Smoking Cessation and a Teachable Moment in Patients With Acute Fractures
Primary Purpose
Tobacco Use Disorder, Bone Fractures
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teaching intervention
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Tobacco Use Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Interventional
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Attitude adjustment
Study-specific 9 question Likert-scale survey
Secondary Outcome Measures
Exploratory Impact Assessment
Single binary question
Full Information
NCT ID
NCT02781038
First Posted
May 2, 2016
Last Updated
November 3, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02781038
Brief Title
Smoking Cessation and a Teachable Moment in Patients With Acute Fractures
Official Title
Smoking Cessation and a Teachable Moment in Patients With Acute Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Bone Fractures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teaching intervention
Other Intervention Name(s)
Pamphlet
Intervention Description
Subjects will receive a pamphlet which describes the relationship between smoking and negative outcomes in fracture healing.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Subjects in this group will not receive the pamphlet
Primary Outcome Measure Information:
Title
Attitude adjustment
Description
Study-specific 9 question Likert-scale survey
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
Secondary Outcome Measure Information:
Title
Exploratory Impact Assessment
Description
Single binary question
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimo Ahn, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22822565
Citation
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.
Results Reference
background
PubMed Identifier
23836474
Citation
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.
Results Reference
background
PubMed Identifier
18083451
Citation
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.
Results Reference
background
PubMed Identifier
1329589
Citation
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.
Results Reference
background
PubMed Identifier
19110395
Citation
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.
Results Reference
background
PubMed Identifier
12828221
Citation
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.
Results Reference
background
PubMed Identifier
10148681
Citation
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.
Results Reference
background
PubMed Identifier
12729175
Citation
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.
Results Reference
background
PubMed Identifier
22472171
Citation
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.
Results Reference
background
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Smoking Cessation and a Teachable Moment in Patients With Acute Fractures
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