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Trial record 13 of 2033 for:    Smoking Cessation

Smoking Cessation Intervention Within the Fracture Clinic

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ClinicalTrials.gov Identifier: NCT02891265
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. J. Werier, Ottawa Hospital Research Institute

Brief Summary:

Tobacco use is the leading preventable cause of death contributing to more than 5 million estimated deaths per year globally. The longterm negative effects of smoking are well established. Complications due to smoking, from an orthopaedic perspective include impair bone and wound healing, and increased risk of infection and osteomyelitis.

The primary outcome of this research is smoking cessation in patients attending the orthopaedic fracture clinic. This is a unique environment whereby previously healthy patients are faced with the impact of disability. This impetus to abstain from the benefit of fracture outcomes provides an opportunity for previously unattained early intervention and thus a greater potential for decreased patient morbidity and mortality. Furthermore it is a high volume clinic that, given the unique nature of traumatic injuries consists of a high proportion of males, ages 24-34 years old, obliged to follow up. This population is traditionally regarded as unattainable from primary prevention smoking cessation strategies. The investigators hypothesize that The Ottawa Hospital Fracture Clinic will serve as an effective environment to employ established primary prevention smoking cessation interventions, reducing the incidence of complications associated with fracture and surgical healing, and result in greater long-term cessation rates.


Condition or disease Intervention/treatment Phase
Focus: Smoking Cessation as it Relates to Fracture Healing Behavioral: Smoking cessation patch Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smoking Cessation Intervention Within the Fracture Clinic
Study Start Date : April 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group A
Group A - smoking cessation with no assistance
Placebo Comparator: Group B
Group B - smoking cessation with the addition of a smoking cessation patch
Behavioral: Smoking cessation patch
To compare the smoking cessation outcome in patients with fractures with or without the help of smoking cessation patches.




Primary Outcome Measures :
  1. Comparison of Rates between no intervention and intervention [ Time Frame: 5 yr total ]
    Spontaneous smoking cessation rates within the orthopaedic trauma population (first cohort) are presently unknown within the literature, however hypothesized to be low. The investigators anticipate a greater than 30% long term cessation rate upon implementation of this model, as compared to its previous implementation in different patient settings. A significant decrease in orthopaedic trauma complications, and long term decreased smoking related morbidity and mortality is expected. The primary outcome of this study will be a comparison of long-term smoking cessation rates between the two cohorts of patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

patients greater than 18 years patients sustained an injury resulting in a fracture date of recruitment is the initial clinic/consultation/post operative visit. clinic visit is within and including 14 days from initial date of injury or operation

Exclusion Criteria:

Patients presenting to the fracture clinic that:

  • Do not meet inclusion criteria
  • Are currently following cessation therapy
  • Cannot understand or read English or French
  • Have abused alcohol within the last six months
  • Have abused illicit drugs within the last six months
  • Are Pregnant or breast feeding
  • Have sustained a pathologic fracture

Definitions

Fractures:

Following fractures are considered one fracture

  • Single or combination of fractures involving hand including and distal to proximal row carpal bones
  • Single or combination of fractures involving foot including and distal to the midfoot
  • Fractures involving radius and ulna presenting at the same level (ie. Distal,diaphyseal, or proximal as per AO classification)
  • Fractures involving tibia and fibula presenting at the same level (ie. Distal,diaphyseal, or proximal as per AO classification)

Polytrauma:

Defined as traumatic incident that has resulted in injury to more than just the MSK system at time of index injury

Spinal Trauma:

Defined as sustaining fracture, subluxation, dislocation, disc herniation or neurologic deficit attributed o spinal injury at time of index injury

Neurovascular Compromise:

Defined as complete loss of motor or cutaneous sensation loss at time of index injury

Illicit substance/drug abuse:

Defined as use of illicit substance or non prescribed narcotic within six months of injury

Alcohol Abuse:

Defined as use of alcohol and positive CAGE questionnaire screening

Pathologic/Insufficiency Fracture:

Fracture secondary to osteoporosis/osteopenia, malignant or non malignant lesion, bisphosphonate use


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 ClinicalTrials.gov identifier (NCT number): NCT02891265


Contacts
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Contact: yusra K Al Mosuli 613-737-8920 ext 74709 yalmosuli@ohri.ca
Contact: Johanna Dobransky 613-737-8920 jdobransky@ohri.ca

Locations
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Canada, Ontario
The Ottawa Hospital Active, not recruiting
Ottawa, Ontario, Canada, K1H 8L6
The Ottawa Hospital- Civic campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Mohamed Al Koussey    613-737-8920 ext 74709    malkoussy@ohri.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Joel Werier, Dr. The Ottawa Hospital

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Responsible Party: Dr. J. Werier, Surgeon, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02891265     History of Changes
Other Study ID Numbers: 20130239-01H
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries