Nicotine Replacement Provided at a Tertiary Care Hospital (N-PATCH)

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. Identifier: NCT01614054
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : March 17, 2014
Providence Health & Services
St. Paul's Hospital, Canada
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Survey of patient's smoking habits Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Patient-centered Approach to Behavioral Modification in a Tertiary-care University-affiliated Hospital and the Incidence of Smoking Cessation
Study Start Date : June 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Survey Group
Patients will receive a survey along with their meal tray, provided by Food and Nutrition Services. The survey will consist of questions related to smoking habits, desire for NRT and desire for assistance with smoking cessation. The results of these surveys will be collected by allied health professionals and forwarded to the CTU team. The CTU team will then be encouraged to use that information to engage in a discussion with the patient regarding prescription of NRT. It will then be left to the discretion of the HCP whether or not to prescribe NRT taking into account patient preference, absence of contraindications and clinical benefit. All those participating in the survey will be offered referral to a smoking cessation clinic upon discharge.
Other: Survey of patient's smoking habits
Nicotine replacement therapy (inhalers, patches, gum, lozenges) at the discretion of the health care provider

No Intervention: Standard of Care
In the control arm, surveys will also be given out to all patients along with their meal trays. However, these surveys will include only questions related to smoking habits in order to get a baseline number of smokers. The surveys will then be collected by the allied health and nursing staff and forwarded only to the research team. The HCP taking care of the patients will still provide standard of care treatment with NRT and smoking cessation referral as clinically indicated.

Primary Outcome Measures :
  1. Number of prescriptions for NRT (as a percentage of the number of active smokers) [ Time Frame: 1 month ]

    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.

Secondary Outcome Measures :
  1. Number of referrals to a smoking cessation clinic (as a percentage of the number of active smokers) [ Time Frame: 1 month ]

    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.

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

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)

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 identifier (NCT number): NCT01614054

Canada, British Columbia
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
University of British Columbia
Providence Health & Services
St. Paul's Hospital, Canada
Principal Investigator: Mark Fitzgerald, MD The Lung Centre, University of British Columbia

Responsible Party: University of British Columbia Identifier: NCT01614054     History of Changes
Other Study ID Numbers: H12-01080
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
Smoking cessation
Nicotine replacement therapy
General Medicine

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action