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A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.
Wallace, Bryan C; Allen, Larry A; Knoepke, Christopher E; Glasgow, Russell E; Lewis, Carmen L; Fairclough, Diane L; Helmkamp, Laura J; Fitzgerald, Monica D; Tzou, Wendy S; Kramer, Daniel B; Varosy, Paul D; Gupta, Sanjaya K; Mandrola, John M; Brancato, Scott C; Peterson, Pamela N; Matlock, Daniel D.
Afiliação
  • Wallace BC; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.
  • Allen LA; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardio
  • Knoepke CE; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.
  • Glasgow RE; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.
  • Lewis CL; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.
  • Fairclough DL; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.
  • Helmkamp LJ; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.
  • Fitzgerald MD; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.
  • Tzou WS; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Me
  • Kramer DB; Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.
  • Varosy PD; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.
  • Gupta SK; Saint Luke's Mid-America Heart Institute, Kansas City, MO.
  • Mandrola JM; Baptist Health Louisville, Louisville, KY.
  • Brancato SC; Providence Heart Institute, Portland, OR.
  • Peterson PN; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.
  • Matlock DD; Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.
Am Heart J ; 226: 161-173, 2020 08.
Article em En | MEDLINE | ID: mdl-32599257
Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Estudos Multicêntricos como Assunto / Técnicas de Apoio para a Decisão / Tomada de Decisão Compartilhada Tipo de estudo: Clinical_trials / Prognostic_studies / Qualitative_research Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Am Heart J Ano de publicação: 2020 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Ensaios Clínicos Controlados Aleatórios como Assunto / Estudos Multicêntricos como Assunto / Técnicas de Apoio para a Decisão / Tomada de Decisão Compartilhada Tipo de estudo: Clinical_trials / Prognostic_studies / Qualitative_research Limite: Humans País/Região como assunto: America do norte Idioma: En Revista: Am Heart J Ano de publicação: 2020 Tipo de documento: Article País de publicação: Estados Unidos