The Genesis of The CHAMP-Path: Pragmatic RCTs Methodology

Abstract

A clinical pathway is an evidence-based integrated plan of care within a pre-defined time frame by multidisciplinary health care professionals. There is conflicting evidence about the utility of clinical pathways in real life settings. The aim of the study is to determine if collaborative, clinical pathway-based care (PC) vs. Usual care (UC) will decrease the length of stay (LOS) across multiple medical diagnoses. CHAMP-Path is a pragmatic, parallel, single blind, and randomized controlled trial. Physicians were randomized into two teams. Patient randomization was computer-generated through permuted blocks in 1:1 ratio, and allocation concealed. Eligibility criteria is age ? fourteen years, hemodynamic stability, and pathway-specific inclusion and exclusion criteria. The intervention is PC compared to UC. The primary outcome is the reduction in LOS. The secondary outcomes are patient- centered outcomes, determinants of LOS, and 30-day re-admission rate. A sample of 512 patients was estimated (Venous Thromboembolism: 128, Asthma: 90, Heart Failure: 90, Community Acquired Pneumonia: 166, Acute kidney injury: 38) to provide 80% power, alpha of 5% and accounting for 20% attrition. Mean LOS ± SD, 95% CI, p-value will be performed for LOS and regression analysis to identify determinants of LOS.