteria
- •Must be a CHOP patient
- •Adult Control Subject Exclusion Criteria
- •<18 years in age.
- •Indicates no combustible tobacco smoking
- •Child Control Subject Exclusion Criteria
- •Not a CHOP patient
研究组 & 干预措施
Intervention Arm
Adult intervention arm participants will receive motivational counseling provided by the study staff member enrolling them. The study team member will offer 4 evidence-based treatment options (varenicline, NRT, quitline, and/or smokefreeTXT), emphasizing that the combination is often more effective than one treatment alone, and that they could start treatment even if they are not ready to quit.
干预措施: Refer2Quit (Other)
Control Arm
Adult control arm participants will receive a handout listing tobacco treatment options that they can connect to on their own
结局指标
主要结局
The proportion of adult participants who engage in any evidence-based tobacco use treatments
时间窗: Baseline, 1 and 6 months
The proportion of adult participants who engage in any evidence-based tobacco use treatments, between the intervention and control arms, by adult participant self-report.
Combustible tobacco quit rate at 1 and 6 months
时间窗: 1 and 6 months
The quit rate, compared between the intervention and control arms, will be assessed by a self-reported 7-day point prevalence smoking abstinence, collected via follow-up survey, and confirmed via breath carbon monoxide (CO) \<5ppm at the time-point
次要结局
未报告次要终点