Smoking CessationN-PATCHNCT01614054
Nicotine Replacement Provided at a Tertiary Care Hospital
A study testing Survey of patient's smoking habits in people with Smoking Cessation, run by University of British Columbia at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Survey of patient's smoking habits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Patient-centered Approach to Behavioral Modification in a Tertiary-care University-affiliated Hospital and the Incidence of Smoking Cessation
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Survey of patient's smoking habits
- Keywords
- Smoking cessation, Nicotine replacement therapy, NRT, Inpatient, General Medicine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of patient's smoking habitsOther
Nicotine replacement therapy (inhalers, patches, gum, lozenges) at the discretion of the health care provider
| Study group | Role | What they receive |
|---|---|---|
| Survey Group | Experimental | 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. Receives: Other: Survey of patient's smoking habits |
| Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Health & Services, St. Paul's Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Mark Fitzgerald, MD, Principal investigator, The Lung Centre, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614054
- Sponsor's protocol ID
- H12-01080
- Acronym
- N-PATCH
- Status last verified
- Mar 2014
- First submitted
- 28 May 2012
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered Approach to Behavioral Modification in a Tertiary-care University-affiliated Hospital and the Incidence of Smoking Cessation
- ClinicalTrials.gov ID
- NCT01614054
- Acronym / sponsor ID
- N-PATCH / H12-01080
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Nicotine replacement therapy, NRT, Inpatient, General Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Providence Health & Services, St. Paul's Hospital, Canada
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survey Group | Experimental | Other: Survey of patient's smoking habitsPatients 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. |
| Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Non-smokers
- Pregnant or actively trying to conceive
- Recent acute coronary syndrome (within 1 month)
- Active temporo-mandibular joint disease
- Currently on NRT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey of patient's smoking habitsNicotine replacement therapy (inhalers, patches, gum, lozenges) at the discretion of the health care provider | Other | Survey Group |
Primary outcome
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.
1 secondary outcome
Number of referrals to a smoking cessation clinic (as a percentage of the number of active smokers)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Fitzgerald, MD principal investigator
The Lung Centre, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey of patient's smoking habits in people with Smoking Cessation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of prescriptions for NRT (as a percentage of the number of active smokers) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.