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

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.