CLEAR Care Companion Application

NCT05578898 | Completed

• 2 other identifiers: UMCC 2021.077HUM00201652
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Radical Cystectomy

Keywords

Mobile application; Post surgical care

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Patient Experience Survey -- Overall Care (first 20 participants)

  The first 20 participants will complete a qualtrix survey.

  42 days post hospital discharge

• 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 Outcomes (3)

• Patient Experience Survey -- Application (all participants)

  42 days post hospital discharge

• Patient Experience Survey -- Application (first 20 participants)

  42 days post hospital discharge

• Readmission rate

  42 days post hospital discharge

Study Arms (1)

CLEAR CC

EXPERIMENTAL

Patients use CLEAR CC application with Smartphone or Tablet

Behavioral: CLEAR Care Companion (CC) application

Interventions

CLEAR Care Companion (CC) application BEHAVIORAL

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.

CLEAR CC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeffery Montgomery, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: August 12, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)