Stories to Educate Patients With Ankle, Foot, and Knee Injuries

August 18, 2016 updated by: University of Pennsylvania

Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries

Study will test the use of narratives on patient satisfaction and translation of an evidence-based approach to the use of X-rays for leg injuries in the Emergency Department (ED). The investigators will identify patients with foot, ankle, or knee injuries for whom X-rays are determined to not be needed. On discharge, patients will receive the current fact-based sheet or that plus a narrative explaining the work-up and treatment of these injuries. Outcomes will be assessed by a survey measuring patient satisfaction and understanding.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute traumatic knee, ankle or foot injury presenting to ED
  • No indication for X-ray by Ottawa Rules criteria
  • ED provider planning to discharge patient

Exclusion Criteria:

  • X-ray obtained
  • Need for X-ray by established Ottawa Rules criteria
  • Children
  • Pregnant women
  • Patient to be admitted to the hospital
  • Patient non-English speaking or illiterate

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrative
This arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information.
Behavioral: Narrative
Narrative form as described above.
Placebo Comparator: Control
This arm will receive a blank piece of paper in addition to the standard of care discharge information.
Behavioral: Control
Blank piece of paper

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 5 minutes after intervention

To measure patient satisfaction, we will use a validated survey instrument. The survey asks patients 5 questions, which they answer by providing responses on a 5-point scale ranging from "Poor" to "Excellent." The questions include:

  1. My satisfaction with the amount of time spent with me by the person who evaluated and treated me was....
  2. The explanation I received of how my illness should be treated was...
  3. The way the health care provider treated me was...
  4. My overall satisfaction with my visit was...
  5. Your care provider determined that you did not need an X-ray for your injury. What is your level of satisfaction with that decision?
5 minutes after intervention

Collaborators and Investigators

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

Sponsor

University of Pennsylvania

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

March 1, 2013

Primary Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 12, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817212

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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