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Use of Visual Decision Aid for Shared Decision Making in Chest Pain

12 avril 2022 mis à jour par: National University Hospital, Singapore

The Use of a Visual Decision Aid for Shared Decision Making Among Patients With Chest Pain

This study aims to evaluate the use of the chest pain choice (CPC) decision aid as a tool to facilitate discussion between the patient and his/her attending physician with regard to subsequent management plans. Patients aged 21 years and above with low-risk chest pain, as determined by the HEART score (HEART score 0-3), will be included. The investigator's hypothesis is that incorporating the Chest Pain Choice visual aid in shared decision making can help to reduce unnecessary admissions for low risk chest pain to the observation ward, as well as increase patient knowledge with regards to their own condition.

Aperçu de l'étude

Description détaillée

Chest pain is a common presenting complaint in the Emergency Department (ED). Cardiac testing in low-risk patients poses unnecessary costs and resource utilisation, which may in part be due to clinicians adopting a very-low-risk threshold for discharge without testing.

The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain, and has shown to be effective in increasing patient knowledge and decreasing the rate of admission to an observation unit for cardiac testing, among patients with chest pain who are at low risk for acute coronary syndromes. Shared decision making with the use of this visual aid has been shown in other centres to be associated with greater patient knowledge, greater patient involvement in decision making and less frequent admissions, with no increase in major adverse cardiac events (MACE) due to the intervention.

The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.

This study aims to assess if using a visual decision aid for shared decision making between physician and patient can safely help to decrease unnecessary admissions to the ED observation unit, as well as its impact on patient knowledge, satisfaction, as well as 30-day and 60-day Major Adverse Cardiac Events (MACE).

Type d'étude

Interventionnel

Inscription (Réel)

18

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Central
      • Singapore, Central, Singapour, 119074
        • Mui Teng Chua

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Aged 21 years and above
  • Have low risk chest pain as defined by the HEART score (0-3 points)
  • Be English-literate
  • Have an initial serum troponin that is less than the 99th centile of the normal reference population
  • Have an initial electrocardiogram that is not suggestive of cardiac ischaemia

Exclusion Criteria:

  • Have a HEART score of 4 or more
  • Are not English-literate
  • Have an elevated initial serum troponin
  • Have an initial electrocardiogram that is suggestive of cardiac ischaemia (ST-segment depression or elevation, new onset left bundle brunch block, T-wave inversions, etc.)
  • Have known coronary artery disease
  • Have a prior plan for cardiac intervention or admission
  • Have barriers to outpatient follow-up
  • Are prisoners
  • Are pregnant
  • Are hearing or visually impaired, or are otherwise unable to use the clinical decision aid
  • Do not consent to participation in the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention Arm
Patients in the intervention arm will receive the Chest Pain Choice visual aid prior to discussion with their primary physician regarding disposition.
The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain. The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.
Aucune intervention: Control Arm
Patients in the control arm will not receive the Chest Pain Choice visual aid and will receive standard care.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Admission to the Emergency Department Observation Unit
Délai: Index visit
Admission to the Emergency Department Observation Unit during index emergency department visit
Index visit

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Major Adverse Cardiac Events (MACE) at 30 days
Délai: 30 days after index visit
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
30 days after index visit
Major Adverse Cardiac Events at 60 days
Délai: 60 days after index visit
MACE is defined as all-cause mortality, myocardial infarction or coronary revascularisation.
60 days after index visit
Emergency Department Attendance at 30 days
Délai: 30 days after index visit
Repeat attendance to the emergency department
30 days after index visit
Emergency Department Attendance at 60 days
Délai: 60 days after index visit
Repeat attendance to the emergency department
60 days after index visit
Stress treadmill electrogram at 30 days
Délai: 30 days after index visit
The presence of stress treadmill electrocardiogram at 30 days post index visit
30 days after index visit
Stress treadmill electrogram at 60 days
Délai: 60 days after index visit
The presence of stress treadmill electrocardiogram at 60 days post index visit
60 days after index visit
Stress myocardial perfusion imaging at 30 days
Délai: 30 days after index visit
The presence of stress myocardial perfusion imaging at 30 days post index visit
30 days after index visit
Stress myocardial perfusion imaging at 60 days
Délai: 60 days after index visit
The presence of stress myocardial perfusion imaging at 60 days post index visit
60 days after index visit
Stress echocardiogram at 30 days
Délai: 30 days after index visit
The presence of stress echocardiogram at 30 days post index visit
30 days after index visit
Stress echocardiogram at 60 days
Délai: 60 days after index visit
The presence of stress echocardiogram at 60 days post index visit
60 days after index visit
Computed tomography of the coronary arteries (CTCA) at 30 days
Délai: 30 days after index visit
The presence of computed tomography of the coronary arteries (CTCA) at 30 days post index visit
30 days after index visit
Computed tomography of the coronary arteries (CTCA) at 60 days
Délai: 60 days after index visit
The presence of computed tomography of the coronary arteries (CTCA) at 60 days post index visit
60 days after index visit

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2019

Achèvement primaire (Réel)

3 septembre 2021

Achèvement de l'étude (Réel)

3 septembre 2021

Dates d'inscription aux études

Première soumission

26 août 2018

Première soumission répondant aux critères de contrôle qualité

14 septembre 2018

Première publication (Réel)

17 septembre 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 avril 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 avril 2022

Dernière vérification

1 août 2021

Plus d'information

Termes liés à cette étude

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Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

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Étudie un produit d'appareil réglementé par la FDA américaine

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