Vascular Physician Offer and Report (VAPOR) Trial

Peripheral Artery Disease (PAD) Clinical Trial

— VAPOR  

Official title:

Vascular Physician Offer and Report (VAPOR) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220686
• Other study ID #: D14197
• Status: Completed
• Phase: N/A
• First received: August 14, 2014
• Last updated: July 25, 2017
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2017
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease (PAD)

Intervention

Behavioral:
• Offer and Report Protocol
Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Roper Hospital	Charleston	South Carolina
United States	Northwestern Memorial	Chicago	Illinois
United States	UF Health	Gainesville	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Utah Hospital	Salt Lake City	Utah
United States	University Health	Shreveport	Louisiana
United States	UMASS Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Society for Vascular Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in smoking status from Baseline Visit to 3 Month Visit