Abstract: A Study Determining Variances in Ostomy Skin Conditions and The Economic Impact (ADVOCATE): Methods and Interim Analysis (49th Annual Conference (May 19-23, 2017))

Tuesday, May 23, 2017: 12:00 AM

Janice Colwell, RN, MS, CWOCN, FAAN, General Surgery, University of Chicago Medicine, Chicago,, IL and Joyce Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Wound Ostomy Continence, Indiana University Health, Indianapolis, IN

Introduction

Peristomal skin complications (PSCs) are common; accounting for 39% of the visits to outpatient stoma clinics.¹ PSCs can cause pain, reduce quality of life (QOL), and contribute to high ostomy product usage, which may raise healthcare costs.^2,3 Maintaining peristomal skin integrity has important implications both to the healthcare economic environment and to the individual with an ostomy. The purpose of this study is to compare the effect of skin barrier on costs and the development of peristomal complications.

Objectives

The primary objective is to compare stoma related costs of care in two groups: subjects using ceramide- infused skin barriers (treatment) versus subjects using control barriers (control). The secondary objective is to compare incidence of PSCs for the two groups.

Methods and Measures

ADVOCATE is an international, IRB/EC approved, double-blind RCT employing an adaptive design. Adults with stomas created in the prior 12 weeks and normal peristomal skin were randomized to control or treatment barrier and evaluated at least every 4 weeks for up to 12 weeks. Investigators recorded utilization data and evaluated the peristomal skin using a validated instrument. Utilization data included healthcare visits, peristomal therapies, and product use.

Interim Results

The first interim analysis was completed for the purpose of sample size re-estimation and included data from 92 subjects (47 control; 45 treatment). Costs were calculated by multiplying utilizations by their respective unit costs. The treatment group average cost was US$47.18 lower than the average cost in the control group (p=.04). The proportion of subjects developing PSCs was lower in the group using ceramide-infused barriers (40% vs 57.5%, p=.10).

Conclusion

Healthcare cost evaluation and improved QOL are vitally important in ostomy care. While positive, the interim results did not meet the statistical threshold for concluding early. Re-estimated sample size to the next interim analysis is 152 subjects.