M203 - Multi-center Validation of a Novel Quality Improvement Protocol to Avoid Post-ileostomy Morbidity from Dehydration, While Allowing Earlier Discharge

Purpose/Background: After implementation of the Affordable Care Act, healthcare resource utilization-metrics are increasingly being used to assess the quality of care provided and determine reimbursement. Ileostomy-related morbidity rates approach 65% with increased risk of readmission, specifically from dehydration. We aimed to show the efficacy of a novel ileostomy-specific quality improvement protocol at an academic center, with subsequent validation at another academic institution.

Methods/Interventions: All patient included in this IRB approved study followed a standardized enhanced recovery after surgery (ERAS) protocol before and after institution of the novel protocol. This prospective study comprised of two phases. The first phase was to establish efficacy of the novel protocol at one institution. In this phase, patients who underwent elective ileostomy creation at University of Florida Health (UF) from 2011-2018 were included. The second phase was to validate the results of phase I at another academic institution. In this phase, all patients who underwent elective ileostomy creation at Baylor College of Medicine from 2018-2023 were included. Postoperative outcomes for the cohort before and after protocol implementation were compared with a matched cohort nationally, based on the Vizient dataset (for UF) and NSQIP (for Baylor). The novel protocol mandated a midline or PICC line for home IV fluids (1,000 ml/night), irrespective of ileostomy output on postoperative day 1 for all new ileostomates. Patients were discharged once tolerating diet and pain was controlled. Patients were called daily after discharge, with counseling and medication adjustments for high ileostomy output. Home IV fluids and the IV line were discontinued when patients were in a positive fluid balance for at least 2 days with oral intake.

Results/Outcomes: A total of 600 patients with a new ileostomy were included in this study. Of these, 250 patients were enrolled in phase I at UF and 350 patients were enrolled in phase II at Baylor. Baseline characteristics were similar for the group pre- and post-protocol institution. Institution of the novel protocol significantly improved the mean length of stay (LOS) (8 days vs 3 days, p< 0.0001), LOS index (2.1 vs 0.5, p< 0.0001), readmission rate (40% vs 8%, p< 0.001), complication rate (65% vs 18%, p< 0.003), cost of care for the index operation ($49,359 vs $19,050, p< 0.0004) and cost for the readmission (if readmitted) ($84,380 versus $15,200, p< 0.0001) for the entire cohort. This was true for both Phase I and II (Figure 1). No PICC/midline-related infection or DVT were noted during the study period.

Conclusion/Discussion: Implementation of a novel ileostomy-specific standardized protocol to avoid morbidity from dehydration significantly improved quality by decreasing LOS, readmissions, complications and cost of care. Validation of this protocol at another institution confirmed these findings, despite the COVID pandemic during phase II.