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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01810523
Recruitment Status : Withdrawn (The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.)
First Posted : March 13, 2013
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Injury Behavioral: Narrative Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries
Study Start Date : March 2013
Estimated Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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?

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810523

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01810523     History of Changes
Other Study ID Numbers: 817212
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by University of Pennsylvania:
not requiring

Additional relevant MeSH terms:
Wounds and Injuries
Knee Injuries
Leg Injuries