Peripheral Artery Disease (PAD)VAPORNCT02220686
Vascular Physician Offer and Report (VAPOR) Trial
A study testing Offer and Report Protocol in people with Peripheral Artery Disease (PAD), run by Dartmouth-Hitchcock Medical Center at 8 sites in United States.
Trial summary
The purpose of the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- Offer and Report Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2014to Mar 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18
- Current smoker
- Plan to have a Vascular Quality Initiative (VQI) procedure in > 7 days
Who cannot join
- Pregnant Women, Fetuses and Neonates
- Children
- People with impaired decision-making capacity
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boston Medical Center
Boston, Massachusetts, 02118
Roper Hospital
Charleston, South Carolina, 29401
Northwestern Memorial
Chicago, Illinois, 60611
UF Health
Gainesville, Florida, 32610-0128
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
University of Utah Hospital
Salt Lake City, Utah, 84132
University Health
Shreveport, Louisiana, 71130
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
The purpose of the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual.
The doctors where you are being treated have been chosen to either provide:
the combination therapy of giving you advice, considering prescribing medications to help you quit smoking, and referring you to a phone quitline, or to continue their usual smoking cessation practices (which may include all, some, or none of the treatments above).
- Conditions
- Peripheral Artery Disease (PAD)
- Being tested
- Offer and Report Protocol
- Keywords
- VAPOR, smoking cessation, PAD
- Medical subject headings
- Peripheral Arterial Disease, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offer and Report ProtocolBehavioural
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| Offer and Report Protocol | Experimental | Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy. Receives: Behavioral: Offer and Report Protocol |
| Usual Care | No intervention | Physician will follow their institution's standard of care for smoking cessation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit
To assess the efficacy of the "Offer and Report" protocol (standardized (1) "very brief advice," (2) referral to telephone-based smoking cessation counseling, and (3) consideration of prescribing nicotine replacement therapy (NRT)) as compared to usual smoking cessation care by vascular physicians in biochemically-validated 3 month smoking cessation rates. A questionnaire will be completed by the patient at the Baseline visit and another questionnaire will be completed at the 3 month visit to assess the change in smoking status.
Measured: Change in smoking status from Baseline Visit to 3 Month Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
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 Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Vascular Surgery
- Responsible party
- Sponsor
- Investigators
- Philip Goodney, MD, MS, Principal investigator, Dartmouth-Hitchcock Medical CenterAlik Farber, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220686
- Sponsor's protocol ID
- D14197
- Acronym
- VAPOR
- Status last verified
- Jul 2017
- First submitted
- 14 Aug 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Spangler EL, Brooke BS, Beck AW, Hoel A, Farber A, Goodney PP; VAPOR Trial Investigators. Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial. J Vasc Surg. 2016 Apr;63(4):1121-5.e2. doi: 10.1016/j.jvs.2015.12.026.
PubMed 27016862
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Physician Offer and Report (VAPOR) Trial
- ClinicalTrials.gov ID
- NCT02220686
- Acronym / sponsor ID
- VAPOR / D14197
- Conditions
- Peripheral Artery Disease (PAD)
- Keywords
- VAPOR, smoking cessation, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Society for Vascular Surgery
- Study start
- Aug 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Aug 2014 (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 the study is to see if vascular physicians (your provider) using a combination of proven smoking cessation tools in an organized way can help vascular patients quit smoking better than usual.
The doctors where you are being treated have been chosen to either provide:
the combination therapy of giving you advice, considering prescribing medications to help you quit smoking, and referring you to a phone quitline, or to continue their usual smoking cessation practices (which may include all, some, or none of the treatments above).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Offer and Report Protocol | Experimental | Behavioral: Offer and Report ProtocolPhysician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy. |
| Usual Care | No intervention | –Physician will follow their institution's standard of care for smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18
- Current smoker
- Plan to have a Vascular Quality Initiative (VQI) procedure in > 7 days
Key exclusion criteria (3 listed)
- Pregnant Women, Fetuses and Neonates
- Children
- People with impaired decision-making capacity
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 |
|---|---|---|
| Offer and Report ProtocolPhysician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy. | Behavioural | Offer and Report Protocol |
Primary outcome
Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit
Time frame: Change in smoking status from Baseline Visit to 3 Month Visit
To assess the efficacy of the "Offer and Report" protocol (standardized (1) "very brief advice," (2) referral to telephone-based smoking cessation counseling, and (3) consideration of prescribing nicotine replacement therapy (NRT)) as compared to usual smoking cessation care by vascular physicians in biochemically-validated 3 month smoking cessation rates. A questionnaire will be completed by the patient at the Baseline visit and another questionnaire will be completed at the 3 month visit to assess the change in smoking status.
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 27 Jul 2017.
- Derived from this study: PubMed 27016862Spangler EL, Brooke BS, Beck AW, Hoel A, Farber A, Goodney PP; VAPOR Trial Investigators. Design and initial enrollment in the Vascular Physicians Offer and Report (VAPOR) trial. J Vasc Surg. 2016 Apr;63(4):1121-5.e2. doi: 10.1016/j.jvs.2015.12.026.
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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.
Philip Goodney, MD, MS principal investigator
Dartmouth-Hitchcock Medical Center
Alik Farber, MD principal investigator
Boston Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offer and Report Protocol in people with Peripheral Artery Disease (PAD), run by Dartmouth-Hitchcock Medical Center at 8 sites 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 3 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit (time frame: Change in smoking status from Baseline Visit to 3 Month Visit). 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 NCT02220686, 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 27 Jul 2017.