Symptom Monitoring in Hemodialysis

Study Overview
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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 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.

Official Title
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Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Conditions
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End Stage Kidney Disease

Intervention / Treatment
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* Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
* Behavioral: Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)<br>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. | Behavioral: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of dialysis-associated symptoms (Effectiveness) | 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. | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (Effectiveness) | 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. | Baseline, 6 months, 12 months | 
| Post-dialysis recovery time (Effectiveness) | Recovery time question | Baseline, 6 months, 12 months | 
| Fatigue (Effectiveness) | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Participants are read questions that relate to fatigue and are asked to provide a response based upon the last 7 days. Lowest score - 0; Highest score - 52. A higher score indicates a better outcome. | Baseline, 6 months, 12 months | 
| Pain interference (Effectiveness) | 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. | Baseline, 6 months, 12 months | 
| Anxiety (Effectiveness) | 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. | Baseline, 6 months, 12 months | 
| Depression (Effectiveness) | 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. | Baseline, 6 months, 12 months | 
| Patient activation (Effectiveness) | Patient Activation Measure Participants are asked to respond to statements with how much they agree (strongly disagree to strongly agree; or does not apply). Using a scoring algorithm (developed by Insignia Health) produces a PAM Score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation. A higher score indicates a better outcome. | Baseline, 6 months, 12 months | 
| Hospitalizations (Effectiveness) | Hospitalization rate | Duration of active 12 month study participation plus 6 months; 18 months total | 
| Mortality (Effectiveness) | Mortality rate | Duration of active 12 month study participation plus 6 months; 18 months total | 
| Missed dialysis sessions (Effectiveness) | The number of missed dialysis sessions during participation in the the trial. | Duration of active 12 month study participation | 
| Shortened dialysis sessions (Effectiveness) | The number of shortened dialysis sessions during participation in the the trial. | Duration of active 12 month study participation | 
| Penetration (Implementation) | SMaRRT-HD completion rates collected from the SMaRRT-HD system and KDQOL™-36 completion rates collected from the dialysis medical record | Duration of active 12 month study participation | 
| Fidelity (Implementation); Clinical action after PROM use; All Clinics | Evidence in the dialysis medical record of clinician action in response to a reported symptom. | Duration of active 12 month study participation | 
| Fidelity (Implementation); Patient-reported clinician follow-up; All Clinics | Patient response to a Computer-Assisted Telephone Interview-administered question about the occurrence of clinician follow-up of a reported symptom. | Baseline, 6 months, and 12 months | 
| Fidelity (Implementation); Patient/clinician-reported follow-up activities; All Clinics | Patient, clinic personnel, and medical provider responses to survey questions about the occurrence of clinician follow-up of a reported symptom. | 6 months, and 12 months | 
| Fidelity (Implementation); Clinician access of symptom guidances; SMaRRT-HD Clinics | 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. | Duration of active 12 month study participation | 
| Fidelity (Implementation); Clinician access of symptom reports; SMaRRT-HD Clinics | 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. | Duration of active 12 month study participation | 
| Fidelity (Implementation); Patient-reported receipt of patient-facing symptom report; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient response to a Computer-Assisted Telephone Interview-administered question about the receipt of a SMaRRT-HD symptom report. | 6 months and 12 months | 
| Acceptability (Implementation); Surveys; All Clinics | Patient, clinic personnel, and medical provider responses to survey questions about the acceptability of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Acceptability (Implementation); Interviews; All Clinics | Patient, clinic personnel, and medical provider responses to interview questions about the acceptability of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Acceptability (Implementation); Surveys; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the acceptability of the SMaRRT-HD system components. | 6 months and 12 months | 
| Acceptability (Implementation); Interviews; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the acceptability of the SMaRRT-HD system components. | 6 months and 12 months | 
| Appropriateness (Implementation); Surveys; All Clinics | Patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Appropriateness (Implementation); Interviews; All Clinics | Patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Appropriateness (Implementation); Surveys; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the appropriateness of the SMaRRT-HD system components. | 6 months and 12 months | 
| Appropriateness (Implementation); Interviews; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the appropriateness of the SMaRRT-HD system components. | 6 months and 12 months | 
| Feasibility (Implementation); Surveys; All Clinics | Patient, clinic personnel, and medical provider responses to survey questions about feasibility of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Feasibility (Implementation); Interviews; All Clinics | Patient, clinic personnel, and medical provider responses to interview questions about feasibility of patient-dialysis care team communication about symptoms. | 6 months and 12 months | 
| Feasibility (Implementation); Interviews; Dialysis provider organization corporate leaders | Corporate leader responses to interview questions about the importance, feasibility, and potential for sustainability of regularly administering PROMs in routine dialysis care. | Interviews will be conducted before the optimization phase and after the end of the trial. | 
| Feasibility (Implementation); Surveys; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to survey questions about the feasibility of the SMaRRT-HD system components. | 6 months and 12 months | 
| Feasibility (Implementation); Interviews; SMaRRT-HD Clinics | In SMaRRT-HD clinics only, patient, clinic personnel, and medical provider responses to interview questions about the feasibility of the SMaRRT-HD system components. | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End stage kidney disease, Kidney, Hemodialysis, Dialysis, Symptom monitoring, Electronic Patient-Reported Outcome Measure (ePROM)