Clinical trial NCT05738330: Symptom Monitoring in Hemodialysis
Official title: Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Keywords: End stage kidney disease
Kidney
Hemodialysis
Dialysis
Symptom monitoring
Electronic Patient-Reported Outcome Measure (ePROM)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Duke University
name: University of New Mexico
name: Fresenius Medical Care North America
name: Patient-Centered Outcomes Research Institute
First posted: 2023-02-22
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 (15 clinics) or the Usual Care group (15 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 purpose: SUPPORTIVE_CARE

Brief 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 30 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 criteria: 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

Primary outcomes:
measure: Severity of dialysis-associated symptoms (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Health-related quality of life (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Post-dialysis recovery time (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Fatigue (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Pain interference (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Anxiety (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Depression (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Healthcare Engagement (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
measure: Hospitalizations (Effectiveness)
timeFrame: Duration of active 12 month study participation plus 6 months; 18 months total
measure: Mortality (Effectiveness)
timeFrame: Duration of active 12 month study participation plus 6 months; 18 months total
measure: Missed dialysis sessions (Effectiveness)
timeFrame: Duration of active 12 month study participation
measure: Shortened dialysis sessions (Effectiveness)
timeFrame: Duration of active 12 month study participation
measure: Penetration (Implementation)
timeFrame: Duration of active 12 month study participation
measure: Fidelity (Implementation); Clinical action after PROM use; All Clinics
timeFrame: Duration of active 12 month study participation
measure: Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics
timeFrame: Baseline, 6 months, and 12 months
measure: Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics
timeFrame: 6 months, and 12 months
measure: Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics
timeFrame: Duration of active 12 month study participation
measure: Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics
timeFrame: Duration of active 12 month study participation
measure: Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics
timeFrame: Baseline, 6 months, and 12 months
measure: Acceptability (Implementation); Surveys; All Clinics
timeFrame: 6 months and 12 months
measure: Acceptability (Implementation); Interviews; All Clinics
timeFrame: 6 months and 12 months
measure: Acceptability (Implementation); Surveys; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
measure: Acceptability (Implementation); Interviews; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
measure: Appropriateness (Implementation); Surveys; All Clinics
timeFrame: 6 months and 12 months
measure: Appropriateness (Implementation); Interviews; All Clinics
timeFrame: 6 months and 12 months
measure: Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
measure: Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
measure: Feasibility (Implementation); Surveys; All Clinics
timeFrame: 6 months and 12 months
measure: Feasibility (Implementation); Interviews; All Clinics
timeFrame: 6 months and 12 months
measure: Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders
timeFrame: Interviews will be conducted before the optimization phase and after the end of the trial.
measure: Feasibility (Implementation); Surveys; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
measure: Feasibility (Implementation); Interviews; SMaRRT-HD Clinics
timeFrame: 6 months and 12 months
Other outcomes:
measure: Quality of patient-clinician communication (Effectiveness)
timeFrame: Baseline, 6 months, 12 months
Locations:
city: Waltham
country: United States
facility: Fresenius Medical Care
state: Massachusetts
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer Flythe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Laura Dember, MD
role: PRINCIPAL_INVESTIGATOR
References: