The Use of Remote Monitoring to Improve Patient-Reported Outcomes and Readmission Rates Following Radical Cystectomy (WATCH)

University of Pittsburgh

Status: Completed

Conditions: Bladder Cancer; Quality of Life

Treatments: Device: provider monitoring and feedback to remote data; Device: participant monitoring of remote data

Study type: Interventional

Funder types: Other

Identifiers

NCT06397040

STUDY23110094

Details and patient eligibility

About

Following radical cystectomy for bladder cancer, nearly two-thirds of patients experience a complication and almost a third are readmitted. Thus, intensified monitoring of this vulnerable group represents an opportunity for improved quality of care in the post-operative setting. By gathering biomarkers passively and continuously, wearable activity monitors augment remote patient monitoring. Further, they facilitate the collection of patient-reported outcomes frequently.

Despite the proven impact of remote monitoring on patient care, there is limited data on the feasibility and impact of employing this technology to trigger real-time provider assessment following cystectomy. The investigators plan to conduct a randomized control trial examining such. The intervention group of participants will receive continuous biomarker monitoring via FitBits and daily patient-reported outcome assessments via connected smartphones. Abnormalities in remote data will trigger automated alerts to providers. Providers will respond in real-time to these alerts and patients will receive education materials discussing preventative measures to mitigate the main risk factors for readmissions. The investigators will evaluate the feasibility of integrating this technology into the post-operative period, as well as the impact of real-time provider attention to abnormal remote data on patient-reported outcomes and rates of readmission. The investigators hypothesize that early assessment of and intervention on remote abnormalities will promote the use of outpatient or reduced intensity therapies, such as oral antibiotics or oral hydration, thus curtailing the severity of patient symptoms, intensity of complications, and need for hospitalizations. Ultimately, this trial builds upon prior research, applying patient-centered technology to improve the quality of care following cystectomy.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing cystectomy at three hospitals within the University of Pittsburgh Medical Center system
• English speaking
• owns smart phone

Exclusion criteria

• unwilling or unable to participate
• non-English speaking
• does not own smart phone

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

remote monitoring without provider feedback

Experimental group

Description:

remote monitoring with FitBit device and daily patient-reported outcome assessment, without real-time provider feedback

Treatment:

Device: participant monitoring of remote data

remote monitoring with provider feedback

Experimental group

Description:

remote monitoring with FitBit device and daily patient-reported outcome assessment, as well as real-time provider feedback in response to remote data

Treatment:

Device: participant monitoring of remote data

Device: provider monitoring and feedback to remote data