A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol.

BACKGROUND: Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients' health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. METHODS: The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. DISCUSSION: While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. TRIAL REGISTRATION: Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.

"You need a team": perspectives on interdisciplinary symptom management using patient-reported outcome measures in hemodialysis care-a qualitative study.

BACKGROUND: Patient-reported outcome measures (PROMs) are standardized instruments used for assessing patients' perspectives on their health status at a point in time, including their health-related quality of life, symptoms, functionality, and physical, mental, and social wellbeing. For people with kidney failure receiving hemodialysis, addressing high symptom burden and complexity relies on care team members integrating their expertise to achieve common management goals. In the context of a program-wide initiative integrating PROMs into routine hemodialysis care, we aimed to explore patients' and clinicians' perspectives on the role of PROMs in supporting interdisciplinary symptom management. METHODS: We employed a qualitative descriptive approach using semi-structured interviews and observations. Eligible participants included adult patients receiving intermittent, outpatient hemodialysis for > 3 months, their informal caregivers, and hemodialysis clinicians (i.e., nurses, nephrologists, and allied health professionals) in Southern Alberta, Canada. Guided by thematic analysis, team members coded transcripts in duplicate and developed themes iteratively through review, refinement, and discussion. RESULTS: Thirty-three clinicians (22 nurses, 6 nephrologists, 5 allied health professionals), 20 patients, and one caregiver participated in this study. Clinicians described using PROMs to coordinate care across provider types using the resources available in their units, whereas patients tended to focus on the perceived impact of this concerted care on symptom trajectory and care experience. We identified 3 overarching themes with subthemes related to the role of PROMs in interdisciplinary symptom management in this setting: (1) Integrating care for interrelated symptoms ("You need a team", conducive setting, role clarity and collaboration); (2) Streamlining information sharing and access (symptom data repository, common language for coordinated care); (3) Reshaping expectations (expectations for follow-up, managing symptom persistence). CONCLUSIONS: We found that use of PROMs in routine hemodialysis care highlighted symptom interrelatedness and complexity and helped to streamline involvement of the interdisciplinary care team. Issues such as role flexibility and resource constraints may influence sustainability of routine PROM use in the outpatient hemodialysis setting.

People with kidney failure receiving hemodialysis are faced with complex symptoms that impact their day-to-day functioning and quality of life. Patient-reported outcome measures (PROMs) are tools used by patients to directly communicate symptoms to their care team and guide symptom-focused care. Little is known about how PROMs could be integrated into the team-based care models of outpatient hemodialysis centres. In this study, we conducted interviews with people receiving hemodialysis and their clinicians about their perspectives on how PROMs could support interdisciplinary symptom management (i.e., integration of expertise to achieve common management goals). Participants described how the interrelatedness of symptoms was well suited to an integrated care approach and how PROMs enhanced communication and access to information across team members. In cases where symptoms persisted despite appropriate treatment, patients and clinicians explained how PROMs served as a tool to set realistic goals and reshape illness perception. Findings from this study suggest that access to resources, role flexibility, and established relationships within hemodialysis centres are important for sustaining PROM use in this setting.

Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT): A Clinical Research Protocol for a Pilot Randomized Controlled Trial to Increase Living Kidney Donation.

Background: Living donor kidney transplantation (LDKT) is the optimal treatment for eligible patients with kidney failure, although it is underutilized. Contextually tailored patient- and family-centered interventions may be effective to increase LDKT. Objective: We outline a protocol to test the feasibility of the Multidisciplinary Support To Access living donor Kidney Transplant (MuST AKT) intervention designed to increase LDKT. Design: Non-blinded single-center pilot randomized controlled trial with a qualitative interview component. Setting: Academic transplant referral center in Northern Alberta Region with a population of more than 2 million in its catchment area. Patients: English-speaking patients of the age range 18 to 75 years who are referred for kidney transplantation are eligible to participate. Measurements: Feasibility will be assessed by indicators of recruitment, retention, and completion rates, treatment fidelity, adherence to intervention, engagement in intervention, and acceptability. Methods: Participants will be randomly assigned 1:1 to either standard care (control) or the experimental group who receive standard care plus the MuST AKT intervention, a person-centered program designed to assist and enable the kidney transplant candidate to achieve what is required to receive an LDKT. The intervention consists of an introductory session and 4 intervention sessions delivered in-person or virtually. Limitations: Inferences cannot be drawn regarding the efficacy/effectiveness of the MuST AKT intervention. This study is non-blinded. Conclusions: This pilot study is the first step in our broader initiative to increase LDKT in our health care jurisdiction. The results of this study will be used to inform the development of a future definitive randomized controlled trial. Trial registration number: NCT04666545.

Contexte: Bien qu'elle soit encore sous-utilisée, la transplantation d'un rein provenant d'un donneur vivant (TRDV) constitue le traitement optimal pour les patients atteints d'insuffisance rénale qui sont admissibles. Des interventions personnalisées, axées sur le patient et la famille, pourraient s'avérer efficaces pour favoriser la TRDV. Objectif: Nous décrivons un protocole examinant la faisabilité de l'intervention MuST AKT (Multidisciplinary Support To Access living donor Kidney Transplant), laquelle vise l'augmentation des TRDV. Conception: Essai clinique pilote unicentrique, sans insu, comportant une composante d'entretiens qualitatifs. Cadre: Un center universitaire pour les transplantations du Nord de l'Alberta, situé dans une zone de référence comptant plus de deux millions de personnes. Sujets: Seront admissibles tous les patients anglophones âgés de 18 à 75 ans aiguillés pour une transplantation rénale. Mesures: La faisabilité sera évaluée par des indicateurs du taux de recrutement, de rétention et d'achèvement, de même que par la fidélité au traitement, l'adhésion à l'intervention, l'engagement dans l'intervention et l'acceptabilité. Méthodologie: Les sujets seront répartis aléatoirement 1:1 dans le groupe témoin, qui recevra les soins habituels, ou dans le groupe expérimental, qui recevra les soins habituels et l'intervention MuST AKT. Ce program axé sur le patient est conçu pour aider les candidats à une greffe rénale à réaliser les étapes nécessaires pour recevoir une TRDV. L'intervention est constituée d'une séance d'introduction et de quatre séances d'intervention réalisées en personne ou virtuellement. Limites: Nous ne serons pas en mesure de tirer des conclusions quant à l'efficacité de l'intervention MuST AKT. Cette étude n'est pas menée en aveugle. Conclusion: Cette étude pilote constitue la première étape d'une initiative plus vaste qui vise à accroître la TRDV dans notre région sanitaire. Les résultats de cette étude seront utilisés pour guider l'élaboration d'un futur essai clinique définitif.

Effect of Immunosuppressive or Immunomodulatory Agents on Severe COVID-19 Outcomes: A Population-Based Cohort Study.

OBJECTIVE: We estimated the association between immunosuppressive and immunomodulatory agent (IIA) exposure and severe COVID-19 outcomes in a population-based cohort study. METHODS: Participants were 18 years or older, tested positive for SARS-CoV-2 between February 6, 2020, and August 15, 2021, and were from administrative health data for the entire province of British Columbia, Canada. IIA use within 3 months prior to positive SARS-CoV-2 test included conventional disease-modifying antirheumatic drugs (antimalarials, methotrexate, leflunomide, sulfasalazine, individually), immunosuppressants (azathioprine, mycophenolate mofetil/mycophenolate sodium [MMF], cyclophosphamide, cyclosporine, individually and collectively), tumor necrosis factor inhibitor (TNFi) biologics (adalimumab, certolizumab, etanercept, golimumab, infliximab, collectively), non-TNFi biologics or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs) (rituximab separately from abatacept, anakinra, secukinumab, tocilizumab, tofacitinib and ustekinumab collectively), and glucocorticoids. Severe COVID-19 outcomes were hospitalizations for COVID-19, ICU admissions, and deaths within 60 days of a positive test. Exposure score-overlap weighting was used to balance baseline characteristics of participants with IIA use compared with nonuse of that IIA. Logistic regression measured the association between IIA use and severe COVID-19 outcomes. RESULTS: From 147,301 participants, we identified 515 antimalarial, 573 methotrexate, 72 leflunomide, 180 sulfasalazine, 468 immunosuppressant, 378 TNFi biologic, 49 rituximab, 144 other non-TNFi biologic or tsDMARD, and 1348 glucocorticoid prescriptions. Risk of hospitalizations for COVID-19 was significantly greater for MMF (odds ratio [95% CI]): 2.82 [1.81-4.40], all immunosuppressants: 2.08 [1.51-2.87], and glucocorticoids: 1.63 [1.36-1.96], relative to nonuse. Similar outcomes were seen for ICU admission and MMF: 2.52 [1.34-4.74], immunosuppressants: 2.88 [1.73-4.78], and glucocorticoids: 1.86 [1.37-2.54]. Only glucocorticoids use was associated with a significant increase in 60-day mortality: 1.58 [1.21-2.06]. No other IIAs displayed statistically significant associations with severe COVID-19 outcomes. CONCLUSION: Current use of MMF and glucocorticoids were associated with an increased risk of severe COVID-19 outcomes compared with nonuse. These results emphasize the variety of circumstances of patients taking IIAs.

Patient-reported outcome measures in the care of in-centre hemodialysis patients.

Kidney failure requiring dialysis is associated with high symptom burden and low health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) are standardized instruments that capture patients' symptom burden, level of functioning, and HRQL. The routine use of PROMs can be used to monitor aspects of patients' health that may otherwise be overlooked, inform care planning, and facilitate the introduction of treatments. Incorporating PROMs into clinical practice is an appropriate strategy to engage patients and enhance their role in decisions regarding their care and outcomes. However, the implementation of PROMs measurement and associated interventions can be challenging given the nature of clinical practice in busy hemodialysis units, the variations in organization and clinical workflow across units, as well as regional programs. Implementing PROMs and linking these with actionable treatment aids to alleviate bothersome symptoms and improve patients' wellbeing is key to improving patients' health. Other considerations in implementing PROMs within a hemodialysis setting include integration into electronic medical records, purchase and configuration of electronic tools (i.e., tablets), storage and disinfection of such tools, and ongoing IT resources. It is important to train clinicians on the practical elements of using PROMs, however there is also a need to engage clinicians to use PROMs on an ongoing basis. This article describes how PROMs have been implemented at in-centre hemodialysis units in Alberta, Canada, addressing each of these elements.