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

NCT ID: NCT04749147

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chest Pain Cardiac Event

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Black and White Print

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.

Group Type EXPERIMENTAL

Black and White Printed Survey

Intervention Type OTHER

This survey will feature black and white text and graphics.

Red Print

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.

Group Type EXPERIMENTAL

Red Printed Survey

Intervention Type OTHER

This survey will feature red text and graphics.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Black and White Printed Survey

This survey will feature black and white text and graphics.

Intervention Type OTHER

Red Printed Survey

This survey will feature red text and graphics.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

CHRISTUS Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthew Vandermause, DO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Vandermause, DO

Role: PRINCIPAL_INVESTIGATOR

CHRISTUS Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRISTUS Health Spohn

Corpus Christi, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

Gerend, Mary, and Sias, Tricia.

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 25611931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19197022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20420292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22075278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25145577 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22618581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21975733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23590177 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22496116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27919865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24530111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18665203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23465250 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-108

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chest Pain Nurse Track
NCT06149819 RECRUITING NA