Suspended

Comparative Effectiveness of Descriptive Versus Narrative Emergency Department Discharge Instructions for Patient Education on Unnecessary Testing for Ankle, Foot and Knee Injuries

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Narrative

+ Control

Behavioral
Who is being recruted

Pathologic Processes+1

+ Pathological Conditions, Signs and Symptoms

+ Disease

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: August 22, 2016
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Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01810523
Principal SponsorUniversity of Pennsylvania
Last updated: August 22, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsDiseaseWounds and Injuries

Criteria

3 inclusion criteria required to participate
Acute traumatic knee, ankle or foot injury presenting to ED
ED provider planning to discharge patient
No indication for X-ray by Ottawa Rules criteria
6 exclusion criteria prevent from participating
Children
Need for X-ray by established Ottawa Rules criteria
Patient non-English speaking or illiterate
Patient to be admitted to the hospital
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
This arm will receive information regarding leg injuries and X-ray usage in narrative form in addition to standard of care discharge information.

Group II

Placebo
This arm will receive a blank piece of paper in addition to the standard of care discharge information.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital of the University of Pennsylvania

Philadelphia, United StatesOpen Hospital of the University of Pennsylvania in Google Maps
SuspendedOne Study Center