Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
08 04 2022
Historique:
entrez: 9 4 2022
pubmed: 10 4 2022
medline: 13 4 2022
Statut: epublish

Résumé

Older patients with advanced chronic kidney disease (CKD) often are inadequately prepared to make informed decisions about treatments including dialysis and cardiopulmonary resuscitation. Further, evidence shows that patients with advanced CKD do not commonly engage in advance care planning (ACP), may suffer from poor quality of life, and may be exposed to end-of-life care that is not concordant with their goals. We aim to study the effectiveness of a video intervention on ACP, treatment preferences and other patient-reported outcomes. The Video Images about Decisions for Ethical Outcomes in Kidney Disease trial is a multi-centre randomised controlled trial that will test the effectiveness of an intervention that includes a CKD-related video decision aid followed by recording personal video declarations about goals of care and treatment preferences in older adults with advancing CKD. We aim to enrol 600 patients over 5 years at 10 sites. Regulatory and ethical aspects of this trial include a single Institutional Review Board mechanism for approval, data use agreements among sites, and a Data Safety and Monitoring Board. We intend to disseminate findings at national meetings and publish our results. NCT04347629.

Identifiants

pubmed: 35396311
pii: bmjopen-2021-059313
doi: 10.1136/bmjopen-2021-059313
pmc: PMC8996022
doi:

Banques de données

ClinicalTrials.gov
['NCT04347629']

Types de publication

Clinical Trial Protocol Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e059313

Subventions

Organisme : NIA NIH HHS
ID : R01 AG066892
Pays : United States

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: NE is a scientific advisor for Somatus and Davita. MKT has received honoraria from the American Federation of Aging Research and serves as Associate Editor at CJASN. Views expressed are those of the authors and not necessarily those of the Department of Veterans Affairs. AV has a financial interest in ACP decisions, a non-profit organisation developing advance care planning video decision support tools. AV’s interests were reviewed and are managed by MGH and Mass General Brigham in accordance with their conflict-of-interest policies. No other disclosures to report.

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Auteurs

Nwamaka D Eneanya (ND)

Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, USA.

Joshua R Lakin (JR)

Harvard Medical School, Boston, Massachusetts, USA jlakin@partners.org.
Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

Michael K Paasche-Orlow (MK)

Boston University School of Medicine, Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts, USA.

Charlotta Lindvall (C)

Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

Edward T Moseley (ET)

Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

Lori Henault (L)

Boston University School of Medicine, Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts, USA.

Amresh D Hanchate (AD)

Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Ernest I Mandel (EI)

Harvard Medical School, Boston, Massachusetts, USA.
Division of Renal (Kidney) Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Susan P Y Wong (SPY)

University of Washington, Seattle, Washington State, USA.

Sophia N Zupanc (SN)

Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.

Aretha Delight Davis (AD)

ACP Decisions Non-profit Foundation, Newton, Massachusetts, USA.

Areej El-Jawahri (A)

Harvard Medical School, Boston, Massachusetts, USA.
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Lisa M Quintiliani (LM)

Boston University School of Medicine, Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts, USA.

Yuchiao Chang (Y)

Harvard Medical School, Boston, Massachusetts, USA.
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Sushrut S Waikar (SS)

Section of Nephrology, Boston University School of Medicine and Boston Medical Center, Boston, Massachusetts, USA.

Amar D Bansal (AD)

Section of Palliative Care and Medical Ethics, Department of General Medicine, Division of Renal-Electrolyte, University of Pittsburgh School of Medicine, UPMC Health System, Pittsburgh, Pennsylvania, USA.

Jane O Schell (JO)

Section of Palliative Care and Medical Ethics, Department of General Medicine, Division of Renal-Electrolyte, University of Pittsburgh School of Medicine, UPMC Health System, Pittsburgh, Pennsylvania, USA.

Andrew L Lundquist (AL)

Harvard Medical School, Boston, Massachusetts, USA.
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

Manjula Kurella Tamura (MK)

Division of Nephrology, Stanford University School of Medicine; and Geriatric Research Education Clinical Center, VA Palo Alto Health Care System, Palo Alto, California, USA.

Margaret K Yu (MK)

Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.

Mark L Unruh (ML)

Department of Medicine, University of New Mexico, Albuquerque, New Mexico, USA.

Christos Argyropoulos (C)

Division of Nephrology, Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, New Mexico, USA.

Michael J Germain (MJ)

Baystate Medical Center-University of Massachusetts Springfield, Springfield, Massachusetts, USA.

Angelo Volandes (A)

Harvard Medical School, Boston, Massachusetts, USA.
ACP Decisions Non-profit Foundation, Newton, Massachusetts, USA.
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.

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