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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Medical Chart Review

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Tacara N Soones; Phone Number: 713-792-4253; Email: tnsoones@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Tacara N. Soones; Phone Number: 713-792-4253; Email: tnsoones@mdanderson.org
      • Principal Investigator: Tacara N. Soones

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to MD Anderson Cancer Center through the Emergency Center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (chart review); Patients' medical charts are reviewed.	Other: Medical Chart Review; Review of medical charts; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tacara N Soones, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Cytopenia; Neoplasms; Febrile Neutropenia
• Other Study ID Numbers: 2020-0394 (Other Identifier: M D Anderson Cancer Center); NCI-2020-06606 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No