Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

This is a single-center, open-label, two-arm, randomized pilot trial of 70 individuals with advanced chronic kidney disease (CKD; eGFR<20 mL/min/1.73 m2). This pilot study will assess reach, feasibility, acceptability (implementation) and preliminary efficacy of patient use of IPOS-Renal (Integrated Patient Outcome Scale-Renal, primary exposure of interest), an instrument designed to assess symptoms among patients with CKD, which will be electronically completed monthly for 12 months. Randomization will occur in a 1:1 ratio at the level of the individual; therefore, 35 individuals will be randomized to the IPOS-Renal electronic patient-reported outcome measure (ePROM) intervention arm, and 35 individuals will be randomized to the control arm (standard of care).

The ePROM intervention has three core components: 1) patient self-reporting of CKD-related symptoms at regular intervals using the Integrated Patient Outcome Scale (IPOS)-Renal survey, 2) feedback of patient responses to clinicians; and 3) provision of guidance for symptom management to clinicians. Patients randomized to the ePROM intervention arm will receive instruction on how to self-report symptoms using an electronic version of the IPOS-Renal instrument. Clinicians will be provided instruction on how to view patient symptom responses and given guidance regarding symptom management strategies; however, treatment decisions will be left entirely to the discretion of the clinician. Whenever a patient has a clinic visit, a symptom report will be generated and printed by the research team and will be given to the treating nephrologist.

All participants will complete two PROMs over the course of participation. At baseline, participants will complete the Kidney Disease Quality of Life-36 (KDQOL) instrument (primary efficacy outcome) and the IPOS-Renal to assess symptom burden at baseline. Participants will be given a choice to complete questionnaires online, via mailed paper forms, or over the telephone. The KDQOL questionnaire will be completed at baseline and months 6 and 12 (+/- 4 weeks each). All study questionnaires will be available in English. Chart abstraction will be conducted by a member of the study team at baseline, 3, 6, 9, and 12 months (+/- 1 months each) to collect demographic and clinical data. Additional information on clinical events (progression to CKD requiring kidney replacement therapy, emergency room visits, hospitalizations, and death) will be abstracted at 24 months. Patient and clinician participants (target n=20 patients and n=10 clinicians) will be invited to participate in semi-structured interviews for qualitative data collection. Qualitative data will be used to explore patient and clinician perspectives on symptom management in the ambulatory nephrology setting and the feasibility and acceptability of the ePROM intervention.

Inclusion criteria

• Adults (age ≥ 18 years)
• Advanced CKD, defined as at least two measurements of creatinine-based or cystatin C-based eGFR ≤ 30 mL/min/1.73m2 separated by at least 90 days in the preceding 12 months
• Able to provide consent to participate in the study
• Able to read and write in English
• Under the care of a nephrologist at a Mass General Brigham nephrology clinic

Exclusion criteria

• Terminal illness likely to lead to death within 6 months of participation
• Patients receiving dialysis treatment at the time of enrollment or scheduled to start dialysis therapy in the next 4 weeks
• Patients scheduled to receive a kidney transplant in the next 6 months
• Patients having their initial clinic visit (i.e., new to the clinic)
• Cognitive deficits that would preclude understanding of consent form and/or questionnaires