Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02891265 |
| Other study ID # |
20130239-01H |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2013 |
| Est. completion date |
July 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Tobacco use is the leading preventable death contributing to more than 5 million estimated
deaths per year globally.1 Nicotine is a highly addictive substance and tobacco remains the
only legal product that, when used as intended, kills. The long term negative effects of
smoking are well established.
Ten percent of all current and former smokers live with chronic disease. Among current
smokers who are ill, the most prevalent conditions are chronic bronchitis, emphysema, and
myocardial infarction.2 Moreover complications due to smoking from an orthopaedic perspective
are well established. With respect to orthopaedic trauma literature, smoking impairs
osteoblastic function, and propagates vasoconstriction resulting in delayed or non -unions.3
Its use has a 3-6 fold increased risk of intra- operative pulmonary complications, impairs
wound healing4, healing of bone, soft tissues, and can lead to flap necrosis. 4-7 Furthermore
smokers are twice as likely to develop an infection and 3.7 times as likely to develop
osteomyelitis8.
Smoking cessation programs are essential in achieving a sustainable health care system.
Health care costs for smokers at a given age are as much as 40 percent higher than those for
non smokers. 9 The cost of treatment of tobacco related illness in British Columbia in 2004
was estimated to be 500 million CDN dollars. The total annual cost of treatment for
conditions related to second hand smoke exposure in North Carolina and Minnesota in 2006
alone were estimated to be greater than 290 and 225 million US dollars respectively. 10, 11
The role of the healthcare practitioner has been recognized as of paramount importance in
smoking cessation. These programs rely on the Transtheoretical Model of patient behavioral
change. In order to maximize intervention a clinician is to provide counseling, motivation,
education, monitoring, and empathy to personalized smoking cessation intervention programs
with extended assistance and follow-up12. Multiple fields of medicine have established
smoking cessation programs either pre-operatively or during hospitalization. Randomized
control trials (RCTs) of hospitalized cardiac patients have exhibited decreased rates of non
fatal infarctions, and re-operation, reduced risk and rates of mortality.13 A systematic
review revealed 8 pre- operative RCTs that have been performed to date across multiple
surgical disciplines with a total of 1156 enrolled patients. Their strategies for counseling
and follow up varied. All had more than 20% loss to follow up and this was limited to a
maximum of 12 months. However there was a significant decrease in post-operative
complications and cessation was maintained at the 12 month follow up.14
Despite the availability of smoking cessation interventions, traditionally they have been
underutilized, in part due to frustration, lack of clinician training and organizational
support, especially in Orthopaedic Surgery12. Only a single randomized control trial within
the setting of an acute fracture clinic has been published to date.15 This multicentred trial
in Sweden utilized a standardized 6 week cessation program with nicotine replacement therapy
if the patient in the intervention group desired. It captured only 18% of the potential
candidates and was limited to a 12 week follow up. Long term cessation rates were not
evaluated.
The acute fracture clinic is a unique environment to establish a smoking cessation program in
order to achieve primary prevention. Previously healthy patients are faced with the impact of
disability and a unique relationship based on trust is established between patients and their
surgeons. Given the negative orthopaedic outcomes associated with smoking aforementioned,
patients present as an engaged audience, faced with the possibility of chronic disability
(poor surgical/fracture outcome) attributed to the continuation of smoking habits. This
impetus to abstain for the benefit of fracture outcomes provides a window of opportunity for
previously unattained early intervention and thus a greater potential for decreased patient
morbidity and mortality. Furthermore, the acute fracture clinic is a high volume clinic
whereby as many as 100 patients may visit per clinic per day (patients from regions within
the Champlain Local Health Integration Network [LHIN] where smoking prevalence is as high as
30%). Given the unique nature of traumatic injuries, this population consists of a high
proportion of males, ages 24-34 years old, who are obliged to follow up for fracture care.
This population (24-35 year old males) is traditionally regarded as unattainable for primary
prevention smoking cessation strategies.
Primary prevention strategies are paramount from a public health perspective. In targeting a
well established smoking cessation campaign in a fracture clinic with the partnership from
the University of Ottawa Heart Institute's Division of Prevention and Rehabilitation,
patients will be provided expert cessation strategies before the onset of smoking relating
disease. The benefits of which extend beyond the patient to their families. The ultimate goal
of this project is to develop an intervention model that can be cost effective and
universally applied to all orthopaedic clinics within North America. A great potential exists
to increase smoking cessation rates, and decrease orthopaedic trauma smoking related
morbidity, long term smoking related morbidity, mortality and health care costs.
