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Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)

10 novembre 2017 aggiornato da: 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:

  1. 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.

  2. 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

898

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Sacramento, California, Stati Uniti, 95817
        • University of California, Davis
    • Florida
      • Jacksonville, Florida, Stati Uniti, 32224
        • Mayo Clinic
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University Hospital: IU
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19107
        • Thomas Jefferson University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 18+ years of age (at least 18).
  2. Admitted to emergency department for chest pain.
  3. Being considered by the treating clinician for admission for cardiac testing.

Exclusion Criteria:

  1. Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
  2. Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
  3. 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).
  4. Cocaine use within the previous 72 hours by clinician history.
  5. Pregnancy.
  6. Referral to the emergency department by a personal physician for admission.
  7. 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.
  8. Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
  9. Homelessness, out-of-town residence or other condition known to preclude follow-up.
  10. Patients in police custody or currently incarcerated individuals.
  11. 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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Chest Pain Choice Decision Aid
Patients randomized to the decision aid arm.
Altro: Chest Pain Choice Decision Aid
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.
Altri nomi:
  • CPC DA
Nessun intervento: Usual Care
Patients randomized to the usual care arm (no decision aid used)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Test if Chest Pain Choice Safely Improves Patient Knowledge.
Lasso di tempo: Directly following intervention (on day 1)
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.
Directly following intervention (on day 1)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
Lasso di tempo: Within 30 days of study enrollment
We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
Within 30 days of study enrollment
Test if the Decision Aid Safely Improves Patient Engagement.
Lasso di tempo: Immediately after the intervention (on day 1)
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.
Immediately after the intervention (on day 1)
Major Adverse Cardiac Event (MACE)
Lasso di tempo: within 30 days of enrollment
A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
within 30 days of enrollment
Total Testing Within 45 Days (a Component of Healthcare Utilization)
Lasso di tempo: 45 days
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.
45 days
Decisional Conflict
Lasso di tempo: Immediately after the visit (day 1)
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.
Immediately after the visit (day 1)
Physician Trust
Lasso di tempo: Immediately after the visit (day 1)
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.
Immediately after the visit (day 1)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mayo Clinic

Collaboratori

Patient-Centered Outcomes Research Institute
University of California, Davis
Indiana University
Thomas Jefferson University

Investigatori

  • Investigatore principale: Erik Hess, MD, MSc, Mayo Clinic, Rochester, MN

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2013

Completamento primario (Effettivo)

1 agosto 2015

Completamento dello studio (Effettivo)

1 dicembre 2015

Date di iscrizione allo studio

Primo inviato

17 ottobre 2013

Primo inviato che soddisfa i criteri di controllo qualità

21 ottobre 2013

Primo Inserito (Stima)

25 ottobre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 agosto 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 13-001359

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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