Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
16 mars 2016 mis à jour par: Sandra Carroll, McMaster University
Development of and Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
Sudden cardiac death (SCD) due to a ventricular arrhythmia is a serious cause of cardiovascular death in Canada. The implantable cardioverter defibrillator (ICD) offers high-risk patients a treatment option to reduce the incidence of SCD by delivering an internal shock to restore a normal rhythm, if needed. Definitive evidence has established the effectiveness of the ICD for reducing mortality when used as prophylaxis for SCD (a primary prevention indication). Approximately 3,700 new candidates accrue annually. Practice guidelines define the criteria to determine patient ICD candidacy for primary prevention. However, in addition to SCD risk, ICD candidates may have chronic diseases such as diabetes, renal insufficiency, hypertension, and atrial fibrillation. Thus, balancing the benefits and risks of an ICD can become complex, particularly when competing mortality risks are present. Research has recognized human costs associated with device complications and shocks affecting psychological, health related quality of life (HRQL), and morbidity outcomes. The complexities surrounding the long-term benefits/risks, complications, replacements, and shocks, warrant decision support to prepare patients to make decisions. In Canada, there is no clear framework to support patients' decision-making in the context of ICD treatment options. Decision support, using a decision aid, could moderate treatment related uncertainty and prepare patients to make active, informed, quality decisions.
Objectives: 1) develop a decision aid for ICD candidates to support quality decision-making (informed, deliberate, values-based choices), 2) to evaluate the decision aid, and 3) to determine the feasibility of conducting a trial.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
82
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
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Ontario
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Hamilton, Ontario, Canada, L8P 2X2
- Hamilton Health Sciences
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Referred for consideration of an ICD(non-CRT)for a primary prevention indication
- English speaking
- able to provide informed consent
Exclusion Criteria:
- unable to understand the decision aid due to a language barrier or visual impairment
- referred for secondary prevention indication
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: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Patient Decision Aid for an ICD (primary prevention, non-CRT)
The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician.
Values are assessed to reveal which features of each option are important to patients.
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The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician.
Values are assessed to reveal which features of each option are important to patients.
Autres noms:
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Aucune intervention: Usual care
The control group will not receive the patient decision aid prior to consultation with the physician.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.
Délai: Phase 1-2 (1- year)
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Development of the decision aid will be guided by the Ottawa Decision Support Framework (ODSF).
Evaluation will include the Decision Aid Acceptability questionnaire comprised of 10 items including comprehensibility, balance of presentation of information, and overall suitability.
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Phase 1-2 (1- year)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pilot RCT (feasibility)
Délai: Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)
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In this feasibility RCT, the feasibility regarding processes (referral and recruitment rates, consent), key to the success of a larger study will be assessed.
This includes successful delivery of the decision aid in an efficient manner, the monitoring of resources (budget), and study management (trial coordination, human resources).
We will assess the proportion of patients who complete the decision aid, quality questionnaires, and missing data.
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Pre-Post consultation - participants will be followed until consultation is completed and at 3 months post consultation (average of 16 weeks)
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Decision quality measures
Délai: Pre consultation (baseline visit)
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Decision quality, the extent to which patients' decisions are informed (knowledge) and values based (values, preferences, decisional conflict).
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Pre consultation (baseline visit)
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Decisional Conflict Scale (DCS)
Délai: Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)
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The Decisional Conflict Scale measures a person's perception of the difficulty in making a decision, the extent to which they feel uncertain about treatment options, are knowledgeable about the risks and benefits of options, clear about personal values, and supported in decision making.
The scale has good test-retest reliability (Cronbach's alpha coefficients > 0.78) and predictive validity.
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Pre and post consultation- (intervention and usual care group, baseline visit + 1 week post consult)
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Sure Test
Délai: Pre-consultation - baseline visit
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The Sure Test is a 4 item decisional conflict screening tool designed for use in clinical practice.
The Sure Test is embedded in the decision aid (intervention group).
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Pre-consultation - baseline visit
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The Center for Epidemiologic Studies Depression Scale (CES-D)
Délai: Pre consultation - baseline visit (intervention and usual care)
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The CES-D has 20 items that measure depressive symptoms.
The CES-D has good reliability and validity across community and clinical settings.
Associations between depressive symptoms and decision choice will be assessed.
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Pre consultation - baseline visit (intervention and usual care)
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Preparation for Decision Making scale
Délai: Post consultation - up to two weeks post baseline visit (intervention group)
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The Preparation for Decision Making Scale has 10 categorical items assessing the usefulness of the decision aid in preparing patients to communicate with a health professional.
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Post consultation - up to two weeks post baseline visit (intervention group)
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The Medical Outcomes Trust Short Form (SF-36v2)
Délai: Pre consultation - baseline visit (intervention and usual care)
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The SF-36 is a reliable and valid generic health related quality of life scale (HRQL) comprised of 36 items.
Associations between HRQL and decision choice will be undertaken.
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Pre consultation - baseline visit (intervention and usual care)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Vital status
Délai: 3 months post baseline visit
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Alive, deceased
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3 months post baseline visit
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Implant status
Délai: Phase 3, three months post baseline visit
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Device status - implantable defibrillator/no implantable defibrillator, deferred
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Phase 3, three months post baseline visit
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Sandra L Carroll, PhD, McMaster University
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.
Publications générales
- Carroll SL, Stacey D, McGillion M, Healey JS, Foster G, Hutchings S, Arthur HM, Browne G, Thabane L. Evaluating the feasibility of conducting a trial using a patient decision aid in implantable cardioverter defibrillator candidates: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 Nov 21;3:49. doi: 10.1186/s40814-017-0189-9. eCollection 2017.
- Carroll SL, McGillion M, Stacey D, Healey JS, Browne G, Arthur HM, Thabane L. Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial. Trials. 2013 Oct 22;14:346. doi: 10.1186/1745-6215-14-346.
Liens utiles
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
1 juin 2012
Achèvement primaire (Réel)
1 septembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
30 mai 2013
Première soumission répondant aux critères de contrôle qualité
11 juin 2013
Première publication (Estimation)
12 juin 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-214
- 119449 Grant number (Autre subvention/numéro de financement: Canadian Institutes of Health Research)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .