NCT02781038

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

May 2, 2016

Last Update Submit

November 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attitude adjustment

    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 Outcomes (1)

  • Exploratory Impact Assessment

    Change from baseline (inpatient) pre-intervention, to 24 hours post-intervention, to first clinical follow up visit (outpatient) 1-3 weeks post-intervention

Study Arms (2)

Interventional

EXPERIMENTAL

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.

Behavioral: Teaching intervention

Control

OTHER

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.

Behavioral: Control

Interventions

Subjects will receive a pamphlet which describes the relationship between smoking and negative outcomes in fracture healing.

Also known as: Pamphlet
Interventional
ControlBEHAVIORAL

Subjects in this group will not receive the pamphlet

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under age 18
  • Under the jurisdiction of the department of corrections
  • Nonsmokers
  • People not currently receiving fracture care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 22822565BACKGROUND
  • 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.

    PMID: 23836474BACKGROUND
  • 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.

    PMID: 18083451BACKGROUND
  • 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.

    PMID: 1329589BACKGROUND
  • 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.

    PMID: 19110395BACKGROUND
  • 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.

    PMID: 12828221BACKGROUND
  • 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.

    PMID: 10148681BACKGROUND
  • 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.

    PMID: 12729175BACKGROUND
  • 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.

    PMID: 22472171BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderFractures, Bone

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersWounds and Injuries

Study Officials

  • Jaimo Ahn, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 24, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share