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Advanced Clinical Evaluation (ACE) and Preparation for Oncology Clinical Trial Patients in the Ambulatory Infusion Clinic


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The Advanced Clinical Evaluation (ACE) program was developed at our institution in 2015 as a strategy to reduce the wait times of adult oncology patients receiving infusions in the ambulatory clinic. This multidisciplinary initiative involves the clinical evaluation of ambulatory oncology patients by registered nurses via phone prior to their treatment day. By evaluating patients prior to their arrival to clinic, we can reasonably determine if they will receive their scheduled treatment. Utilizing this information, pharmacy prepares ‘ACE Cleared’ patients’ intravenous drugs in advance of their appointment. This process shifts workload and care from a just-in-time model to one that allows for evaluation and product preparation during off-hour evening shifts, thereby reducing delays in drug preparation and delivery during busy clinic hours, alleviating same day issues, as well as improving patient safety.

The objective of this project was for the Investigational Drug Services (IDS) pharmacy to implement the ACE program for adult oncology clinical trial patients receiving investigational drugs administered in the ambulatory infusion clinic. The goal of this initiative was to ensure all drugs were delivered prior to patients’ scheduled appointment times, decrease same day inefficiencies, and work to resolve research related issues in advance of patients’ scheduled treatment days.

A multidisciplinary team including representation from pharmacy, nursing, and investigators developed detailed processes, training material and competencies for all staff involved in the program, in accordance with our institute’s Chemotherapy Policies. Lead nurses and pharmacists were trained first, and then given responsibility to train other team members. A patient assessment tool was used to guide research nurses’ clinical evaluations of patients via telephone encounters. After an initial 6 month training and implementation period (Sep. 2017 - Feb. 2018), data was collected over a 19 week period (Mar. 2018 - Aug. 2018) to examine ACE program utilization and efficiency of drug delivery, as well as waste metrics.

Utilizing a multidisciplinary approach, the implementation of the ACE program for adult oncology clinical trial patients has increased the efficiency of the IDS pharmacy by shifting approximately 20% of clinic-administered investigational drug preparation away from busy clinic hours. A total of 371 investigational drugs from 67 different protocols were prepared in advance during the examination period. The pharmacy delivered 92% of drugs prepared in advance to the clinic prior to the patient’s scheduled infusion time. Wasted investigational drugs prepared in advance accounted for 0.6% (11/1810) of all investigational drugs prepared for the clinic. Overall waste was 1.7% (30/1810), which is below the institutional goal of 2% and indicates minimal risk taken upon program implementation as there was no excessive waste of investigational drugs.

In addition to shifting workload away from busy clinic hours, preparing investigational drugs in advance allows for the timely resolution of issues, including vial assignment required by sponsors, inventory discrepancies, or investigation into aberrant lab results. In the future we hope to increase the percentage of ACE cleared clinical trial patients by engaging and training additional research nurses. It is also our goal to deliver 100% of investigational drugs prepared in advance to the clinic prior the patient’s chair time; therefore, monitoring and troubleshooting late delivery is an ongoing process.

Authors of this presentation have no disclosures concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.

Corresponding author: Christine Collins, PharmD, MS. The Johns Hopkins Hospital, Oncology IDS Pharmacy. 401 North Broadway, Weinberg 2430. Baltimore, MD 21287. [email protected]

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