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Vascular Physician Offer and Report (VAPOR) Trial (VAPOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220686
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
Society for Vascular Surgery
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief 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.

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).


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease (PAD) Behavioral: Offer and Report Protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vascular Physician Offer and Report (VAPOR) Trial
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Offer and Report Protocol
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
Behavioral: Offer and Report Protocol
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.

No Intervention: Usual Care
Physician will follow their institution's standard of care for smoking cessation.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18
  • Current smoker
  • Plan to have a Vascular Quality Initiative (VQI) procedure in > 7 days

Exclusion Criteria:

  • Pregnant Women, Fetuses and Neonates
  • Children
  • People with impaired decision-making capacity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220686


Locations
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United States, Florida
UF Health
Gainesville, Florida, United States, 32610-0128
United States, Illinois
Northwestern Memorial
Chicago, Illinois, United States, 60611
United States, Louisiana
University Health
Shreveport, Louisiana, United States, 71130
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Society for Vascular Surgery
Investigators
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Principal Investigator: Philip Goodney, MD, MS Dartmouth-Hitchcock Medical Center
Principal Investigator: Alik Farber, MD Boston Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02220686    
Other Study ID Numbers: D14197
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Keywords provided by Dartmouth-Hitchcock Medical Center:
VAPOR
smoking cessation
PAD
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases