Symptom Management in Patients on Dialysis

End-stage Kidney Disease Clinical Trial

Official title: Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study

Status Active, not recruiting

Clinical Trial Summary

This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis.

Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).

Clinical Trial Description

In Canada, 20,000-25,000 patients with end-stage kidney disease (ESKD) experience a range of symptoms such as chronic pain, itchiness, fatigue, anxiety, depression and sleep disturbances [1-5]. These may impact quality of life, increase mortality, decrease treatment adherence, and increased hospitalizations [6-8]. These symptoms are under-managed and under-recognized among these patients, but screening and managing symptoms using patient reported outcomes measures (PROMs) may be a useful and inexpensive solution. PROMS have previously been used successfully in cancer care [8-9], and have potential for clinical care of patients with kidney failure as well.

Electronic collection of PROMs (ePROMs) facilitates PROMs use by allowing linkage to electronic patient records [10-11] and immediate scoring and presentation of results to patients and clinicians [12-14]. ePROMs allow the use of computer adaptive testing (CAT) to personalize questions, increase the precision of measurements and reduce survey burden [15-17]. The investigators also developed a self-management support and decision support resource hub(https://symptomcare.org) to help dialysis patients and their clinical team in identifying and managing relevant physical and psychological symptoms that require further assessment and potential intervention.

Patients will complete Patient Reported Outcome Measurement Information System (PROMIS) CAT surveys on an electronic data capture system (SUPPORT-Dialysis) every four weeks during their dialysis treatment for six months. In the intervention, patients with moderate/severe symptoms will be flagged for the clinical team. Moderate/severe symptoms will be determined based on whether the participants score above a pre-defined cut-off in the surveys. The participant, primary nurse, and nephrologist will also receive an output report and be given access to https://symptomcare.org for suggested symptom management actions.

To establish the feasibility and acceptability of the intervention, the investigators will assess

1. Recruitment Rate

2. Retention and Completion rate

3. Acceptability

4. Patient satisfaction

5. Staff satisfaction

Based on the objectives of this study, the investigators hypothesize the following:

1. Recruitment goals will be met; >50% of approached patients will consent; completion rate will be > 80% of participants at least 50% of the time, and dropout rate will be < 30%.

2. >80% of patients find the toolkit acceptable; <20% of staff find the process intrusive to workflow. ;

Related Conditions & MeSH terms

• End-stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT05515991
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2023
• Completion date: May 2024