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| ID | Type | Description | Link |
|---|---|---|---|
| 1R35CA197573-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco quitline EHR referral | Behavioral | Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Rates come from cumulative data collected over the course of 6 months. |
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Clinic Eligibility:
Inclusion Criteria:
Exclusion Criteria:
(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)
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| Name | Affiliation | Role |
|---|---|---|
| Michael Fiore, MD, MPH, MBA | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 57311-2027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36209149 | Derived | 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. | |
| 31089727 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Clinic surveys were anonymous and, as such, no demographic information was collected. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participant data were derived from EHR records. | Posted | Count of Participants | Participants | Rates come from cumulative data collected over the course of 6 months. |
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Adverse event data not collected. This was an EHR-based study.
Adverse event data not collected. This was an EHR-based study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Zehner, MS | Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health | 6082627568 | mark.zehner@ctri.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Jul 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Tobacco quitline Fax referral | Behavioral | Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics. |
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| 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. | 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. | Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| 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. | Participant data were derived from Quit Line records. | Posted | Count of Participants | Participants | Rates come from cumulative data collected over the course of 6 months. |
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| 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. | Participant data were derived from Quit Line records. | Posted | Count of Participants | Participants | 7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line. |
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| 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. | Clinic staff in the study clinics. | Posted | Mean | Standard Deviation | units on a scale | Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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