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Completed

NCT Number: NCT05578898

CLEAR Care Companion Application

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Radical Cystectomy Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Frequency of engagement with application

    Time frame: 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.

  2. Duration of engagement with application

    Time frame: 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.

  3. Patient Experience Survey -- Overall Care (all participants)

    Time frame: 42 days post hospital discharge

    Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.

  4. Patient Experience Survey -- Overall Care (first 20 participants)

    Time frame: 42 days post hospital discharge

    The first 20 participants will complete a qualtrix survey.

  5. Readmission intensity

    Time frame: 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 outcomes

  1. Patient Experience Survey -- Application (all participants)

    Time frame: 42 days post hospital discharge

    Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) GLOBAL 10 questionnaire.

  2. Patient Experience Survey -- Application (first 20 participants)

    Time frame: 42 days post hospital discharge

    The first 20 participants will complete a qualtrix survey.

  3. Readmission rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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