Multicentre, cluster-randomized clinical trial of algorithms for critical-care enteral and parenteral therapy (ACCEPT)

Abstract

Background: The provision of nutritional support for patients in intensive care units (ICUs) varies widely both within and between institutions. We tested the hypothesis that evidence-based algorithms to improve nutritional support in the ICU would improve patient outcomes.

Methods: A cluster-randomized controlled trial was performed in the ICUs of 11 community and 3 teaching hospitals between October 1997 and September 1998. Hospital ICUs were stratified by hospital type and randomized to the intervention or control arm. Patients at least 16 years of age with an expected ICU stay of at least 48 hours were enrolled in the study (n = 499). Evidence-based recommendations were introduced in the 7 intervention hospitals by means of in-service education sessions, reminders (local dietitian, posters) and academic detailing that stressed early institution of nutritional support, preferably enteral.

Results: Two hospitals crossed over and were excluded from the primary analysis. Compared with the patients in the control hospitals (n = 214), the patients in the intervention hospitals (n = 248) received significantly more days of enteral nutrition (6.7 v. 5.4 per 10 patient-days; p = 0.042), had a significantly shorter mean stay in hospital (25 v. 35 days; p = 0.003) and showed a trend toward reduced mortality (27% v. 37%; p = 0.058). The mean stay in the ICU did not differ between the control and intervention groups (10.9 v. 11.8 days; p = 0.7).

Interpretation: Implementation of evidence-based recommendations improved the provision of nutritional support and was associated with improved clinical outcomes.

Fig. 1: Algorithms A, B and C (depicted on this page and the next one) for critical-care nutritional support, developed in 1996 and used in the intervention hospitals to guide selection and management and assist in the assessment of diarrhea associated with tube feeding and tolerance to tube feeding. ICU = intensive care unit, EN = enteral nutrition, TPN = total parenteral nutrition, PN = parenteral nutrition, C. = Clostridium.

Figure 1. Continued.

Figure 1. Continued.

Fig. 2: Patient flow during the randomized phase in the 7 intervention and 7 control ICUs. “Data missing” refers to the primary outcome (mortality and length of stay). Complete data on nutritional support were available for 487 patients. The 2 inappropriately randomized hospitals contributed 84 admissions (9 eligible and enrolled patients) to the control group and 58 admissions (22 eligible and 21 enrolled patients) to the intervention group. R = randomization.

Fig. 3: Cluster-specific mean proportions, and 95% confidence intervals, of patients receiving nutritional support in the appropriately randomized control and intervention hospitals on each study day. Day 1 is the day of ICU admission. The p values were obtained from a t test of cluster-specific means.