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Tobacco Use DisorderNCT02781038

Smoking Cessation and a Teachable Moment in Patients With Acute Fractures

A study testing Teaching intervention in people with Tobacco Use Disorder and Bone Fractures, run by University of Pennsylvania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use Disorder, Bone Fractures
What is being tested?
Teaching intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Feb 2014to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Read the 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.

Being tested
Teaching intervention, Control
Medical subject headings
Tobacco Use Disorder, Fractures, Bone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teaching interventionBehavioural

    Also called Pamphlet

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

  • ControlBehavioural

    Subjects in this group will not receive the pamphlet

Study groups in NCT02781038
Study groupRoleWhat they receive
InterventionalExperimentalAll 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.
Receives: Behavioral: Teaching intervention
ControlOtherAll 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.
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attitude adjustment

    Study-specific 9 question Likert-scale survey

    Measured: 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)

  1. Exploratory Impact Assessment

    Single binary question

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2016 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781038
Sponsor's protocol ID
819551
Status last verified
Nov 2017
First submitted
2 May 2016
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22822565

  • 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.

    PubMed 23836474

  • 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.

    PubMed 18083451

  • 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.

    PubMed 1329589

  • 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.

    PubMed 19110395

  • 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.

    PubMed 12828221

  • 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.

    PubMed 10148681

  • 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.

    PubMed 12729175

  • 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.

    PubMed 22472171

Questions about this trial

What is this clinical trial studying?

A study testing Teaching intervention in people with Tobacco Use Disorder and Bone Fractures, run by University of Pennsylvania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02781038, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.

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