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Ventricular Assist Device Decision Aid
Study Questions:
What are the characteristics of caregivers of patients considering destination therapy left ventricular assist device (DT-LVAD), and what is the effectiveness of a shared decision-making (SDM) intervention?
Methods:
The study investigators performed a six-center, stepped-wedge trial from 2015 to 2017. 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). Only one caregiver per patient was enrolled. The decision support intervention included: 1) delivery of an in-person 2.5-hour clinician-directed decision support training of local staff by the study team; and 2) formal integration of the 26-minute video and eight-page pamphlet DAs developed by the group into each programs’ education process. With facilitation by local physician champions, sites were then instructed to formally integrate the DAs and tenants learned from the coaching session into existing education, decision-making, and informed consent processes. Therefore, local differences in how the intervention was delivered were probable. The primary outcome was decision quality, measured by knowledge and values-choice concordance. Secondary outcomes included validated measures of decisional conflict, decision regret, perceived stress, preparedness for caregiving, satisfaction with care, and depression screen (via the Patient Health Questionnaire-2). Acceptability of the educational materials was also measured at the post-education time point.
Results:
The study authors enrolled 182 caregivers of patients considering DT-LVAD (control group, n = 111; intervention group, n = 71; the overall recruitment rate was 84%). 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, 0.04-0.71; p = 0.03). When asked broadly about whether they would recommend to others the LVAD “educational materials” that were provided during the education process, caregivers in the control group were more likely to “definitely recommend” (93.5% control vs. 74.5% intervention) and those in the intervention group were more likely to “probably recommend” (5.4% control vs. 23.6% intervention, overall p = 0.004). Caregivers reported decisional conflict (0-100) 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:
The study authors concluded that SDM 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.
Perspective:
This is an important study because it suggests that involving caregivers is desirable. As the authors point out, more research on caregivers is needed in this complex and nuanced situation for both patients and their caregivers.
Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support
Keywords: Cardiac Surgical Procedures, Caregivers, Chronic Disease, Decision Support Techniques, Depression, Heart-Assist Devices, Heart Failure, Informed Consent, Mentors, Pamphlets, Personal Satisfaction, Terminal Care
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