EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer

This study will formally test the quality improvement intervention of an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity.

Study Overview

• Status: Completed
• Conditions: Metastatic Solid Tumor; Chemotherapeutic Toxicity; Oncology
• Intervention / Treatment: Other: Oncology Consultation; Other: Chemotherapy toxicity tool

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• New outpatient visits with a medical oncologist following a new diagnosis of cancer and no prior history of chemotherapy treatment.
• aged > 65 will be included.

Exclusion Criteria:

• Patients who opt out of clinical research will be excluded from analysis, but not the intervention (which will be applied to all patients). Specifically, as sometimes opt-in/opt out status is coded ambiguously in the data we will only analyze results of patients with clear opt in and no history of opt out.
• Patients with no EHR data after initial oncologist appointment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care	Other: Oncology Consultation; Oncologists will consult new patient with a new diagnosis of cancer.
Experimental: Chemotherapy Toxicity Tool	Other: Oncology Consultation; Oncologists will consult new patient with a new diagnosis of cancer.; Other: Chemotherapy toxicity tool; CARG is an EMR based tool that informs medical oncologists visiting a patient for the first time of potential risk of chemotherapy toxicity. This intervention will make available a simple calculator which includes: Gender, Height and weight, Cancer Subtype, Hemoglobin, How is your hearing (with hearing aid, if needed)?, Number of falls in the past 6 months, Can you take your own medicines, Does your health limit you in walking one block., During the past 4 weeks, how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? and Glomerular filtration rate. The CARG chemotoxicity calculator will be built into the patient navigator and its use will be assessed on a monthly basis and used to inform iteration.; Other Names: CARG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospitalization rate	Measured at the patient level as a binary outcome (yes/no) based on date of initial visit with the oncologist.	Within 3 months of the Index Visit with the oncologist

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare contact days	Measured at the patient level as a continuous outcome (number of days).	Within 3 and 6 months of the Index Visit with the oncologist
Chemotherapy use rate	Measured at the patient level as a binary outcome (yes/no) if patient ever received systemic cancer-directed treatment.	Within 3 months of the Index Visit with the oncologist
Chemotherapy modification rate	Measured at the patient level as a binary outcome (yes/no) if patient had dose, schedule, or number of chemotherapy changed.	Within 3 months of the Index Visit with the oncologist
Palliative Care Referral	Measured at the patient level as a binary outcome (yes/no) based on presence of a scheduled palliative care appointment	Within 6 months of the Index Visit with the oncologist
Chemotherapy toxicity tool use rate	Measured at the patient level as a binary outcome (yes/no) based on whether the oncologist used the tool for that patient.	Within 3 months of the Index Visit with the oncologist

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2022LS125; STUDY00015357 (Other Identifier: IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be housed as subset within the existing Center for Learning Health System Science/Center for Quality Outcomes, Discovery and Evaluation database covered by IRB 597 Protocol: STUDY00014481. Patient level data will not be shared with anyone outside the study team. Aggregated data will be shared with quality officials, hospital administrators, and more broadly disseminated in academic meetings and for publication.

Drug and device information, study documents

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