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临床试验/NCT02735382
NCT02735382已完成不适用

Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of the Electronic Health Record to Deliver Comprehensive Chronic Care Treatment for Smoking: Study 1: the EHR and Fax Referral Study

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 14,930 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14,930
试验地点
2
主要终点
Number of Participants Referred

研究概览

简要总结

This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based, closed-loop referrals for tobacco cessation from primary care clinics to a state telephone tobacco quitline service can increase the number/percentage of adult tobacco users receiving evidence-based tobacco dependence treatment when compared to paper-based fax referrals. This study also will survey clinic staff to evaluate satisfaction with the referral process.

详细描述

Aim 1: To evaluate the rates of referral of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system. Analyses will address the change in rates of referrals from pre- to post-intervention and the trajectory of referral post-intervention and will reflect per clinic rates.

Aim 2: To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system (quality referrals are defined as ones that result in individuals who enroll in and receive WTQL counseling and/or medication treatment services). Analyses will address the change in referrals from pre- to post-intervention and will reflect per clinic rates.

Aim 3: To examine variation in referral rates across clinics to test the hypothesis that the eReferral system will result in greater consistency in referral in addition to higher rates of referral. Qualitative methods will be used to understand the sources of variation.

Aim 4: To assess clinician and staff satisfaction with the eReferral and paper fax referral systems via self-report questionnaires.

Aim 5: To evaluate smoking abstinence rates of tobacco users who were referred to and accepted services from the WTQL, comparing those who were referred via an EHR-based referral system vs. those referred via a manual paper fax referral system.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The presence of discrete primary care clinical services within the clinic (defined as general internal medicine or family medicine clinical services);
  • At least three primary care clinician providers in the clinic (physicians or nurse practitioners/physician assistants who see patients independently of a physician);
  • A total primary care clinical volume of at least 60 patients each week;
  • An existing EHR requirement for staff to document tobacco use status including smoking status on all adult patients visiting the clinic at every visit;
  • A capacity to enumerate patient visit information including adult patients/month and adult tobacco users/month by clinician and by clinic;
  • A willingness to participate in the proposed research;
  • A lead physician or a clinic manager on site who agree to serve as a clinic champion for the project;
  • Prior use of the fax referral system to refer patients to the Wisconsin Tobacco Quit Line with use data available for the 12 months prior to study launch;
  • A willingness to accept random assignment to either of the two experimental conditions.

排除标准

  • Those clinics not meeting the above criteria (e.g. too small, limited EHR capacity).
  • (Note: In this study, the clinics are the "subjects" under study. The patients that will be referred by the clinic to the Wisconsin Tobacco Quit Line will be least 18 years old and Cigarette smokers)

研究组 & 干预措施

EHR-based referral to quit line

Experimental

Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.

Intervention: Behavioral: Tobacco quitline EHR referral

干预措施: Tobacco quitline EHR referral (Behavioral)

Fax-based referral to quit line

Active Comparator

Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.

Intervention: Behavioral: Tobacco quitline Fax referral

干预措施: Tobacco quitline Fax referral (Behavioral)

EHR-based Clinic Staff

Experimental

Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.

干预措施: Tobacco quitline EHR referral (Behavioral)

Fax-based referral to quit line Clinic Staff

Active Comparator

Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.

干预措施: Tobacco quitline Fax referral (Behavioral)

结局指标

主要结局

Number of Participants Referred

时间窗: Rates come from cumulative data collected over the course of 6 months.

EHR-based vs. Fax-based rates of referral of adult tobacco users visiting primary care clinics to the tobacco quitline. The rate of referral will be determined by the ratio of total referrals to total smokers identified in the clinic's EHR over a period of 6 months of study observation.

次要结局

  • Number of Participants Meeting Criteria for Quality Referral(Rates come from cumulative data collected over the course of 6 months.)
  • Number of Participants Self-reporting Smoking Abstinence(7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line.)
  • Change in Global Staff Satisfaction With the Referral Intervention(Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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