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Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain

Primary Purpose

Chest Pain, Cardiac Event

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Black and White Printed Survey
Red Printed Survey
Sponsored by
CHRISTUS Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chest Pain focused on measuring Emergency Department, HEART score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All patients 18 years or age and older presenting to the ED with a complaint of chest pain who are found to have a HEART score of 3 or less.

Exclusion Criteria:

  • Patients who refuse to provide consent.
  • Patients unable to fill out the survey due to clinical instability, severe pain, or disorientation as determined by an emergency physician.
  • Incarcerated patients.
  • Patients who have a HEART score of >3.
  • Pregnant women.

Sites / Locations

  • CHRISTUS Health Spohn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Black and White Print

Red Print

Arm Description

The survey concerns the patients' chest pain, perception of their safety, and their comfort with their discharge. This group's survey will be printed in black and white and feature black and white graphics.

The survey concerns the patients' chest pain, perception of their safety, and their comfort with their discharge. This group's survey will be printed in red text and feature red graphics.

Outcomes

Primary Outcome Measures

Chest Pain Questionnaire
To assess a patient's level of relief/worry with being discharged from the emergency department (ED) after presenting with a chief complaint of chest pain and subsequently being informed they have a less than 2% chance of a major adverse cardiac event (heart attack) in the next six weeks. The questionnaire grades their level of relief/worry from (1) Very Relieved, (2) Somewhat Relieved (3) No Change (4) Somewhat Worried (5) Very Worried.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2021
Last Updated
February 6, 2023
Sponsor
CHRISTUS Health
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1. Study Identification

Unique Protocol Identification Number
NCT04749147
Brief Title
Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain
Official Title
Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHRISTUS Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This will be a prospective cross-sectional study evaluating a convenience sample of patients in the ED with low-risk chest pain defined by a HEART score of 3 or less.
Detailed Description
This will be a prospective cross-sectional study. We will evaluate a convenience sample of patients in the ED with low-risk chest pain defined by a HEART score of 3 or less. Patients will be consented for participation and will fill out one of two surveys concerning their chest pain and chances of adverse cardiac events based on their HEART score. One survey will be printed in red text and feature red graphics; the other will be printed in black-and-white and feature black and-white graphics. The surveys will otherwise be identical. Enrolled patients will be asked to fill out survey questions related to their perception of their safety and their comfort with their discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, Cardiac Event
Keywords
Emergency Department, HEART score

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Black and White Print
Arm Type
Experimental
Arm Description
The survey concerns the patients' chest pain, perception of their safety, and their comfort with their discharge. This group's survey will be printed in black and white and feature black and white graphics.
Arm Title
Red Print
Arm Type
Experimental
Arm Description
The survey concerns the patients' chest pain, perception of their safety, and their comfort with their discharge. This group's survey will be printed in red text and feature red graphics.
Intervention Type
Other
Intervention Name(s)
Black and White Printed Survey
Intervention Description
This survey will feature black and white text and graphics.
Intervention Type
Other
Intervention Name(s)
Red Printed Survey
Intervention Description
This survey will feature red text and graphics.
Primary Outcome Measure Information:
Title
Chest Pain Questionnaire
Description
To assess a patient's level of relief/worry with being discharged from the emergency department (ED) after presenting with a chief complaint of chest pain and subsequently being informed they have a less than 2% chance of a major adverse cardiac event (heart attack) in the next six weeks. The questionnaire grades their level of relief/worry from (1) Very Relieved, (2) Somewhat Relieved (3) No Change (4) Somewhat Worried (5) Very Worried.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All patients 18 years or age and older presenting to the ED with a complaint of chest pain who are found to have a HEART score of 3 or less. Exclusion Criteria: Patients who refuse to provide consent. Patients unable to fill out the survey due to clinical instability, severe pain, or disorientation as determined by an emergency physician. Incarcerated patients. Patients who have a HEART score of >3. Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Vandermause, DO
Organizational Affiliation
CHRISTUS Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRISTUS Health Spohn
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigator is interested in pursuing potential collaborations and grants in the future.
Citations:
Citation
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Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain

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