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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03229356
Other study ID # IRB00124880
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2017
Est. completion date May 30, 2019

Study information

Verified date February 2023
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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, 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date May 30, 2019
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Johns Hopkins Community Physicians Primary Care Practices (Internal Medicine and Family Medicine) Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practices Advisory (BPA)
BPA: The BPA is an Epic prompt that fires when a provider opens an encounter with a patient who is actively smoking. Providers will be asked to assess smoking cessation readiness and to refer patients to the free Maryland Quit Line if the patient is receptive. The Quit Line will receive an electronic referral with the patient's details. A Quit Line certified smoking cessation counselor will then call the patient at a later date and provide counseling. Receptive patient will receive up to four calls. They will receive counseling from a trained quit coach and be offered free access to NRT. Quit Line: This free telephone-based counseling service is offered to smoker in Maryland. Services offered include on-the-phone smoking cessation counseling and free nicotine replacement.
BPA + Enhanced Education
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.

Locations

Country Name City State
United States Johns Hopkins Community Physcians Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Maryland Department of Health and Mental Hygiene

Country where clinical trial is conducted

United States, 

References & Publications (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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Provider Electronic Referrals to the Maryland Quit Line Number of referrals made out of total eligible for referral. 6 months
Secondary Prescription of Pharmacotherapy for Smoking Cessation Nicotine replacement, Varenicline or Bupropion prescription. 12 months
Secondary Patient Engagement With the Quit Line Number of patients that accepted services or declined or were not reached or were already enrolled. 6 months
Secondary Provider Electronic Referrals to the Maryland Quit Line Number of referrals made out of total eligible for referral. 12 months
Secondary Patient Engagement With the Quit Line Number of patients that accepted services or declined or were not reached or were already enrolled. 12 months
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