EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

Not Applicable

Completed

• Conditions: Chemotherapeutic Toxicity; Oncology; Metastatic Solid Tumor
• Interventions: Other: Oncology Consultation; Other: Chemotherapy toxicity tool

• Registration Number: NCT05809557
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-04-12
• Primary Completion: 2023-06-09
• Study Completion: 2024-01-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Oncology Consultation	-
Chemotherapy Toxicity Tool	Oncology Consultation	-
Chemotherapy Toxicity Tool	Chemotherapy toxicity tool	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Masonic Cancer Center, University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States