Item request has been placed!
×
Item request cannot be made.
×
Processing Request
Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial.
Item request has been placed!
×
Item request cannot be made.
×
Processing Request
- Additional Information
- Source:
Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
- Publication Information:
Original Publication: [London] : BioMed Central, 2006-
- Subject Terms:
- Abstract:
Competing Interests: Declarations. Ethics approval and consent to participate: The trial protocol has been approved by the Biomedical Research Ethics Committee of West China Hospital of Sichuan University (approval number: 2022–1709). The study will be conducted in accordance with the Declaration of Helsinki (as revised in 2013). Informed consent will be obtained from all the participants. Any major modifications to the trial protocol, including changes in eligibility criteria, outcome indicators, or analysis methods, will be determined by a working meeting organised by the TSC and promptly notified to all relevant parties, including the ethics committee and research sponsors. The updated version number and date on the clinical trial platform will also be used to track the history of these changes. Consent for publication: Not applicable. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. Competing interests: The authors declare that they have no competing interests.
Background: Enteral nutrition for stroke patients in China presents major shortcomings. This aspect of care involves multiple components, and poor implementation of any one of them may affect the patients' enteral nutrition. Most current studies only confirm the effectiveness of the application of single interventions and lack any scientific evaluation of the overall ensemble of enteral nutrition interventions in stroke patients. This study focuses on evaluating the overall effectiveness of a care bundles for the management of enteral nutrition in stroke patients by targeting multiple simultaneous interventions.
Methods: This study is to be conducted over 10 periods in the stroke patient wards of eight hospitals across China. As the trial progresses, each hospital begins by receiving the control group care and then shifts to the intervention group care. The point at which each hospital shifts care is randomised. During this time, the control group implements its usual care, while the intervention group implements an evidence-based care bundles for enteral nutrition management in stroke patients. The primary indicator in this study is feeding intolerance; indicators for the evaluation of nutritional status, gastrointestinal complications, and disease prognosis are also included.
Discussion: We anticipate that the care bundles developed by pooling this evidence will be manifestly more beneficial than harmful and will be worthy of replication. Hence, we chose a stepped wedge cluster randomised trial to validate the application of these interventions. This study will provide experience and reference on how to promote the clinical translation of evidence-based evidence and standardise enteral nutrition care management in stroke patients.
Trial Registration: ChiCTR2300067930. Registered on January 31, 2023.
(© 2024. The Author(s).)
- References:
Nutr Clin Pract. 2021 Feb;36(1):40-49. (PMID: 33242218)
Acta Anaesthesiol Scand. 2014 Sep;58(8):914-22. (PMID: 24611520)
Lancet Neurol. 2019 Apr;18(4):394-405. (PMID: 30878104)
J Clin Epidemiol. 2016 Jan;69:137-46. (PMID: 26344808)
Stroke. 2009 Mar;40(3):e66-74. (PMID: 19164799)
Int J Epidemiol. 2020 Jun 1;49(3):979-995. (PMID: 32087011)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
BMJ. 2015 Feb 06;350:h391. (PMID: 25662947)
Int J Nurs Stud. 2017 Mar;68:1-8. (PMID: 28013104)
Intensive Care Med. 2009 Jul;35(7):1180-6. (PMID: 19308354)
Eur J Clin Nutr. 2020 Oct;74(10):1420-1427. (PMID: 32152512)
Lancet Neurol. 2021 Oct;20(10):795-820. (PMID: 34487721)
BMJ. 2006 Feb 18;332(7538):413-6. (PMID: 16484270)
JAMA. 2013 Jan 16;309(3):249-56. (PMID: 23321763)
Qual Saf Health Care. 2003 Feb;12(1):47-52. (PMID: 12571345)
BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488)
Clin Nutr. 2012 Jun;31(3):345-50. (PMID: 22122869)
Implement Sci. 2016 Jul 04;11(1):88. (PMID: 27377404)
BMC Anesthesiol. 2022 Jul 19;22(1):231. (PMID: 35854215)
Nutrients. 2016 Dec 20;8(12):. (PMID: 27999383)
Intensive Care Med. 2012 Mar;38(3):384-94. (PMID: 22310869)
Arch Gerontol Geriatr. 2011 Sep-Oct;53(2):e149-52. (PMID: 20801531)
Qual Saf Health Care. 2003 Feb;12(1):40-6. (PMID: 12571344)
Clin Nutr. 2010 Apr;29(2):210-6. (PMID: 19709786)
Implement Sci. 2017 Nov 29;12(1):142. (PMID: 29187217)
- Contributed Indexing:
Keywords: Enteral nutrition; Feeding intolerance; Patient care bundles; Stepped wedge cluster randomised trial; Stroke
- Publication Date:
Date Created: 20241126 Date Completed: 20241126 Latest Revision: 20241212
- Publication Date:
20250114
- Accession Number:
PMC11587749
- Accession Number:
10.1186/s13063-024-08645-1
- Accession Number:
39587615
No Comments.