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COMPAR-EU Web RCTs

A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial)

Author: Kostick, K. M. Country/countries: United States Number of patients participating in the study: 105 This study was focused on patients living with Heart Failure
Intervention analysed in the study: Usual Care Plus Intervention components: UCP
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Setting of implementation: N/A Professionals delivering the intervention: Educator Targeted self-management behaviours: N/A
Intervention analysed in the study: Shared decision making Intervention components: E+SD
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Setting of implementation: Outpatient care (hospital) Professionals delivering the intervention: Physicians Targeted self-management behaviours: decision making / knowledge

Outcomes measured in the study

Desenlace Medida Tool
Knowledge Knowledge N/A
Participation and decisions making Shared decision-making Satisfaction with Decision Scale (SWD)
Participation and decisions making Shared decision-making Decision Regret Scale (DRS)
Participation and decisions making Shared decision-making CollaboRATE
Participation and decisions making Shared decision-making N/A

Patient characteristics

Age: 59.77 years (+/- a standard deviation of 12.08) Gender: 23.0% female/77.0% male Time since diagnosis of Heart Failure: N/A Severity of the disease: N/A Multi-morbidity: N/A
  • Number of co-morbidities: N/A

Level of health literacy: N/A
  • Tool: N/A

Socio-economic characteristics: N/A

Risk of Bias of this study

Desenlace Random sequence generation Allocation concealment Blinding performance Blinding detection objective outcomes assessment Attrition incomplete outcome Incorrect statistical methods Recruitment bias Selective outcome reporting
Knowledge - Knowledge
Participation and decisions making - Shared decision-making
Participation and decisions making - Shared decision-making
Participation and decisions making - Shared decision-making
Participation and decisions making - Shared decision-making

Other publications associated with this study

Assessment of patients’ and caregivers’ informational and decisional needs for left ventricular assist device placement: Implications for informed consent and shared decision-making Development and Pilot-Testing of a Patient Decision Aid for Left Ventricular Assist Device Placement Enlace: 10.13023/VAD.2016.01