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

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:
  • Pamphlet
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.

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

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

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.

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