Video Images about Decisions for Ethical Outcomes in Kidney Disease (VIDEO-KD): the study protocol for a multi-centre randomised controlled trial.
chronic renal failure
dialysis
end stage renal failure
geriatric medicine
nephrology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
08 04 2022
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
e059313Subventions
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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