Nicotine Replacement Provided at a Tertiary Care Hospital

Smoking Cessation Clinical Trial

— N-PATCH  

Official title:

A Patient-centered Approach to Behavioral Modification in a Tertiary-care University-affiliated Hospital and the Incidence of Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614054
• Other study ID #: H12-01080
• Status: Completed
• Phase: N/A
• First received: May 28, 2012
• Last updated: March 14, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to show that a patient-centered survey asking about smoking habits, with the option for nicotine replacement therapy (NRT) will increase the prescription rates among health care providers (HCP). The investigators also believe that this intervention can also lead to increased referrals to smoking cessation clinics and ultimately increase rates of smoking cessation.

Description:

Since the past decade, there has been an increased awareness of the effects of smoking of general health. In 2000, 18.1% of all US deaths were related to tobacco use. Multiple trials have proven that providing nicotine-replacement therapies to help smoking cessation were efficacious with various types of populations. However, smoking has not been eradicated in North America and was associated with a 3.1 million YPLL (years of potential life lost), along with 96.8 billion in productivity losses in the US4.

We are carrying out a study of 200 inpatients on a general medicine ward to attempt to improve prescription rates of nicotine replacement therapy (NRT) and smoking cessation. Our goal is to use a patient centred approach to determine which patients would benefit from NRT and which patients would be in the contemplative stage of smoking cessation. We will want to look at whether a simple, short survey taken by patients can encourage the health care provider (HCP) to provide more NRT and more referrals to a smoking cessation clinic. We hope that this tool will improve the ability of HCP to provide optimal, comprehensive care. The study's findings should help to guide future practices for hospitalized smokers.

Currently, standard treatment involves NRT being prescribed completely at the discretion of the physician. This occasionally involves a discussion with the patient regarding their preferences, but more often is a unilateral decision made by the health care provider. Additionally, we believe that this method misses a lot of potential patients who may benefit from this therapy but are otherwise not identified. We will not be using a placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to the general medicine ward

• Currently smoking (or quit within the last two weeks)

• 18 years and over

• Able to read in the English language or have a translator present

Exclusion Criteria:

• Non-smokers

• Pregnant or actively trying to conceive

• Recent acute coronary syndrome (within 1 month)

• Active temporo-mandibular joint disease

• Currently on NRT

• Allergy to nicotine

• Acute delirium/chronic dementia

• Inability to complete survey secondary to language/educational issues (if no translator present)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Other:
• Survey of patient's smoking habits
Nicotine replacement therapy (inhalers, patches, gum, lozenges) at the discretion of the health care provider

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Providence Health & Services, St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of prescriptions for NRT (as a percentage of the number of active smokers)	By eliciting patient attitudes toward smoking cessation, we aim to increase the rate of prescription of nicotine replacement by 15% on the medical wards at St. Paul's Hospital by 15% over a 1month period.; We will measure the number of prescriptions for NRT of any kind by referencing pharmacy databases. This will be calculated as a percentage of active smokers.	1 month	No
Secondary	Number of referrals to a smoking cessation clinic (as a percentage of the number of active smokers)	We hope to increase the number of referrals to smoking cessation clinics by 15% over one month.; We will measure the number of patients referred for smoking cessation by contacting the clinic and cross-referencing the data by attending physician making the referral. This will be calculated as a percentage of active smokers.	1 month	No