Clinical trial NCT05515991: Symptom Management in Patients on Dialysis
Official title: Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: End-stage Kidney Disease
Keywords: end-stage renal disease
hemodialysis
dialysis
chronic kidney disease
kidney failure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Humber River Hospital
First posted: 2022-08-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Target
timeFrame: Baseline
measure: Proportion of Eligible Patients who decline consent
timeFrame: Baseline
measure: Proportion of Participants who miss or refuse ePROMs follow-ups
timeFrame: Baseline to follow-up (6 months)
measure: Proportion of Enrolled Patients who Drop-Out From the Study
timeFrame: Baseline to follow-up (6 months)
Secondary outcomes:
measure: Patient Acceptability
timeFrame: Follow-up (every 4 weeks, up to 6 months)
measure: Clinical Team Acceptability
timeFrame: Follow-up (every 4 weeks, up to 6 months)
Other outcomes:
measure: Incidence Rate of Healthcare Use
timeFrame: Baseline to Follow-up (6 months)
measure: Physical Health Component Score
timeFrame: Baseline to Follow-up (6 months)
measure: Mental Health Component Score
timeFrame: Baseline to Follow-up (6 months)
measure: Kidney Disease Quality of Life
timeFrame: Baseline to Follow-up (6 months)
Locations:
city: Brampton
country: Canada
facility: Etobicoke General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Istvan Mucsi
role: PRINCIPAL_INVESTIGATOR
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