NCT05515991

Symptom Management in Patients on Dialysis

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• End-stage Kidney Disease

Interventions

Type	Name	Description
OTHER	SUPPORT-DIALYSIS with Access to Output Report and Information Hub	SUPPORT-Dialysis is a symptom assessment response toolkit, consisting of a screening and response component. Participants will be screened for symptoms and distress using an electronic assessment(ePROMs). Output reports based on ePROMs scores will be provided to patients as well as the clinical care team. Participants at Toronto General Hospital will complete the screening every 4 weeks for 6 months, and each time the output report will be provided to both patients and the clinical team.The second, response component of the intervention is the information support and self-management hub (https://symptomcare.org). All participants and the clinical team will be given access to this website, which provides information about self-management for patients as well as management advice for healthcare professionals.
OTHER	SUPPORT-DIALYSIS Only	SUPPORT-Dialysis screening will also be implemented at Humber River Hospital, but participants and clinical team will not be receiving the output screening report or be given access to the information hub with symptom management resources.

Timeline

• Start date: 2023-04-19
• Primary completion: 2024-01-09
• Completion: 2025-12-01
• First posted: 2022-08-25
• Last updated: 2025-05-02

Locations

2 sites across 1 country: Canada