NCT05881434

Brief 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 emergency room visit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

January 12, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

January 12, 2022

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    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

    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

    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

    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

    After patient discharge instructions given (or for patients being admitted/transferred, after admission/transfer request), up to 15 minutes after either event

Study Arms (2)

Expectations Questionnaire

EXPERIMENTAL

Provision of expectations questionnaire and associated instructions to patient.

Other: Emergency Department Visit Expectations Questionnaire

Control

NO INTERVENTION

Usual care (no expectations questionnaire or further instruction)

Interventions

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.

Expectations Questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orange Park Medical Center

Orange Park, Florida, 32073, United States

Location

MeSH Terms

Conditions

EmergenciesPatient Satisfaction

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

May 31, 2023

Study Start

January 31, 2022

Primary Completion

October 17, 2022

Study Completion

October 17, 2022

Last Updated

May 31, 2023

Record last verified: 2023-05

Locations