CONNECT: COmpreheNsive TraiNing and Engagement in Cessation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9,133
- 试验地点
- 1
- 主要终点
- Accepted electronic (e)Referral to Quitline
研究概览
简要总结
This phase IV clinical trial determines the impact of implementing a Quitline electronic (e)Referral system with an enhanced academic detailing implementation strategy on Quitline reach, tobacco cessation assistance and self-reported quit rates among patients in community health centers. It also examines the cost-effectiveness of Quitline eReferrals both with and without enhanced academic detailing. If this implementation strategy is effective, this strategy could be used to increase tobacco cessation treatment through the collaboration between state Quitlines and community health centers that serve large numbers of socioeconomically disadvantaged patients who use tobacco.
详细描述
PRIMARY OBJECTIVES:
I. Implement a Quitline electronic (e)Referral system with enhanced academic detailing (AD) (intervention; n=10 community health centers [CHCs]) and without enhanced AD (comparison; n=10 CHCs) to compare rates of eReferral offers, eReferral acceptance, Quitline enrollment, orders for tobacco cessation medication, and receipt of in-clinic counseling among patients identified as currently using tobacco.
II. Assess the effectiveness of implementing a Quitline eReferral system with enhanced AD (intervention) versus without enhanced AD (comparison) on self-reported tobacco quit rates among all patients identified as current persons using tobacco using electronic health record (EHR) data.
III. Estimate the total annual costs and incremental cost-effectiveness of a Quitline eReferral system, with and without enhanced AD.
OUTLINE: Clinics are randomized to 1 of 2 arms.
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
- 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
- 是
入选标准
- •In Oregon
- •On the OCHIN Epic EHR for >= 1 year
- •Willing to be randomized to the intervention or comparison condition
- •Willing to recruit a provider to serve as a clinic champion (to share monthly performance audit and feedback at all-staff meetings, determine desired content of booster sessions with clinic team members, and complete a survey at the completion of the intervention period) and a clinic manager to coordinate training and booster sessions
- •Study Patient Inclusion Criteria:
- •Adult patients (>= 18 years of age)
- •Identified as current tobacco users during >= 1 ambulatory and/or telehealth visit to one of the eligible study clinics over the 24-month study period
排除标准
- 未提供
研究组 & 干预措施
Arm I (Quitline eReferral)
Clinics are notified via email that the Quitline eReferral system is available with a link to an online publication that includes an overview of Quitline services, information on Quitline effectiveness, and a detailed eReferral workflow with corresponding EHR screenshots, including how to identify eligible patients, create an eReferral, and access Quitline follow-up data in the EHR. Clinics also gain access to technological assistance, as needed.
干预措施: Informational Intervention (Other)
ARM II (Quitline eReferral plus enhanced AD)
Clinics receive standard online materials access to remote technological assistance as in Arm I. Clinics also receive group training of clinic staff prior to activation of the eReferral system and 12 months post-activation, follow-up booster sessions and monthly performance audit and feedback.
干预措施: Enhanced Academic Detailing (Behavioral)
ARM II (Quitline eReferral plus enhanced AD)
Clinics receive standard online materials access to remote technological assistance as in Arm I. Clinics also receive group training of clinic staff prior to activation of the eReferral system and 12 months post-activation, follow-up booster sessions and monthly performance audit and feedback.
干预措施: Informational Intervention (Other)
结局指标
主要结局
Accepted electronic (e)Referral to Quitline
时间窗: At any point during the 24-month intervention period
Proportion of patients who accepted a Quitline eReferral in intervention (EAD) versus comparator clinics. Will use a logistic mixed effects model that addresses the following design features of the study: 1) will include random intercepts for providers and clinic to account for clustering of patients within providers within clinics; 2) will perform an intent-to-treat analysis; 3) hypothesis tests will be two-sided.
次要结局
- Quitline eReferral offered(At any point during the 24-month intervention period)
- Quitline enrollment(At any point during the 24-month intervention period)
- Receipt of in-office counseling(At any point during the 24-month intervention period)
- Tobacco cessation medication ordered(At any point during the 24-month intervention period)
- Tobacco cessation(At any point during the 24-month intervention period or up to 6 months post-intervention)
- Annual intervention costs(Years 1-4)
- Cost-effectiveness(Years 1-4)
- Incremental cost-effectiveness ratio(Years 1-4)
研究者
Steffani Bailey
Principal Investigator
Oregon Health and Science University