EmergenciesNCT05881434
Influence of a Questionnaire on Patients' Emergency Room Expectations
A study testing Emergency Department Visit Expectations Questionnaire in people with Emergencies and Satisfaction, Patient, run by Orange Park Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergencies, Satisfaction, Patient, Expectations
- What is being tested?
- Emergency Department Visit Expectations Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2022to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Park Medical Center
Orange Park, Florida, 32073
About this study
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.
- Being tested
- Emergency Department Visit Expectations Questionnaire
- Medical subject headings
- Emergencies, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department Visit Expectations QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Expectations Questionnaire | Experimental | Provision of expectations questionnaire and associated instructions to patient. Receives: Other: Emergency Department Visit Expectations Questionnaire |
| Control | No intervention | Usual care (no expectations questionnaire or further instruction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported provider understanding of patient's visit expectations
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)
Measured: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
Secondary outcomes (4)
Patient reported degree to which visit expectations were met
Q: "My expectations for my ER visit today were met" with agreement responses on a 5-point Likert scale (strongly disagree to strongly agree)
Measured: 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
Q: "Courtesy of your provider" with response options from Very Poor to Very Good
Measured: 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
Q: "Your provider took the time to listen to you" with response options from Very Poor to Very Good
Measured: 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
Q: "Your provider included you in decisions about your treatment" with response options from Very Poor to Very Good
Measured: After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start31 Jan 2022
- Primary completion17 Oct 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orange Park Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881434
- Sponsor's protocol ID
- Expectations
- Status last verified
- May 2023
- First submitted
- 12 Jan 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Questionnaire on Patients' Emergency Room Expectations
- ClinicalTrials.gov ID
- NCT05881434
- Acronym / sponsor ID
- Expectations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Orange Park Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expectations Questionnaire | Experimental | Other: Emergency Department Visit Expectations QuestionnaireProvision of expectations questionnaire and associated instructions to patient. |
| Control | No intervention | –Usual care (no expectations questionnaire or further instruction) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Department Visit Expectations QuestionnairePatients 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. | Other | Expectations Questionnaire |
Primary outcome
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)
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department Visit Expectations Questionnaire in people with Emergencies and Satisfaction, Patient, run by Orange Park Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.