Feasibility Testing of Decision Support for Patients Who Are Candidates for an Implantable Defibrillator
16. März 2016 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
82
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ontario
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Hamilton, Ontario, Kanada, L8P 2X2
- Hamilton Health Sciences
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
Andere Namen:
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Kein Eingriff: Usual care
The control group will not receive the patient decision aid prior to consultation with the physician.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Primary Outcomes(composite): i) decision aid development, and ii) decision aid evaluation.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pilot RCT (feasibility)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Vital status
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Sandra L Carroll, PhD, McMaster University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2012
Primärer Abschluss (Tatsächlich)
1. September 2014
Studienabschluss (Tatsächlich)
1. Dezember 2014
Studienanmeldedaten
Zuerst eingereicht
30. Mai 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Juni 2013
Zuerst gepostet (Schätzen)
12. Juni 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. März 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. März 2016
Zuletzt verifiziert
1. März 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 12-214
- 119449 Grant number (Andere Zuschuss-/Finanzierungsnummer: Canadian Institutes of Health Research)
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