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

This study has been withdrawn prior to enrollment.
(The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.)
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: March 7, 2013
Last updated: August 18, 2016
Last verified: August 2016
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 Intervention
Injury Behavioral: Narrative Behavioral: Control

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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?

Enrollment: 0
Study Start Date: March 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01810523     History of Changes
Other Study ID Numbers: 817212
Study First Received: March 7, 2013
Last Updated: August 18, 2016

Keywords provided by University of Pennsylvania:
not requiring

Additional relevant MeSH terms:
Wounds and Injuries
Knee Injuries
Leg Injuries processed this record on September 18, 2017