Symptom Monitoring in Hemodialysis
- Conditions
- End Stage Kidney Disease
- Interventions
- Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)Behavioral: Usual Care
- Registration Number
- NCT05738330
- Lead Sponsor
- University of Pennsylvania
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2400
- Age ≥ 18 years
- Treatment with hemodialysis at a participating dialysis clinic
- English or Spanish speaking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis) Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) 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. Usual Care 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.
- Primary Outcome Measures
Name Time Method Severity of dialysis-associated symptoms (Effectiveness) Baseline, 6 months, 12 months This outcome will be assessed as change in the Dialysis Symptom Index-Severity Score over 12 months (primary endpoint).
Participants are asked whether or not they experienced symptoms during the past week. If the response is yes, the participant is asked to indicate "How much did it bother you?". Lowest score - 0; Highest score - 150. A higher score indicates a worse outcome.
- Secondary Outcome Measures
Name Time Method Depression (Effectiveness) Baseline, 6 months, 12 months Patient Health Questionnaire (PHQ)-8
Participants are asked to report how much during the last 2 weeks they have experienced problems. Lowest score - 0; Highest score - 24. Higher score indicates a worse outcome.Anxiety (Effectiveness) Baseline, 6 months, 12 months Generalized Anxiety Disorder (GAD)-7
Participants are asked to report how often during the past 2 weeks they have had symptoms or experiences. Lowest score - 0; Highest score - 21. Higher score indicates a worse outcome.Health-related quality of life (Effectiveness) Baseline, 6 months, 12 months EuroQOL 5D-5L (EQ-5D-5L)
Participants are asked about 5 different domains that can affect people's quality of life (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression). Participants respond on a scale of 1 to 5 where 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. An EQ-5D summary index is derived by applying a formula (developed by EuroQol Group) that attaches values (weights) to each of the levels in each dimension. A higher score indicates a better outcome.Mortality (Effectiveness) Duration of active 12 month study participation plus 6 months; 18 months total Mortality rate
Missed dialysis sessions (Effectiveness) Duration of active 12 month study participation The number of missed dialysis sessions during participation in the the trial.
Penetration (Implementation) Duration of active 12 month study participation SMaRRT-HD completion rates collected from the SMaRRT-HD system and KDQOL™-36 completion rates collected from the dialysis medical record
Post-dialysis recovery time (Effectiveness) Baseline, 6 months, 12 months Recovery time question
Fatigue (Effectiveness) Baseline, 6 months, 12 months PROMIS Fatigue SF 6a
Fatigue will be measured using the PROMIS Fatigue Short Form (SF) 6a. Normalized score reported as t-values. The full range of possible scores is 26.2 - 65.6. 50 indicates the population mean with a standard deviation of 10. A lower score represents a better outcome.Pain interference (Effectiveness) Baseline, 6 months, 12 months Brief Pain Inventory (BPI)- Interference
Participants are asked how much, during the past week, pain has interfered with different activities. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score indicates a worse outcome.Healthcare Engagement (Effectiveness) Baseline, 6 months, 12 months Healthcare Engagement - Short Form 8a (PHE-8a)
Participants are asked to respond to statements with how true each statement is for them at the time the questionnaire is administered. Responses range from "Not at all true" to "Very true". The PHE-8a uses item response theory-based scoring converted to standardized T-scores. A higher score indicates a better outcome.Hospitalizations (Effectiveness) Duration of active 12 month study participation plus 6 months; 18 months total Hospitalization rate
Shortened dialysis sessions (Effectiveness) Duration of active 12 month study participation The number of shortened dialysis sessions during participation in the the trial.
Fidelity (Implementation); Clinical action after PROM use; All Clinics Duration of active 12 month study participation Evidence in the dialysis medical record of clinician action in response to a reported symptom.
Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics Baseline, 6 months, and 12 months Patient response to a Computer-Assisted Telephone Interview-administered question about the occurrence of clinician follow-up of a reported symptom.
Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics 6 months, and 12 months Patient, clinic personnel, and medical provider responses to survey questions about the occurrence of clinician follow-up of a reported symptom.
Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics Duration of active 12 month study participation In SMaRRT-HD clinics only, evidence in the SMaRRT-HD system of clinician access of symptom guidances within 7 days of each administration of the SMaRRT-HD symptom ePROM.
Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics Duration of active 12 month study participation In SMaRRT-HD clinics only, evidence in the SMaRRT-HD system of clinician access of symptom reports within 7 days of each administration of the SMaRRT-HD symptom ePROM.
Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics Baseline, 6 months, and 12 months Patient response to a Computer-Assisted Telephone Interview-administered question about the receipt of symptom summaries.
Acceptability (Implementation); Surveys; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to survey questions about the acceptability of patient-dialysis care team communication about symptoms.
Acceptability (Implementation); Interviews; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to interview questions about the acceptability of patient-dialysis care team communication about symptoms.
Acceptability (Implementation); Surveys; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the acceptability of the SMaRRT-HD system components.
Acceptability (Implementation); Interviews; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the acceptability of the SMaRRT-HD system components.
Appropriateness (Implementation); Surveys; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of patient-dialysis care team communication about symptoms.
Appropriateness (Implementation); Interviews; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of patient-dialysis care team communication about symptoms.
Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of the SMaRRT-HD system components.
Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of the SMaRRT-HD system components.
Feasibility (Implementation); Surveys; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to survey questions about feasibility of patient-dialysis care team communication about symptoms.
Feasibility (Implementation); Interviews; All Clinics 6 months and 12 months Patient, clinic personnel, and medical provider responses to interview questions about feasibility of patient-dialysis care team communication about symptoms.
Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders Interviews will be conducted before the optimization phase and after the end of the trial. Corporate leader responses to interview questions about the importance, feasibility, and potential for sustainability of regularly administering PROMs in routine dialysis care.
Feasibility (Implementation); Surveys; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the feasibility of the SMaRRT-HD system components.
Feasibility (Implementation); Interviews; SMaRRT-HD Clinics 6 months and 12 months In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the feasibility of the SMaRRT-HD system components.
Trial Locations
- Locations (1)
Fresenius Medical Care
🇺🇸Waltham, Massachusetts, United States