Symptom Monitoring in Hemodialysis

End Stage Kidney Disease Clinical Trial

— SMaRRT-HD  

Official title:

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738330
• Other study ID #: 852661
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2023
• Est. completion date: September 2027

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: September 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Fresenius Medical Care	Waltham	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	Duke University, Fresenius Medical Care North America, Patient-Centered Outcomes Research Institute, University of New Mexico, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of patient-clinician communication (Effectiveness)	In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS)- Communication and Caring Domain	Baseline, 6 months, 12 months
Primary	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	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
Secondary	Post-dialysis recovery time (Effectiveness)	Recovery time question	Baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospitalizations (Effectiveness)	Hospitalization rate	Duration of active 12 month study participation plus 6 months; 18 months total
Secondary	Mortality (Effectiveness)	Mortality rate	Duration of active 12 month study participation plus 6 months; 18 months total
Secondary	Missed dialysis sessions (Effectiveness)	The number of missed dialysis sessions during participation in the the trial.	Duration of active 12 month study participation
Secondary	Shortened dialysis sessions (Effectiveness)	The number of shortened dialysis sessions during participation in the the trial.	Duration of active 12 month study participation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	Baseline, 6 months, and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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