Symptom Monitoring in Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-24

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The design is a multi-center cluster-randomized trial with randomization performed at the level of the dialysis clinic. Dialysis clinics will be assigned to either the SMaRRT-HD group (18 clinics) or the Usual Care group (18 clinics). SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a patient reported outcome measure (PROM) and 2) supported clinician follow-up consisting of symptom alerts, symptom management guidance, and tracking reports to share with patients. Dialysis clinics assigned to Usual Care will not use SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical interactions with participants and by administering a HRQOL survey. The trial uses a hybrid Type 1 effectiveness-implementation approach with effectiveness of the intervention assessed with patient-reported outcomes and biomedical outcomes, and implementation assessed with integrated qualitative and quantitative outcomes.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

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.

Usual 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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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.

Interventions

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Symptom 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.

Intervention Type BEHAVIORAL

Usual 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No