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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01810523
First received: March 7, 2013
Last updated: March 12, 2013
Last verified: February 2013
  Purpose

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 Blind (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 ] [ Designated as safety issue: No ]

    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?


Estimated Enrollment: 30
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01810523

Contacts
Contact: Zachary Meisel, MD, MPH, MS 215-586-0267 zachary.meisel@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Zachary Meisel, MD, MPH, MS         
Sponsors and Collaborators
University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01810523     History of Changes
Other Study ID Numbers: 817212
Study First Received: March 7, 2013
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Acute
lower
extremity
not requiring
diagnostic
imaging

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

ClinicalTrials.gov processed this record on October 23, 2014