EHR Integrated Remote Patient Monitoring to Reduce Readmission for Patients With Bladder Cancer Undergoing Cystectomy
CLEAR Cystectomy: A Pilot Randomized Trial Assessing Remote Patient Monitoring in Bladder Cancer Patients
This clinical trial tests the feasibility of an electronic health record (EHR) integrated remote patient monitoring intervention to reduce readmission for patients with bladder cancer undergoing cystectomy. Cystectomy is the preferred treatment for locally advanced bladder cancer and involves removal of the bladder, prostate or uterus and part of vagina, and pelvic lymph nodes along with reconstruction of the urinary tract using a segment of bowel. Hospital readmission rates following cystectomy exceed 25% and are among the highest of any surgery. A significant barrier to identifying complications early arises from our inability to monitor patients once they are discharged from the hospital. The EHR integrated remove patient monitoring intervention helps with monitoring of symptoms after a patient's discharge from a cystectomy procedure and provides a direct line of communication between patients and their care team when concerning symptoms arise. This may reduce readmission rate for patients with bladder cancer undergoing cystectomy.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Rogel Cancer Center
-
Contact:
- Tudor Borza
- Phone Number: 734-936-7030
- Email: tborza@med.umich.edu
-
Principal Investigator:
- Tudor Borza
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults age 18 and older
- English speaking
- Patient currently inpatient at the University of Michigan (Michigan Medicine) who has undergone a radical cystectomy with reconstruction for bladder cancer
- Personal access or access via a caregiver to a compatible device where notifications from the Michigan Medicine MyUofMHealth account can be enabled
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (EHR integrated remote monitoring app)
Patients receive access to the MyUofMHealth App and, starting at discharge, receive notifications, up to 3 times per day with frequency decreasing to daily, then less frequently over time, prompting them to complete medication and pain assessments, record food and fluid intake and exercise and triage/symptom tracking, and provide a direct line of communication to their care team if concerning symptoms arise, up to day 35 post discharge. |
Ancillary studies Ancillary studies Communicate with care team Receive access to the MyUofMHealth App
Other Names:
Receive notifications
Other Names:
Complete assessments
Other Names:
|
|
Experimental: Arm II (Standard care)
Patients receive access to the MyUofMHealth App and undergo standard post-operative care. |
Ancillary studies Ancillary studies Receive access to the MyUofMHealth App
Other Names:
Receive notifications
Other Names:
Undergo standard post-operative care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trial randomization meeting goal of 50 patients (feasibility)
Time Frame: Up to 6 months
|
Will be reported as number of participants accrued and randomized. |
Up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)
Time Frame: Up to 6 months
|
Will be reported as proportions with the associated 95% binomial confidence intervals. |
Up to 6 months
|
|
Trial enrollment of ≥ 50% of eligible patients (acceptability)
Time Frame: Up to 6 months
|
Will be reported as proportions with the associated 95% binomial confidence intervals. |
Up to 6 months
|
|
Hospital free days
Time Frame: Up to 90 days from discharge
|
A hospital day will be a day that includes an emergency department visit or acute care hospital or hospitalization within 90 days from discharge. A hospital-free day will be any day that is not a hospital day and when a patient is alive. Will be reported by arm using a median or mean, and effect sizes will be calculated and their associated confidence intervals. |
Up to 90 days from discharge
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tudor Borza, University of Michigan Rogel Cancer Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urologic Neoplasms
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Therapeutics
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Quality Indicators, Health Care
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Guidelines as Topic
- Quality Assurance, Health Care
- Interviews as Topic
- Standard of Care
- Palliative Care
- Practice Guidelines as Topic
Other Study ID Numbers
- UMCC 2026.050
- NCI-2026-07233 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UMCC 2026.050 (Other Identifier: University of Michigan Rogel Cancer Center)
- R34CA297281 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
we will share a de-identified version of the quantitative data, including the data output from the application (e.g., frequency of patient engagement, patient symptoms, pain medications, etc.) and the responses to both the PROMIS and satisfaction questionnaires.
IPD Sharing Time Frame
for up to 10 years
IPD Sharing Access Criteria
For interested researchers
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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