Clinical trial NCT05578898: CLEAR Care Companion Application
Official title: CLEAR Care Companion Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Radical Cystectomy
Keywords: Mobile application
Post surgical care
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of engagement with application
timeFrame: 42 days post hospital discharge
measure: Duration of engagement with application
timeFrame: 42 days post hospital discharge
measure: Patient Experience Survey -- Overall Care (all participants)
timeFrame: 42 days post hospital discharge
measure: Patient Experience Survey -- Overall Care (first 20 participants)
timeFrame: 42 days post hospital discharge
measure: Readmission intensity
timeFrame: 42 days post hospital discharge
Secondary outcomes:
measure: Patient Experience Survey -- Application (all participants)
timeFrame: 42 days post hospital discharge
measure: Patient Experience Survey -- Application (first 20 participants)
timeFrame: 42 days post hospital discharge
measure: Readmission rate
timeFrame: 42 days post hospital discharge
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Jeffery Montgomery, M.D.
role: PRINCIPAL_INVESTIGATOR
References: