CLEAR Care Companion Application

Bladder Cancer Clinical Trial

Official title:

CLEAR Care Companion Application

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05578898
• Other study ID #: UMCC 2021.077
• Secondary ID: HUM00201652
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Radical Cystectomy
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of engagement with application	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
Primary	Duration of engagement with application	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
Primary	Patient Experience Survey -- Overall Care (all participants)	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.	42 days post hospital discharge
Primary	Patient Experience Survey -- Overall Care (first 20 participants)	The first 20 participants will complete a qualtrix survey.	42 days post hospital discharge
Primary	Readmission intensity	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	Patient Experience Survey -- Application (all participants)	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.	42 days post hospital discharge
Secondary	Patient Experience Survey -- Application (first 20 participants)	The first 20 participants will complete a qualtrix survey.	42 days post hospital discharge
Secondary	Readmission rate	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