CLEAR Care Companion Application

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05578898
Collaborator
(none)
250
1
1
36
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CLEAR Care Companion (CC) application
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
CLEAR Care Companion Application
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CLEAR CC

Patients use CLEAR CC application with Smartphone or Tablet

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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of engagement with application [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 [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) [42 days post hospital discharge]

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

  4. Patient Experience Survey -- Overall Care (first 20 participants) [42 days post hospital discharge]

    The first 20 participants will complete a qualtrix survey.

  5. Readmission intensity [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 Outcome Measures

  1. Patient Experience Survey -- Application (all participants) [42 days post hospital discharge]

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

  2. Patient Experience Survey -- Application (first 20 participants) [42 days post hospital discharge]

    The first 20 participants will complete a qualtrix survey.

  3. Readmission rate [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Rogel Cancer Center Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Jeffery Montgomery, M.D., University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier:
NCT05578898
Other Study ID Numbers:
  • UMCC 2021.077
  • HUM00201652
First Posted:
Oct 13, 2022
Last Update Posted:
Jan 10, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Michigan Rogel Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023