RecruitingNot ApplicableNCT05738330

Symptom Monitoring in Hemodialysis

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Sponsor

University of Pennsylvania

Enrollment

2,400 participants

Start Date

Jun 24, 2023

Study Type

INTERVENTIONAL

Conditions

End-stage Kidney Disease

Summary

The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Age ≥ 18 years
Treatment with hemodialysis at a participating dialysis clinic
English or Spanish speaking

Exclusion Criteria4

Not willing to report their symptoms using the SMaRRT-HD platform
Not willing to share clinically acquired data with the research team
Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
Incarceration

Interventions

BEHAVIORALSymptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)

Dialysis clinics randomized to the SMaRRT-HD group will use the SMaRRT-HD system to capture patient-reported symptoms and support clinician follow-up. The online system includes the patient symptom ePROM surveys, clinician real-time email alerts, clinician guidances for symptom management, and patient-facing symptom reports as well as an administrative dashboard supporting management of trial participants at clinics using SMaRRT-HD. Designated clinic personnel (i.e., patient care technicians and nurses) will receive training on how to use the system to administer the symptom ePROM surveys to patients on tablet computers. Designated clinic nurses and medical providers will receive training on how to access guidances for symptom management and patient-facing symptom reports in the SMaRRT-HD system. For trial participants in SMaRRT-HD clinics, the SMaRRT-HD system will be implemented in addition to the Usual Care approach to symptom monitoring.

BEHAVIORALUsual Care

Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a CMS-mandated Health-Related Quality of Life (HRQOL) survey that includes questions about symptoms.