NCT02735382

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,930

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 13, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

April 1, 2016

Results QC Date

June 25, 2019

Last Update Submit

August 14, 2019

Conditions

Keywords

Translational Medical ResearchClinical Practice GuidelinesElectronic Health RecordsSmokingTobaccoQuitline

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Referred

    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.

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

Secondary Outcomes (3)

  • 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

Study Arms (4)

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

Behavioral: Tobacco quitline EHR referral

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

Behavioral: Tobacco quitline Fax referral

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.

Behavioral: Tobacco quitline EHR referral

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.

Behavioral: Tobacco quitline Fax referral

Interventions

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

EHR-based Clinic StaffEHR-based referral to quit line

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

Fax-based referral to quit lineFax-based referral to quit line Clinic Staff

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 57311-2027, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Tobacco Use CessationTobacco SmokingSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorTobacco Use

Results Point of Contact

Title
Mark Zehner, MS
Organization
Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health

Study Officials

  • Michael Fiore, MD, MPH, MBA

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 12, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

September 3, 2019

Results First Posted

August 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations