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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01810523
Other study ID # 817212
Secondary ID
Status Withdrawn
Phase N/A
First received March 7, 2013
Last updated August 18, 2016
Start date March 2013

Study information

Verified date August 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Narrative
Narrative form as described above.
Control
Blank piece of paper

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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?
5 minutes after intervention No
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