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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05904899
Other study ID # 2022-1034
Secondary ID NCI-2023-04326
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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