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.

How the Routine Use of Patient-Reported Outcome Measures for Hemodialysis Care Influences Patient-Clinician Communication: A Mixed-Methods Study.

BACKGROUND AND OBJECTIVES: Patient-reported outcome measures invite patients to self-report aspects of their quality of life and have been reported to enhance communication with clinicians. We aimed to examine how routine use of patient-reported outcome measures in in-center hemodialysis units influenced patient-clinician communication. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A concurrent, longitudinal, mixed-methods approach was used. We used data from a cluster randomized controlled trial of 17 hemodialysis units in northern Alberta that introduced a patient-reported outcome measures intervention. Patient-clinician communication was assessed using a modified Communication Assessment Tool. Using interpretive description, we explored patients' and nurses' perceptions of communication pertaining to routine patient-reported outcome measure use. Through purposeful sampling, we interviewed ten patients and eight nurses and conducted six observations in the dialysis units, which were documented in field notes. We reviewed 779 patient responses to open-ended survey questions from randomized controlled trial data. Qualitative data were thematically analyzed. RESULTS: Overall, patient-reported outcome measure use did not substantively improve patient-clinician communication. There was a small positive change in mean total Communication Assessment Tool scores (range, 1-5) from baseline to 12 months in patient-reported outcome measure use units (0.25) but little difference from control group units that did not use patient-reported outcome measures (0.21). The qualitative findings provide in-depth insights into why patient-reported outcome measure use did not improve patient-clinician communication. The purpose of patient-reported outcome measure use was not always understood by patients and clinicians; patient-reported outcome measures were not implemented as originally intended in the trial, despite clinician training; there were challenges using patient-reported outcome measures as a means to communicate; and patient-reported outcome measure use was perceived to have limited value. CONCLUSIONS: While patient-reported outcome measures use did not improve patient-clinician communication, qualitative data suggest implementation challenges, including limited clarity of purpose and perceived limited value, that may have limited the effectiveness of the intervention.

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.

Burden of mental health symptoms and perceptions of their management in in-centre hemodialysis care: a mixed methods study.

BACKGROUND: We aimed to describe (1) depressive and anxiety symptom burdens reported by adults on in-centre hemodialysis in Northern Alberta, Canada and (2) patients' and nurses' perceptions of managing such symptoms using routine patient-reported outcome measures (PROMs). METHODS: A longitudinal mixed methods approach was employed. Cluster randomized controlled trial data exposed the prevalence of positive screens (scores ≥ 3) for depressive (PHQ-2) and anxiety (GAD-2) symptoms. A descriptive qualitative approach was used to understand patients' and nurses' perceptions of managing these symptoms using the ESAS-r: Renal and EQ-5D-5L. Using purposeful sampling, patients and nurses were invited for interviews. Field notes were documented from 6 dialysis unit observations. Patients' responses to open-ended survey questions and nurses' electronic chart notes related to mental health were compiled. Thematic and content analyses were used. RESULTS: Average age of patients (n = 408) was 64.0 years (SD 15.4), 57% were male, and 87% were not working; 29% screened positive for depressive symptoms, 21% for anxiety symptoms, and 16% for both. From patient (n = 10) and nurse (n = 8) interviews, unit observations, patient survey responses (n = 779) and nurses' chart notes (n = 84), we discerned that PROMs (ESAS-r: Renal/EQ-5D-5L) had the potential to identify and prompt management of mental health concerns. However, opinions differed about whether mental health was within kidney care scope. Nonetheless, participants agreed there was a lack of mental health resources. CONCLUSIONS: Prevalence of depressive and anxiety symptoms aligned with existing literature. Tensions regarding mental health management highlight the need for systemic decisions about how routine PROM use, including mental health assessment, may be optimized to meet patients' needs.

Voicing Individual Concerns for Engagement in Hemodialysis (VOICE-HD): A Mixed Method, Randomized Pilot Trial of Digital Health in Dialysis Care Delivery.

BACKGROUND: People receiving in-center hemodialysis (HD) have prioritized the need for more individualized health information and better communication with nephrologists. The most common setting for patient-nephrologist interactions is during the HD treatment, which is a time pressured setting that lacks privacy. OBJECTIVE: To facilitate effective communication in the hemodialysis (HD) unit, we evaluated the usability of a web application (web app) from both the patient and physician perspective. The main aim of the web app was to support patients in prioritizing their dialysis concerns outside of the clinical HD encounter. DESIGN: Mixed method, parallel arm, multi-site, pilot randomized controlled trial. SETTING: Two outpatient Canadian HD centers. PARTICIPANTS: Adult patients receiving in-center HD and their attending nephrologists. METHODS: Patients were randomized to either a web application or an active control (paper form) for logging concerns to be addressed at weekly encounters with the nephrologist over 8 weeks. Topics included: HD treatment, symptoms, modality, and medications. The primary outcome was usability, defined as effectiveness (engagement with the tool, frequency of submitted concerns, whether the concern was satisfactorily addressed) and satisfaction with the tool using a priori thresholds and explored in interviews with patients and nephrologists. RESULTS: 77 patients (30 women, median age 61, interquartile range [53,67], median 2 years [1,4] on dialysis) and 19 nephrologists (4 women, median age 46 [36,65]) were enrolled. Patient use of a digital device at baseline was low (20%). Engagement with the tool was 70% (web app) and 100% (paper) with a lower proportion of patients in the web app group submitting at least one concern over 8 weeks compared to the paper form group: 56.7% vs 87.9%. Weekly concerns were satisfactorily addressed in both groups and ≥70% of patients would continue to use the tools. For patients, both tools promoted preparation and participation in the encounter; however, only the web app facilitated greater privacy in relaying concerns. For most nephrologists, the tools were disruptive to their workflow and were perceived as unnecessary given existing processes and familiarity with patients. For future versions of the app, patients suggested more features to facilitate self-management and nephrologists suggested integration with health databases and multidisciplinary teams. LIMITATIONS: Tertiary setting may limit generalizability. CONCLUSIONS: Both tools promoted fundamental components of self-management; however, patients in the paper form group submitted concerns more often and this tool was easier to remember to use. Although modifications would likely enhance web app usability, successful future adoption is limited by physician acceptance.Trial registration ClinicalTrials.gov NCT03605875.

CONTEXTE: Les personnes qui reçoivent l'hémodialyse (HD) en center hospitalier jugent nécessaire d'obtenir des informations de santé plus individualisées et d'avoir une meilleure communication avec les néphrologues. Les interactions entre les patients et les néphrologues ont plus souvent lieu pendant l'hémodialyse, mais ce contexte manque d'intimité et les parties sont souvent pressées par le temps. OBJECTIFS: Pour aider à établir une communication plus efficace dans l'unité d'hémodialyse (HD), nous avons évalué la convivialité d'une application Web du point de vue du patient et du médecin. Cette application Web devait aider les patients à faire part de leurs préoccupations liées à la dialyze en dehors des séances d'HD. TYPE D'ÉTUDE: Essai multicentrique randomisé contrôlé avec groupes parallèles, réalisé par méthodes mixtes. CADRE: Deux centers d'hémodialyse canadiens en consultation externe. SUJETS: Des adultes recevant des traitements d'HD en center hospitalier et leurs néphrologues traitants. MÉTHODOLOGIE: Les patients ont été répartis aléatoirement pour utiliser l'application Web ou un témoin actif (formulaire papier) pour consigner, sur une période de huit semaines, les préoccupations à aborder lors des rencontres hebdomadaires avec leur néphrologue. Les sujets abordés concernaient le traitement d'HD, les symptômes, la modalité et les médicaments. Le principal critère d'évaluation était la facilité d'utilization, définie par l'efficacité (engagement avec l'outil, fréquence des soumissions, si le problème a été traité de façon satisfaisante). La satisfaction à l'égard de l'outil a été évaluée avec des seuils préétablis et explorée lors d'entrevues avec les patients et les néphrologues. RÉSULTATS: Ont été inclus 77 patients (30 femmes) sous dialyze depuis 2 ans (durée médiane; intervalle interquartile [1,4]) et dont l'âge médian s'établissait à 61 ans [53-67]. Ont aussi été inclus 19 néphrologues (4 femmes; âge médian : 46 ans [36-65]). Au début de l'étude, l'utilization d'un dispositif numérique par les patients était faible (20 %). L'engagement avec l'outil était de 70 % (application Web) et de 100 % (formulaire). Les patients du groupe « application Web ¼ sont moins nombreux à avoir soumis au moins une préoccupation au cours des huit semaines comparativement au groupe utilisant les formulaires papier (56,7 % c. 87,9 %). Les préoccupations hebdomadaires ont été abordées de façon satisfaisante dans les deux groupes et plus de 70 % des patients continueraient d'utiliser ces outils. Pour les patients, les deux outils ont favorisé la préparation et la participation à la rencontre, mais seule l'application Web a permis d'accroître la confidentialité dans la transmission des préoccupations. La plupart des néphrologues ont trouvé que ces outils perturbaient leur flux de travail et les ont perçus comme inutiles puisqu'ils jugent qu'un processus et une familiarité avec les patients existent déjà. Les patients ont suggéré que les futures versions de l'application aient plus de caractéristiques pour faciliter l'autogestion; les néphrologues ont quant à eux suggéré qu'elle soit intégrée aux bases de données sur la santé et aux équipes multidisciplinaires. LIMITES: Étude menée dans des centers de soins tertiaires, ceci pourrait limiter la généralisabilité des résultats. CONCLUSION: Les deux outils ont facilité des composantes fondamentales de l'autogestion. Cependant, les patients qui utilisaient des formulaires papier ont plus souvent fait part de leurs préoccupations. Il s'est également avéré qu'on pensait davantage à utiliser cet outil que l'application. Bien que des modifications puissent accroître la convivialité de l'application Web, son adoption demeure limitée par l'acceptation des médecins.