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

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122118
• Other study ID #: 19D.411
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: March 5, 2021

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Solid Neoplasm

Intervention

Other:
• Medical Chart Review
Review of medical chart
• Educational Intervention
Receive pharmacist-led education
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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