CLEAR Care Companion Application

Study Overview
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Brief Summary
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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
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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.

Official Title
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CLEAR Care Companion Application

Conditions
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Bladder Cancer, Radical Cystectomy

Intervention / Treatment
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* Behavioral: CLEAR Care Companion (CC) application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLEAR CC<br>Patients use CLEAR CC application with Smartphone or Tablet | Behavioral: CLEAR Care Companion (CC) application<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience Survey -- Application (all participants) | 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) | The first 20 participants will complete a qualtrix survey. | 42 days post hospital discharge | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile application, Post surgical care