Abstract
Abstract Background and Aims People on haemodialysis (HD) often experience overwhelming and debilitating symptoms of fatigue, pain, nausea, itching, sleeping problems and depression that contribute to poor quality of life. Trials in oncology have shown that active symptom monitoring can improve quality of life and survival, but it remains unknown if this intervention is effective in people on HD. The use of PROMs is increasing in nephrology care; but they are not routinely collected in kidney registries. The SWIFT pilot aims to assess the feasibility and acceptability of tablet-based symptom monitoring with feedback to clinicians in preparation of a large-scale, registry-based cluster-randomised trial to assess the clinical- and cost-effectiveness of this intervention in HD (SWIFT; ACTRN12618001976279). Method This pragmatic, multicenter cluster-randomised controlled pilot study tests the hypothesis that 3-monthly tablet-based PROMs monitoring using the Integrated Palliative Outcome Scale-Renal Symptom Tool with electronic feedback to clinicians using the Australia and New Zealand Dialysis and Transplant Registry (ANZDATA) compared with usual care will improve health-related quality of life measured by EQ-5D-5L and is technically feasible and clinically acceptable to patients, nurses and nephrologists in different HD settings. Acceptability and feasibility outcomes are assessed through a process evaluation using the Medical Research Council framework: (1) patient acceptability of ePROMS (5-point Likert scale; focus groups with 20 purposively sampled participants), (2) feasibility of embedding ePROMS in routine care (response rates, time from data capture to feedback, ease of generating PROMs reports by the ANZDATA registry), (3) acceptability and usefulness of ePROMs data for nephrologists and nurses (qualitative semi-structured interviews with thematic analysis). Results 163 adult patients from 4 HD units across Australia were enrolled (83 in the intervention units and 80 to the control units) and completed baseline PROMs, representing 77% of eligible patients (range 44-90%). At 3-months, 61% of enrolled patients in the intervention units completed the PROMs (range 48-73%). Reasons for non-completion included transfer to another unit and lack of ability to read English. Severe or overwhelming symptoms were reported by 30 of 83 enrolled patients (36%) at baseline and by 32 of 62 (52%) at 3 months. Technical feasibility was demonstrated by successful development of a Qualtrics survey platform presented on tablet computers, use of QR reader codes for linkage with the ANZDATA registry which captures clinical outcomes, and linkage to the relevant survey for the patient’s allocation and trial timepoint. Emails containing a short report of any symptoms identified as severe or overwhelming along with a summary of evidence-based guidelines for management of those symptoms were sent to and opened by treating clinicians. Assessment of patient and clinician acceptability of the feedback mechanism is ongoing. Conclusion Electronic symptom monitoring in adults on HD with feedback to clinicians is feasible and provides a template for ongoing registry-based monitoring of PROMs to facilitate patient-centred care and the infrastructure for future evaluations of interventions to improve patients’ quality of life and survival.
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