Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial

Abstract 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 applicat...

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Main Authors: Cong Wang, Shanshan Liu, Shiqi Jia, Cai Yan, Xue Zhang, Yuan liu, Liang Du, Yan Jiang
Format: Article
Language:English
Published: BMC 2024-11-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-024-08645-1
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author Cong Wang
Shanshan Liu
Shiqi Jia
Cai Yan
Xue Zhang
Yuan liu
Liang Du
Yan Jiang
author_facet Cong Wang
Shanshan Liu
Shiqi Jia
Cai Yan
Xue Zhang
Yuan liu
Liang Du
Yan Jiang
author_sort Cong Wang
collection DOAJ
description Abstract 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.
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spelling doaj-art-0b85f07042c64a84a672b8d7ee922f052024-12-01T12:43:23ZengBMCTrials1745-62152024-11-0125111310.1186/s13063-024-08645-1Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trialCong Wang0Shanshan Liu1Shiqi Jia2Cai Yan3Xue Zhang4Yuan liu5Liang Du6Yan Jiang7Department of Neurosurgery, West China Hospital, Sichuan UniversityEvidence-Based Nursing Center, West China Hospital, Sichuan UniversityDepartment of Neurosurgery, West China Hospital, Sichuan UniversityEvidence-Based Nursing Center, West China Hospital, Sichuan UniversitySchool of Nursing, Sichuan UniversitySchool of Nursing, Sichuan UniversityChinese Evidence-Based Medicine Center, West China Hospital, Sichuan UniversityEvidence-Based Nursing Center, West China Hospital, Sichuan UniversityAbstract 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.https://doi.org/10.1186/s13063-024-08645-1StrokeEnteral nutritionPatient care bundlesFeeding intoleranceStepped wedge cluster randomised trial
spellingShingle Cong Wang
Shanshan Liu
Shiqi Jia
Cai Yan
Xue Zhang
Yuan liu
Liang Du
Yan Jiang
Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
Trials
Stroke
Enteral nutrition
Patient care bundles
Feeding intolerance
Stepped wedge cluster randomised trial
title Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
title_full Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
title_fullStr Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
title_full_unstemmed Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
title_short Care bundles to improve enteral nutrition management in stroke patients: study protocol for a stepped wedge cluster randomised trial
title_sort care bundles to improve enteral nutrition management in stroke patients study protocol for a stepped wedge cluster randomised trial
topic Stroke
Enteral nutrition
Patient care bundles
Feeding intolerance
Stepped wedge cluster randomised trial
url https://doi.org/10.1186/s13063-024-08645-1
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