Trial Outcomes & Findings for EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study (NCT NCT02735382)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14930 participants

Primary outcome timeframe

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

Results posted on

2019-09-03

Participant Flow

This cluster randomized clinical trial was conducted in 23 primary care clinics, representing 2 health systems in Wisconsin, randomized to eReferral (intervention; n = 11) or Fax-to-Quit (usual care; n = 12). All participants were adult patients attending visits at their primary care clinics.

Participant milestones

Participant milestones
Measure	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 Tobacco quitline EHR referral: 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.	EHR-based Referral to Quit Line Clinic Staff Staff in these clinics that use EHR-based referral to the quit line will complete surveys to address Aim 4 of the study.	Fax-based Referral to Quit Line Clinic Staff Staff in these clinics that use Fax-based referral to the quit line will complete surveys to address Aim 4 of the study.
Overall Study STARTED	7481	7155	184	110
Overall Study COMPLETED	7481	7155	184	110
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinic surveys were anonymous and, as such, no demographic information was collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EHR-based Referral to Quit Line n=7481 Participants 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 Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line n=7155 Participants 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.	EHR-based Clinic Staff n=184 Participants 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. Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line Clinic Staff n=110 Participants 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. Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.	Total n=14930 Participants Total of all reporting groups
Age, Continuous	50.0 years n=7481 Participants • Clinic surveys were anonymous and, as such, no demographic information was collected.	48.8 years n=7155 Participants • Clinic surveys were anonymous and, as such, no demographic information was collected.	—	—	49.4 years n=14636 Participants • Clinic surveys were anonymous and, as such, no demographic information was collected.
Sex/Gender, Customized Female	0 Participants n=7481 Participants	0 Participants n=7155 Participants	0 Participants n=184 Participants	0 Participants n=110 Participants	0 Participants n=14930 Participants
Sex/Gender, Customized Male	0 Participants n=7481 Participants	0 Participants n=7155 Participants	0 Participants n=184 Participants	0 Participants n=110 Participants	0 Participants n=14930 Participants
Sex/Gender, Customized Unknown	7481 Participants n=7481 Participants	7155 Participants n=7155 Participants	184 Participants n=184 Participants	110 Participants n=110 Participants	14930 Participants n=14930 Participants
Race/Ethnicity, Customized White	5712 Participants n=7481 Participants	5682 Participants n=7155 Participants	0 Participants n=184 Participants	0 Participants n=110 Participants	11394 Participants n=14930 Participants
Race/Ethnicity, Customized African American	1631 Participants n=7481 Participants	1142 Participants n=7155 Participants	0 Participants n=184 Participants	0 Participants n=110 Participants	2773 Participants n=14930 Participants
Race/Ethnicity, Customized Other	78 Participants n=7481 Participants	106 Participants n=7155 Participants	0 Participants n=184 Participants	0 Participants n=110 Participants	184 Participants n=14930 Participants
Race/Ethnicity, Customized Unknown	60 Participants n=7481 Participants	225 Participants n=7155 Participants	184 Participants n=184 Participants	110 Participants n=110 Participants	579 Participants n=14930 Participants
Region of Enrollment United States	7481 participants n=7481 Participants	7155 participants n=7155 Participants	184 participants n=184 Participants	110 participants n=110 Participants	14930 participants n=14930 Participants

PRIMARY outcome

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

Population: Participant data were derived from EHR records.

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.

Outcome measures

Outcome measures
Measure	EHR-based Referral to Quit Line n=7481 Participants 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 Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line n=7155 Participants 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Number of Participants Referred	1380 Participants	331 Participants

SECONDARY outcome

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

Population: Participant data were derived from Quit Line records.

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.

Outcome measures

Outcome measures
Measure	EHR-based Referral to Quit Line n=7481 Participants 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 Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line n=7155 Participants 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Number of Participants Meeting Criteria for Quality Referral	400 Participants	121 Participants

SECONDARY outcome

Timeframe: 7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line.

Population: Participant data were derived from Quit Line records.

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.

Outcome measures

Outcome measures
Measure	EHR-based Referral to Quit Line n=7481 Participants 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 Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line n=7155 Participants 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Number of Participants Self-reporting Smoking Abstinence	34 Participants	14 Participants

SECONDARY outcome

Timeframe: Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score

Population: Clinic staff in the study clinics.

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.

Outcome measures

Outcome measures
Measure	EHR-based Referral to Quit Line n=184 Participants 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 Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.	Fax-based Referral to Quit Line n=110 Participants 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 Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Change in Global Staff Satisfaction With the Referral Intervention	0.76 units on a scale Standard Deviation 1.37	0.32 units on a scale Standard Deviation 1.28

Adverse Events

EHR-based Referral to Quit Line

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fax-based Referral to Quit Line

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EHR-based Referral to Quit Line Clinic Staff

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fax-based Referral to Quit Line Clinic Staff

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Zehner, MS

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

Phone: 6082627568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place