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

Primary Purpose

Peripheral Artery Disease (PAD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Offer and Report Protocol
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease (PAD) focused on measuring VAPOR, smoking cessation, PAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health
  • Northwestern Memorial
  • University Health
  • Boston Medical Center
  • UMASS Memorial Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Roper Hospital
  • University of Utah Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Offer and Report Protocol

Usual Care

Arm Description

Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.

Physician will follow their institution's standard of care for smoking cessation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2014
Last Updated
July 25, 2017
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Society for Vascular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT02220686
Brief Title
Vascular Physician Offer and Report (VAPOR) Trial
Acronym
VAPOR
Official Title
Vascular Physician Offer and Report (VAPOR) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Society for Vascular Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease (PAD)
Keywords
VAPOR, smoking cessation, PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Offer and Report Protocol
Arm Type
Experimental
Arm Description
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Physician will follow their institution's standard of care for smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Offer and Report Protocol
Intervention Description
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
Primary Outcome Measure Information:
Title
Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit
Description
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.
Time Frame
Change in smoking status from Baseline Visit to 3 Month Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Goodney, MD, MS
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alik Farber, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0128
Country
United States
Facility Name
Northwestern Memorial
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University Health
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
UMASS Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27016862
Citation
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.
Results Reference
derived

Learn more about this trial

Vascular Physician Offer and Report (VAPOR) Trial

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