- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05904899
An Evaluation of the Implementation of the Care and Monitoring at Home Program- A New Paradigm for Acute Care Management of Cancer Patients
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of Life questionnaires (QOL)
Time Frame: through study completion; an average of 1 year
|
through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josiah Halm, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-1034
- NCI-2023-04326 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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