Chest Pain Clinical Trial
Official title:
Color Priming and Patient Decision-Making in the Emergency Department: Priming "Threat" in Patients With Low-Risk Chest Pain
NCT number | NCT04749147 |
Other study ID # | 2018-108 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 4, 2019 |
Est. completion date | May 1, 2022 |
Verified date | February 2023 |
Source | CHRISTUS Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | May 1, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | CHRISTUS Health Spohn | Corpus Christi | Texas |
Lead Sponsor | Collaborator |
---|---|
CHRISTUS Health |
United States,
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. — View 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. — View 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. — View 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. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23. — View Citation
Gerend, Mary, and Sias, Tricia.
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. — View 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. — View 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. — View 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. — View 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. doi: 10.1177/0022146509361193. — View Citation
majic, A., Merritt, S., Banister, C., and Blinebry, A. (2014).
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. — View 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. — View 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. doi: 10.1007/BF03086144. — View Citation
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. — View 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.
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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