- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05881434
Influence of a Questionnaire on Patients' Emergency Room Expectations
May 30, 2023 updated by: Orange Park Medical Center
The goal of this study is to determine whether a novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) improves patient-provider communication as evaluated by an exit survey during an emergency room visit.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
308
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
-
-
Florida
-
Orange Park, Florida, United States, 32073
- Orange Park Medical Center
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients who arrive through the ED main entrance (non-EMS)
- Patients aged 18 years and older
- Patients who demonstrate decision making capacity
- Patients who willingly consent to participate
Exclusion criteria:
- Patients in distress (physical, emotional, or other) as determined by investigator
- Patients who demonstrate altered mental status or lack of capacity to consent
- Patients who require immediate medical intervention including diagnostic and/or treatment intervention
- Prisoners and patient under involuntary holds
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Expectations Questionnaire
Provision of expectations questionnaire and associated instructions to patient.
|
Patients presented with novel questionnaire designed to illicit patient's self-reported expectations across four domains (overall purpose of visit, medication intervention, imaging intervention and disposition) during check-in when arriving at the emergency department.
Patients instructed to present the completed questionnaire to the treating provider.
|
|
No Intervention: Control
Usual care (no expectations questionnaire or further instruction)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient reported provider understanding of patient's visit expectations
Time Frame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Q: "My ER provider understood my expectations for my ER visit today" with agreement responses on a 5-point Likert scale (strongly disagree to strongly agree)
|
After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient reported degree to which visit expectations were met
Time Frame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Q: "My expectations for my ER visit today were met" with agreement responses on a 5-point Likert scale (strongly disagree to strongly agree)
|
After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
|
Patient reported provider courtesy
Time Frame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Q: "Courtesy of your provider" with response options from Very Poor to Very Good
|
After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
|
Patient reported provider listening
Time Frame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Q: "Your provider took the time to listen to you" with response options from Very Poor to Very Good
|
After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
|
Patient reported inclusion in treatment decisions
Time Frame: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
Q: "Your provider included you in decisions about your treatment" with response options from Very Poor to Very Good
|
After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
|
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 (Actual)
January 31, 2022
Primary Completion (Actual)
October 17, 2022
Study Completion (Actual)
October 17, 2022
Study Registration Dates
First Submitted
January 12, 2022
First Submitted That Met QC Criteria
May 30, 2023
First Posted (Actual)
May 31, 2023
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 30, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Expectations
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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