- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781038
Smoking Cessation and a Teachable Moment in Patients With Acute Fractures
November 3, 2017 updated by: University of Pennsylvania
Patients who smoke and suffer from fractures are worse off than those who do not smoke.
Orthopaedic patients represent a group that can benefit from physician contributions to smoking cessation, and a special opportunity to cue this can begin with the orthopaedic surgeon in the acute setting.
However, the best way to appropriately counsel these patients and assess the impact as a teachable moment remains undetermined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
If the patient self-identifies as a smoker, the investigators will consent and randomize to receive the intervention or not.
Either way, all will receive a baseline attitude survey.
The patient will be given a series of questions that target the areas of interest noted in the model.
At some point in their hospitalization, preferably at least one day later and no greater than one week later, the patients will be given the teaching intervention (or not), and receive another attitude survey.
After discharge, the patients will be expected in orthopaedic follow up clinic.
At that time they will receive another attitude survey.
If unable to deliver at that time, they will be contacted by phone or sought at their second clinic follow up.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults age 18 or over, who are not under the jurisdiction of the department of corrections
- Individuals receiving care from University of Pennsylvania Health System clinicians for orthopaedic injuries
- Individuals who self-identify as smokers
Exclusion Criteria:
- Under age 18
- Under the jurisdiction of the department of corrections
- Nonsmokers
- People not currently receiving fracture care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional
All subjects will receive a baseline attitude survey.
At some point in their hospitalization, preferably at least one day later and no greater than one week later, the patients will be given a teaching intervention and receive another attitude survey.
|
Subjects will receive a pamphlet which describes the relationship between smoking and negative outcomes in fracture healing.
Other Names:
|
|
Other: Control
All subjects will receive a baseline attitude survey.
At some point in their hospitalization, preferably at least one day later and no greater than one week later, the patients will receive another attitude survey.
|
Subjects in this group will not receive the pamphlet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attitude adjustment
Time Frame: Change from baseline (inpatient) pre-intervention, to 24 hours post-intervention, to first clinical follow up visit (outpatient) 1-3 weeks post-intervention
|
Study-specific 9 question Likert-scale survey
|
Change from baseline (inpatient) pre-intervention, to 24 hours post-intervention, to first clinical follow up visit (outpatient) 1-3 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exploratory Impact Assessment
Time Frame: Change from baseline (inpatient) pre-intervention, to 24 hours post-intervention, to first clinical follow up visit (outpatient) 1-3 weeks post-intervention
|
Single binary question
|
Change from baseline (inpatient) pre-intervention, to 24 hours post-intervention, to first clinical follow up visit (outpatient) 1-3 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaimo Ahn, MD, PhD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McBride CM, Emmons KM, Lipkus IM. Understanding the potential of teachable moments: the case of smoking cessation. Health Educ Res. 2003 Apr;18(2):156-70. doi: 10.1093/her/18.2.156.
- Prochaska JO, DiClemente CC, Norcross JC. In search of how people change. Applications to addictive behaviors. Am Psychol. 1992 Sep;47(9):1102-14. doi: 10.1037//0003-066x.47.9.1102.
- Dohnke B, Ziemann C, Will KE, Weiss-Gerlach E, Spies CD. Do hospital treatments represent a 'teachable moment' for quitting smoking? A study from a stage-theoretical perspective. Psychol Health. 2012;27(11):1291-307. doi: 10.1080/08870446.2012.672649. Epub 2012 Apr 4.
- Al-Hadithy N, Sewell MD, Bhavikatti M, Gikas PD. The effect of smoking on fracture healing and on various orthopaedic procedures. Acta Orthop Belg. 2012 Jun;78(3):285-90.
- Patel RA, Wilson RF, Patel PA, Palmer RM. The effect of smoking on bone healing: A systematic review. Bone Joint Res. 2013 Jun 14;2(6):102-11. doi: 10.1302/2046-3758.26.2000142. Print 2013.
- An LC, Foldes SS, Alesci NL, Bluhm JH, Bland PC, Davern ME, Schillo BA, Ahluwalia JS, Manley MW. The impact of smoking-cessation intervention by multiple health professionals. Am J Prev Med. 2008 Jan;34(1):54-60. doi: 10.1016/j.amepre.2007.09.019.
- Lawson PJ, Flocke SA. Teachable moments for health behavior change: a concept analysis. Patient Educ Couns. 2009 Jul;76(1):25-30. doi: 10.1016/j.pec.2008.11.002. Epub 2008 Dec 24.
- Fonarow GC. In-hospital initiation of statins: taking advantage of the 'teachable moment'. Cleve Clin J Med. 2003 Jun;70(6):502, 504-6. doi: 10.3949/ccjm.70.6.502. No abstract available.
- Glasgow RE, Stevens VJ, Vogt TM, Mullooly JP, Lichtenstein E. Changes in smoking associated with hospitalization: quit rates, predictive variables, and intervention implications. Am J Health Promot. 1991 Sep-Oct;6(1):24-9. doi: 10.4278/0890-1171-6.1.24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 19, 2016
First Posted (Estimate)
May 24, 2016
Study Record Updates
Last Update Posted (Actual)
November 7, 2017
Last Update Submitted That Met QC Criteria
November 3, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 819551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.