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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Rogel Cancer Center
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Ta kontakt med:
- Tudor Borza
- Telefonnummer: 734-936-7030
- E-post: tborza@med.umich.edu
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Hovedetterforsker:
- Tudor Borza
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Receive notifications
Andre navn:
Complete assessments
Andre navn:
|
|
Eksperimentell: 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
Andre navn:
Receive notifications
Andre navn:
Undergo standard post-operative care
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Trial randomization meeting goal of 50 patients (feasibility)
Tidsramme: Up to 6 months
|
Will be reported as number of participants accrued and randomized. |
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention deployment in > 90% of patients randomized to intervention arm (feasibility)
Tidsramme: 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)
Tidsramme: Up to 6 months
|
Will be reported as proportions with the associated 95% binomial confidence intervals. |
Up to 6 months
|
|
Hospital free days
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tudor Borza, University of Michigan Rogel Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Urologiske neoplasmer
- Urinblæresykdommer
- Neoplasmer i urinblæren
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Undersøkelsesteknikker
- Epidemiologiske metoder
- Terapeutikk
- Datainnsamling
- Helsevesenets evalueringsmekanismer
- Kvalitet på helsehjelpen
- Folkehelse
- Miljø og folkehelse
- Kvalitetsindikatorer, helsehjelp
- Pasientbehandling
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Retningslinjer som emne
- Kvalitetssikring, helsehjelp
- Intervjuer som emne
- Standard for omsorg
- Palliativ omsorg
- Øv retningslinjer som emne
Andre studie-ID-numre
- UMCC 2026.050
- NCI-2026-07233 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- UMCC 2026.050 (Annen identifikator: University of Michigan Rogel Cancer Center)
- R34CA297281 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
for up to 10 years
Tilgangskriterier for IPD-deling
For interested researchers
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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