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Management of Adverse Events in Early Clinical Trials by Advanced Practice Providers in the Outpatient Setting: The
Fedricker D Barber1, Erick Campbell1, Yuko Yamamura1
1Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Background:
Advanced practice providers (APPs) play important roles in enrolling, educating, and caring for patients in clinical trials. However, much remains unknown about the role of APPs in managing adverse events (AEs) in early (phase I to II) clinical trials. In this study, we assessed the outpatient management of grade 3 to 4 AEs by APPs in early trials and characterized the workflow of our APP Phase I to II Fast Track (FT) Clinic.
Patients And Methods:
We retrospectively reviewed records of patients with advanced or metastatic solid tumors enrolled in phase I to II clinical trials who were seen by APPs from September 2017 to August 2018 in the APP phase I to II FT clinic in the Department of Investigational Cancer Therapeutics.
Results:
A total of 808 patients enrolled in 159 clinical trials were seen in 2,697 visits (median 3 visits per patient; range 1-28) by 10 APPs. Treatment was interrupted in 6.9% of visits, and grade 3 to 4 AEs were seen in 5.4% of visits; however, patients from 1.4% of visits were sent to the emergency center (EC) and/or admitted. Patients referred to the EC and/or admitted were more likely to have baseline hypoalbuminemia, high lactate dehydrogenase, and poor Eastern Cooperative Oncology Group performance status (i.e., ECOG > 1; p < .001). There were no associations between EC referral and gender, APP years of experience, or type of treatment.
Conclusions:
The APP Phase I to II FT Clinic has an important role in the management of AEs by APPs in early clinical trials in the outpatient setting, potentially avoiding EC visits and admissions.
Insights
Advanced practice providers effectively manage severe adverse events in early-phase clinical trials. Their specialized clinic may reduce emergency visits and hospital admissions for patients in oncology trials.
Area of Science:
- Oncology
- Clinical Trials
- Advanced Practice Providers
Background:
- Advanced practice providers (APPs) are integral to clinical trial patient care.
- The role of APPs in managing adverse events (AEs) in early-phase trials requires further investigation.
Purpose of the Study:
- To assess the outpatient management of grade 3 to 4 AEs by APPs in early phase I to II clinical trials.
- To characterize the workflow of an APP-led Phase I to II Fast Track (FT) Clinic.
Main Methods:
- Retrospective review of patient records from September 2017 to August 2018.
- Analysis of data from patients with advanced or metastatic solid tumors in phase I to II clinical trials managed by APPs.
Main Results:
- 10 APPs managed 808 patients across 159 trials over 2,697 visits.
- Grade 3-4 AEs occurred in 5.4% of visits, with 1.4% requiring emergency center (EC) referral or admission.
- EC referral was associated with hypoalbuminemia, high LDH, and poor ECOG performance status (p < .001).
Conclusions:
- The APP Phase I to II FT Clinic effectively manages AEs in the outpatient setting.
- APP management of AEs may help avoid unnecessary EC visits and hospital admissions.
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