EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

NCT05809557 | Completed

• 2 other identifiers: 2022LS125STUDY00015357
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Chemotherapeutic Toxicity; Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Healthcare contact days

  Within 3 and 6 months of the Index Visit with the oncologist

• Chemotherapy use rate

  Within 3 months of the Index Visit with the oncologist

• Chemotherapy modification rate

  Within 3 months of the Index Visit with the oncologist

• Palliative Care Referral

  Within 6 months of the Index Visit with the oncologist

• Chemotherapy toxicity tool use rate

  Within 3 months of the Index Visit with the oncologist

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Other: Oncology Consultation

Chemotherapy Toxicity Tool

EXPERIMENTAL

Other: Chemotherapy toxicity tool; Other: Oncology Consultation

Interventions

Chemotherapy toxicity tool OTHER

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.

Also known as: CARG

Chemotherapy Toxicity Tool

Oncology Consultation OTHER

Oncologists will consult new patient with a new diagnosis of cancer.

Chemotherapy Toxicity Tool; Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Providers, who were selected based on having at least 20 new patients with metastatic solid tumors in a 6-month period in 2021, will be randomized in a 1:1 ratio, stratified by quartiles of patient volume.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: January 9, 2023
• Primary Completion: June 9, 2023
• Study Completion: January 9, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)