- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03229356
An EPIC Based BPA to Enhance Quit Line Referral and Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Smoking is the number one cause of preventable death in the United States. Given the magnitude of the problem, interventions aimed at promoting smoking cessation have the potential to make large changes in improving health outcomes. Resources to aid with smoking cessation such as telephone-based counseling are generally underutilized. The electronic medical record (EMR) in use at Johns Hopkins has limited decision support to promote referral to the Maryland Quit Line, a free smoking cessation counseling resource. The investigators propose a cluster randomized trial (Implementation-RCT hybrid design) with a waitlist control at the 22 Johns Hopkins Community Physicians (JHCP) sites, which offer primary care. The intervention will include a multi-modality intervention to promote provider use of smoking cessation resources which include an Epic-based Best Practice Advisory (BPA) that allows providers to electronically refer to the Maryland State Quit Line, educational materials, and provider visits with Quit Line representatives to review use of smoking cessation practices. Sites will be randomized to one of three arms with increasing support: 1) six-month waitlist control; 2) BPA with optional educational modules; 3) BPA with online educational modules, a quick-reference educational document, and additional visit with Quit Line representatives. The investigators hypothesize that by implementing a new Epic BPA that allows providers to easily refer to the Maryland Quit Line electronically, The investigators will increase use of this resource. The investigators also hypothesize that adding additional educational materials and having Quit Line representatives perform educational outreach visits will further increase use of the Quit Line and will increase prescription of medications to assist with smoking cessation. Ultimately, the investigators hope to improve patient care by increasing providers' use the Maryland Quit Line and pharmacotherapy. The investigators hope that the use of these resources will decrease smoking rates and thereby improve patient health and outcomes while improving JHCP quality metrics.
The primary goal of this study is to test the effectiveness of instituting an Epic BPA in increasing Maryland Quit Line referrals. The secondary goals are to measure the BPA's effect and the effect of additional provider education on patient engagement with the Quit Line, and on prescription of medications that aid in smoking cessation.
Aim 1: In a three-arm, cluster randomized trial, to test the effectiveness of an Epic BPA with provider educational support and provider detailing in provision of smoking cessation services.
Hypothesis 1: An Epic-based BPA to prompt providers to electronically refer people who are ready to quit smoking to the Maryland Quit Line will increase use of this service compared to waitlist control.
Hypothesis 2: An Epic-based BPA supplemented with educational materials and academic detailing will increase Quit-Line referral compared to control.
Hypothesis 3: Additional provider support including educational materials, in-person academic detailing, will increase successful referrals to the Quit Line and prescription of cessation pharmacotherapy compared to waitlist control and BPA only
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21211
- Johns Hopkins Community Physcians
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Johns Hopkins Community Physicians Primary Care Practices (Internal Medicine and Family Medicine)
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Waitlist Control
BPA will be rolled out to waitlist control sites after 6 months
|
|
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Active Comparator: Best Practices Advisory (BPA)
Clinicians will receive an email describing the BPA and order set, along with internet links to MD Quit Line without additional supplemental education.
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|
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Active Comparator: BPA+ Enhanced Education
Clinicians will receive an email describing the new smoking BPA, educational materials offered, and a small tutorial on using the BPA and a new smoking cessation smart set in Epic.
Education materials will include the educational hand out and academic detailing from Maryland Quit Line counselors.
|
BPA with Quitline Referral plus 1)Consolidated educational hand out: The hand out will include a information about counseling, pharmacotherapy, and cessation referrals 2)Online modules: Providers will be directed to optional, self-paced educational modules through the Maryland HABITS program 3)Academic detailing: This will include a single session during a clinic day in which counseling experts from the MD Quit Line will visit providers in their practice setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Provider Electronic Referrals to the Maryland Quit Line
Time Frame: 6 months
|
Number of referrals made out of total eligible for referral.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prescription of Pharmacotherapy for Smoking Cessation
Time Frame: 12 months
|
Nicotine replacement, Varenicline or Bupropion prescription.
|
12 months
|
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Patient Engagement With the Quit Line
Time Frame: 6 months
|
Number of patients that accepted services or declined or were not reached or were already enrolled.
|
6 months
|
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Provider Electronic Referrals to the Maryland Quit Line
Time Frame: 12 months
|
Number of referrals made out of total eligible for referral.
|
12 months
|
|
Patient Engagement With the Quit Line
Time Frame: 12 months
|
Number of patients that accepted services or declined or were not reached or were already enrolled.
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Geetanjali Chander, MD, MHS, Johns Hopkins University
Publications and helpful links
General Publications
- Sharifi M, Adams WG, Winickoff JP, Guo J, Reid M, Boynton-Jarrett R. Enhancing the electronic health record to increase counseling and quit-line referral for parents who smoke. Acad Pediatr. 2014 Sep-Oct;14(5):478-84. doi: 10.1016/j.acap.2014.03.017.
- Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
- O'Brien MA, Rogers S, Jamtvedt G, Oxman AD, Odgaard-Jensen J, Kristoffersen DT, Forsetlund L, Bainbridge D, Freemantle N, Davis DA, Haynes RB, Harvey EL. Educational outreach visits: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD000409. doi: 10.1002/14651858.CD000409.pub2.
- Hu SS, Neff L, Agaku IT, Cox S, Day HR, Holder-Hayes E, King BA. Tobacco Product Use Among Adults - United States, 2013-2014. MMWR Morb Mortal Wkly Rep. 2016 Jul 15;65(27):685-91. doi: 10.15585/mmwr.mm6527a1.
- Stead LF, Hartmann-Boyce J, Perera R, Lancaster T. Telephone counselling for smoking cessation. Cochrane Database Syst Rev. 2013 Aug 12;(8):CD002850. doi: 10.1002/14651858.CD002850.pub3.
- Boyle R, Solberg L, Fiore M. Use of electronic health records to support smoking cessation. Cochrane Database Syst Rev. 2014 Dec 30;2014(12):CD008743. doi: 10.1002/14651858.CD008743.pub3.
- Wadlin J, Ford DE, Albert MC, Wang NY, Chander G. Implementing an EMR-Based Referral for Smoking Quitline Services with Additional Provider Education, a Cluster-Randomized Trial. J Gen Intern Med. 2022 Aug;37(10):2438-2445. doi: 10.1007/s11606-021-07275-6. Epub 2022 Mar 8.
- Bernstein SL, Rosner J, DeWitt M, Hsiao A, Dziura J, Toll B. Design and implementation of decision support for tobacco dependence treatment in an inpatient electronic medical record. Implement Sci. 2015;10(S1):A1. doi:10.1186/1748-5908-10-S1-A1.
- Carson KV, Verbiest ME, Crone MR, Brinn MP, Esterman AJ, Assendelft WJ, Smith BJ. Training health professionals in smoking cessation. Cochrane Database Syst Rev. 2012 May 16;2012(5):CD000214. doi: 10.1002/14651858.CD000214.pub2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB00124880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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