Readmission and Mortality in Malnourished, Older, Hospitalized Adults Treated With a Specialized Oral Nutritional Supplement: A Randomized Clinical Trial
Clinical Nutrition. 2016 Feb; 35(1):18-26. doi: 10.1016/j.clnu.2015.12.010. Epub 2016 Jan 18.
Deutz, N. E., Matheson, E. M., Matarese, L. E., Luo, M., Baggs, G. E., Nelson, J. L., Hegazi, R. A., Tappenden, K. A., Ziegler, T. R., & NOURISH Study Group
Abstract
Background: Hospitalized, malnourished older adults have a high risk of readmission and mortality.
Objective: Evaluation of a high-protein oral nutritional supplement (HP-HMB) containing beta-hydroxy-beta-methylbutyrate on postdischarge outcomes of nonelective readmission and mortality in malnourished, hospitalized older adults.
Design: Multicenter, randomized, placebo-controlled, double-blind trial.
Setting: Inpatient and posthospital discharge.
Patients: Older (≥65 years), malnourished (Subjective Global Assessment [SGA] class B or C) adults hospitalized for congestive heart failure, acute myocardial infarction, pneumonia, or chronic obstructive pulmonary disease.
Interventions: Standard-of-care plus HP-HMB (n = 328) or a placebo supplement (n = 324), 2 servings/day.
Measurements: Primary composite endpoint was 90-day postdischarge incidence of death or nonelective readmission. Other endpoints included 30- and 60-day postdischarge incidence of death or readmission, length of stay (LOS), SGA class, body weight, and activities of daily living (ADL).
Results: The primary composite endpoint was similar between HP-HMB (26.8%) and placebo (31.1%). No between-group differences were observed for 90-day readmission rate, but 90-day mortality was significantly lower with HP-HMB relative to placebo (4.8% vs. 9.7%; relative risk 0.49, 95% confidence interval [CI], 0.27 to 0.90; p = 0.018). The number-needed-to-treat to prevent 1 death was 20.3 (95% CI: 10.9, 121.4). Compared with placebo, HP-HMB resulted in improved odds of better nutritional status (SGA class, OR, 2.04, 95% CI: 1.28, 3.25, p = 0.009) at day 90, and an increase in body weight at day 30 (p = 0.035). LOS and ADL were similar between treatments.
Limitations: Limited generalizability; patients represent a selected hospitalized population.
Conclusions: Although no effects were observed for the primary composite endpoint, compared with placebo HP-HMB decreased mortality and improved indices of nutritional status during the 90-day observation period.