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

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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, Fairclough, Diane L., Leister, Erin C., Glasgow, Russell E., Cleveland, Joseph C., Phillips, Clifford, Baldridge, Vicie, Walsh, Mary Norine, Matlock, Daniel D.·2018·JAMA Internal Medicine

DOI 10.1001/jamainternmed.2017.8713PMC PMC5876922

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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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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.
ORCID: Allen, Larry A.
McIlvennan, Colleen K.
Thompson, Jocelyn S.
Dunlay, Shannon M.
LaRue, Shane J.
Lewis, Eldrin F.
Patel, Chetan B.
Blue, Laura
Glasgow, Russell E.
Cleveland, Joseph C.
Phillips, Clifford
Walsh, Mary Norine
Matlock, Daniel D.
Venue: JAMA Internal Medicine
Publisher: American Medical Association (AMA)
Published: 2018-04-01
Volume: 178
Issue: 4
Pages: 520
ISSN: 2168-6106 (ISSN-L)
DOI: 10.1001/jamainternmed.2017.8713
PMC: PMC5876922
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: hybrid
doi.org
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
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › 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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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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