Corpus Christi, Texas 78404

  • Cardiac Event

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2018-108


NCT ID:

NCT04749147


Secondary ID:


Study Acronym:


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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

CHRISTUS Health


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Matthew Vandermause, DO
Principal Investigator
CHRISTUS Health
Primary Contact:Matthew Vandermause, DO
361-861-1864
m.vandermause@gmail.com
Backup Contact:Johnlukas Webb, MD
361-861-1864
johnlukas.webb@gmail.com

Study Dates

Start Date:March 4, 2019
Completion Date:March 2021
Completion Type:Anticipated
Primary Completion Date:March 2021
Primary Completion Type:Anticipated
Verification Date:February 2021
Last Changed Date:February 9, 2021
First Received Date:January 30, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Chest Pain Questionnaire
Time Frame:2 years
Safety Issues:False
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 (he

Study Interventions

Intervention Type:Other
Name:Red Printed Survey
Description:This survey will feature red text and graphics.
Arm Name:Red Print
Intervention Type:Other
Name:Black and White Printed Survey
Description:This survey will feature black and white text and graphics.
Arm Name:Black and White Print

Study Arms

Study Arm Type:Experimental
Arm Name:Red Print
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.
Study Arm Type:Experimental
Arm Name:Black and White Print
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:CHRISTUS Health

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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PMID:23465250
Reference Type:Reference
Citation:Six AJ, Backus BE, Kelder JC. Chest pain in the emergency room: value of the HEART score. Neth Heart J. 2008 Jun;16(6):191-6.
PMID:18665203
Reference Type:Reference
Citation:Chen JC, Cooper RJ, Lopez-O'Sullivan A, Schriger DL. Measuring patient tolerance for future adverse events in low-risk emergency department chest pain patients. Ann Emerg Med. 2014 Aug;64(2):127-36, 136.e1-3. doi: 10.1016/j.annemergmed.2013.12.025. Epub 2014 Feb 13.
PMID:24530111
Reference Type:Reference
Citation:Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.
PMID:27919865
Reference Type:Reference
Citation:Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012 May;5(3):251-9. doi: 10.1161/CIRCOUTCOMES.111.964791. Epub 2012 Apr 10.
PMID:22496116
Reference Type:Reference
Citation:Isaacs CG, Kistler C, Hunold KM, Pereira GF, Buchbinder M, Weaver MA, McLean SA, Platts-Mills TF. Shared decision-making in the selection of outpatient analgesics for older individuals in the emergency department. J Am Geriatr Soc. 2013 May;61(5):793-8. doi: 10.1111/jgs.12207. Epub 2013 Apr 16.
PMID:23590177
Reference Type:Reference
Citation:Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Légaré F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. doi: 10.1002/14651858.CD001431.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;1:CD001431.
PMID:21975733
Reference Type:Reference
Citation:Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. Epub 2012 May 23. Review.
PMID:22618581
Reference Type:Reference
Citation:Blumenthal-Barby JS, Krieger H. Cognitive biases and heuristics in medical decision making: a critical review using a systematic search strategy. Med Decis Making. 2015 May;35(4):539-57. doi: 10.1177/0272989X14547740. Epub 2014 Aug 21. Review.
PMID:25145577
Reference Type:Reference
Citation:Gorini A, Pravettoni G. An overview on cognitive aspects implicated in medical decisions. Eur J Intern Med. 2011 Dec;22(6):547-53. doi: 10.1016/j.ejim.2011.06.008. Epub 2011 Jul 7. Review.
PMID:22075278
Reference Type:Reference
Citation:Lutfey KE, Eva KW, Gerstenberger E, Link CL, McKinlay JB. Physician cognitive processing as a source of diagnostic and treatment disparities in coronary heart disease: results of a factorial priming experiment. J Health Soc Behav. 2010 Mar;51(1):16-29.
PMID:20420292
Reference Type:Reference
Citation:Mehta R, Zhu RJ. Blue or red? Exploring the effect of color on cognitive task performances. Science. 2009 Feb 27;323(5918):1226-9. doi: 10.1126/science.1169144. Epub 2009 Feb 5.
PMID:19197022
Reference Type:Reference
Citation:Shi J, Zhang C, Jiang F. Does red undermine individuals' intellectual performance? A test in China. Int J Psychol. 2015 Feb;50(1):81-4. doi: 10.1002/ijop.12076. Epub 2014 May 5.
PMID:25611931
Reference Type:Reference
Citation:majic, A., Merritt, S., Banister, C., and Blinebry, A. (2014).
Reference Type:Reference
Citation:Gerend, Mary, and Sias, Tricia.
Reference Type:Reference
Citation:The population studied will be a convenience sample of adult patients presenting to the ED with chest pain as a primary complaint who then are risk-stratified with the HEART score and are found to have a score of 3 or less.

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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