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Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:Multimorbidity increases care needs and primary care use among people with chronic diseases. The Concerto Health Program (CHP) has been developed to optimise chronic disease management in primary care services. However, in its current version, the CHP primarily targets clinicians and does not aim to answer directly patients' and their informal caregivers' needs for chronic disease management. Various studies have shown that interventions that increase patient activation level are associated with better health outcomes. Furthermore, educational tools must be adapted to patients and caregivers in terms of health literacy and usability. This project aims to develop, implement and evaluate a user-centred, multifunctional and personalised eHealth platform (CONCERTO+) to promote a more active patient role in chronic disease management and decision-making. METHODS AND ANALYSIS:This project uses a collaborative research approach, aiming at the personalisation of CHP through three phases: (1) the development of one module of an eHealth platform based on scientific evidence and user-centred design; (2) a feasibility study of CONCERTO+ through a pilot cluster randomised controlled trial where patients with chronic diseases from a primary healthcare practice will receive CONCERTO+ during 6 months and be compared to patients from a control practice receiving usual care and (3) an analysis of CONCERTO+ potential for scaling up. To do so, we will conduct two focus groups with patients and informal caregivers and individual interviews with health professionals at the two study sites, as well as health care managers, information officers and representatives of the Ministry of Health. ETHICS AND DISSEMINATION:This study received ethical approval from Ethics Committee of Université Laval. The findings will be used to inform the effectiveness of CONCERTO+ to improve management care in chronic diseases. We will disseminate findings through presentations in scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03628963; Pre-results.

SUBMITTER: Gagnon MP

PROVIDER: S-EPMC6500232 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial.

Gagnon Marie-Pierre MP Ndiaye Mame Awa MA Larouche Alain A Chabot Guylaine G Chabot Christian C Buyl Ronald R Fortin Jean-Paul JP Giguère Anik A Leblanc Annie A Légaré France F Motulsky Aude A Sicotte Claude C Witteman Holly O HO Kavanagh Eric E Lépinay Frédérick F Roberge Jacynthe J Délétroz Carole C Abbasgholizadeh-Rahimi Samira S

BMJ open 20190402 4

<h4>Introduction</h4>Multimorbidity increases care needs and primary care use among people with chronic diseases. The Concerto Health Program (CHP) has been developed to optimise chronic disease management in primary care services. However, in its current version, the CHP primarily targets clinicians and does not aim to answer directly patients' and their informal caregivers' needs for chronic disease management. Various studies have shown that interventions that increase patient activation leve ...[more]

PMID: 30944143

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Project description:Background Tuberculosis (TB) is among the leading causes of infectious death worldwide. Contact investigation is an evidence-based, World Health Organisation-endorsed intervention for timely TB diagnosis, treatment, and prevention but has not been widely and effectively implemented. Methods We are conducting a stepped-wedge, cluster-randomised, hybrid Type III implementation-effectiveness trial comparing a user-centred to a standard strategy for implementing TB contact investigation in 12 healthcare facilities in Uganda. The user-centred strategy consists of several client-focused components including 1) a TB-education booklet, 2) a contact-identification algorithm, 3) an instructional sputum-collection video, and 4) a community-health-rider service to transport clients, CHWs, and sputum samples, along with several healthcare-worker-focused components, including 1) collaborative improvement meetings, 2) regular audit-and-feedback reports, and 3) a digital group-chat application designed to develop a community of practice. Sites will cross from the standard to the user-centred strategy in six, eight-week transition steps following a randomly determined site-pairing scheme and timeline. The primary implementation outcome is the proportion of symptomatic close contacts completing TB evaluation within 60 days of TB treatment initiation by the index person with TB. The primary clinical effectiveness outcomes are the proportion of contacts diagnosed with and initiating active TB disease treatment and the proportion initiating TB preventative therapy within 60 days. We will assess outcomes from routine source documents using intention-to-treat analyses. We will also conduct nested mixed-methods studies of implementation fidelity and context and perform cost-effectiveness and impact modelling. The Makerere School of Public Health IRB (#554), the Uganda National Council for Science and Technology (#HS1720ES), and the Yale Institutional Review Board (#2000023199) approved the study with a waiver of informed consent for the main trial implementation-effectiveness outcomes. We will submit trial results for publication in a peer-reviewed journal and disseminate findings to local shareholders, including policymakers and representatives of affected communities. Discussion This pragmatic, quasi-experimental implementation trial will inform efforts to find and prevent undiagnosed persons with TB in high-burden setting using contact investigation. It will help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustain evidence-based interventions in low-and-middle-income countries. Trial registration number ClinicalTrials.gov Identifier: NCT05640648.

Project description:BackgroundTuberculosis(TB) is among the leading causes of infectious death worldwide. Contact investigation is an evidence-based, World Health Organisation-endorsed intervention for timely TB diagnosis, treatment, and prevention but has not been widely and effectively implemented.MethodsWe are conducting a stepped-wedge, cluster-randomised, hybrid Type III implementation-effectiveness trial comparing a user-centred to a standard strategy for implementing TB contact investigation in 12 healthcare facilities in Uganda. The user-centred strategy consists of several client-focused components including (1) a TB-education booklet, (2) a contact-identification algorithm, (3) an instructional sputum-collection video, and (4) a community-health-rider service to transport clients, CHWs, and sputum samples, along with several healthcare-worker-focused components, including (1) collaborative improvement meetings, (2) regular audit-and-feedback reports, and (3) a digital group-chat application designed to develop a community of practice. Sites will cross-over from the standard to the user-centred strategy in six, eight-week transition steps following a randomly determined site-pairing scheme and timeline. The primary implementation outcome is the proportion of symptomatic close contacts completing TB evaluation within 60 days of TB treatment initiation by the index person with TB. The primary clinical effectiveness outcomes are the proportion of contacts diagnosed with and initiating active TB disease treatment and the proportion initiating TB preventative therapy within 60 days. We will assess outcomes from routine source documents using intention-to-treat analyses. We will also conduct nested mixed-methods studies of implementation fidelity and context and perform cost-effectiveness and impact modelling. The Makerere School of Public Health IRB(#554), the Uganda National Council for Science and Technology(#HS1720ES), and the Yale Institutional Review Board(#2000023199) approved the study and waived informed consent for the main trial implementation-effectiveness outcomes. We will submit results for publication in peer-reviewed journals and disseminate findings to local policymakers and representatives of affected communities.DiscussionThis pragmatic, quasi-experimental implementation trial will inform efforts to find and prevent undiagnosed persons with TB in high-burden settings using contact investigation. It will also help assess the suitability of human-centred design and communities of practice for tailoring implementation strategies and sustaining evidence-based interventions in low-and-middle-income countries.Trial registrationThe trial was registered(ClinicalTrials.gov Identifier NCT05640648) on 16 November 2022, after the trial launch on 7 March 2022.

Project description:Background:In Great Britain, 19% of trips to primary school within 1 mile, and 62% within 1-2 miles, are by car. Active travel to school (ATS) offers a potential source of moderate-to-vigorous physical activity (MVPA). This study tested the feasibility of an intervention to promote ATS in 9-10 year olds and associated trial procedures. Methods:A parallel cluster randomised pilot trial was conducted over 9 weeks in two schools from a low-income area in northeast England. Measures included daily parental ATS reports (optionally by SMS) and child ATS reports, as well as accelerometry (ActiGraph GT3X+). At baseline, all children were asked to wear the accelerometer for the same week; in the post-randomisation phase, small subsamples were monitored each week. In the 2 weeks when a child wore the accelerometer, parents also reported the start and finish times of the journey to school. The intervention consisted of a lottery-based incentive scheme; every ATS day reported by the parent, whether by paper or SMS, corresponded to one ticket entered into a weekly £5 voucher draw. Before each draw session, the researcher prepared the tickets and placed them into an opaque bag, from which one was randomly picked by the teacher at the draw session. Results:Four schools replied positively (3.3%, N = 123) and 29 participants were recruited in the two schools selected (33.0%, N = 88). Participant retention was 93.1%. Most materials were returned on time: accelerometers (81.9%), parental reports (82.1%) and child reports (97.9%). Draw sessions lasted on average 15.9 min (IQR 10-20) and overall session attendance was 94.5%. Parent-child report agreement regarding ATS was moderate (k = 0.53, CI 95% 0.45; 0.60). Differences in minutes of accelerometer-assessed MVPA between parent-reported ATS and non-ATS trips were assessed during two timeframes: during the journey to school based on the times reported by the parent (U = 390.5, p < 0.05, 2.46 (n = 99) vs 0.76 (n = 13)) and in the hour before classes (U = 665.5, p < 0.05, 4.99 (n = 104) vs 2.55 (n = 19)). Differences in MVPA minutes between child-reported ATS and non-ATS trips were also significant for each of the timeframes considered (U = 596.5, p < 0.05, 2.40 (n = 128) vs 0.81 (n = 15) and U = 955.0, p < 0.05, 4.99 (n = 146) vs 2.59 (n = 20), respectively). Conclusions:Data suggest the feasibility of an ATS incentive scheme and of most trial procedures. School recruitment stood out as requiring further piloting. Trial registration:ClinicalTrials.gov: NCT02282631. Registered 5th September 2014.

Project description:BackgroundSupporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation.Methods/designA two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff.Trial registrationISRCTN18912042.

Project description:ObjectivesAssess feasibility, acceptability and costs of delivering a physically active lessons (PAL) training programme to secondary school teachers and explore preliminary effectiveness for reducing pupils' sedentary time.Design and settingSecondary schools in East England; one school participated in a pre-post feasibility study, two in a pilot cluster-randomised controlled trial. In the pilot trial, blinding to group assignment was not possible.ParticipantsAcross studies, 321 randomly selected students (51% male; mean age: 12.9 years), 78 teachers (35% male) and 2 assistant head teachers enrolled; 296 (92%) students, 69 (88%) teachers and 2 assistant head teachers completed the studies.InterventionPAL training was delivered to teachers over two after-school sessions. Teachers were made aware of how to integrate movement into lessons; strategies included students collecting data from the environment for class activities and completing activities posted on classroom walls, instead of sitting at desks.Primary and secondary outcomesQuantitative and qualitative data were collected to assess feasibility and acceptability of PAL training and delivery. Outcomes were assessed at baseline and ~8 weeks post-training; measures included accelerometer-assessed activity, self-reported well-being and observations of time-on-task. Process evaluation was conducted at follow-up.ResultsIn the feasibility study, teachers reported good acceptability of PAL training and mixed experiences of delivering PAL. In the pilot study, teachers' acceptability of training was lower and teachers identified aspects of the training in need of review, including the outdoor PAL training and learning challenge of PAL strategies. In both studies, students and assistant head teachers reported good acceptability of the intervention. Preliminary effectiveness for reducing students' sedentary time was not demonstrated in either study.ConclusionsNo evidence of preliminary effectiveness on the primary outcome and mixed reports of teachers' acceptability of PAL training suggest the need to review the training. The results do not support continuation of research with the current intervention.Trial registration numberISRCTN38409550.

Project description:BackgroundMobile health (mHealth) has the potential to improve access to healthcare, especially in developing countries. The proliferation of mHealth has not been accompanied by a corresponding growth in design guidelines for mHealth applications. This paper proposes a framework for mHealth application design that combines the Information Systems Research (ISR) framework and design thinking. We demonstrate a use case for the proposed framework in the form of an app to read the result of the tuberculin skin test (TST), which is used to screen for latent tuberculosis infection. The framework was used in the re-design of the TST reading app but could also be used in earlier stages of mHealth app design.MethodsThe ISR framework and design thinking were merged based on how the modes of design thinking integrate with the cycles of the ISR framework. Using the combined framework, we re-designed an mHealth app for TST reading, intended to be used primarily in a developing context by healthcare workers. Using the proposed framework, the app was iterated upon and developed with the aid of personas, observations, prototyping and questionnaires.ResultThe combined framework was applied through engagement with end-users, namely ten healthcare workers and ten graduate students. Through review of the literature and iterations of the app prototype, we identified various usability requirements and limitations. These included challenges related to image capture and a misunderstanding of instructions. These insights influenced the development and improvement of the app.ConclusionThe combined framework allowed for engagement with end-users and for low-cost, rapid development of the app while addressing contextual challenges and needs. The integration of design thinking modes with the ISR cycles was effective in achieving the objectives of each approach. The combined framework acknowledges the importance of engaging users when implementing mHealth technologies, especially in developing and under-resourced contexts. Findings from this study support the use of this framework as a guide in the design of user-centred mHealth interventions.

Project description:BackgroundAcross eHealth intervention studies involving children, adolescents, and their parents, researchers have measured user experience to assist with intervention development, refinement, and evaluation. To date, no widely accepted definitions or measures of user experience exist to support a standardized approach for evaluation and comparison within or across interventions.ObjectiveWe conduct a scoping review with subsequent Delphi consultation to identify how user experience is defined and measured in eHealth research studies, characterize the measurement tools used, and establish working definitions for domains of user experience that could be used in future eHealth evaluations.MethodsWe systematically searched electronic databases for published and gray literature available from January 1, 2005, to April 11, 2019. We included studies assessing an eHealth intervention that targeted any health condition and was designed for use by children, adolescents, and their parents. eHealth interventions needed to be web-, computer-, or mobile-based, mediated by the internet with some degree of interactivity. We required studies to report the measurement of user experience as first-person experiences, involving cognitive and behavioral factors reported by intervention users. We appraised the quality of user experience measures in included studies using published criteria: well-established, approaching well-established, promising, or not yet established. We conducted a descriptive analysis of how user experience was defined and measured in each study. Review findings subsequently informed the survey questions used in the Delphi consultations with eHealth researchers and adolescent users for how user experience should be defined and measured.ResultsOf the 8634 articles screened for eligibility, 129 articles and 1 erratum were included in the review. A total of 30 eHealth researchers and 27 adolescents participated in the Delphi consultations. On the basis of the literature and consultations, we proposed working definitions for 6 main user experience domains: acceptability, satisfaction, credibility, usability, user-reported adherence, and perceived impact. Although most studies incorporated a study-specific measure, we identified 10 well-established measures to quantify 5 of the 6 domains of user experience (all except for self-reported adherence). Our adolescent and researcher participants ranked perceived impact as one of the most important domains of user experience and usability as one of the least important domains. Rankings between adolescents and researchers diverged for other domains.ConclusionsFindings highlight the various ways in which user experience has been defined and measured across studies and what aspects are most valued by researchers and adolescent users. We propose incorporating the working definitions and available measures of user experience to support consistent evaluation and reporting of outcomes across studies. Future studies can refine the definitions and measurement of user experience, explore how user experience relates to other eHealth outcomes, and inform the design and use of human-centered eHealth interventions.

Project description:Background:Isolation precautions are intended to prevent transmission of infectious agents, yet healthcare provider (HCP) adherence remains suboptimal. This may be due to ambiguity regarding the required precautions or to cognitive overload of HCPs. In response to the challenge of changing HCP behaviour, increasing attention should be paid to the role of engineering controls and facility design that incorporate human factors elements. In the current study, we aimed to develop an isolation precaution signage system that provides visual cues, serves as a cognitive aid at the point of care, and removes ambiguity regarding which precautions are necessary (e.g. masks, gowns, gloves, single rooms) when caring for isolated patients. Methods:We employed a user-centred, participatory design approach in which HCPs were actively involved in generating an isolation precaution signage system based on human factors design principles. HCPs were purposefully sampled for each design phase to include a representative sample of potential system users. We conducted front-end analysis through interviews and observations to identify challenges related to the existing signage and to establish design requirements for new signage. This was followed by the creation of user personas, design thinking workshops, and prototyping, which then underwent iterative cycles of evaluation. Graphical symbols were developed and tested for comprehensibility. Results:Front-end analysis revealed several barriers to use of the current signage system such as unclear target audience, low signal-to-noise ratio, and ambiguity regarding the applicable precautions. A comprehensive list of design requirements was generated. The project ultimately resulted in a collection of validated, comprehensible symbols and signs for contact, droplet, and airborne isolation, as well as the identification of several systems-level solutions for work re-organisation to improve compliance with isolation precautions. Conclusions:The introduction of visual cues in the form of signage offers a promising opportunity to make guidelines available directly at the frontline. Anecdotal evidence based on observations and interviews with HCP have shown that the current solution is superior to previous isolation signage. User-centred participatory design was a useful approach that holds potential for further improving design in healthcare settings.

Dataset Information

Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial.

Publications

Optimising patient active role with a user-centred eHealth platform (CONCERTO+) in chronic diseases management: a study protocol for a pilot cluster randomised controlled trial.

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