Symptom Monitoring in Hemodialysis (SMaRRT-HD)

University of Pennsylvania

Status: Enrolling

Conditions: End Stage Kidney Disease

Treatments: Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD); Behavioral: Usual Care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05738330

852661

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

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

Active Comparator group

Description:

Dialysis clinics randomized to SMaRRT-HD will implement the SMaRRT-HD symptom monitoring system. SMaRRT-HD consists of 1) tablet-based symptom reporting using a patient reported outcome measure (PROM) and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. For trial participants in SMaRRT-HD clinics, the SMaRRT-HD system will be implemented in addition to the Usual Care approach to symptom monitoring.

Treatment:

Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care