Dataset Information

Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol.

ABSTRACT:

Introduction

Chronic kidney disease (CKD) affects up to 16% of adults in the UK. Patient quality of life is particularly reduced in end-stage renal disease and is strongly associated with increased hospitalisation and mortality. Thus, accurate and responsive healthcare is a key priority. Electronic patient-reported outcome measures (ePROMs) are online questionnaires which ask patients to self-rate their health status. Evidence in oncology suggests that the use of ePROM data within routine care, alongside clinical information, may enhance symptom management and improve patient outcomes. However, National Health Service (NHS)-based ePROM research in CKD is lacking. This pilot trial will assess the feasibility of undertaking a full-scale randomised controlled trial (RCT) in patients with CKD within the NHS.

Methods and analysis

The renal ePROM pilot trial is an investigator-led single-centre, open-label, two-arm randomised controlled pilot trial of 66 participants ?18 years with advanced CKD. Participants will be randomised to receive either usual care or usual care supplemented with an ePROM intervention. Participants within the intervention arm will be asked to submit monthly self-reports of their health status using the ePROM system. The system will provide tailored information to patients in response to each report and notify the clinical team of patient deterioration. The renal clinical team will monitor for ePROM notifications and will respond with appropriate action, in line with standard clinical practice. Measures of study feasibility, participant quality of life and CKD severity will be completed at 3 monthly intervals. Health economic outcomes will be assessed. Clinicians will record treatment decision-making. Acceptability and feasibility of the protocol will be assessed alongside outcome measure and intervention compliance rates. Qualitative process evaluation will be conducted.

Ethics and dissemination

The findings will inform the design of a full-scale RCT and the results will be submitted for publication in peer-reviewed journals. The study has ethical approval.

Trial registration numbers

ISRCTN12669006; Pre-results.

SUBMITTER: Kyte D

PROVIDER: S-EPMC6224762 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol.

Kyte Derek D Bishop Jon J Brettell Elizabeth E Calvert Melanie M Cockwell Paul P Dutton Mary M Eddington Helen H Hadley Gabby G Ives Natalie J NJ Jackson Louise J LJ Stringer Stephanie S Valente Marie M

BMJ open 20181028 10

<h4>Introduction</h4>Chronic kidney disease (CKD) affects up to 16% of adults in the UK. Patient quality of life is particularly reduced in end-stage renal disease and is strongly associated with increased hospitalisation and mortality. Thus, accurate and responsive healthcare is a key priority. Electronic patient-reported outcome measures (ePROMs) are online questionnaires which ask patients to self-rate their health status. Evidence in oncology suggests that the use of ePROM data within routin ...[more]

PMID: 30373785

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Project description:BACKGROUND:Family-centered care is a valued approach to improving child and family outcomes in early intervention (EI), yet there is need to implement interventions that support information exchange for shared decision-making when planning and monitoring EI care. This study aims at estimating the feasibility, acceptability, and value of implementing the Young Children's Participation and Environment Measure (YC-PEM), a valid electronic patient-reported outcome (e-PRO) that is designed to support family engagement when planning care and monitoring outcomes of care. METHODS:Data were gathered from caregivers (N?=?139) that were enrolled in a Phase 1 trial of the YC-PEM e-PRO as implemented within 1 month of their child's next EI evaluation of progress. YC-PEM e-PRO feasibility was estimated according to enrollment and completion rates, and mean completion time. Chi-square tests were used to examine parent perceptions of YC-PEM e-PRO acceptability by caregiver education and family income. Caregiver feedback via open-ended responses were content coded to inform intervention and protocol optimizations. YC-PEM e-PRO value was estimated via composite and item-level scores to capture the extent of participation difficulty in home and community activities, and common areas of need regarding caregivers desired change in their child's participation. RESULTS:Feasibility of implementing the YC-PEM e-PRO in routine EI care was mixed, as evidenced by low enrollment rates (21.0-29.2%), a high completion rate (85.3%), and limited missing data (80.6% of completed cases contained no missing data). More than half of the participants reported that the completion of the YC-PEM e-PRO was at least somewhat helpful, regardless of family income or caregiver education, providing support for its acceptability. As for its value, the YC-PEM e-PRO results were viewed by 64% of caregivers, whose desire for change most often pertained to the child's participation in non-discretionary activities at home and structured activities in the community. CONCLUSIONS:Results may support the implementation of YC-PEM e-PRO as a feasible, acceptable, and valued option for engaging families in planning the child's EI care. Results also inform select intervention and protocol optimizations prior to undertaking a multi-site pragmatic trial of its effectiveness on family engagement and shared decision-making within an EI clinical workflow. TRIAL REGISTRATION:Trial number: NCT03904797 . Trial registered at Clinicaltrials.gov . Registered 22 March 2019. Retrospectively registered.

Project description:Patient-reported outcome measures (PROMs) provide an opportunity for meaningful patient engagement and shared decision-making. The objective of this research programme is to improve health outcomes for paediatric solid organ transplant patients by implementing PROMs into clinical care. The current study aims to create Voxe, a paediatric user-centred electronic PROM platform, by engaging patients and healthcare providers throughout the design and development process. The creation of Voxe will occur over two phases that build on previous research. The user interface design phase employs a 'user-centric' approach to identify end-users' needs and iteratively refine the look and layout of Voxe to meet these needs. Transplant recipients, aged 10-17, and healthcare providers will participate in three rounds of testing (24 participants total). Participants will: (1) complete task-based activities (outcomes-effectiveness and efficiency), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. The following phase involves software development and Voxe usability testing. Transplant recipients, aged 8-17, and healthcare providers will participate in four rounds of iterative testing (24-40 participants total). The think-aloud technique will be employed, and participants will describe their thoughts and feelings while interacting with a Voxe prototype. Participants will: (1) log into Voxe and complete tasks (outcomes-time on task, successful task completion, frequency of critical and non-critical errors and error-free rate), (2) complete questionnaires (outcome-satisfaction) and (3) participate in a semi-structured interview. Findings will result in the creation and launch of a user-centred electronic PROM platform. Research ethics board approval has been provided by The Hospital for Sick Children. This research is critical to answering methodological and operational questions to inform Voxe implementation in paediatric clinical settings and facilitate PROM data collection. Future investigations will include an implementation-effectiveness evaluation.

Project description:BackgroundPatient reported outcomes (PROs) have been associated with improved symptom management and quality of life in patients with cancer. However, the implementation of PROs in an academic clinical practice has not been thoroughly described. Here we report on the execution, feasibility and healthcare utilization outcomes of an electronic PRO (ePRO) application for cancer patients at an academic medical center.MethodsWe conducted a randomized trial comparing an experimental ePRO arm to standard of care in patients with advanced cancer in the thoracic, gastrointestinal, and genitourinary oncology groups at Stanford Cancer Center from March 2018 to November 2019. We describe the pre-implementation, implementation, and post-implementation phases of the ePRO arm, technological barriers, electronic health record (EHR) integration, clinician burden, and patient data privacy and security. Feasibility was pre-specified to be at least 70% completion of all questionnaires. Acceptability was based on patient and clinician feedback. Ambulatory healthcare utilization was assessed by reviewing numbers of phone messages, electronic portal messages, and referrals for supportive care.ResultsOf 617 ePRO questionnaires sent to 72 patients, 445 (72%) were completed. Most clinicians (87.5%) and patients (93%) felt neutral or positive about the ePRO tool's ease of use. Exposure to ePRO did not cause a measurable change in ambulatory healthcare utilization, with a median of less than two phone messages and supportive care referrals, and 5-6 portal messages.ConclusionsWeb-based ePRO tools for patients with advanced cancer are feasible and acceptable without increasing clinical burden. Key lessons include the importance of pilot testing, engagement of stakeholders at all levels, and the need for customization by disease group. Future directions for this work include completion of EHR integration, expansion to other centers, and development of integrated workflows for routine clinical practice.

Project description:IntroductionAdvanced chronic kidney disease (CKD) has a major effect on the quality of life and health status of patients and requires accurate and responsive management. The use of electronic patient-reported outcome measures (ePROMs) could assist patients with advanced pre-dialysis CKD, and the clinicians responsible for their care, by identifying important changes in symptom burden in real time. We report the protocol for 'Using Patient-Reported Outcome measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney Disease' (PRO-trACK) project, which will explore the feasibility and validity of an ePROM system for use in patients with advanced CKD.Methods and analysisThe project will use a mixed-methods approach in three studies: (1) usability testing of the ePROM system involving up to 30 patients and focusing on acceptability and technical performance/stability; (2) ascertaining the views of patient and clinician stakeholders on the optimal use and administration of the CKD ePROM system-this will involve qualitative face-to-face/telephone interviewing with up to 30 patients or until saturation is achieved, focus groups with up to 15 clinical staff, management and IT team members; (3) psychometric assessment of the system, within a cohort of at least 180 patients with advanced CKD, to establish the measurement properties of the ePROM.Ethics and disseminationThis project was approved by the West Midlands Edgbaston Research Ethics Committee (Reference 17/WM/0010) and received Health Research Authority (HRA) approval on 24 February 2017.The findings from this project will be provided to clinicians at the Department of Renal Medicine, Queen Elizabeth Hospitals, Birmingham (QEHB), NHS England, presented at conferences and to the Kidney Patients' Association, British Kidney Patient Association and the British Renal Society. Articles based on the findings will be written and submitted for publication in peer-reviewed journals.

Project description:BackgroundFew measures capture the complex symptoms and concerns of those receiving palliative care.AimTo validate the Integrated Palliative care Outcome Scale, a measure underpinned by extensive psychometric development, by evaluating its validity, reliability and responsiveness to change.DesignConcurrent, cross-cultural validation study of the Integrated Palliative care Outcome Scale - both (1) patient self-report and (2) staff proxy-report versions. We tested construct validity (factor analysis, known-group comparisons, and correlational analysis), reliability (internal consistency, agreement, and test-retest reliability), and responsiveness (through longitudinal evaluation of change).Setting/participantsIn all, 376 adults receiving palliative care, and 161 clinicians, from a range of settings in the United Kingdom and Germany.ResultsWe confirm a three-factor structure (Physical Symptoms, Emotional Symptoms and Communication/Practical Issues). Integrated Palliative care Outcome Scale shows strong ability to distinguish between clinically relevant groups; total Integrated Palliative care Outcome Scale and Integrated Palliative care Outcome Scale subscale scores were higher - reflecting more problems - in those patients with 'unstable' or 'deteriorating' versus 'stable' Phase of Illness (F = 15.1, p < 0.001). Good convergent and discriminant validity to hypothesised items and subscales of the Edmonton Symptom Assessment System and Functional Assessment of Cancer Therapy-General is demonstrated. The Integrated Palliative care Outcome Scale shows good internal consistency (α = 0.77) and acceptable to good test-retest reliability (60% of items kw > 0.60). Longitudinal validity in form of responsiveness to change is good.ConclusionThe Integrated Palliative care Outcome Scale is a valid and reliable outcome measure, both in patient self-report and staff proxy-report versions. It can assess and monitor symptoms and concerns in advanced illness, determine the impact of healthcare interventions, and demonstrate quality of care. This represents a major step forward internationally for palliative care outcome measurement.

Project description:Background Validity is the ability of an instrument to measure what it claims to measure. It means the degree to which the empirical evidence supports the trustworthiness of interpretations based on the calculated scores. The hematological malignancy (HM) specific patient reported outcome measure (HM-PRO), is a newly developed instrument for use in daily clinical practice as well as in research. This study, provides the evidence for construct validity of the HM-PRO, specifically focusing on the convergent and divergent validity compared to the other established instruments used in hematology. Methods This validation study adopted a prospective cross-sectional design where a heterogeneous group of patients diagnosed with different HMs and different disease state were recruited. A total of 905 patients were recruited from seven secondary care hospitals in the UK and online through five patient organizations. Patients were asked to complete the HM-PRO and other cancer specific PRO’s, FACT-G and EORTC QLQ C-30. Data analysis was performed using IBM SPSS 23 statistical software. Results A total of 486 males (53.7%) and 419 females (46.3%), with a mean age of 64.3 (± 12.4) years and mean time since diagnosis of 4.6 ( ± 5.2) were recruited. The total score of Part A of the HM-PRO highly correlated with the five functional scales of the EORTC QLQ-C30 (Physical = ?0.71, Role = ?0.72, Emotional = ?0.64, Cognitive = ?0.58, Social = ?0.74—p < 0.001). With respect to correlation with FACT-G, the total score of Part A of the HM-PRO highly correlated with Physical (?0.74), Emotional (?0.57), Functional (?0.66) domains and overall score of FACT-G (?0.74). Similarly, the total score of Part B of the HM-PRO highly correlated with three symptoms scales of EORTC QLQ-C30 (Fatigue scale = ?0.74, Nausea and Vomiting = ?0.52, Pain = ?0.59—p < 0.001) and individual symptom items (Dyspnea = 0.51, Insomnia= 0.43, Appetite loss = 0.54—p < 0.001). Conclusion The construct validity evidence presented in this research is a testimony to the HM-PRO’s ability to measure HRQoL issues which it intends to measure. This is of utmost importance when a PRO is used in routine clinical practice so that the interpretation of the scores or response to an individual item is understood by the clinicians/nurses as intended by the patients.

Project description:BACKGROUND:In the past years, a mobile health (mHealth) app called the Dutch Talking Touch Screen Questionnaire (DTTSQ) was developed in The Netherlands. The aim of development was to enable Dutch physical therapy patients to autonomously complete a health-related questionnaire regardless of their level of literacy and digital skills. OBJECTIVE:The aim of this study was to evaluate the usability (defined as the effectiveness, efficiency, and satisfaction) of the prototype of the DTTSQ for Dutch physical therapy patients with diverse levels of experience in using mobile technology. METHODS:The qualitative Three-Step Test-Interview method, including both think-aloud and retrospective probing techniques, was used to gain insight into the usability of the DTTSQ. A total of 24 physical therapy patients were included. The interview data were analyzed using a thematic content analysis approach aimed at analyzing the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took the participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating that was used to provide a rough estimate of the need for additional usability efforts. RESULTS:All participants within this study were very satisfied with the ease of use of the DTTSQ. Overall, 9 participants stated that the usability of the app exceeded their expectations. The group of 4 average-/high-experienced participants encountered only 1 problem in total, whereas the 11 little-experienced participants encountered an average of 2 problems per person and the 9 inexperienced participants an average of 3 problems per person. A total of 13 different kind of problems were found during this study. Of these problems, 4 need to be addressed before the DTTSQ will be released because they have the potential to negatively influence future usage of the tool. The other 9 problems were less likely to influence future usage of the tool substantially. CONCLUSIONS:The usability of the DTTSQ needs to be improved before it can be released. No problems were found with satisfaction or efficiency during the usability test. The effectiveness needs to be improved by (1) making it easier to navigate through screens without the possibility of accidentally skipping one, (2) enabling the possibility to insert an answer by tapping on the text underneath a photograph instead of just touching the photograph itself, and (3) making it easier to correct wrong answers. This study shows the importance of including less skilled participants in a usability study when striving for inclusive design and the importance of measuring not just satisfaction but also efficiency and effectiveness during such studies.

Dataset Information

Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration numbers

Publications

Use of an electronic patient-reported outcome measure in the management of patients with advanced chronic kidney disease: the RePROM pilot trial protocol.

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