CLEAR Care Companion Application

January 7, 2025 updated by: University of Michigan Rogel Cancer Center
Hospital readmissions are common after major cancer surgery, leading to poorer patient outcomes, increased mortality and additional costs. In this study, Clinical and Engineering Approaches to Readmission (CLEAR) Care Companion Application, investigators aim to utilize a smartphone application that tracks concerning postoperative symptoms and provides educational interventions to determine if this can minimize delays in communication between patients and medical providers, increase patient satisfaction with the care received, and reduce or lessen the severity of readmissions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients complete clinically meaningful questions and validated questionnaires pertaining to physiological and psychological symptoms that serve as early indicators of readmission, with the aim to improve experience by empowering patient to be active participants in their recovery, identify complications early to minimize morbidity and reduce overall readmissions.

The study has the following three objectives: (1) Assess patient engagement with the CLEAR Care Companion application for patients that have undergone radical cystectomy (2) Measure patient experience with the application and its effect on satisfaction with overall care (3) Evaluate the effect of the application on case complexity (readmission intensity) and overall readmission rates.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Rogel Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing a radical cystectomy with reconstruction through GU Oncology Clinic
  • Patient at the University of Michigan (Michigan Medicine)
  • Access to compatible smartphone or tablet device

Exclusion Criteria:

  • Non-English speaking patients
  • Patients without access to a smart phone or tablet with internet capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLEAR CC
Patients use CLEAR CC application with Smartphone or Tablet
Behavioral: CLEAR Care Companion (CC) application
The CLEAR CC application is an EPIC-based, electronic application, downloaded to the patient's Smartphone or Tablet. The CLEAR CC leverages patient-reported symptoms assessment vis-a-vis push notifications to complete clinically meaningful questions and validated questionnaires pertaining to symptoms that serve as early indicators of readmission. The CLEAR CC application will send notifications beginning two days prior to surgery and continue until the 6 week post operative appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of engagement with application
Time Frame: 42 days post hospital discharge
To measure patient engagement with the application, the number of responses to application notifications and patient inputs will be captured in the electronic medical record (EMR). Descriptive statistics will be used to assess frequency and duration of engagement.
42 days post hospital discharge
Duration of engagement with application
Time Frame: 42 days post hospital discharge
To measure patient engagement with the application, the number of responses to application notifications and patient inputs will be captured in the electronic medical record (EMR). Descriptive statistics will be used to assess frequency and duration of engagement.
42 days post hospital discharge
Patient Experience Survey -- Overall Care (all participants)
Time Frame: 42 days post hospital discharge
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
42 days post hospital discharge
Patient Experience Survey -- Overall Care (first 20 participants)
Time Frame: 42 days post hospital discharge
The first 20 participants will complete a qualtrix survey.
42 days post hospital discharge
Readmission intensity
Time Frame: 42 days post hospital discharge
To measure the change in complexity of readmissions (readmission intensity), readmissions will be captured in the application and the EMR. For patients readmitted to Michigan Medicine, readmission parameters (reason for readmission, length of stay, interventions, ICU admission, etc.) will be captured and used to create a measure of readmission intensity. Descriptive statistics including (but not limited to) mean and standard deviation.
42 days post hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experience Survey -- Application (all participants)
Time Frame: 42 days post hospital discharge
Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
42 days post hospital discharge
Patient Experience Survey -- Application (first 20 participants)
Time Frame: 42 days post hospital discharge
The first 20 participants will complete a qualtrix survey.
42 days post hospital discharge
Readmission rate
Time Frame: 42 days post hospital discharge
Readmissions will be captured in the application and the EMR. Descriptive statistics including (but not limited to) mean and standard deviation.
42 days post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Jeffery Montgomery, M.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2022

Primary Completion (Actual)

July 24, 2024

Study Completion (Actual)

July 24, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2021.077
  • HUM00201652 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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