Dataset Information

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.

ABSTRACT:

Introduction

Patients with advanced cancers often face significant symptoms from their cancer and adverse effects from cancer-associated therapy. Patient-generated health data (PGHD) are routinely collected information about symptoms and activity levels that patients either directly report or passively record using devices such as wearable accelerometers. The objective of this study was to test the impact of an intervention integrating remote collection of PGHD with clinician and patient nudges to inform communication between patients with advanced cancer and their oncology team regarding symptom burden and functional status.

Methods and analysis

This single-centre prospective randomised controlled trial randomises patients with metastatic gastrointestinal or lung cancers into one of three arms: (A) usual care, (B) an intervention that integrates PGHD (including weekly text-based symptom surveys and passively recorded step counts) into a dashboard delivered to oncology clinicians at each visit and (C) the same intervention as arm B but with an additional text-based active choice intervention to patients to encourage discussing their symptoms with their oncology team. The study will enrol approximately 125 participants. The coprimary outcomes are patient perceptions of their oncology team's understanding of their symptoms and their functional status. Secondary outcomes are intervention utility and adherence.

Ethics and dissemination

This study has been approved by the institutional review board at the University of Pennsylvania. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement.

Trial registration numbers

NCT04616768 and 843 616.

SUBMITTER: Parikh RB

PROVIDER: S-EPMC9109034 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.

Parikh Ravi B RB Ferrell William W Wakim Jonathan J Williamson Joelle J Khan Neda N Kopinsky Michael M Balachandran Mohan M Gabriel Peter E PE Zhang Yichen Y Schuchter Lynn M LM Shulman Lawrence N LN Chen Jinbo J Patel Mitesh S MS Manz Christopher R CR

BMJ open 20220512 5

<h4>Introduction</h4>Patients with advanced cancers often face significant symptoms from their cancer and adverse effects from cancer-associated therapy. Patient-generated health data (PGHD) are routinely collected information about symptoms and activity levels that patients either directly report or passively record using devices such as wearable accelerometers. The objective of this study was to test the impact of an intervention integrating remote collection of PGHD with clinician and patient ...[more]

PMID: 35551088

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Project description:IntroductionLung cancer is the leading cause of cancer-related mortality globally, with non-small cell lung cancer (NSCLC) comprising the majority of cases. For advanced NSCLC, immunotherapy offers substantial survival benefits but is often accompanied by severe immune-related adverse events symptoms, significantly affecting health-related quality of life (HRQoL). Routinely collection of patient-reported outcomes (PROs) followed by automated alerts has been shown to improve overall survival and HRQoL for cancers. However, there is limited evidence for PRO-based symptom monitoring on advanced NSCLC during immunotherapy. This study proposes an electronic PRO-based symptom tracking intervention, integrated with reactive alerts and nudges (PRO-NET) to improve HRQoL for advanced NSCLC patients receiving immunotherapy in China. Secondary objectives include assessing the effect of PRO-symptom monitoring on survival, physical function, symptom control, mental health, cost-effectiveness and implementation fidelity.Methods and analysisThe PRO-NET study is a two-arm, parallel randomised controlled trial. The study will enrol at least 300 advanced NSCLC patients undergoing immunotherapy in China. Participants will be randomly assigned to either the intervention or control group in a ratio of 1:1 via PRO-NET programme. The intervention involves weekly electronic collection of immune-related PROs and reactive alerts sent directly to patients, combined with nudges over a 6-month period. Patients in the control group will follow usual care and will not trigger the alerts. Both the intervention and control groups will receive outcome assessments at baseline, 3 months and 6 months. Primary outcome focuses on HRQoL, while secondary outcomes include survival, physical function, symptom burden, mental health, cost-effectiveness and implementation fidelity. Differences in HRQoL between the groups will be compared using general linear mixed model, accounting for potential confounding.Ethics and disseminationThe study was approved by the Institutional Review Board of the Peking University protocol on 21 July 2024 (No. IRB 00001052-24066). This protocol is based on V2.0, 6 July 2024 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences.Trials registration numberChiCTR2400088408.

Project description:IntroductionWhile some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients.Methods and analysisA total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes).Ethics and disseminationEthical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts.Trial registration numberNCT02356081.

Project description:BackgroundPatient-generated health data (PGHD) have been largely collected through mobile health (mHealth) apps and wearable devices. PGHD can be especially helpful in mental health, as patients' illness history and symptom narratives are vital to developing diagnoses and treatment plans. However, the extent to which clinicians use mental health-related PGHD is unknown.ObjectiveA mixed methods study was conducted to understand clinicians' perspectives on PGHD and current mental health apps. This approach uses information gathered from semistructured interviews, workflow analysis, and user-written mental health app reviews to answer the following research questions: (1) What is the current workflow of mental health practice and how are PGHD integrated into this workflow, (2) what are clinicians' perspectives on PGHD and how do they choose mobile apps for their patients, (3) and what are the features of current mobile apps in terms of interpreting and sharing PGHD?MethodsThe study consists of semistructured interviews with 12 psychiatrists and clinical psychologists from a large academic hospital. These interviews were thematically and qualitatively analyzed for common themes and workflow elements. User-posted reviews of 56 sleep and mood tracking apps were analyzed to understand app features in comparison with the information gathered from interviews.ResultsThe results showed that PGHD have been part of the workflow, but its integration and use are not optimized. Mental health clinicians supported the use of PGHD but had concerns regarding data reliability and accuracy. They also identified challenges in selecting suitable apps for their patients. From the app review, it was discovered that mHealth apps had limited features to support personalization and collaborative care as well as data interpretation and sharing.ConclusionsThis study investigates clinicians' perspectives on PGHD use and explored existing app features using the app review data in the mental health setting. A total of 3 design guidelines were generated: (1) improve data interpretation and sharing mechanisms, (2) consider clinical workflow and electronic health record integration, and (3) support personalized and collaborative care. More research is needed to demonstrate the best practices of PGHD use and to evaluate their effectiveness in improving patient outcomes.

Project description:ObjectiveNudges are interventions that alter the way options are presented, enabling individuals to more easily select the best option. Health systems and researchers have tested nudges to shape clinician decision-making with the aim of improving healthcare service delivery. We aimed to systematically study the use and effectiveness of nudges designed to improve clinicians' decisions in healthcare settings.DesignA systematic review was conducted to collect and consolidate results from studies testing nudges and to determine whether nudges directed at improving clinical decisions in healthcare settings across clinician types were effective. We systematically searched seven databases (EBSCO MegaFILE, EconLit, Embase, PsycINFO, PubMed, Scopus and Web of Science) and used a snowball sampling technique to identify peer-reviewed published studies available between 1 January 1984 and 22 April 2020. Eligible studies were critically appraised and narratively synthesised. We categorised nudges according to a taxonomy derived from the Nuffield Council on Bioethics. Included studies were appraised using the Cochrane Risk of Bias Assessment Tool.ResultsWe screened 3608 studies and 39 studies met our criteria. The majority of the studies (90%) were conducted in the USA and 36% were randomised controlled trials. The most commonly studied nudge intervention (46%) framed information for clinicians, often through peer comparison feedback. Nudges that guided clinical decisions through default options or by enabling choice were also frequently studied (31%). Information framing, default and enabling choice nudges showed promise, whereas the effectiveness of other nudge types was mixed. Given the inclusion of non-experimental designs, only a small portion of studies were at minimal risk of bias (33%) across all Cochrane criteria.ConclusionsNudges that frame information, change default options or enable choice are frequently studied and show promise in improving clinical decision-making. Future work should examine how nudges compare to non-nudge interventions (eg, policy interventions) in improving healthcare.

Project description:BACKGROUND:The provision of psychometrically valid patient reported outcomes (PROs) improves patient outcomes and reflects their quality of life. Consequently, ad hoc clinician-generated questionnaires of the past are being replaced by more rigorous instruments. This change, while beneficial, risks the loss/orphaning of decades-long information on difficult to capture/chronically ill populations. The goal of this study was to assess to the quality of data retrieved from these legacy questionnaires. METHODS:Participants included 8563 patients who generated a total of 12,626 hospital admissions over the 2004-2014 study period. Items used to screen for issues related to function, mood, symptoms, and social support among patients with chronic disease were identified in our medical center's patient information questionnaire. Cluster and exploratory factor analyses (EFA) followed by multidimensional item response theory (MIRT) analyses were used to select items that defined factors. Scores were derived with summation and MIRT approaches; inter-factor relationships and relationships of factor scores to assigned diagnostic codes were assessed. Rasch analyses assessed the constructs' measurement properties. RESULTS:Literature review and clinician interviews yielded four hypothesized constructs: psychological distress/wellbeing, symptom burden, social support, and physical function. Rasch analyses showed that, while all had good measurement properties, only one, function, separated individuals well. In exploratory factor analyses (EFA), 11 factors representing depression, respiratory symptoms, musculoskeletal pain, family support, mobility, activities of daily living, alcohol consumption, weight loss, fatigue, neurological disorders, and fear at home were identified. Based on the agreement between EFA and cluster analyses as well as Cronbach's alpha, six domains were retained for analyses. Correlations were strong between activities of daily living and mobility (.84), and moderate between pain and mobility (.37) and psychological distress (.59) Known-group validity was supported from the relationships between factor scores and the relevant diagnostic code assignments (.12 to .20). CONCLUSIONS AND DISCUSSION:Items from ad hoc clinician-generated patient information questionnaires can be aggregated into valid factors that assess supportive care domains among chronically ill patients. However, the binary response options offered by many screening items limit their information content and consequently, as highlighted by Rasch analyses, their ability to meaningfully discriminate trait levels in these populations.

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Dataset Information

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration numbers

Publications

Patient and clinician nudges to improve symptom management in advanced cancer using patient-generated health data: study protocol for the PROStep randomised controlled trial.

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