Tobacco Smoking, Tobacco Use Cessation
Conditions
Keywords
Translational Medical Research, Clinical Practice Guidelines, Electronic Health Records, Smoking, Tobacco, Quitline
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.
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.
Interventions
BEHAVIORALTobacco quitline EHR referral
Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.
BEHAVIORALTobacco quitline Fax referral
Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Clinic Eligibility: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Referred | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting Criteria for Quality Referral | Rates come from cumulative data collected over the course of 6 months. | 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. |
| 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. | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7,481 |
| 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. | 7,155 |
| 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.
Tobacco quitline EHR referral: Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics. | 184 |
| 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.
Tobacco quitline Fax referral: Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics. | 110 |
| Total | 14,930 |
Baseline characteristics
| Characteristic | EHR-based Referral to Quit Line | Total | Fax-based Referral to Quit Line | Fax-based Referral to Quit Line Clinic Staff | EHR-based Clinic Staff |
|---|---|---|---|---|---|
| Age, Continuous | 50.0 years | 49.4 years | 48.8 years | — | — |
| Race/Ethnicity, Customized African American | 1631 Participants | 2773 Participants | 1142 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 78 Participants | 184 Participants | 106 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 60 Participants | 579 Participants | 225 Participants | 110 Participants | 184 Participants |
| Race/Ethnicity, Customized White | 5712 Participants | 11394 Participants | 5682 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7481 participants | 14930 participants | 7155 participants | 110 participants | 184 participants |
| Sex/Gender, Customized Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Unknown | 7481 Participants | 14930 Participants | 7155 Participants | 110 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Rates come from cumulative data collected over the course of 6 months.
Population: Participant data were derived from EHR records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EHR-based Referral to Quit Line | Number of Participants Referred | 1380 Participants |
| Fax-based Referral to Quit Line | Number of Participants Referred | 331 Participants |
p-value: <0.000195% CI: [4.116, 5.283]Chi-squared, Corrected
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EHR-based Referral to Quit Line | Change in Global Staff Satisfaction With the Referral Intervention | 0.76 units on a scale | Standard Deviation 1.37 |
| Fax-based Referral to Quit Line | Change in Global Staff Satisfaction With the Referral Intervention | 0.32 units on a scale | Standard Deviation 1.28 |
Comparison: A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.p-value: 0.00795% CI: [0.123, 0.757]t-test, 2 sided
Secondary
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.
Time frame: Rates come from cumulative data collected over the course of 6 months.
Population: Participant data were derived from Quit Line records.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EHR-based Referral to Quit Line | Number of Participants Meeting Criteria for Quality Referral | 400 Participants |
| Fax-based Referral to Quit Line | Number of Participants Meeting Criteria for Quality Referral | 121 Participants |
p-value: <0.000195% CI: [2.672, 4.035]Chi-squared, Corrected
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EHR-based Referral to Quit Line | Number of Participants Self-reporting Smoking Abstinence | 34 Participants |
| Fax-based Referral to Quit Line | Number of Participants Self-reporting Smoking Abstinence | 14 Participants |
p-value: 0.843895% CI: [0.42, 1.698]Chi-squared, Corrected