Effect of digital psychoeducation and peer support on the mental health of family carers supporting individuals with psychosis in England (COPe-support): a randomised clinical trial.

BACKGROUND: Psychoeducation delivered face-to-face is effective in alleviating mental health morbidities in family carers of individuals with psychosis. However, research in such interventions delivered online is scarce. We evaluated the effectiveness of a digital multicomponent intervention-COPe-support-in improving carers' mental wellbeing and caregiving-related outcomes. METHODS: In this two-arm, individually randomised, superiority trial, people aged 18 years or older who provided at least weekly support in any format for a relative or close friend affected by psychosis across England were randomly assigned (1:1) to either COPe-support or a passive online information resource using an independent online system. Participants were recruited through 30 mental health UK National Health Service trusts. The study team were masked to allocation and assessment of outcomes as all data collection took place online. Participants had access to either condition for 40 weeks and were advised to spend at least half an hour per week over the initial 20 weeks to go through materials at their own pace and to allow time to integrate knowledge and skills learned into practice. It was not feasible to mask participants or the online facilitator to intervention allocation. COPe-support provided psychoeducation on psychosis-related caregiving strategies and forums with professionals and other carers, and the control intervention comprised a passive online information resource. The primary outcome at 20 weeks was mental wellbeing measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS; minimally clinically important difference [MCID] 3). This trial is registered with ISRCTN, 89563420. FINDINGS: Between March 1, 2018, and Feb 14, 2020, 407 participants were randomly assigned, with 204 allocated to COPe-support and 203 allocated to control. The participants (mean age 53·1 years, SD 13·2) were mostly female (330 [81%] of 407 participants) and White (359 [88%] of 407 participants). 346 (85%) of 407 participants provided primary endpoint data, 174 (85%) of 204 participants in the COPe-support group and 172 (85%) of 203 participants in the control group. The mean WEMWBS score at 20 weeks was 44·5 (SD 8·31) for the COPe-support group and 43·3 (9·19) for the control group. We found no evidence of a difference in wellbeing between the two groups (adjusted mean difference 0·37, 95% CI -1·14 to 1·88; p=0·63). In the COPe-support group, 106 (52%) of 204 participants met the complier definition of a minimum of two logins in separate weeks. The complier average causal effect analysis increased the difference in WEMWBS scores (adjusted difference 0·83, 95% CI -1·45 to 3·11; p=0·47), but this was lower than the MCID. There were no adverse events. INTERPRETATION: Our findings did not support the use of COPe-support over a passive online information resource. However, further research to optimise digital interventions adjunctive to face-to-face support for carers remains important. FUNDING: National Institute for Health Research.

Perceived Acceptability and Experiences of a Digital Psychoeducation and Peer Support Intervention (COPe-support): Interview Study With Carers Supporting Individuals With Psychosis.

BACKGROUND: Web-based mental health interventions offer a novel, accessible, and self-paced approach to care delivery to family carers (ie, relatives and close friends who support a loved one with psychosis). We coproduced COPe-support (Carers fOr People with Psychosis e-support), a psychoeducational intervention delivered via an enriched web-based learning environment with network support from professionals and peers. In addition to the rigorous investigation of the effectiveness of COPe-support on the well-being of carers and mental health outcomes, it is imperative to understand the experiences of using the web-based intervention by carers and its associated web-based implementation and facilitation strategies. OBJECTIVE: This study aims to explore the experiences of carers and perceived acceptability of COPe-support and its different components, how carers found engagement with COPe-support affected their own well-being and caregiving, and the ideas of carers for improving COPe-support and its delivery to inform any future wider implementation. METHODS: We conducted a qualitative study, individually interviewing 35 carers, following their use of COPe-support for 8 months through a web-based, randomized controlled trial across England. A semistructured guide with open-ended questions was used to explore the experiences of carers and perceived acceptability of the intervention and their ideas to improve the provision. All interviews were conducted remotely through mobile phones or internet communication media, audio recorded and transcribed verbatim. We used a thematic analysis framework to analyze the data. RESULTS: Three key themes were identified: remote, flexible, and personalized support; impacts on well-being and outlook on caregiving; and future implementation and integration with existing services. Overall, carers found COPe-support a flexible source of knowledge and support from professionals and peers that they could personalize to suit their own needs and convenience. Participants described gaining self-confidence, hope, and a sense of connectivity with others in a similar situation, which helped ameliorate isolation and perceived stigma. Most importantly, COPe-support promoted self-care among the carers themselves. Participants' experiences, use, and activity on COPe-support varied greatly and differed among carers of various ages and levels of computer literacy. CONCLUSIONS: Nearly all participants had a positive experience with COPe-support and supported its wider implementation as a beneficial adjunctive support resource for carers in the future. Any future scale-up of such an intervention needs to consider feedback from carers and suggestions for further improvement. These included having more graphics and audiovisual content materials, improving the navigation, and building in more interactional and customization options to suit various user styles, such as emoji reactions, live web-based chat, opting in and out of updates, and choosing the frequency of reminders. To ensure successful implementation, we should also consider factors pertinent to reaching more carers and integrating the web-based resources with other conventional services. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN) 89563420; https://www.isrctn.com/ISRCTN89563420. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-020-02528-w.

The Development of a Virtual World Problem-Based Learning Tutorial and Comparison With Interactive Text-Based Tutorials.

Collaborative learning through case-based or problem-based learning (PBL) scenarios is an excellent way to acquire and develop workplace knowledge associated with specific competencies. At St George's, University of London we developed an interactive online form of decision-based PBL (D-PBL) for our undergraduate medical course using web-based virtual patients (VPs). This method of delivery allowed students to consider options for clinical management, to take decisions and to explore the consequences of their chosen actions. Students had identified this as a more engaging type of learning activity compared to conventional paper-based/linear PBL and demonstrated improved exam performance in controlled trials. We explored the use of Second Life (SL), a virtual world and immersive 3D environment, as a tool to provide greater realism than our interactive image and text-based D-PBL patient cases. Eighteen separate tutorial groups were provided with their own experience of the same patient scenario in separate locations within the virtual world. The study found that whilst a minority of students reported that the Second Life experience felt more realistic, most did not. Students favored the simpler interaction of the web-based VPs, which already provided them with the essential learning needed for practice. This was in part due to the time proximity to exams and the extra effort required to learn the virtual world interface. Nevertheless, this study points the way towards a scalable process for running separate PBL sessions in 3D environments.

COPe-support - a multi-component digital intervention for family carers for people affected by psychosis: study protocol for a randomized controlled trial.

BACKGROUND: Psychosis often causes significant distress and impacts not only in the individuals, but also those close to them. Many relatives and friends ('carers') provide long-term support and need resources to assist them. We have co-produced a digital mental health intervention called COPe-support (Carers fOr People with Psychosis e-support) to provide carers with flexible access to high quality psychoeducation and interactive support from experts and peers. This study evaluates the effectiveness of COPe-support to promote mental wellbeing and caregiving experiences in carers. METHODS: This study is a single-blind, parallel arm, individually randomized controlled trial (RCT) comparing COPe-support, with attention control. Both groups continue to receive usual care. COPe-support provides interactive web-based psychoeducation on psychosis-related issues, wellbeing-promotion and network support through forums. The attention-control is a non-interactive online information resource pack. Carers living in England are eligible if they provide at least weekly support to a family member or close friend affected by psychosis, and use internet communication (including emails) daily. All trial procedures are run online, including collection of outcome measurements which participants will directly input into our secure platform. Following baseline assessment, a web-based randomization system will be used to allocate 360 carers to either arm. Participants have unlimited access to the allocated condition for 40 weeks. Data collection is at three time points (10, 20, and 40 weeks after randomization). Analyses will be conducted by trial statisticians blinded to allocation. The primary outcome is mental wellbeing measured by Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), at 20 weeks. As well as an intention-to-treat analysis, a complier average causal effect (CACE) analysis will be conducted to estimate the intervention effect in participants who have accessed COPe-support content twice or more. The secondary objectives and analysis will examine other health and caregiving-related outcomes and explore mechanisms. In a process evaluation, we will interview 20% of the intervention arm participants regarding the acceptability of COPe-support. We will explore in detail participants' usage patterns. DISCUSSION: The results of this trial will provide valuable information about the effectiveness of COPe-support in promoting wellbeing and caregiving experiences in carers. TRIAL REGISTRATION: The RCT is registered with the Current Controlled Trials registration (ISRCTN 89563420, registration date: 02/03/2018).

Usability evaluation of an eHealth intervention for family carers of individuals affected by psychosis: A mixed-method study.

BACKGROUND: Existing research suggests that eHealth interventions targeting family carers of individuals with long-term illness offer a promising approach to care delivery. In particular, digital psychoeducational interventions with interactive psychosocial support are well-received with high rates of satisfaction and acceptability. However, development of such interventions for psychosis carers is lacking. We developed a multi-component eHealth intervention specifically for carers of individuals affected by psychosis, called COPe-support (Carers fOr People with Psychosis e-support). OBJECTIVE: Using mixed methods to evaluate usability, system heuristics and perceived acceptability, we conducted a usability study to establish the suitability of the intervention prototype for the target user group. METHODS: Twenty-three carers were recruited to the study and participated in a think-aloud test or a remote online trial of the intervention. Qualitative feedback, post-use System Usability Scale (SUS) scores, and real-world usage data collected from the tests were analysed. These were also supplemented with heuristic evaluation data provided by an independent eLearning technology expert. RESULTS: Participants evaluated the intervention content as useful and helpful, and indicated that the system had satisfactory usability with a mean SUS score of 73%, above the usability quality benchmark threshold. Study results identified some minor usability issues, which were corroborated with the eLearning expert's heuristic evaluation findings. We used these results to refine the COPe-support intervention. CONCLUSIONS: The usability study with end-users and service providers identified real-life usage and usability issues. The study results helped us refine COPe-support and its delivery strategy before its launch as part of a large-scale clinical trial.

A Multicomponent eHealth Intervention for Family Carers for People Affected by Psychosis: A Coproduced Design and Build Study.

BACKGROUND: Psychosis, including schizophrenia, is the most common severe mental illness affecting 1% of the population worldwide. A large number of people provide long-term support and care for a relative with psychosis. Although psychoeducational interventions, especially those delivered through a face-to-face group format, have an established evidence base for improving the caregiving experience, well-being, and health outcomes, large-scale implementation and access remain limited. There is a demand for such provision to be made through the internet for greater flexibility and wider access. OBJECTIVE: This study aimed to integrate participatory research methodologies by the public, patients, and carers into the eHealth (electronic health) intervention design and build process to improve the product's usability and acceptability. METHODS: We adapted a structured eHealth intervention build method to include participatory research activities involving key stakeholders and end users to co-design and coproduce our intervention. An expert advisory group (EAG) comprising public involvement members led the formative design and build work using an agile build process. Carers independent from the study were consulted on the evolving drafts of the intervention prototype through focus group meetings. These results were fed back into the intervention build work continuously to ensure end users' input inform every stage of the process. RESULTS: An EAG comprising individuals with lived experience of psychosis, carers, health care professionals, researchers, voluntary organization workers, and eLearning experts (n=14) was established. A total of 4 coproduction workshops were held over 1 year during which the alpha and beta prototypes were designed and built through the participatory research work. Alongside this, 2 rounds of focus group study with carers (n=24, in 4 groups) were conducted to seek consultation on end users' views and ideas to optimize the intervention design and usability. Finally, the EAG carried out a Web-based walk-through exercise on the intervention prototype and further refined it to make it ready for an online usability test. The final product contains multiple sections providing information on psychosis and related caregiving topics and interactive discussion forums with experts and peers for psychosocial support. It provides psychoeducation and psychosocial support for carers through the internet, promoting flexible access and individualized choices of information and support. CONCLUSIONS: The participatory research work led to the coproduction of a eHealth intervention called COPe-support (Carers fOr People with Psychosis e-support). We believe the study methodology, results, and output have optimized the intervention design and usability, fitting the end users' needs and usage pattern. COPe-support is currently being tested for its effectiveness in promoting carers' health outcome through an online randomized controlled trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN89563420; http://www.isrctn.com/ISRCTN89563420.

Virtual Patient Simulations in Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

BACKGROUND: Virtual patients are interactive digital simulations of clinical scenarios for the purpose of health professions education. There is no current collated evidence on the effectiveness of this form of education. OBJECTIVE: The goal of this study was to evaluate the effectiveness of virtual patients compared with traditional education, blended with traditional education, compared with other types of digital education, and design variants of virtual patients in health professions education. The outcomes of interest were knowledge, skills, attitudes, and satisfaction. METHODS: We performed a systematic review on the effectiveness of virtual patient simulations in pre- and postregistration health professions education following Cochrane methodology. We searched 7 databases from the year 1990 up to September 2018. No language restrictions were applied. We included randomized controlled trials and cluster randomized trials. We independently selected studies, extracted data, and assessed risk of bias and then compared the information in pairs. We contacted study authors for additional information if necessary. All pooled analyses were based on random-effects models. RESULTS: A total of 51 trials involving 4696 participants met our inclusion criteria. Furthermore, 25 studies compared virtual patients with traditional education, 11 studies investigated virtual patients as blended learning, 5 studies compared virtual patients with different forms of digital education, and 10 studies compared different design variants. The pooled analysis of studies comparing the effect of virtual patients to traditional education showed similar results for knowledge (standardized mean difference [SMD]=0.11, 95% CI -0.17 to 0.39, I2=74%, n=927) and favored virtual patients for skills (SMD=0.90, 95% CI 0.49 to 1.32, I2=88%, n=897). Studies measuring attitudes and satisfaction predominantly used surveys with item-by-item comparison. Trials comparing virtual patients with different forms of digital education and design variants were not numerous enough to give clear recommendations. Several methodological limitations in the included studies and heterogeneity contributed to a generally low quality of evidence. CONCLUSIONS: Low to modest and mixed evidence suggests that when compared with traditional education, virtual patients can more effectively improve skills, and at least as effectively improve knowledge. The skills that improved were clinical reasoning, procedural skills, and a mix of procedural and team skills. We found evidence of effectiveness in both high-income and low- and middle-income countries, demonstrating the global applicability of virtual patients. Further research should explore the utility of different design variants of virtual patients.

Virtual patients designed for training against medical error: Exploring the impact of decision-making on learner motivation.

OBJECTIVES: Medical error is a significant cause of patient harms in clinical practice, but education and training are recognised as having a key role in minimising their incidence. The use of virtual patient (VP) activities targeting training in medical error allows learners to practice patient management in a safe environment. The inclusion of branched decision-making elements in the activities has the potential to drive additional generative cognitive processing and improved learning outcomes, but the increased cognitive load on learning risks negatively affecting learner motivation. The aim of this study is to better understand the impact that the inclusion of decision-making and inducing errors within the VP activities has on learner motivation. METHODS: Using a repeated study design, over a period of six weeks we provided undergraduate medical students at six institutions in three countries with a series of six VPs written around errors in paediatric practice. Participants were divided into two groups and received either linearly structured VPs or ones that incorporated branched decision-making elements. Having completed all the VPs, each participant was asked to complete a survey designed to assess their motivation and learning strategies. RESULTS: Our analysis showed that in general, there was no significant difference in learner motivation between those receiving the linear VPs and those who received branched decision-making VPs. The same results were generally reflected across all six institutions. CONCLUSIONS: The findings demonstrated that the inclusion of decision-making elements did not make a significant difference to undergraduate medical students' motivation, perceived self-efficacy or adopted learning strategies. The length of the intervention was sufficient for learners to overcome any increased cognitive load associated with branched decision-making elements being included in VPs. Further work is required to establish any immediate impact within periods shorter than the length of our study or upon achieved learning outcomes.

Medical Student and Tutor Perceptions of Video Versus Text in an Interactive Online Virtual Patient for Problem-Based Learning: A Pilot Study.

BACKGROUND: The impact of the use of video resources in primarily paper-based problem-based learning (PBL) settings has been widely explored. Although it can provide many benefits, the use of video can also hamper the critical thinking of learners in contexts where learners are developing clinical reasoning. However, the use of video has not been explored in the context of interactive virtual patients for PBL. OBJECTIVE: A pilot study was conducted to explore how undergraduate medical students interpreted and evaluated information from video- and text-based materials presented in the context of a branched interactive online virtual patient designed for PBL. The goal was to inform the development and use of virtual patients for PBL and to inform future research in this area. METHODS: An existing virtual patient for PBL was adapted for use in video and provided as an intervention to students in the transition year of the undergraduate medicine course at St George's, University of London. Survey instruments were used to capture student and PBL tutor experiences and perceptions of the intervention, and a formative review meeting was run with PBL tutors. Descriptive statistics were generated for the structured responses and a thematic analysis was used to identify emergent themes in the unstructured responses. RESULTS: Analysis of student responses (n=119) and tutor comments (n=18) yielded 8 distinct themes relating to the perceived educational efficacy of information presented in video and text formats in a PBL context. Although some students found some characteristics of the videos beneficial, when asked to express a preference for video or text the majority of those that responded to the question (65%, 65/100) expressed a preference for text. Student responses indicated that the use of video slowed the pace of PBL and impeded students' ability to review and critically appraise the presented information. CONCLUSIONS: Our findings suggest that text was perceived to be a better source of information than video in virtual patients for PBL. More specifically, the use of video was perceived as beneficial for providing details, visual information, and context where text was unable to do so. However, learner acceptance of text was higher in the context of PBL, particularly when targeting clinical reasoning skills. This pilot study has provided the foundation for further research into the effectiveness of different virtual patient designs for PBL.