Abstract P5-15-07: Time savings with trastuzumab subcutaneous (SC) injection vs. trastuzumab intravenous (IV) infusion: First results from a Time-and-Motion study (T&amp;M)
Authors: E de Cock, S Tao, U Alexa, X Pivot, A Knoop
Journal: Cancer Research (2012)

Abstract Objective: To quantify resource utilization in terms of “active” health care professional (HCP) time and consumables, as well as associated costs, related to trastuzumab (TRA) SC injection and TRA IV infusion in the treatment of patients with HER2-positive EBC within the PrefHer trial setting. Using time and resource use inputs, we will estimate average time and cost for SC and IV processes on a per patient and per site basis, as well as estimate potential time and cost savings with a switch from IV to SC administration route per site and per country. Methods: This is a multi-country (6 countries), multi-centre (17 centres), prospective, T&amp;M study, run as a sub-study to the PrefHer trial (ClinicalTrials.gov identifier NCT01401166). Using a structured questionnaire, we conducted on-site interviews with a nurse and pharmacy member in each centre to elicit practice pattern flow and to obtain time estimates for trastuzumab-related tasks for both IV and SC processes. The information served to tailor generic Case Report Forms (CRFs) to reflect centre-specific practices. For each task we defined adequate “start” and “stop” descriptions for pre-specified tasks to ensure accurate and unbiased collection of T&amp;M data. Data collection is performed by trained observers who measure time using a stop watch and record onto paper CRFs. This is a descriptive non-comparative study with convenience-based sample sizes ranging between 10–30 observations per process per site. While data collection is currently ongoing (final data expected during Q4 2012 and are planned to be reported at the meeting), first results presented in this abstract are based on interview data and for SC process on preliminary data from the T&amp;M study (in the absence of staff-elicited time estimates for SC process due to lack of experience). Estimated total time is calculated as the sum of individual task times and results are pooled across all sites. Results: Patient hospital arrival/registration, blood sampling, and physician visit account for a median 39 minutes (min) and are expected to be similar for both processes (i.e. “non-observed” time; not included in T&amp;M data collection). Median total HCP time for tasks included in the T&amp;M study (i.e. “observed” time) is estimated at 59 and 20 min, respectively (estimated 66% reduction with SC). For IV, the majority of “observed” task time is for account of TRA pharmacy reconstitution (25%) and infusion initiation (17%), with the remaining 58% distributed across other care unit tasks. For SC, injection (35%) and TRA pharmacy dispensing (30%) constitute the bulk of “observed” task time, with 35% for other care unit tasks. Time savings are expected because of avoiding time related mainly to infusion line (dis)connection, and IV pharmacy reconstitution, tasks which are only partially being replaced by SC injection and discarding. Conclusion: A switch from IV to SC TRA may result in important care unit and pharmacy time savings to be reinvested in improving overall patient care. Patients could potentially be moved out of the chemotherapy care unit to receive SC administration in other settings and free up valuable chair time, thereby increasing the unit's throughput and overall efficiency. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-15-07.