SmokingEHR ProjectNCT02358330
Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking
An observational study of Smoking and Nicotine Dependence, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound health and economic costs, smoking treatment is infrequently provided in healthcare settings, and when provided, it is not sufficiently effective. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Nicotine Dependence, Electronic Health Records
- What is being tested?
- EHR Enhanced Clinic Intervention
- How many people
- 28,095 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a multiple baseline design with the unit of analysis as the clinic. 20-28 clinics will be recruited.
Who may be able to join
- The clinics participating in the MBD experiment will be selected based on the following criteria:
- Size: clinics will be fairly large, including at least 4-6 clinicians, to ensure adequate recruitment for clinical trials connected with thye EHR recruitment.
- Location: clinics will be concentrated in Southcentral and Southeastern Wisconsin so that case managers from UW-CTRI Madison and Milwaukee research sites can provide services at multiple clinics.
- Diversity: clinics from each of the two health systems will include both urban and rural locations, and at least one high- and one low-SES clinic (based on rates of Medicaid and uninsured patients).
- Independence: clinics will not share staff or be physically adjacent to one another to combat bleeding of interventions across clinics (see 87 for the independence requirement for MBD).
- All clinics will routinely collect the data that will serve as dependent variables in the MBD design (this will be universal among the three health system clinics).
Who cannot join
- Any clinic not meeting the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, 53711
About this study
Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound health and economic costs, smoking treatment is infrequently provided in healthcare settings, and when provided, it is not sufficiently effective. To address this, this project will develop and evaluate more efficient electronic health record (EHR) methods to identify smokers and engage them in evidence-based treatment.
Read the detailed description
Specifically, this Project will develop and test new EHR enhancements and associated healthcare practices that are designed to efficiently identify smokers and recruit them into a chronic care treatment for smoking (which will be developed and evaluated in Projects 2-4). The EHR enhancements will include: 1) smoker identification and documentation aids, 2) a "Smoker Registry" (which stores relevant data on smokers and facilitates tracking their smoking status over time), 3) a 1-click system to refer smokers to the chronic care treatment for smoking, 4) a closed-loop function to provide EHR feedback to clinicians on the outcomes of their referrals, and 5) communications resources to inform smokers of treatment options and to increase their recruitment into treatment. The effects of the EHR-based enhancements and the chronic care smoking treatment will be evaluated with a multiple baseline design involving 18 primary care clinics in three healthcare systems in Wisconsin; all participants for affiliated clinical research Projects will be recruited from these clinics. This highly innovative research will evaluate the impact of an integrated set of EHR enhancements-coupled with a chronic care approach to smoking treatment-on smoker identification, and smoking treatment referral and engagement. In addition, this research will explore factors that influence the use of EHR-based enhancements in clinics. In sum, this research will develop a set of EHR-based health system enhancements that increase both the adoption of chronic care treatment by healthcare systems and smokers' engagement in that treatment.
- Being tested
- EHR Enhanced Clinic Intervention
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EHR Enhanced Clinic InterventionOther
The clinics assigned to the experimental condition will have EHR enhancements introduced.
| Study group | Role | What they receive |
|---|---|---|
| EHR Enhanced Clinic Referral | A set of standard EHR modifications will be implemented in 18 clinics as part of the MBD (multiple baseline design) experiment.The key new EHR functions that will be implemented and tested are: 1) a modified "screen for smoking sta-tus" to enhance the identification and documentation of all smokers visiting targeted primary care clinics; 2) a "Smoker Registry" to track smokers, document their receipt of treatment services, and organize direct-to-consumer communications; 3) a 1-click referral system to evidence-based smoking treat-ment with UW-CTRI case managers; 4) a closed-loop feedback feature to communicate to the clinician the fate of a referral, documenting receipt of the referral and treatment engagement; and 5) EHR-based communication options to inform smokers of treatment resources Receives: Other: EHR Enhanced Clinic Intervention | |
| Standard care (control) clinics | 10 control clinics will also be inducted into the study. These clinics will use existing EHR resources to identify smokers (e.g., the expanded vital signs) and to document their smoking status, and then use the standard paper fax-to-quit methods to refer patients to the Wisconsin Tobacco Quit Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment engagement rate among smokers at a clinic
Percentage of those smokers identified in a clinic who engage in smoking related treatment
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 posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 28,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael C Fiore, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358330
- Sponsor's protocol ID
- 2014-1041 EHR
- Other IDs
- A534252, SMPH\MEDICINE\TOBACCO RE
- Acronym
- EHR Project
- Status last verified
- May 2020
- First submitted
- 3 Feb 2015
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking
- ClinicalTrials.gov ID
- NCT02358330
- Acronym / sponsor ID
- EHR Project / 2014-1041 EHR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,095 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
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 leading preventable cause of cancer mortality in the US. Despite its profound health and economic costs, smoking treatment is infrequently provided in healthcare settings, and when provided, it is not sufficiently effective. To address this, this project will develop and evaluate more efficient electronic health record (EHR) methods to identify smokers and engage them in evidence-based treatment.
Detailed description
Specifically, this Project will develop and test new EHR enhancements and associated healthcare practices that are designed to efficiently identify smokers and recruit them into a chronic care treatment for smoking (which will be developed and evaluated in Projects 2-4). The EHR enhancements will include: 1) smoker identification and documentation aids, 2) a "Smoker Registry" (which stores relevant data on smokers and facilitates tracking their smoking status over time), 3) a 1-click system to refer smokers to the chronic care treatment for smoking, 4) a closed-loop function to provide EHR feedback to clinicians on the outcomes of their referrals, and 5) communications resources to inform smokers of treatment options and to increase their recruitment into treatment. The effects of the EHR-based enhancements and the chronic care smoking treatment will be evaluated with a multiple baseline design involving 18 primary care clinics in three healthcare systems in Wisconsin; all participants for affiliated clinical research Projects will be recruited from these clinics. This highly innovative research will evaluate the impact of an integrated set of EHR enhancements-coupled with a chronic care approach to smoking treatment-on smoker identification, and smoking treatment referral and engagement. In addition, this research will explore factors that influence the use of EHR-based enhancements in clinics. In sum, this research will develop a set of EHR-based health system enhancements that increase both the adoption of chronic care treatment by healthcare systems and smokers' engagement in that treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHR Enhanced Clinic Referral | – | Other: EHR Enhanced Clinic InterventionA set of standard EHR modifications will be implemented in 18 clinics as part of the MBD (multiple baseline design) experiment.The key new EHR functions that will be implemented and tested are: 1) a modified "screen for smoking sta-tus" to enhance the identification and documentation of all smokers visiting targeted primary care clinics; 2) a "Smoker Registry" to track smokers, document their receipt of treatment services, and organize direct-to-consumer communications; 3) a 1-click referral system to evidence-based smoking treat-ment with UW-CTRI case managers; 4) a closed-loop feedback feature to communicate to the clinician the fate of a referral, documenting receipt of the referral and treatment engagement; and 5) EHR-based communication options to inform smokers of treatment resources |
| Standard care (control) clinics | – | –10 control clinics will also be inducted into the study. These clinics will use existing EHR resources to identify smokers (e.g., the expanded vital signs) and to document their smoking status, and then use the standard paper fax-to-quit methods to refer patients to the Wisconsin Tobacco Quit Line |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a multiple baseline design with the unit of analysis as the clinic. 20-28 clinics will be recruited.
Key inclusion criteria (6 listed)
- The clinics participating in the MBD experiment will be selected based on the following criteria:
Key exclusion criteria (1 listed)
- Any clinic not meeting the above inclusion criteria
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 |
|---|---|---|
| EHR Enhanced Clinic InterventionThe clinics assigned to the experimental condition will have EHR enhancements introduced. | Other | EHR Enhanced Clinic Referral |
Primary outcome
Treatment engagement rate among smokers at a clinic
Time frame: 12 months
Percentage of those smokers identified in a clinic who engage in smoking related treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- University of Wisconsin Center for Tobacco Research and InterventionLink provided by the sponsor.
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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.
Michael C Fiore, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Nicotine Dependence, run by University of Wisconsin, Madison 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 6 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 13 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment engagement rate among smokers at a clinic (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2020.