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Caregivers for advanced heart failure patients considering a destination-therapy left ventricular assist device (LVAD) did not appear to be more at ease with the process of shared decision-making when they got more comprehensive and less biased education materials, researchers reported.

Education materials similarly improved knowledge level about LVAD treatment among the 182 caregivers in a randomized trial whether the hospital was providing standard versus clinician-developed materials (mean score improved from 64.2% at baseline to 73.3% versus from 62.6% to 76.4%, P=0.08).

One month later, the intervention group that got "relatively unbiased" clinician-developed materials expressed treatment choices that were better aligned with their stated values, Colleen McIlvennan, DNP, ANP, of the University of Colorado School of Medicine in Aurora, and colleagues reported in .

However, the controls experienced a bigger drop in decisional conflict and were more likely to "definitely recommend" the educational materials than those in the intervention group (93.5% versus 74.5%, P=0.004).

They suggested that this preference may be because the decision aids developed for the intervention:

• Give recognition to the highly complex and emotional nature of the decision
• Present risks and burdens more clearly
• Confronts the limited lifespan inherent in the decision to pursue destination-therapy LVAD

An accompanying editorial described the findings as "abstruse and unsettling."

The process of shared decision-making in mechanical circulatory support (MCS) surgery is highlighted in heart failure guidelines and included in the Medicare National Coverage Determinations Manual, wrote Jennifer Cowger, MD, of Henry Ford Hospital in Detroit. "In response, institutions have embraced SDM [shared decision-making] skills training of health professions and MCS programs have devised decision aids for MCS."

The findings raise questions about the the best tools and how to compare them for promoting SDM with LVAD patients and their caregivers, she wrote.

"For example, did the decision tools better characterize the potential risks and quality-of-life adjustments associated with LVAD therapy, leaving more decisional conflict and potentially more regret for caregivers? Alternatively, were the decision aids actually less beneficial to caregivers than information received during control education?"

The DECIDE-LVAD study was performed as a stepped-wedge randomized trial at six U.S. centers. All sites began in the control period using their existing materials during formal education (usually industry pamphlets and videos and program-specific LVAD documents) before to transitioning to clinician-directed education and non-industry decision aids.

The participating caregivers -- mostly women, mostly spouses -- completed a 10-item LVAD knowledge test and a single-question values scale. Such a relatively-homogeneous population of caregivers limits the trial's generalizability, McIlvennan and colleagues acknowledged.

Another major limitation of the trial was frequently missing data, commonly due to participant withdrawal from the study.

Predicting preoperatively who will do well after LVAD implantation is challenging, Cowger wrote. "Thus, for MCS candidates and their loved ones, the process of shared decision making is integral to upholding the principles of medical ethics."

"Although not to be trivialized, death for the destination therapy LVAD patient is inevitable. For the many who survive surgery, the responsibilities and emotional burden of MCS extends beyond the patient's integument; they also permeate into the lives and psychology of caregivers," the editorialist emphasized.