Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
16 marzo 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
82
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
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Ontario
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Hamilton, Ontario, Canada, L8P 2X2
- Hamilton Health Sciences
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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:
- 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
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
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: Usual care
The control group will not receive the patient decision aid prior to consultation with the physician.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Pilot RCT (feasibility)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Vital status
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Sandra L Carroll, PhD, McMaster University
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
- 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.
Collegamenti utili
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 giugno 2012
Completamento primario (Effettivo)
1 settembre 2014
Completamento dello studio (Effettivo)
1 dicembre 2014
Date di iscrizione allo studio
Primo inviato
30 maggio 2013
Primo inviato che soddisfa i criteri di controllo qualità
11 giugno 2013
Primo Inserito (Stima)
12 giugno 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
17 marzo 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
16 marzo 2016
Ultimo verificato
1 marzo 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 12-214
- 119449 Grant number (Altro numero di sovvenzione/finanziamento: Canadian Institutes of Health Research)
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 .