Author + information
- Received May 13, 2018
- Revision received June 3, 2018
- Accepted June 14, 2018
- Published online October 10, 2018.
- Colleen K. McIlvennan, DNP, ANPa,∗ (, )
- Daniel D. Matlock, MD, MPHa,b,
- Jocelyn S. Thompson, MAa,
- Shannon M. Dunlay, MD, MSc,
- Laura Blue, DNP, ANPd,
- Shane J. LaRue, MD, MPHSe,
- Eldrin F. Lewis, MD, MPHf,
- Chetan B. Patel, MDd,
- Diane L. Fairclough, DrPHa,g,
- Erin C. Leister, MSa,g,
- Keith M. Swetz, MD, MAh,
- Vicie Baldridgei,
- Mary Norine Walsh, MDj and
- Larry A. Allen, MD, MHSa
- aAdult and Child Consortium for Health Outcomes Research and Delivery Science, University of Colorado School of Medicine, Aurora, Colorado
- bVeteran Affairs Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado
- cDepartment of Internal Medicine, Mayo Clinic, Rochester, Minnesota
- dDuke University Medical Center, Durham, North Carolina
- eWashington University School of Medicine, St. Louis, Missouri
- fBrigham and Women's Hospital, Boston, Massachusetts
- gDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado
- hUniversity of Alabama School of Medicine, Birmingham, Alabama
- iCaregiver representative, Aurora, Colorado
- jSt. Vincent Heart Center, Division of Cardiology, Indianapolis, Indiana
- ↵∗Address for correspondence:
Dr. Colleen K. McIlvennan, University of Colorado School of Medicine, 12631 East 17th Avenue, B130, Aurora, Colorado 80045.
Objectives This study aims to characterize caregivers of patients considering destination therapy left ventricular assist device (DT-LVAD) and evaluate the effectiveness of a shared decision-making (SDM) intervention.
Background Caregivers play an integral role in the care of patients with chronic illness. At the extreme, pursuing a DT-LVAD is a major preference-sensitive decision that requires high-level caregiver engagement. Yet, little is known about caregivers of patients considering DT-LVAD, and there is a paucity of research on the involvement of caregivers in medical decision-making.
Methods A 6-center, stepped-wedge trial was conducted. After varying time in usual care (control), sites were transitioned to an SDM intervention consisting of staff education and pamphlet and video decision aids (DAs). The primary outcome was decision quality, measured by knowledge and values-choice concordance.
Results From 2015 to 2017, 182 caregivers of patients considering DT-LVAD were enrolled (control group, n = 111; intervention group, n = 71). The median age was 61 years, 86.5% were female, and 75.8% were spouses. Caregiver knowledge (0% to 100%) improved from baseline to post-education in both groups: in the control group it improved from 64.2% to 73.3%; in the intervention group it improved from 62.6% to 76.4% (adjusted difference of difference, 4.8%, p = 0.08). At 1 month, correlation between stated values and caregiver-reported treatment choice was stronger in the intervention group (difference in Kendall’s tau: 0.36, 95% confidence interval: 0.04 to 0.71; p = 0.03). Caregivers reported decisional conflict (0 to 100) at baseline (control group: 19.0 ± 2.1; intervention group: 21.4 ± 2.6), which decreased post-education more in the control group (control group: 9.0 ± 1.9, intervention group: 18.8 ± 2.4; p = 0.009). Caregivers in the control group were more likely to “definitely recommend” the educational materials than those in the intervention group (93.5% vs. 74.5%, respectively; p = 0.004).
Conclusions An SDM intervention improved concordance between caregiver values and treatment choice for their loved ones but did not significantly impact knowledge. Caregivers found the DAs less acceptable than more biased educational materials and exposure to DAs led to higher conflict initially. These findings highlight the complexity of SDM involving caregivers of patients with chronic illness. (PCORI-1310-06998 Trial of a Decision Support Intervention for Patients and Caregivers Offered Destination Therapy Heart Assist Device [DECIDE-LVAD]; NCT02344576)
- end-of-life care
- mechanical circulatory support
- patient decision aids
- shared decision making
- ventricular assist device
This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Program Award (CDR-1310-06998), Washington, DC. All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its Board of Governors, or Methodology Committee. This work was also supported in part by the National Heart, Lung and Blood Institute (NHLBI) (1K23HL105896-01, Allen), Bethesda, Maryland; the Heart Failure Society of America (to Dr. McIlvennan), Rockville, Maryland; the National Institute on Aging (1K23AG040696, to Dr. Matlock), Baltimore, MD; Research Electronic Data Capture database hosting through University of Colorado supported by NIH/NCRR Colorado CTSI (grant number UL1 TR001082), Aurora, Colorado. Dr. Matlock has received a grant from the American College of Cardiology Foundation. Dr. Blue has received personal fees from Abbott and Medtronic. Dr. Patel has received personal fees from Abbott and Medtronic. Ms. Baldridge is a caregiver stakeholder. Dr. Allen has received grants from PCORI, National Institute of Health (NIH), NHLBI, and the American Heart Association; and has received personal fees from ACI Clinical, Janssen, Cytokinetics, Novartis, Boston Scientific, Amgen, and Duke Clinical Research Institute. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 13, 2018.
- Revision received June 3, 2018.
- Accepted June 14, 2018.
- 2018 American College of Cardiology Foundation
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