EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05809557
• Other study ID #: 2022LS125
• Secondary ID: STUDY00015357
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: January 9, 2024

Study information

• Verified date: February 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 9, 2024
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Metastatic Solid Tumor
• Neoplasms
• Oncology

Intervention

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.
• Oncology Consultation
Oncologists will consult new patient with a new diagnosis of cancer.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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