Tobacco Use CessationNCT02735382

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

A study testing Tobacco quitline EHR referral and Tobacco quitline Fax referral in people with Tobacco Use Cessation and Tobacco Smoking, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Tobacco Use Cessation, Tobacco Smoking
What is being tested?: Tobacco quitline EHR referral and Tobacco quitline Fax referral
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14,930 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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;

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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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 57311-2027

Other trials in United States

About this study

Official title: 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

Read the detailed description

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: Tobacco Use Cessation, Tobacco Smoking
Being tested: Tobacco quitline EHR referral, Tobacco quitline Fax referral
Keywords: Translational Medical Research, Clinical Practice Guidelines, Electronic Health Records, Smoking, Tobacco, Quitline
Medical subject headings: Tobacco Use Cessation, Tobacco Smoking, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02735382
Study group	Role	What they receive
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 Receives: 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 Receives: 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. Receives: 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. Receives: Behavioral: Tobacco quitline Fax referral

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Number of Participants Meeting Criteria for Quality Referral
To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the tobacco quitline. Quality referrals are defined as ones that result in individuals who enroll in and receive tobacco quit line services.
Measured: Rates come from cumulative data collected over the course of 6 months.
Number of Participants Self-reporting Smoking Abstinence
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.
Measured: 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
In order to assess clinician and staff satisfaction with the eReferral and paper-based referral systems, a single-item "The steps I need to take to address my patients' tobacco use are efficient and well designed" was administered to healthcare system clinical staff. The response format was 1 = Strongly disagree; 2 = Disagree; 3 = Mildly disagree; 4 = Feel neutral; 5 = Mildly agree; 6 = Agree; 7 = Strongly agree. Higher scores indicate greater satisfaction with the assigned intervention (EHR-based vs Fax-based referral systems). The item is not part of any existing validated scale and was created for purposes of the project; this item was selected from a larger set of items and determined to be the most appropriate measure of overall staff satisfaction.
Measured: Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Apr 2018

First posted12 Apr 2016 (estimated)
Study startSep 2016
Primary completionMar 2018
Study completionApr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14,930 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02735382
Sponsor's protocol ID: 2015-0844
Other IDs: 1R35CA197573-01
Status last verified: Aug 2019
First submitted: 1 Apr 2016
Last updated: 3 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 36209149
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.
PubMed 31089727

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02735382
Acronym / sponsor ID: 2015-0844
Conditions: Tobacco Use Cessation, Tobacco Smoking
Keywords: Translational Medical Research, Clinical Practice Guidelines, Electronic Health Records, Smoking, Tobacco, Quitline
Study type: Interventional
Recruitment status: Completed
Enrolment: 14,930 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Sep 2016 (actual)
Primary completion: Mar 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 12 Apr 2016 (estimated)
Results: Posted 13 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
EHR-based referral to quit line	Experimental	Behavioral: Tobacco quitline EHR referralClinics 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
Fax-based referral to quit line	Active comparator	Behavioral: Tobacco quitline Fax referralClinics 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
EHR-based Clinic Staff	Experimental	Behavioral: Tobacco quitline EHR referralClinics 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.
Fax-based referral to quit line Clinic Staff	Active comparator	Behavioral: Tobacco quitline Fax referralClinics 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tobacco quitline EHR referralUsing an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Behavioural	EHR-based Clinic Staff, EHR-based referral to quit line
Tobacco quitline Fax referralUsing an Fax--based referral to the tobacco quitline from primary care outpatient clinics.	Behavioural	Fax-based referral to quit line, Fax-based referral to quit line Clinic Staff

Primary outcome

Number of Participants Referred
Time frame: 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.

3 secondary outcomes

Number of Participants Meeting Criteria for Quality Referral
Time frame: Rates come from cumulative data collected over the course of 6 months.
Number of Participants Self-reporting Smoking Abstinence
Time frame: 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
Time frame: Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score

Results and safety

Results posted to the registry on 13 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EHR-based Referral to Quit Line	7,481	7,481
Fax-based Referral to Quit Line	7,155	7,155
EHR-based Referral to Quit Line Clinic Staff	184	184
Fax-based Referral to Quit Line Clinic Staff	110	110

Primary outcome: Number of Participants Referred

Time frame: Rates come from cumulative data collected over the course of 6 months.. Count of participants. Unit: Participants

Measure	EHR-based Referral to Quit Line n = 7481	Fax-based Referral to Quit Line n = 7155
Value	1380	331

EHR-based Referral to Quit Line vs Fax-based Referral to Quit Line: Odds Ratio (OR): 4.663 (95% CI 4.116 to 5.283), p <.0001, Chi-squared, Corrected

Population analysed: Participant data were derived from EHR records.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data not collected. This was an EHR-based study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
EHR-based Referral to Quit Line	0 of 0	0 of 0
Fax-based Referral to Quit Line	0 of 0	0 of 0
EHR-based Referral to Quit Line Clinic Staff	0 of 0	0 of 0
Fax-based Referral to Quit Line Clinic Staff	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36209149Zehner 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.
Derived from this study: PubMed 31089727Fiore 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Fiore, MD, MPH, MBA principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Referred (time frame: Rates come from cumulative data collected over the course of 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02735382, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.