Symptom Management in Patients on Dialysis

Not Applicable

Active, not recruiting

• Conditions: End-stage Kidney Disease
• Interventions: Other: SUPPORT-DIALYSIS with Access to Output Report and Information Hub; Other: SUPPORT-DIALYSIS Only

• Registration Number: NCT05515991
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-25
• Study Start: 2023-04-19
• Status Verified: 2023-09
• Primary Completion: 2024-01-09
• Study Completion: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients undergoing maintenance hemodialysis for more than 3 months

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Exclusion Criteria

• Patients with severe acute illness or condition that hampers questionnaire completion assessed by clinical team.
• Dementia indicated in the medical record, indicated by the managing healthcare team.
• Unable to understand English - as assessed by clinical team.
• Life expectancy < 6 months as assessed by main responsible nephrologist.
• Unwilling or unable to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SUPPORT-DIALYSIS with Access to Output Report and Information Hub	SUPPORT-DIALYSIS with Access to Output Report and Information Hub	Feasibility of SUPPORT-Dialysis at Toronto General Hospital
SUPPORT-DIALYSIS Only	SUPPORT-DIALYSIS Only	Usual Treatment at Humber River Hospital

Primary Outcome Measures

Name	Time	Method
Proportion of Eligible Patients who decline consent	Baseline	Feasibility of toolkit will be confirmed if decline rate is \<50% for eligible patients.
Proportion of Participants who miss or refuse ePROMs follow-ups	Baseline to follow-up (6 months)	Feasibility of toolkit will be confirmed if \<30% of participants complete \<50% of all follow-up visits.
Recruitment Target	Baseline	Feasibility of toolkit will be confirmed if recruitment target of 30 participants at each site are obtained in a 3-month period of the pilot.
Proportion of Enrolled Patients who Drop-Out From the Study	Baseline to follow-up (6 months)	Feasibility of toolkit will be confirmed if the dropout rate is \< 30%.

Secondary Outcome Measures

Name	Time	Method
Patient Acceptability	Follow-up (every 4 weeks, up to 6 months)	Proportion of patients who find the tool 1) acceptable, 2) not burdensome and 3) important, based on responses to the "Patient Satisfaction Survey" they will complete.
Clinical Team Acceptability	Follow-up (every 4 weeks, up to 6 months)	Proportion of staff who do not find the use of the tool intrusive to the workflow, based on responses to the "Staff Satisfaction Survey" they will complete.

Trial Locations

Locations (2)

Etobicoke General Hospital; 🇨🇦 Brampton, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada