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Chest PainNCT04749147

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

A study testing Black and White Printed Survey and Red Printed Survey in people with Chest Pain and Cardiac Event, run by CHRISTUS Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chest Pain, Cardiac Event
What is being tested?
Black and White Printed Survey and Red Printed Survey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteUnited States
Study dates
4 Mar 2019to 1 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CHRISTUS Health Spohn

    Corpus Christi, Texas, 78404

Other trials in United States

About this study

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.

Read the 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.

Being tested
Black and White Printed Survey, Red Printed Survey
Keywords
Emergency Department, HEART score
Medical subject headings
Chest Pain, Cardiovascular Diseases, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Black and White Printed SurveyOther

    This survey will feature black and white text and graphics.

  • Red Printed SurveyOther

    This survey will feature red text and graphics.

Study groups in NCT04749147
Study groupRoleWhat they receive
Black and White PrintExperimentalThe 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.
Receives: Other: Black and White Printed Survey
Red PrintExperimentalThe 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.
Receives: Other: Red Printed Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2021
  2. Study start4 Mar 2019
  3. Primary completion15 Mar 2022
  4. Study completion1 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04749147
Sponsor's protocol ID
2018-108
Status last verified
Feb 2023
First submitted
30 Jan 2021
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigator is interested in pursuing potential collaborations and grants in the future.

Publications

  • 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.

  • Gerend, Mary, and Sias, Tricia.

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

  • 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.

    PubMed 25611931

  • 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.

    PubMed 19197022

  • 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.

    PubMed 20420292

  • 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.

    PubMed 22075278

  • 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.

    PubMed 25145577

  • 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.

    PubMed 22618581

  • 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.

    PubMed 21975733

  • 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.

    PubMed 23590177

  • 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.

    PubMed 22496116

  • 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.

    PubMed 27919865

  • 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.

    PubMed 24530111

  • 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.

    PubMed 18665203

Questions about this trial

What is this clinical trial studying?

A study testing Black and White Printed Survey and Red Printed Survey in people with Chest Pain and Cardiac Event, run by CHRISTUS Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest Pain Questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04749147, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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