CLEAR Care Companion Application

Not Applicable

Completed

• Conditions: Bladder Cancer; Radical Cystectomy
• Interventions: Behavioral: CLEAR Care Companion (CC) application

• Registration Number: NCT05578898
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

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 Timeline

• Study Start: 2022-08-12
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Primary Completion: 2024-07-24
• Study Completion: 2024-07-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLEAR CC	CLEAR Care Companion (CC) application	Patients use CLEAR CC application with Smartphone or Tablet

Primary Outcome Measures

Name	Time	Method
Frequency of engagement with application	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.
Duration of engagement with application	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.
Patient Experience Survey -- Overall Care (first 20 participants)	42 days post hospital discharge	The first 20 participants will complete a qualtrix survey.
Patient Experience Survey -- Overall Care (all participants)	42 days post hospital discharge	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.
Readmission intensity	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.

Secondary Outcome Measures

Name	Time	Method
Readmission rate	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.
Patient Experience Survey -- Application (first 20 participants)	42 days post hospital discharge	The first 20 participants will complete a qualtrix survey.
Patient Experience Survey -- Application (all participants)	42 days post hospital discharge	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States