A multi-center, stepped-wedge cluster randomized controlled trial is currently underway in China to assess the effectiveness of care bundles for managing enteral nutrition in stroke patients. The study aims to determine if these care bundles can reduce feeding intolerance and improve overall outcomes for this vulnerable patient population.
The trial, conducted across eight hospitals in Chengdu, Deyang, Mianzhu, Luzhou, and Leshan, employs a stepped-wedge design. This design involves a sequential rollout of the intervention, with hospitals randomly transitioning from control care to the intervention care over a 10-period duration. The primary hypothesis is that the implementation of care bundles will significantly reduce the incidence of feeding intolerance among stroke patients requiring enteral nutrition.
Trial Design and Setting
The study is designed as a superiority trial, ultimately achieving a 1:1 allocation ratio of all patients in different clusters between the control and intervention groups. At the beginning, all hospitals are in the control period and receive the control group care. Starting from the second period, one hospital is randomly selected each month to enter the training period and is switched to the intervention period. By the last period of the study, all the hospitals are in the intervention period and have received the intervention group programme.
Patient Population and Intervention
The trial includes adult patients (≥18 years) diagnosed with stroke who require enteral nutrition. Exclusion criteria involve a history of gastrointestinal diseases or contraindications to enteral nutrition components. The intervention consists of care bundles comprising six core measures:
- Establishment of a nurse-led multidisciplinary stroke enteral nutrition management team.
- Application of a quality management index system for enteral nutrition.
- Formation of standardized feeding pathways and modalities.
- Establishment of an enteral nutrition monitoring scheme.
- Provision of individualized enteral nutrition preparation.
- Prevention and control of enteral nutrition complications.
During the control period, patients receive traditional nutritional measures as per the standard of care at each hospital. The primary outcome is feeding intolerance, defined by the presence of two or more of the following: insufficient enteral intake (less than 2/3 of planned volume in 24 hours), gastrointestinal symptoms (abdominal distension, diarrhea, vomiting, etc.), or high gastric residual volume (>250 mL or >50% of enteral intake 4 hours after feeding).
Sample Size and Statistical Analysis
Based on an expected reduction in feeding intolerance from 44.1% to less than 30% post-intervention, a sample size of 1224 patients was calculated, with 144 cases per hospital. Data will be analyzed using a generalized linear mixed model (GLMM), with interventions included as fixed effects and hospitals as random effects, adjusted for demographic factors, Barthel index (BI), and nutritional status at baseline.
Expected Impact
This trial has the potential to significantly impact the management of enteral nutrition in stroke patients. By implementing standardized care bundles, the study aims to reduce feeding intolerance, improve nutritional outcomes, and enhance the overall recovery process for individuals affected by stroke. The results of this study will be reported in writing to the funder and are planned for publication in a peer-reviewed scientific journal. Additionally, the research content and findings will be disseminated to stakeholders in the field of enteral nutrition for stroke patients through meetings, forums, and other channels.
