Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

Official title

Use of an Electronic Patient-Reported Outcome Measure for Symptom Monitoring With Supported Feedback in Advanced Chronic Kidney Disease

Overview

Patient-reported outcome measures (PROMs) are validated tools to reliably measure outcomes highly prioritized by patients, such as health-related quality of life (HRQOL) and symptoms, but the current clinical impact of PROMs is limited by a lack of evidence-based methods to incorporate them into routine care. Symptoms, which are highly prevalent among persons living with chronic kidney disease (CKD), substantially contribute to the reduced HRQOL experienced by this patient population. HRQOL spans several domains of wellbeing affected by disease, including physical, mental, and social health, functionality, and symptoms. Both HRQOL and symptom burden are consistently identified by patients with CKD as top clinical and research priorities. These issues are particularly salient to individuals living with advanced CKD, who suffer significant symptom burden that is often underrecognized and undertreated by nephrology providers, yet is a key factor considered by nephrologists for the timing of dialysis initiation. Randomized controlled trials of patients with other chronic illnesses show that routine assessment of symptoms with PROMs improves symptom burden, patient-provider communication, and HRQOL; yet, standardized approaches to regular symptom monitoring among patients with advanced CKD are lacking. This pilot, randomized trial of a PROM-based intervention for routine symptom reporting by patients with feedback of responses to nephrologists aims to address the lack of data on PROM use for symptom assessment in nephrology care. We will evaluate the implementation (reach, feasibility, and acceptability) and preliminary efficacy of monthly patient report of CKD-related symptoms using the electronic IPOS-Renal questionnaire with supported clinician follow-up for 12 months versus standard of care. This trial will utilize complementary quantitative and qualitative methods to evaluate the implementation of the PROM-based intervention. The results of this pilot study will inform a definitive, cluster-randomized trial on the effect of a PROM-based symptom assessment intervention to improve HRQOL and clinical outcomes among patients living with advanced CKD.

Detailed description

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.

Interventions

• Behavioral Electronic patient-reported outcome measure (ePROM) for symptom monitoring
  Patients randomized to the ePROM intervention arm will be asked to complete monthly reporting of their CKD-associated symptoms using an electronic version of the Integrated Patient Outcome Scale (IPOS)-Renal survey. Their responses will be provided in summary form to their nephrology clinicians at regular intervals and prior to any nephrology clinic visits. Clinicians will be provided with guidance on symptom management and will have the option to participate in an informational session on how t

Primary outcome measures

• Reach (Implementation); Screen-eligibility [Time frame: Baseline]
• Reach (Implementation); Rate of consenting [Time frame: Baseline]
• Feasibility (Implementation); symptom survey completion rate [Time frame: Duration of active 12-month study participation]
• Feasibility (Implementation); Symptom documentation [Time frame: Duration of active 12-month study participation]
• Feasibility (Implementation); Interviews [Time frame: 3-12 months of participation]
• Acceptability (Implementation); Interviews [Time frame: 3-12 months of participation]

Secondary outcome measures (4)

• Progression to End-Stage Kidney Disease [Time frame: Duration of active 12-month study participation plus 12 months; 24 months total]
• Emergency Room Visits [Time frame: Duration of active 12-month study participation plus 12 months; 24 months total]
• Hospitalizations [Time frame: Duration of active 12-month study participation plus 12 months; 24 months total]
• Mortality [Time frame: Duration of active 12-month study participation plus 12 months; 24 months total]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Mass General Brigham — Boston

Identifiers

NCT: NCT07186218 · 2024p002276 · 1K23DK140642-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗