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| Name | Class |
|---|---|
| Maryland Department of Health and Mental Hygiene | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practices Advisory (BPA) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Provider Electronic Referrals to the Maryland Quit Line | Number of referrals made out of total eligible for referral. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Prescription of Pharmacotherapy for Smoking Cessation | Nicotine replacement, Varenicline or Bupropion prescription. | 12 months |
| Patient Engagement With the Quit Line | Number of patients that accepted services or declined or were not reached or were already enrolled. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geetanjali Chander, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Community Physcians | Baltimore | Maryland | 21211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27416365 | Background | 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. | |
| 23934971 | Background | 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. |
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Waitlist Control Sites A and B were together (8) in the first 6 months after which they were randomized to A (4) and B (4).
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| ID | Title | Description |
|---|---|---|
| FG000 | Waitlist Control - A | BPA+ Enhanced Education will be rolled out to waitlist control sites after 6 months. |
| FG001 | Waitlist Control - B | BPA will be rolled out to waitlist control sites after 6 months. |
| FG002 | 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. Best Practices Advisory (BPA): 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. |
| FG003 | 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 + 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 (Months 1-6) |
| |||||||||||||
| Phase 2 (Months 7-12) |
|
Number of participants is not available for this study, only practice-level data collected.
| ID | Title | Description |
|---|---|---|
| BG000 | Waitlist Control - A | BPA+ Enhanced Education will be rolled out to waitlist control sites after 6 months. |
| BG001 | Waitlist Control - B | BPA will be rolled out to waitlist control sites after 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | No age data 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 | Provider Electronic Referrals to the Maryland Quit Line | Number of referrals made out of total eligible for referral. | This assessment was on number of service referrals made out of eligible encounters and not individual participants. Individual participants analyzed was not collected. Referrals were not made for Waitlist control groups A and B because they were not randomized yet at this time to either BPA or BPA+ Enhanced Education. Data not collected from the waitlist groups at this time point as the intervention had not been rolled out. | Posted | Number | referrals | 6 months | Eligible Encounters | Eligible Encounters |
|
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Adverse events were not assessed.
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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 | Waitlist Control - A | BPA+ Enhanced Education will be rolled out to waitlist control sites after 6 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geetanjali Chander | Johns Hopkins University | 443-287-2030 | gchande1@jhmi.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 | May 23, 2019 | Apr 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| BPA + Enhanced Education | Other | 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. |
|
| 6 months |
| Provider Electronic Referrals to the Maryland Quit Line | Number of referrals made out of total eligible for referral. | 12 months |
| Patient Engagement With the Quit Line | Number of patients that accepted services or declined or were not reached or were already enrolled. | 12 months |
| 25169159 | Background | 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. |
| Background | 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. |
| 25547090 | Background | 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. |
| 22592671 | Background | 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. |
| 17943742 | Background | 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. |
| 2104640 | Background | Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56. |
| 35260960 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | 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. Best Practices Advisory (BPA): 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. |
| BG003 | 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 + 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. |
| BG004 | Total | Total of all reporting groups |
| Practice Sites |
|
| Number |
| participants |
| Participants |
|
| Sex/Gender, Customized | No sex data was collected. | Number | participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity data was not collected. | Number | participants | Participants |
|
| Region of Enrollment | Number | Practice Sites | Practice Sites |
|
| Waitlist Control - B |
BPA will be rolled out to waitlist control sites after 6 months. |
| OG002 | 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. Best Practices Advisory (BPA): 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. |
| OG003 | 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 + 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. |
|
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| Secondary | Prescription of Pharmacotherapy for Smoking Cessation | Nicotine replacement, Varenicline or Bupropion prescription. | Data was not collected for this outcome measure. | Posted | 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. | This assessment was on number of service referrals and not individual participants. Individual participants analyzed was not collected. This assessment was not done for Waitlist control groups A and B. Due to differences in the timeline of data collection between data from the EMR (within the trial period) and those received from the quitline (monthly summary reports), there are minor discrepancies between the referral totals of this outcome and outcome 1. | Posted | Number | service referrals | 6 months | Number of service referrals | Number of service referrals |
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|
|
| Secondary | Provider Electronic Referrals to the Maryland Quit Line | Number of referrals made out of total eligible for referral. | This assessment was on number of service referrals made out of eligible encounters and not individual participants. Individual participants analyzed was not collected. | Posted | Number | referrals | 12 months | Eligible Encounters | Eligible Encounters |
|
|
|
| Secondary | Patient Engagement With the Quit Line | Number of patients that accepted services or declined or were not reached or were already enrolled. | This assessment was on number of service referrals and not individual participants. Individual participants analyzed was not collected. This assessment was not done for Waitlist control groups A and B. | Posted | Number | service referrals | 12 months | Number of service referrals | Number of service referrals |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Waitlist Control - B | BPA will be rolled out to waitlist control sites after 6 months. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. Best Practices Advisory (BPA): 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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 + 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Number of service referrals |
|
| Already enrolled |
|
| Not reached |
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| Pending/incomplete |
|
| Eligible Encounters |
|
| Number of service referrals |
|
| Already enrolled |
|
| Not reached |
|
| Pending/incomplete |
|