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NCT04557709 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

Official title:
A Descriptive Study of Major Complications in Oncology Patients With Neutropenic Fever Potentially Eligible for a Hospital at Home Program

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04557709
Other study ID # 2020-0394
Secondary ID NCI-2020-0660620
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2020
Est. completion date September 30, 2025

Study information
Verified date March 2024
Source M.D. Anderson Cancer Center
Contact Tacara N Soones
Phone 713-792-4253
Email tnsoones@mdanderson.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 126
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Medical Chart Review
Review of medical charts

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients who experience major complications that require escalated care 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. 1 month
Secondary Patient demographic, clinical, and psychosocial features 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. 1 month
Secondary 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 Will enumerate situations and treatments observed in the study sample that could not be handled optimally in the HaH environment. 1 month
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