Symptom Management in Patients on Dialysis

Study Overview
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Brief Summary
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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
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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 Recruitment Rate Retention and Completion rate Acceptability Patient satisfaction Staff satisfaction Based on the objectives of this study, the investigators hypothesize the following: 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%. >80% of patients find the toolkit acceptable; <20% of staff find the process intrusive to workflow.

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

Conditions
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End-stage Kidney Disease

Intervention / Treatment
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* Other: SUPPORT-DIALYSIS with Access to Output Report and Information Hub
* Other: SUPPORT-DIALYSIS Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing maintenance hemodialysis for more than 3 months 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUPPORT-DIALYSIS with Access to Output Report and Information Hub<br>Feasibility of SUPPORT-Dialysis at Toronto General Hospital | Other: SUPPORT-DIALYSIS with Access to Output Report and Information Hub<br>* 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.<br>|
| Experimental: SUPPORT-DIALYSIS Only<br>Usual Treatment at Humber River Hospital | Other: SUPPORT-DIALYSIS Only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Target | 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. | Baseline | 
| Proportion of Eligible Patients who decline consent | Feasibility of toolkit will be confirmed if decline rate is <50% for eligible patients. | Baseline | 
| Proportion of Participants who miss or refuse ePROMs follow-ups | Feasibility of toolkit will be confirmed if <30% of participants complete <50% of all follow-up visits. | Baseline to follow-up (6 months) | 
| Proportion of Enrolled Patients who Drop-Out From the Study | Feasibility of toolkit will be confirmed if the dropout rate is < 30%. | Baseline to follow-up (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability | 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. | Follow-up (every 4 weeks, up to 6 months) | 
| Clinical Team Acceptability | 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. | Follow-up (every 4 weeks, up to 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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end-stage renal disease, hemodialysis, dialysis, chronic kidney disease, kidney failure