Major Complication Rate in Cancer Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04557709
Collaborator
National Cancer Institute (NCI) (NIH)
126
1
26.6
4.7

Study Details

Study Description

Brief Summary

This study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "Hospital at Home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. Learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVE:
  1. Estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever.
SECONDARY OBJECTIVES:
  1. Describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever.

  2. Describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography [CT] scans).

OUTLINE:

Patients' medical charts are reviewed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
126 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Descriptive Study of Major Complications in Oncology Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program
Actual Study Start Date :
Jul 13, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Observational (chart review)

Patients' medical charts are reviewed.

Other: Medical Chart Review
Review of medical charts
Other Names:
  • Chart Review
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of patients who experience major complications that require escalated care [1 month]

      Percentages will be presented with exact binomial 95% confidence interval. Also, will identify significant predictors of major complications (yes or no) using univariable logistic regression.

    Secondary Outcome Measures

    1. Patient demographic, clinical, and psychosocial features [1 month]

      Will describe the study sample demographic, clinical, and psychosocial features. Descriptors will include frequencies, percentages, means with standard deviations, or medians with interquartile ranges, and minimum and maximum values as appropriate.

    2. Situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home (HaH) program [1 month]

      Will enumerate situations and treatments observed in the study sample that could not be handled optimally in the HaH environment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019

    • Be at low risk for major complications as defined by a Multinational Association for Supportive Care in Cancer (MASCC) score < 21

    Exclusion Criteria:
    • Reside in a nursing home

    • Homelessness

    • Hospice enrollment

    • A secondary reason for admission to the hospital or high risk clinical feature not captured in the MASCC score that places them at high risk for major complications in a hospital at home program

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Tacara N Soones, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04557709
    Other Study ID Numbers:
    • 2020-0394
    • NCI-2020-06606
    • 2020-0394
    First Posted:
    Sep 22, 2020
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022