Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
10 november 2017 bijgewerkt door: Erik P. Hess, Mayo Clinic
Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:
Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.
Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
- Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.
Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
898
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Sacramento, California, Verenigde Staten, 95817
- University of California, Davis
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Mayo Clinic
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University Hospital: IU
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Thomas Jefferson University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 18+ years of age (at least 18).
- Admitted to emergency department for chest pain.
- Being considered by the treating clinician for admission for cardiac testing.
Exclusion Criteria:
- Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
- Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
- Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
- Cocaine use within the previous 72 hours by clinician history.
- Pregnancy.
- Referral to the emergency department by a personal physician for admission.
- Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
- Homelessness, out-of-town residence or other condition known to preclude follow-up.
- Patients in police custody or currently incarcerated individuals.
- Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Chest Pain Choice Decision Aid
Patients randomized to the decision aid arm.
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The clinician will review the decision aid with the patient.
The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack.
The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.
Andere namen:
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Geen tussenkomst: Usual Care
Patients randomized to the usual care arm (no decision aid used)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Test if Chest Pain Choice Safely Improves Patient Knowledge.
Tijdsspanne: Directly following intervention (on day 1)
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Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
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Directly following intervention (on day 1)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
Tijdsspanne: Within 30 days of study enrollment
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We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
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Within 30 days of study enrollment
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Test if the Decision Aid Safely Improves Patient Engagement.
Tijdsspanne: Immediately after the intervention (on day 1)
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1) Patient engagement in the decision-making process as measured by the OPTION scale.
The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100.
Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
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Immediately after the intervention (on day 1)
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Major Adverse Cardiac Event (MACE)
Tijdsspanne: within 30 days of enrollment
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A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
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within 30 days of enrollment
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Total Testing Within 45 Days (a Component of Healthcare Utilization)
Tijdsspanne: 45 days
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In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days.
Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
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45 days
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Decisional Conflict
Tijdsspanne: Immediately after the visit (day 1)
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Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale.
The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25.
The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
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Immediately after the visit (day 1)
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Physician Trust
Tijdsspanne: Immediately after the visit (day 1)
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The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25.
The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
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Immediately after the visit (day 1)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Erik Hess, MD, MSc, Mayo Clinic, Rochester, MN
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 oktober 2013
Primaire voltooiing (Werkelijk)
1 augustus 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
17 oktober 2013
Eerst ingediend dat voldeed aan de QC-criteria
21 oktober 2013
Eerst geplaatst (Schatting)
25 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 augustus 2018
Laatste update ingediend die voldeed aan QC-criteria
10 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13-001359
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
A link to the pre-test probability web tool and the Chest Pain Choice decision aid (DA) can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/.
De-identified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic after 12/31/2017.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .