Study Stopped
The study was stopped due to methodological issues that require additional consideration prior to resuming the trial.
Stories to Educate Patients With Ankle, Foot, and Knee Injuries
Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedAugust 22, 2016
August 1, 2016
3 months
March 7, 2013
August 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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: 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?
5 minutes after intervention
Study Arms (2)
Narrative
EXPERIMENTALThis arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information.
Control
PLACEBO COMPARATORThis arm will receive a blank piece of paper in addition to the standard of care discharge information.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 13, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2013
Last Updated
August 22, 2016
Record last verified: 2016-08