Session number: 1063
Abstract title: Cost Evaluation in a Clinical Trial of Therapeutic Footwear
Author(s):
ML Maciejewski - Northwest Center for Outcomes Research in Older Adults
GE Reiber - Northwest Center for Outcomes Research in Older Adults
D Smith - University of Washington Department of Medicine
Objectives: To evaluate ulcer-attributable and overall cost differences across three arms of a clinical trial of therapeutic footwear for patients with diabetes at high risk for reulceration. We also examined costs between VA patients and non-VA patients enrolled in the trial.
Methods: Cost data for 392 patients in a clinical trial of therapeutic footwear was obtained from DSS cost accounting systems being used by the VA and non-VA health system from which study patients were drawn. Ulcer-attributable utilization and costs were identified from primary CPT-4 procedure codes and ICD-9 diagnosis codes related to ulcers and abnormal skin conditions, peripheral vascular disease and other conditions. Intervention costs related to study visits, calls, shoes, inserts and slippers were captured in administrative records maintained by study staff.
Results: There were no significant differences in resource use of any kind across the three study arms, with the exception of study shoes, insoles and slippers. Arm 1 and Arm 2 participants had study shoe costs that were significantly higher than Arm 3 participants. Despite the higher study shoe costs in Arms 1 and 2, there were no significant offsets in health care costs. Two-year ulcer-attributable outpatient costs were $497, $515, and $603 for participants in Arms 1, 2, and 3, respectively. Two-year ulcer-attributable inpatient costs were $416, $403, and $589 in Arms 1, 2, and 3, respectively. While VA and non-VA utilization was not significantly different, costs for VA patients were nearly twice as high as costs for non-VA patients.
Conclusions: The provision of therapeutic footwear had no clinical benefit or cost offset for patients with diabetes at high-risk for reulceration. Inpatient and outpatient care for high-risk VA patients with diabetes appears to be twice as expensive as health care for similar patients in a non-VA setting.
Impact statement: VA administrators may want to reconsider therapeutic footwear benefits for veterans with similar characteristics as those in this trial, in light of insignificant clinical benefits and cost offset that was observed. Other types of interventions may necessary to reduce the reulceration rates in this group of veterans.