Back to resultsStories to Educate Patients With Ankle, Foot, and Knee Injuries
Primary Purpose
Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrative
Control
Sponsored by
About this trial
This is an interventional health services research trial for Injury focused on measuring Acute, lower, extremity, not requiring, diagnostic, imaging
Eligibility 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
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Narrative
Control
Arm Description
This arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information.
This arm will receive a blank piece of paper in addition to the standard of care discharge information.
Outcomes
Primary Outcome Measures
Patient Satisfaction
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:
My satisfaction with the amount of time spent with me by the person who evaluated and treated me was....
The explanation I received of how my illness should be treated was...
The way the health care provider treated me was...
My overall satisfaction with my visit was...
Your care provider determined that you did not need an X-ray for your injury. What is your level of satisfaction with that decision?
Secondary Outcome Measures
Full Information
NCT ID
NCT01810523
First Posted
March 7, 2013
Last Updated
August 18, 2016
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01810523
Brief Title
Stories to Educate Patients With Ankle, Foot, and Knee Injuries
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury
Keywords
Acute, lower, extremity, not requiring, diagnostic, imaging
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Narrative
Arm Type
Experimental
Arm Description
This arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm will receive a blank piece of paper in addition to the standard of care discharge information.
Intervention Type
Behavioral
Intervention Name(s)
Narrative
Intervention Description
Narrative form as described above.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Blank piece of paper
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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:
My satisfaction with the amount of time spent with me by the person who evaluated and treated me was....
The explanation I received of how my illness should be treated was...
The way the health care provider treated me was...
My overall satisfaction with my visit was...
Your care provider determined that you did not need an X-ray for your injury. What is your level of satisfaction with that decision?
Time Frame
5 minutes after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stories to Educate Patients With Ankle, Foot, and Knee Injuries
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