Intervention Supporting Shared Decision Making for Destination Therapy LVAD

Study Questions:

What is the effectiveness of a shared decision support intervention for patients considering destination therapy left ventricular assist device (DT LVAD) placement?

Methods:

The study investigators conducted a randomized, stepped-wedge trial in six US LVAD implanting centers from 2015-2017. They included 248 heart failure (HF) patients being considered for DT LVAD, from these six centers. After randomly varying time in usual care, sites were transitioned to an intervention consisting of clinician education and use of DT LVAD pamphlet and video patient decision aids. Follow-up occurred at 1 and 6 months. Decision quality (as measured by knowledge and values-choice concordance) was the primary outcome measure. Secondary outcomes included validated measures of decision conflict, decision regret, control preferences, illness acceptance, perceived stress, depression (Patient Health Questionnaire-2), and quality of life (EuroQol Visual Analogue Scale).

Results:

In total, 113 patients were enrolled during the intervention and 135 patients during control periods. At enrollment, 23.8% (n = 59) of participants were in intensive care, 24.1% (n = 60) were aged >70 years, 15.7% (n = 39) were women, 18.1% (n = 45) were racial/ethnic minorities, and 25.0% (n = 62) were college graduates. Enrolled patients were more likely to be white non-Hispanic (75.8% vs. 63.9%, p = 0.03). Patients in the intervention period were more likely to be enrolled as outpatient (31% vs. 17%, p = 0.007) and to have been diagnosed with HF <4 years prior (29.8% vs 18.2%, p = 0.03) than those enrolled in the control period. Patient knowledge (mean test performance) during the decision-making period improved from 59.5% to 64.9% in the control group vs. 59.1% to 70.0% in the intervention group (adjusted difference of difference, 5.5%; p = 0.03). Patient values on the 10-tier Likert scale were generally in the direction of more aggressive care to maximize survival (i.e., closer to 1): control period baseline 1 score mean of 2.19 (standard error [SE], 0.26); 1-month, 2.37 (SE, 0.28); 6-month, 3.12 (SE, 0.33); intervention period baseline, 2.98 (SE, 0.30); 1-month, 3.33 (SE, 0.32); 6-month, 3.65 (SE, 0.39); adjusted overall difference p = 0.06. Patient-reported treatment choice at 1 month favored LVAD more in the control group (than in the intervention group (47 [59.5%] vs. 95 [91.3%], p < 0.001). Correlation between stated values and patient-reported treatment choice at 1 month was stronger in the intervention group than in the control group (difference in Kendall’s τ, 0.28; 95% confidence interval [CI], 0.05-0.45); however, there was no improved correlation between stated values and actual treatment received by 6 months for the intervention compared with the control group (difference in Kendall’s τ, 0.01; 95% CI, −0.24 to 0.25). By 6 months, 110 (83.3%) (adjusted rate, 79.9%) patients in the control group and 54 (52.4%) (adjusted rate, 53.9%) patients in the intervention group had undergone LVAD implantation (53.9%, p = 0.008), with significant variation by site. There were no differences in decision conflict, decision regret, or preferred control.

Conclusions:

The study authors concluded that shared decision-making intervention for DT LVAD modestly improved patient decision quality as measured by patient knowledge and concordance between stated values and patient-reported treatment choice, but did not improve concordance between stated values and actual treatment received. The rate of implantation of LVADs was substantially lower in the intervention compared with the control group.

Perspective:

This study is important because it provides unique insights into a population of patients who have to make important choices that may impact their survival, and many of these patients may also have an element of cerebral hypoperfusion. This study suggests that evaluation of the decision-making process needs to be continuously assessed in this rapidly evolving field of medicine.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: Cardiac Surgical Procedures, Choice Behavior, Decision Making, Decision Support Techniques, Depression, Geriatrics, Heart-Assist Devices, Heart Failure, Outcome Assessment (Health Care), Outpatients, Pamphlets, Quality of Life


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