Cited by 179Patient-Provider Communication in HealthcarePalliative Care and End-of-Life IssuesMechanical Circulatory Support Devices

Effectiveness of an Intervention Supporting Shared Decision Making for Destination Therapy Left Ventricular Assist Device: The DECIDE-LVAD Randomized Clinical Trial

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Allen, Larry A., McIlvennan, Colleen K., Thompson, Jocelyn S., Dunlay, Shannon M., LaRue, Shane J., Lewis, Eldrin F., Patel, Chetan B., Blue, Laura +8 more·2018·JAMA Internal Medicine

Abstract

Importance: Shared decision making helps patients and clinicians elect therapies aligned with patients' values and preferences. This is particularly important for invasive therapies with considerable trade-offs. Objective: To assess the effectiveness of a shared decision support intervention for patients considering destination therapy left ventricular assist device (DT LVAD) placement. Design, Setting, and Participants: From 2015 to 2017, a randomized, stepped-wedge trial was conducted in 6 US LVAD implanting centers including 248 patients being considered for DT LVAD. 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. Main Outcomes and Measures: Decision quality as measured by knowledge and values-choice concordance. Results: In total, 135 patients were enrolled during control and 113 during intervention periods. At enrollment, 59 (23.8%) participants were in intensive care, 60 (24.1%) were older than 70 years, 39 (15.7%) were women, 45 (18.1%) were racial/ethnic minorities, and 62 (25.0%) were college graduates. 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 = .03). Stated values at 1 month (scale 1 = "do everything I can to live longer…" to 10 = "live with whatever time I have left…") were a mean of 2.37 in control and 3.33 in intervention (P = .03). 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 < .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% 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). The adjusted rate of LVAD implantation by 6 months was higher for those in the control group (79.9%) than those in the intervention group (53.9%, P = .008), with significant variation by site. There were no differences in decision conflict, decision regret, or preferred control. Conclusions and Relevance: A 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. Trial Registration: clinicaltrials.gov Identifier: NCT02344576.

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  • Decision aids have decreased rates of implementation of left ventricular assist devices in outpatients with congestive heart failure.

    “decreased rates of implementation of left ventricular assist devices in outpatients with congestive heart failure”

    From Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation (2019) · cites this paper as [31]

    The Results (Decision Quality: Knowledge and Values-Choice Concordance; page unavailable) report lower LVAD implantation by six months in the intervention group than in controls. But the intervention combined decision aids with clinician training, so the study does not isolate the effect of decision aids. The Results (Patients; page unavailable) also show that most participants were enrolled as inpatients, not outpatients, and do not establish the claimed decrease specifically among outpatients. (LLM, conf=0.90)

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  • Some recent studies found that family support interventions did not reduce psychological symptoms in family members.

    “However, some recent studies found that family support interventions did not reduce psychological symptoms in family members. 66,67,75,79”

    From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [75]

    The Results (Secondary Outcomes; page unavailable) report no significant intervention–control difference in stress or depression. But the reported outcomes concern the LVAD decision-support study’s patients; although Methods (Study Participants; page unavailable) says patient–caregiver dyads were enrolled, this passage does not establish that psychological symptoms in family members were measured or unchanged. (LLM, conf=0.82)

    Experimental — accuracy not yet measured
  • Communication supported by strategies such as video decision aids may be associated with improved family satisfaction, according to recent studies.

    “Furthermore, according to recent studies, communication supported by other strategies such as video decision aids may be associated with improved family satisfaction. 67,75,78”

    From European Resuscitation Council Guidelines 2021: Ethics of resuscitation and end of life decisions (2021) · cites this paper as [75]

    The Introduction and Methods > Intervention describe video decision aids used alongside clinician training for patients and caregivers considering destination-therapy LVAD. The Methods > Outcomes and Results report patient decision-making measures, not family satisfaction; the claimed improvement in family satisfaction is therefore unsupported by this paper. (LLM, conf=0.84)

    Experimental — accuracy not yet measured
  • Decision aids have decreased hospital transfer rates in nursing home residents with dementia.

    “decreased hospital transfer rates in nursing home residents with dementia (31, 32)”

    From Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation (2019) · cites this paper as [31]

    The Methods (Study Participants; page unavailable) describe patients with end-stage heart failure being considered for a left ventricular assist device, not nursing home residents with dementia. The Conclusions (page unavailable) report changes in decision knowledge and device implantation, but not hospital transfer rates; searches for dementia, nursing homes, and hospital transfers found no passage addressing the claim. (LLM, conf=0.76)

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Authors
Allen, L. A., McIlvennan, C. K., Thompson, J. S., Dunlay, S. M., LaRue, S. J., Lewis, E. F., Patel, C. B., Blue, L., Fairclough, D. L., Leister, E. C., Glasgow, R. E., Cleveland, J. C., Phillips, C., Baldridge, V., Walsh, M. N., & Matlock, D. D.
Affiliations
  • University of Colorado Anschutz (US)
  • Mayo Clinic (US)
  • Washington University in St. Louis (US)
  • Brigham and Women's Hospital (US)
  • Duke Medical Center (US)
  • Colorado School of Public Health (US)
  • VA Eastern Colorado Health Care System (US)
  • Patient stakeholder
  • Caregiver stakeholder
  • St Vincent Hospital (US)
Corresponding author
Allen, Larry A.
Venue
JAMA Internal Medicine
Published
2018-04-01
Volume
178
Issue
4
Pages
520
ISSN
2168-6106 (ISSN-L)
OpenAlex
W2792883637
Cited by
179
References
50
Citations by year
2026: 16 · 2025: 11 · 2024: 23 · 2023: 21 · 2022: 23 · 2021: 27 · 2020: 21 · 2019: 27 · 2018: 10
FWCI
32.45
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • JAMA Internal Medicine (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Digital Commons@Becker (Washington University School of Medicine) (submittedVersion, cc-by)
Funders
Patient-Centered Outcomes Research Institute
Topics
  • Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
  • Physical Sciences › Engineering › Biomedical Engineering › Mechanical Circulatory Support Devices
Keywords
shared decision-making, patient decision aids, patient education, patient knowledge, treatment selection, end-of-life care, advanced heart failure, clinician education, patient-centered care, intervention effectiveness, patient-reported outcomes, quality of life, health-related quality of life, patient satisfaction
MeSH terms
Aged, Decision Making, Decision Support Techniques, Female, Heart Failure, Heart-Assist Devices, Humans, Health Knowledge, Attitudes, Practice, Male, Middle Aged, Patient Participation, Patient Preference

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