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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2,400
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.
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.
Fresenius Medical Care
Waltham, Massachusetts, United States
RECRUITINGSeverity 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.
Time frame: Baseline, 6 months, 12 months
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.
Time frame: Baseline, 6 months, 12 months
Post-dialysis recovery time (Effectiveness)
Recovery time question
Time frame: Baseline, 6 months, 12 months
Fatigue (Effectiveness)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months, 12 months
Healthcare Engagement (Effectiveness)
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.
Time frame: Baseline, 6 months, 12 months
Hospitalizations (Effectiveness)
Hospitalization rate
Time frame: Duration of active 12 month study participation plus 6 months; 18 months total
Mortality (Effectiveness)
Mortality rate
Time frame: 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.
Time frame: Duration of active 12 month study participation
Shortened dialysis sessions (Effectiveness)
The number of shortened dialysis sessions during participation in the the trial.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of active 12 month study participation
Fidelity (Implementation); Patient-reported receipt of symptom summary; All Clinics
Patient response to a Computer-Assisted Telephone Interview-administered question about the receipt of symptom summaries.
Time frame: Baseline, 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months and 12 months
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