NCT03229356

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

July 11, 2017

Results QC Date

April 13, 2022

Last Update Submit

February 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Provider Electronic Referrals to the Maryland Quit Line

    Number of referrals made out of total eligible for referral.

    6 months

Secondary Outcomes (4)

  • Prescription of Pharmacotherapy for Smoking Cessation

    12 months

  • Patient Engagement With the Quit Line

    6 months

  • Provider Electronic Referrals to the Maryland Quit Line

    12 months

  • Patient Engagement With the Quit Line

    12 months

Study Arms (3)

Waitlist Control

NO INTERVENTION

BPA will be rolled out to waitlist control sites after 6 months

Best Practices Advisory (BPA)

ACTIVE COMPARATOR

Clinicians will receive an email describing the BPA and order set, along with internet links to MD Quit Line without additional supplemental education.

Other: Best Practices Advisory (BPA)

BPA+ Enhanced Education

ACTIVE COMPARATOR

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.

Other: BPA + Enhanced Education

Interventions

1. 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. 2. 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.

Best Practices Advisory (BPA)

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.

BPA+ Enhanced Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Johns Hopkins Community Physicians Primary Care Practices (Internal Medicine and Family Medicine)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Community Physcians

Baltimore, Maryland, 21211, United States

Location

Related Publications (9)

  • 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.

    PMID: 27416365BACKGROUND
  • 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.

    PMID: 23934971BACKGROUND
  • 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.

    PMID: 25169159BACKGROUND
  • Bernstein SL, Weiss J, DeWitt M, Tetrault JM, Hsiao AL, Dziura J, Sussman S, Miller T, Carpenter K, O'Connor P, Toll B. A randomized trial of decision support for tobacco dependence treatment in an inpatient electronic medical record: clinical results. Implement Sci. 2019 Jan 22;14(1):8. doi: 10.1186/s13012-019-0856-8.

    PMID: 30670043BACKGROUND
  • 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.

    PMID: 25547090BACKGROUND
  • 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.

    PMID: 22592671BACKGROUND
  • 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.

    PMID: 17943742BACKGROUND
  • Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.

    PMID: 2104640BACKGROUND
  • 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.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Geetanjali Chander
Organization
Johns Hopkins University

Study Officials

  • Geetanjali Chander, MD, MHS

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 25, 2017

Study Start

April 18, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2019

Last Updated

November 18, 2023

Results First Posted

November 18, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations