Abstract: Ostomy Skin Barriers and Costs of Care: ADVOCATE Randomized Controlled Trial (50th Annual Conference)

Janice Colwell, MS, RN, CWOCN, FAAN, University of Chicago, Advanced Practice Nurse - Ostomy Care Services, Chicago, IL, Joy Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Wound Ostomy Continence, Indiana University Health, Indianapolis, IN and Rose Raizman, RN-EC, MSc, MNurs, CETN, professional practice, Scarborough and Rouge Hospital, toronto, ON, Canada

Ostomy Skin Barriers and Costs of Care: ADVOCATE Randomized Controlled Trial

Objective

Maintaining peristomal skin integrity has important implications both to the healthcare economic environment and to the individual with an ostomy. The aim was to compare the effect of ostomy skin barriers on costs and peristomal skin complications (PSC) comparing ceramide infused skin barriers (treatment) to control skin barriers (control). Quality of life and satisfaction were also examined.

Methods

The ADVOCATE study is an international double-blind Randomized Controlled Trial employing an adaptive design. Adults having ostomy surgery in the prior 12 weeks and normal peristomal skin were randomized and followed up to 12 weeks. Utilization data included healthcare visits, peristomal therapies, and product use. Peristomal skin was assessed using a validated instrument. QOL was measured using SF-12v2. Patient reported outcomes were collected using a study-specific questionnaire.

Results

153 adults from 25 sites in the US, Canada and Europe participated. Subjects were seen in hospital and outpatient settings. The ceramide infused barrier significantly reduced stoma-related cost of care over a 12 week period; adjusted average costs were $223.73 (treatment) and $260.19 (control) [95% CI of the difference: 6.49, 66.43, p=0.017]. The incidence of PSCs in the study was 40.5% for treatment, 55.4% for control [95% CI of the difference: -1.2, 30.4, p=0.069]. Post-operative improvement in QoL was noted in both groups. Significantly more participants using the ceramide infused skin barrier were ‘very satisfied’ with barrier performance (75% vs. 55%; p=0.033), leakage prevention (63% vs. 38%; p<.01), and itching prevention (53% vs. 31%; p=0.016).

Conclusion

Healthcare cost evaluation is vitally important and is closely tied to PSCs. The ADVOCATE RCT compared the effect of ostomy skin barriers on ostomy care cost and found the use of the ceramide infused barrier reduced costs and that the group who used this product sustained fewer PSCs.

R38 Ostomy Skin Barriers and Costs of Care: ADVOCATE Randomized Controlled Trial