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EMR Chemotoxicity Risk Calculator To Decrease Chemotherapy Toxicity

Sponsor
Masonic Cancer Center, University of Minnesota (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05809557
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Chemotherapy toxicity tool
  • Other: Oncology Consultation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of an EMR Chemotoxicity Risk Calculator Availability To Decrease Chemotherapy Toxicity in Adults With Cancer
Actual Study Start Date :
Jan 9, 2023
Actual Primary Completion Date :
Jan 9, 2023
Anticipated Study Completion Date :
Jan 9, 2024

Arms and Interventions

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: 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

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    3. 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.

    4. 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

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Masonic Cancer Center, University of Minnesota Minneapolis Minnesota United States 55455

    Sponsors and Collaborators

    • Masonic Cancer Center, University of Minnesota

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Masonic Cancer Center, University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT05809557
    Other Study ID Numbers:
    • 2022LS125
    • STUDY00015357
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2023