Bryan C Wallace1, Jacqueline Jones2, Frederick A Masoudi3,4, Carolyn T Nowels5, Paul Varosy4,6,7, Richard Thomson8, Glyn Elwyn9, Angela G Brega10, Travis Vermilye11, Christopher E Knoepke1,4, Amneet Sandhu12, Larry A Allen1,4,6,13, Daniel D Matlock1,12,14. 1. Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, Colorado, USA. 2. College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 3. Ascension Health, St Louis MO. 4. Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA. 5. Division of General Internal Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 6. Colorado Cardiovascular Outcomes Research Consortium, Denver, Colorado, USA. 7. Cardiology Section, VA Eastern Colorado Health Care System, Aurora, Colorado, USA. 8. Population Health Sciences Institute, Newcastle University, UK. 9. Coproduction Laboratory, Dartmouth Institute, Lebanon, New Hampshire, USA. 10. Department of Community and Behavioral Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA. 11. Department of Visual Arts, University of Colorado Denver, Denver, Colorado, USA. 12. VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado, USA. 13. 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, Colorado, USA. 14. Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Abstract
BACKGROUND: Using DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs. METHODS: Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option GridTM conversation aid, a four-page in-depth paper tool, a 17-minute video, and an interactive website. Trial Phase: At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed-methods evaluation exploring acceptability and feasibility. RESULTS: Twenty-one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = .06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence. CONCLUSIONS: Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed.
BACKGROUND: Using DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs. METHODS: Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option GridTM conversation aid, a four-page in-depth paper tool, a 17-minute video, and an interactive website. Trial Phase: At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed-methods evaluation exploring acceptability and feasibility. RESULTS: Twenty-one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = .06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence. CONCLUSIONS: Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed.
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