SmokingF2Q/EADNCT00989755
Center for Disease Control (CDC) Fax to Quit/Academic Detailing Grant
A study testing Fax to Quit (F2Q) in people with Smoking, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Fax to Quit (F2Q)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Aug 2011
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years of age or older)
- Smoker seeking medical care from general practice (internal medicine) clinic (clinic enrolled in study)
- Smoker motivated to make a quit attempt
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Tobacco Research and Intervention
Madison, Wisconsin, 53711
About this study
Official title: An Evaluation of the Fax to Quit Program and Wisconsin Tobacco Quitline Utilization by Southeastern Wisconsin Clinics
The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Successful integration of quitlines into healthcare delivery will transform regular healthcare visits into easily implemented, cost-beneficial avenues via which smokers all across America will be routinely inducted into effective cessation intervention. F2Q will be evaluated as follows:
- Does F2Q increase contacts and "quality contacts," between the quitline and patients who smoke and receive health care at a participating clinic? A "quality contact" is defined as a quitline referral that results in the individual enrolling in the quitline counseling services. This aim will be assessed by measuring the rates of quitline referrals in 49 clinics before and after F2Q has been implemented.
- Are contact rates and enrollment rates of F2Q increased by "Enhanced Academic Detailing" at clinic sites (with enhanced academic detailing comprising ongoing training/technical assistance as well as performance feedback)?
- What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to implement, as well as features that were unhelpful and difficult? This information will be gathered in qualitative assessments that also will identify clinic strategies and organizational features that facilitated successful implementation.
- What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do these costs compare to other quitline promotional strategies (e.g., paid media, medication give-away programs)?
- Conditions
- Smoking
- Being tested
- Fax to Quit (F2Q)
- Keywords
- Tobacco dependence treatment in primary health care setting, Fax to Quit, Fax to Quit plus Enhanced Academic Detailing, Fax referral, Quitline
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fax to Quit (F2Q)Other
Clinics in this group receive electronic and hard copies of all materials necessary for implementing Fax to Quit within their clinics.
| Study group | Role | What they receive |
|---|---|---|
| Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) | Experimental | Clinics in this group receive Fax to Quit materials and in person training from a Regional Outreach Specialist (ROS). The ROS also provides on-going training/technical assistance and performance feedback. Receives: Other: Fax to Quit (F2Q) |
| Fax to Quit alone | Placebo comparator | Clinics in this group receive Fax to Quit materials and can download materials from a website. Receives: Other: Fax to Quit (F2Q) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fax to Quit referrals
Measured: One year following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 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 MPH MBA, Principal investigator, University of Wisconsin--CTRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989755
- Sponsor's protocol ID
- M-2008-1335
- Acronym
- F2Q/EAD
- Status last verified
- Dec 2015
- First submitted
- 1 Oct 2009
- Last updated
- 9 Dec 2015
- Results posted
- No
Publications
Sheffer MA, Baker TB, Fraser DL, Adsit RT, McAfee TA, Fiore MC. Fax referrals, academic detailing, and tobacco quitline use: a randomized trial. Am J Prev Med. 2012 Jan;42(1):21-8. doi: 10.1016/j.amepre.2011.08.028.
PubMed 22176842
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Fax to Quit Program and Wisconsin Tobacco Quitline Utilization by Southeastern Wisconsin Clinics
- ClinicalTrials.gov ID
- NCT00989755
- Acronym / sponsor ID
- F2Q/EAD / M-2008-1335
- Conditions
- Smoking
- Keywords
- Tobacco dependence treatment in primary health care setting, Fax to Quit, Fax to Quit plus Enhanced Academic Detailing, Fax referral, Quitline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 Oct 2009 (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.
The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Successful integration of quitlines into healthcare delivery will transform regular healthcare visits into easily implemented, cost-beneficial avenues via which smokers all across America will be routinely inducted into effective cessation intervention. F2Q will be evaluated as follows:
- Does F2Q increase contacts and "quality contacts," between the quitline and patients who smoke and receive health care at a participating clinic? A "quality contact" is defined as a quitline referral that results in the individual enrolling in the quitline counseling services. This aim will be assessed by measuring the rates of quitline referrals in 49 clinics before and after F2Q has been implemented.
- Are contact rates and enrollment rates of F2Q increased by "Enhanced Academic Detailing" at clinic sites (with enhanced academic detailing comprising ongoing training/technical assistance as well as performance feedback)?
- What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to implement, as well as features that were unhelpful and difficult? This information will be gathered in qualitative assessments that also will identify clinic strategies and organizational features that facilitated successful implementation.
- What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do these costs compare to other quitline promotional strategies (e.g., paid media, medication give-away programs)?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) | Experimental | Other: Fax to Quit (F2Q)Clinics in this group receive Fax to Quit materials and in person training from a Regional Outreach Specialist (ROS). The ROS also provides on-going training/technical assistance and performance feedback. |
| Fax to Quit alone | Placebo comparator | Other: Fax to Quit (F2Q)Clinics in this group receive Fax to Quit materials and can download materials from a website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years of age or older)
- Smoker seeking medical care from general practice (internal medicine) clinic (clinic enrolled in study)
- Smoker motivated to make a quit attempt
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 |
|---|---|---|
| Fax to Quit (F2Q)Clinics in this group receive electronic and hard copies of all materials necessary for implementing Fax to Quit within their clinics. | Other | Fax to Quit alone, Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) |
Primary outcome
Number of Fax to Quit referrals
Time frame: One year following enrollment
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 9 Dec 2015.
- Derived from this study: PubMed 22176842Sheffer MA, Baker TB, Fraser DL, Adsit RT, McAfee TA, Fiore MC. Fax referrals, academic detailing, and tobacco quitline use: a randomized trial. Am J Prev Med. 2012 Jan;42(1):21-8. doi: 10.1016/j.amepre.2011.08.028.
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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 MPH MBA principal investigator
University of Wisconsin--CTRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fax to Quit (F2Q) in people with Smoking, 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 3 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 9 Dec 2015. 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. Some participants in this study may receive a placebo. 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?
Number of Fax to Quit referrals (time frame: One year following enrollment). 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 NCT00989755, which also lists 1 linked publication.
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 9 Dec 2015.