Clinical trial NCT01614054: Nicotine Replacement Provided at a Tertiary Care Hospital
Official title: A Patient-centered Approach to Behavioral Modification in a Tertiary-care University-affiliated Hospital and the Incidence of Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Nicotine replacement therapy
NRT
Inpatient
General Medicine
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
name: St. Paul's Hospital, Canada
First posted: 2012-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of prescriptions for NRT (as a percentage of the number of active smokers)
timeFrame: 1 month
Secondary outcomes:
measure: Number of referrals to a smoking cessation clinic (as a percentage of the number of active smokers)
timeFrame: 1 month
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: The Lung Centre, University of British Columbia
name: Mark Fitzgerald, MD
role: PRINCIPAL_INVESTIGATOR
References: