An Evaluation of the Implementation of the Care and Monitoring at Home Program- A New Paradigm for Acute Care Management of Cancer Patients

Cancer Clinical Trial

Official title:

An Evaluation of the Implementation of the Care and Monitoring at Home Program- A New Paradigm for Acute Care Management of Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904899
• Other study ID #: 2022-1034
• Secondary ID: NCI-2023-04326
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Tacara Soones, MD, MPH
• Phone: (346) 720-7352
• Email: tnsoones[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To understand the experience of patients receiving care in the Care and Monitoring at Home program at MD Anderson. Researchers intend to use this information to study and possibly improve the hospital care at home program.

Description:

OBJECTIVES

Primary Objectives

The objective of this observational study is to assess the feasibility of providing hospital substitution hospital level care in the home for patients with cancer through the CaMH Program. Our primary gauge of feasibility will be a care escalation rate of <20%, defined as the proportion of patients who initiate care in our HaH program but are transferred back to the inpatient setting to complete the care episode. This threshold is consistent with the published literature.15 In addition, a "feasible" designation will require a median score > 3 on each of three post-discharge survey implementation measures - the Feasibility of Implementation Measure, Acceptability of Implementation Measure, and Intervention Appropriateness Measure.

Secondary Objectives

Secondary objectives will include patient experience and perception about CaMH, length of stay, rate of clinical adverse events during CaMH (falls, pressure ulcers, medication errors) and 30-days after discharge, 7-day readmission, 30-day readmission, and 30-day emergency department visit rate. (Note, the aforementioned adverse events could occur as a result of participation in CaMH. However, minimal adverse events are expected a result of participation in this observational study (see adverse events below)). A patient will be considered to have an ER visit or hospital readmission if these events are documented in the medical record OR the patient reports the event on the survey.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants will be eligible for enrollment in this study if they have accepted enrollment in CaMH. No patients will be excluded if they are enrolled in CaMH.

• Cognitively impaired adults will be able to participate in the study if an adults proxy provides informed consent and completes survey materials on their behalf.

Exclusion Criteria:

• Children and pregnant women will not be enrolled in the CaMH program, and therefore not eligible for this study.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life questionnaires (QOL)		through study completion; an average of 1 year

External Links

•   MD Anderson Cancer Center