Assessing the Feasibility of Self-reported MeasUrement of Physical and PsychosOcial Symptoms and Response Tool in Patients on Dialysis- Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Recruitment Target
Study Overview
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
- Recruitment Rate
- Retention and Completion rate
- Acceptability
- Patient satisfaction
- Staff satisfaction
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SUPPORT-DIALYSIS with Access to Output Report and Information Hub
Feasibility of SUPPORT-Dialysis at Toronto General Hospital
Intervention: SUPPORT-DIALYSIS with Access to Output Report and Information Hub (Other)
SUPPORT-DIALYSIS Only
Usual Treatment at Humber River Hospital
Intervention: SUPPORT-DIALYSIS Only (Other)
Outcomes
Primary Outcomes
Recruitment Target
Time Frame: 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 Eligible Patients who decline consent
Time Frame: 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
Time Frame: Baseline to follow-up (6 months)
Feasibility of toolkit will be confirmed if \<30% of participants complete \<50% of all follow-up visits.
Proportion of Enrolled Patients who Drop-Out From the Study
Time Frame: Baseline to follow-up (6 months)
Feasibility of toolkit will be confirmed if the dropout rate is \< 30%.
Secondary Outcomes
- Patient Acceptability(Follow-up (every 4 weeks, up to 6 months))
- Clinical Team Acceptability(Follow-up (every 4 weeks, up to 6 months))