Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor

Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center

This trial studies how well pharmacist-led transitions of care works in the outpatient oncology infusion center for patients with solid tumor. Having a pharmacist in the outpatient oncology infusion center may help to identify and correct medical related problems and improve overall patient and staff satisfaction. Patients receiving education may benefit from gaining a better understanding of their antineoplastic therapy. Understanding the side effects associated with the therapy may also help patients better be prepared to manage any adverse effects they may experience.

Study Overview

• Status: Completed
• Conditions: Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Medical Chart Review; Other: Educational Intervention

Detailed Description

PRIMARY OBJECTIVE:

I. To demonstrate the effectiveness of a clinical oncology pharmacist in the outpatient infusion center through education, and the identification and correction of medication related problem (MRP)s.

SECONDARY OBJECTIVE:

I. To evaluate overall patient and staff satisfaction with the added clinical oncology pharmacy education.

EXPLORATORY OBJECTIVE:

I. Estimate the cost avoidance utilizing the pharmacy services provided in the prospective trial.

OUTLINE:

PHASE I: Patients' medical records are reviewed.

PHASE II: Patients receive pharmacist-led education on antineoplastic therapies including what to expect during infusion, general drug facts, common adverse effects, side effect management, and when to contact provider.

After completion of study, patients are followed up periodically.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Solid tumor diagnosis
• Starting day 1 of new antineoplastic infusion
• English speaking (and/or English-speaking primary caregiver/proxy)

Exclusion Criteria:

• Metastasis to the brain and/or central nervous system (CNS) with evidence of impaired cognition
• Severe cognitive impairment including dementia with inability to consent to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hearth services research (pharmacist-led education); PHASE I: Patients' medical records are reviewed. PHASE II: Patients receive pharmacist-led education on antineoplastic therapies including what to expect during infusion, general drug facts, common adverse effects, side effect management, and when to contact provider.	Other: Survey Administration; Ancillary studies; Other: Medical Chart Review; Review of medical chart; Other Names: Chart Review; Other: Educational Intervention; Receive pharmacist-led education; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medical related problem (MRP)s identified by the pharmacist through retrospective chart reviews (Phase I)	MRPs will be assigned to a specific category and the total number of MRPs in each category will be recorded. Categories include but are not limited to: incorrect dose, therapeutic duplication, drug not indicated, drug interaction, monitoring recommendation, drug allergy, or potential for adverse event.	Up to 1 year
Percent of MRPs corrected as a result of the clinical oncology pharmacist services (Phase II)	In phase 2 (prospective) MRPs will also be recorded and categorized, but in addition the outcomes relating to each MRP pharmacist intervention will be recorded. MRPs found by the pharmacist will be communicated to the patient's oncologist or primary care provider, and the pharmacist will follow-up to see if changes were made.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and provider satisfaction with the pharmacist-led education	The survey results will help determine the need for a clinical oncology pharmacist in the outpatient infusion center. Satisfaction will be assessed using a Likert-scale survey. Scale ranges from 1 (strongly disagree) to 5 (strongly agree).	Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate of Cost avoidance utilizing pharmacy services	In order to determine cost avoidance the type of interventions made and the time associated with each intervention will be recorded. The cost per intervention will be calculated by multiplying the pharmacist salary in minutes by the time for each intervention. The intervention types will be assigned cost avoidance values based on previous literature and these will be used to determine the cost benefit for the interventions made during the study period.	Up to 1 year

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Gloria Espinosa, PharmD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): March 5, 2021
• Study Completion (Actual): March 5, 2021

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19D.411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No