EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study

NCT ID: NCT02735382

Last Updated: 2019-09-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14930 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Cessation Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EHR-based referral to quit line

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

Group Type EXPERIMENTAL

Tobacco quitline EHR referral

Intervention Type BEHAVIORAL

Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.

Fax-based referral to quit line

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

Group Type ACTIVE_COMPARATOR

Tobacco quitline Fax referral

Intervention Type BEHAVIORAL

Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.

EHR-based Clinic Staff

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.

Group Type EXPERIMENTAL

Tobacco quitline EHR referral

Intervention Type BEHAVIORAL

Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.

Fax-based referral to quit line Clinic Staff

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.

Group Type ACTIVE_COMPARATOR

Tobacco quitline Fax referral

Intervention Type BEHAVIORAL

Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.

Interventions

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Tobacco quitline EHR referral

Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.

Intervention Type BEHAVIORAL

Tobacco quitline Fax referral

Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Fiore, MD, MPH, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Zehner ME, Kirsch JA, Adsit RT, Gorrilla A, Hayden K, Skora A, Rosenblum M, Baker TB, Fiore MC, McCarthy DE. Electronic health record closed-loop referral ("eReferral") to a state tobacco quitline: a retrospective case study of primary care implementation challenges and adaptations. Implement Sci Commun. 2022 Oct 8;3(1):107. doi: 10.1186/s43058-022-00357-4.

Reference Type DERIVED
PMID: 36209149 (View on PubMed)

Fiore M, Adsit R, Zehner M, McCarthy D, Lundsten S, Hartlaub P, Mahr T, Gorrilla A, Skora A, Baker T. An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):778-786. doi: 10.1093/jamia/ocz044.

Reference Type DERIVED
PMID: 31089727 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R35CA197573-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015-0844

Identifier Type: -

Identifier Source: org_study_id

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