Surgeon-Patient Communication: A Randomized Controlled Trial Evaluating the Impact of an Orthopaedic Related Smoking Cessation Discussion After Fracture Surgery

April 24, 2018 updated by: Nkemakolam Egekeze, University of Missouri, Kansas City
In this study, the investigators are interested in evaluating the impact of an orthopaedic related smoking cessation discussion after fracture surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center

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:

  • Patients 18 year old or older,
  • daily smoker
  • inpatient post fracture operation,
  • patient that have never received an orthopaedic related smoking cessation discussion

Exclusion Criteria:

  • Younger than 18,
  • patients unable to provide consent
  • patients that suffer from auditory/visual/mental disability requiring another individual as a decision-maker

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (Intervention Group)
The discussion about how smoking cigarettes impacts patient orthopaedic management plus aid
Behavioral: Intervention
Discussion
Active Comparator: (Control Group)
The discussion about how smoking cigarettes impacts patient orthopaedic management.
Behavioral: Verbal Group
Detailed Discussion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Comprehension
Time Frame: 20 minutes
Knowledge-Based Question
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Nkem Egekeze, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
  • Study Director: Akin Cil, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
  • Study Director: Karen Williams, PhD, UMKC DEPT OF BIOINFORMATICS
  • Study Director: Jonathan Dubin, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
  • Study Chair: Mark Bernhardt, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY
  • Study Director: Dane Church, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY

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 (Actual)

January 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 15-248

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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