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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
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 2, 2016
    Last Updated
    November 3, 2017
    Sponsor
    University of Pennsylvania
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    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
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    Smoking Cessation and a Teachable Moment in Patients With Acute Fractures

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