- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01810523
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Withdrawn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
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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-
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.
|
Narrative form as described above.
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Placebo Comparator: Control
This arm will receive a blank piece of paper in addition to the standard of care discharge information.
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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:
|
5 minutes after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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