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

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ClinicalTrials.gov Identifier: NCT04122118
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Solid Neoplasm Other: Medical Chart Review Other: Educational Intervention Other: Survey Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

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: Medical Chart Review
Review of medical chart
Other Name: Chart Review

Other: Educational Intervention
Receive pharmacist-led education
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Educational

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Number of medical related problem (MRP)s identified by the pharmacist through retrospective chart reviews (Phase I) [ Time Frame: Up to 1 year ]
    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.

  2. Percent of MRPs corrected as a result of the clinical oncology pharmacist services (Phase II) [ Time Frame: Up to 1 year ]
    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.


Secondary Outcome Measures :
  1. Patient and provider satisfaction with the pharmacist-led education [ Time Frame: Up to 1 year ]
    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).


Other Outcome Measures:
  1. Estimate of Cost avoidance utilizing pharmacy services [ Time Frame: Up to 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122118


Contacts
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Contact: Gloria Espinosa, PharmD 215-955-9046 gloria.espinosa@jefferson.edu

Locations
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United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Gloria Espinosa    215-955-9046    gloria.espinosa@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Gloria Espinosa, PharmD Sidney Kimmel Cancer Center at Thomas Jefferson University

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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04122118     History of Changes
Other Study ID Numbers: 19D.411
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No