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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05904899
Collaborator
(none)
40
1
5.1
7.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Jul 30, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life questionnaires (QOL) [through study completion; an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Tacara Soones, MD, MPH, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05904899
    Other Study ID Numbers:
    • 2022-1034
    • NCI-2023-04326
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 15, 2023