Smoking CessationNCT03229356
An EPIC Based BPA to Enhance Quit Line Referral and Use
A study testing Best Practices Advisory (BPA) and BPA + Enhanced Education in people with Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Best Practices Advisory (BPA) and BPA + Enhanced Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2017to 30 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Johns Hopkins Community Physicians Primary Care Practices (Internal Medicine and Family Medicine)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Community Physcians
Baltimore, Maryland, 21211
About this study
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.
Read the 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
- Conditions
- Smoking Cessation
- Being tested
- Best Practices Advisory (BPA), BPA + Enhanced Education
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practices Advisory (BPA)Other
- 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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: BPA + Enhanced Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Electronic Referrals to the Maryland Quit Line
Number of referrals made out of total eligible for referral.
Measured: 6 months
Secondary outcomes (4)
Prescription of Pharmacotherapy for Smoking Cessation
Nicotine replacement, Varenicline or Bupropion prescription.
Measured: 12 months
Patient Engagement With the Quit Line
Number of patients that accepted services or declined or were not reached or were already enrolled.
Measured: 6 months
Provider Electronic Referrals to the Maryland Quit Line
Number of referrals made out of total eligible for referral.
Measured: 12 months
Patient Engagement With the Quit Line
Number of patients that accepted services or declined or were not reached or were already enrolled.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start18 Apr 2017
- Primary completion30 May 2018
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Responsible party
- Sponsor
- Investigators
- Geetanjali Chander, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229356
- Sponsor's protocol ID
- IRB00124880
- Status last verified
- Feb 2023
- First submitted
- 11 Jul 2017
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27416365Stead 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.
PubMed 23934971Sharifi 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.
PubMed 25169159Bernstein 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.
PubMed 25547090Carson 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.
PubMed 22592671O'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.
PubMed 17943742Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
PubMed 2104640Wadlin 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.
PubMed 35260960
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EPIC Based BPA to Enhance Quit Line Referral and Use
- ClinicalTrials.gov ID
- NCT03229356
- Acronym / sponsor ID
- IRB00124880
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Maryland Department of Health and Mental Hygiene
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waitlist Control | No intervention | –BPA will be rolled out to waitlist control sites after 6 months |
| Best Practices Advisory (BPA) | Active comparator | Other: 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. |
| BPA+ Enhanced Education | Active comparator | Other: BPA + Enhanced EducationClinicians 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Johns Hopkins Community Physicians Primary Care Practices (Internal Medicine and Family Medicine)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Best Practices Advisory (BPA) |
| BPA + Enhanced EducationBPA 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. | Other | BPA+ Enhanced Education |
Primary outcome
Provider Electronic Referrals to the Maryland Quit Line
Time frame: 6 months
Number of referrals made out of total eligible for referral.
4 secondary outcomes
Prescription of Pharmacotherapy for Smoking Cessation
Time frame: 12 months
Patient Engagement With the Quit Line
Time frame: 6 months
Provider Electronic Referrals to the Maryland Quit Line
Time frame: 12 months
Patient Engagement With the Quit Line
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27416365Hu 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.
- Background: PubMed 23934971Stead 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.
- Background: PubMed 25169159Sharifi 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.
- BackgroundBernstein 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.
- Background: PubMed 25547090Boyle 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.
- Background: PubMed 22592671Carson 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.
- Background: PubMed 17943742O'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.
- Background: PubMed 2104640Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
- Derived from this study: PubMed 35260960Wadlin 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.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geetanjali Chander, MD, MHS principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practices Advisory (BPA) and BPA + Enhanced Education in people with Smoking Cessation, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider Electronic Referrals to the Maryland Quit Line (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229356, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.