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

NCT04749147 | Completed

• 1 other identifier: 2018-108
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Cardiac Event

Keywords

Emergency Department; HEART score

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

Black and White Print

EXPERIMENTAL

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.

Other: Black and White Printed Survey

Red Print

EXPERIMENTAL

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.

Other: Red Printed Survey

Interventions

Black and White Printed Survey OTHER

This survey will feature black and white text and graphics.

Black and White Print

Red Printed Survey OTHER

This survey will feature red text and graphics.

Red Print

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHRISTUS Health: lead

Study Sites (1)

CHRISTUS Health Spohn

Corpus Christi, Texas, 78404, United States

Location

Related Publications (16)

• 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.

  BACKGROUND

• Gerend, Mary, and Sias, Tricia.

  BACKGROUND

• majic, A., Merritt, S., Banister, C., and Blinebry, A. (2014).

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1177/0022146509361193.

  PMID: 20420292 BACKGROUND

• 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.

  PMID: 22075278 BACKGROUND

• 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.

  PMID: 25145577 BACKGROUND

• 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. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.

  PMID: 22618581 BACKGROUND

• Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare 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.

  PMID: 21975733 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1007/BF03086144.

  PMID: 18665203 BACKGROUND

• Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.

  PMID: 23465250 BACKGROUND

MeSH Terms

Conditions

Chest Pain; Cardiovascular Diseases; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Matthew Vandermause, DO

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 11, 2021
• Study Start: March 4, 2019
• Primary Completion: March 15, 2022
• Study Completion: May 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)