Development and delivery cost of digital health technologies for mental health: Application to the Narrative Experiences Online Intervention.

Background: The increasing development and use of digital health interventions requires good quality costing information to inform development and commissioning choices about resource allocation decisions. The Narrative Experiences Online (NEON) Intervention is a web-application that delivers recorded mental health recovery narratives to its users. Two randomized controlled trials are testing the NEON Intervention in people with experience of psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O). Aim: This study describes and estimates the cost components and total cost of developing and delivering the NEON Intervention. Materials and methods: Total costs for the NEON Trial (739 participants) and NEON-O Trial (1,024 participants) were estimated by: identifying resource use categories involved in intervention development and delivery; accurate measurement or estimation of resource use; and a valuation of resource use to generate overall costs, using relevant unit costs. Resource use categories were identified through consultation with literature, costing reporting standards and iterative consultation with health researchers involved in NEON Intervention development and delivery. Sensitivity analysis was used to test assumptions made. Results: The total cost of developing the NEON Intervention was £182,851. The largest cost components were software development (27%); Lived Experience Advisory Panel workshops (23%); coding the narratives (9%); and researchers' time to source narratives (9%). The total cost of NEON Intervention delivery during the NEON Trial was £118,663 (£349 per NEON Intervention user). In the NEON-O Trial, the total delivery cost of the NEON Intervention was £123,444 (£241 per NEON Intervention user). The largest cost components include updating the narrative collection (50%); advertising (19%); administration (14%); and software maintenance (11%). Uncertainty in the cost of administration had the largest effect on delivery cost estimates. Conclusion: Our work shows that developing and delivering a digital health intervention requires expertise and time commitment from a range of personnel. Teams developing digital narrative interventions need to allocate substantial resources to curating narrative collections. Implications for practice: This study identifies the development and delivery resource use categories of a digital health intervention to promote the consistent reporting of costs and informs future decision-making about the costs of delivering the NEON Intervention at scale. Trial registration: NEON Trial: ISRCTN11152837, registered 13 August 2018, http://www.isrctn.com/ISRCTN11152837. NEON-O Trial: ISRCTN63197153, registered 9 January 2020, http://www.isrctn.com/ISRCTN63197153.

How do recorded mental health recovery narratives create connection and improve hopefulness?

BACKGROUND: Mental health recovery narratives are an active ingredient of recovery-oriented interventions such as peer support. Recovery narratives can create connection and hope, but there is limited evidence on the predictors of impact. AIMS: The aim of this study was to identify characteristics of the narrator, narrative content and participant which predict the short-term impact of recovery narratives on participants. METHOD: Independent studies were conducted in an experimental (n = 40) and a clinical setting (n = 13). In both studies, participants with mental health problems received recorded recovery narratives and rated impact on hopefulness and connection. Predictive characteristics were identified using multi-level modelling. RESULTS: The experimental study found that narratives portraying a narrator as living well with mental health problems that is intermediate between no and full recovery, generated higher self-rated levels of hopefulness. Participants from ethnic minority backgrounds had lower levels of connection with narrators compared to participants from a white background, potentially due to reduced visibility of a narrator's diversity characteristics. CONCLUSIONS: Narratives describing partial but not complete recovery and matching on ethnicity may lead to a higher impact. Having access to narratives portraying a range of narrator characteristics to maximise the possibility of a beneficial impact on connection and hopefulness.

Recorded Mental Health Recovery Narratives as a Resource for People Affected by Mental Health Problems: Development of the Narrative Experiences Online (NEON) Intervention.

BACKGROUND: The internet enables sharing of narratives about health concerns on a substantial scale, and some digital health narratives have been integrated into digital health interventions. Narratives describing recovery from health problems are a focus of research, including those presented in recorded (eg, invariant) form. No clinical trial has been conducted on a web-based intervention providing access to a collection of Recorded Recovery Narratives (RRNs). OBJECTIVE: This study presents knowledge produced through the development of the Narrative Experiences Online (NEON) Intervention, a web-based intervention incorporating the algorithmic recommendation of RRNs. METHODS: Knowledge was gathered through knowledge integration (KI) activities. KI1 synthesized previous studies to produce the NEON Impact Model describing how accessing RRNs produces health-related outcomes. KI2 developed curation principles for the NEON Collection of RRNs through consultation with the NEON Lived Experience Advisory Panel and the curation of a preliminary collection. KI3 identified harm minimization strategies for the NEON Intervention through consultation with the NEON International Advisory Board and Lived Experience Advisory Panel. The NEON Intervention was finalized through 2 research studies (RS). In RS1, mental health service users (N=40) rated the immediate impact of randomly presented narratives to validate narrative feedback questions used to inform the recommendation algorithm. In RS2, mental health service users (n=25) were interviewed about their immediate response to a prototype of the NEON Intervention and trial procedures and then were interviewed again after 1 month of use. The usability and acceptability of the prototype and trial procedures were evaluated and refinements were made. RESULTS: KI1 produced the NEON Impact Model, which identifies moderators (recipient and context), mechanisms of connection (reflection, comparison, learning, and empathy), processes (identification of change from narrative structure or content and internalization of observed change), and outcomes (helpful and unhelpful). KI2 identified 22 curation principles, including a mission to build a large, heterogeneous collection to maximize opportunities for connection. KI3 identified seven harm minimization strategies, including content warnings, proactive and reactive blocking of narratives, and providing resources for the self-management of emotional distress. RS1 found variation in the impact of narratives on different participants, indicating that participant-level feedback on individual narratives is needed to inform a recommender system. The order of presentation did not predict narrative feedback. RS2 identified amendments to web-based trial procedures and the NEON Intervention. Participants accessed some narratives multiple times, use reduced over the 4-week period, and narrative feedback was provided for 31.8% (105/330) of narrative accesses. CONCLUSIONS: RRNs can be integrated into web-based interventions. Evaluating the NEON Intervention in a clinical trial is feasible. The mixed methods design for developing the NEON Intervention can guide its extension to other clinical populations, the design of other web-based mental health interventions, and the development of narrative-based interventions in mental health.

Patient and public involvement in palliative care research: What works, and why? A qualitative evaluation.

BACKGROUND: Public involvement is increasingly considered a prerequisite for high-quality research. However, involvement in palliative care is impeded by limited evidence on the best approaches for populations affected by life-limiting illness. AIM: To evaluate a strategy for public involvement in palliative care and rehabilitation research, to identify successful approaches and areas for improvement. DESIGN: Co-produced qualitative evaluation using focus groups and interviews. Thematic analysis undertaken by research team comprising public contributors and researchers. SETTING/PARTICIPANTS: Researchers and public members from a palliative care and rehabilitation research institute, UK. RESULTS: Seven public members and 19 researchers participated. Building and maintaining relationships, taking a flexible approach and finding the 'right' people were important for successful public involvement. Relationship building created a safe environment for discussing sensitive topics, although public members felt greater consideration of emotional support was needed. Flexibility supported involvement alongside unpredictable circumstances of chronic and life-limiting illness, and was facilitated by responsive communication, and opportunities for in-person and virtual involvement at a project- and institution-level. However, more opportunities for two-way feedback throughout projects was suggested. Finding the 'right' people was crucial given the diverse population served by palliative care, and participants suggested more care needed to be taken to identify public members with experience relevant to specific projects. CONCLUSION: Within palliative care research, it is important for involvement to focus on building and maintaining relationships, working flexibly, and identifying those with relevant experience. Taking a strategic approach and developing adequate infrastructure and networks can facilitate public involvement within this field.

Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis, people experiencing other mental health problems and for informal carers: Narrative Experiences Online (NEON) study protocol for three randomised controlled trials.

BACKGROUND: Mental health recovery narratives have been defined as first-person lived experience accounts of recovery from mental health problems which refer to events or actions over a period of time and which include elements of adversity or struggle, and also self-defined strengths, successes or survival. They are readily available in invariant recorded form, including text, audio or video. Previous studies have provided evidence that receiving recorded recovery narratives can provide benefits to recipients. This protocol describes three pragmatic trials that will be conducted by the Narrative Experiences Online (NEON) study using the NEON Intervention, a web application that delivers recorded recovery narratives to its users. The aim of the NEON Trial is to understand whether receiving online recorded recovery narratives through the NEON Intervention benefits people with experience of psychosis. The aim of the NEON-O and NEON-C trials is to evaluate the feasibility of conducting a definitive trial on the use of the NEON Intervention with people experiencing non-psychosis mental health problems and those who care for others experiencing mental health problems respectively. METHODS: The NEON Trial will recruit 683 participants with experience of psychosis. The NEON-O Trial will recruit at least 100 participants with experience of non-psychosis mental health problems. The NEON-C Trial will recruit at least 100 participants with experience of caring for others who have experienced mental health problems. In all three trials, participants will be randomly allocated into one of two arms. Intervention arm participants will receive treatment as usual plus immediate access to the NEON Intervention for 1 year. Control arm participants will receive treatment as usual plus access to the NEON Intervention after 1 year. All participants will complete demographics and outcome measures at baseline, 1 week, 12 weeks and 52 weeks. For the NEON Trial, the primary outcome measure is the Manchester Short Assessment of Quality of Life at 52 weeks, and secondary outcome measures are the CORE-10, Herth Hope Index, Mental Health Confidence Scale and Meaning in Life Questionnaire. A cost-effectiveness analysis will be conducted using data collected through the EQ-5D-5 L and the Client Service Receipt Inventory. DISCUSSION: NEON Trial analyses will establish both effectiveness and cost-effectiveness of the NEON Intervention for people with experience of psychosis, and hence inform future clinical recommendations for this population. TRIAL REGISTRATION: All trials were prospectively registered with ISRCTN. NEON Trial: ISRCTN11152837 . Registered on 13 August 2018. NEON-C Trial: ISRCTN76355273 . Registered on 9 January 2020. NEON-O Trial: ISRCTN63197153 . Registered on 9 January 2020.

Towards an understanding of the burdens of medication management affecting older people: the MEMORABLE realist synthesis.

BACKGROUND: More older people are living in the community with multiple diagnoses and medications. Managing multiple medications produces issues of unrivalled complexity for those involved. Despite increasing literature on the subject, gaps remain in understanding how, why and for whom complex medication management works, and therefore how best to improve practice and outcomes. MEMORABLE, MEdication Management in Older people: Realist Approaches Based on Literature and Evaluation, aimed to address these gaps. METHODS: MEMORABLE used realism to understand causal paths within medication management. Informed by RAMESES (Realist And Meta-narrative Evidence Synthesis: and Evolving Standards) guidelines, MEMORABLE involved three overlapping work packages: 1) Realist Review of the literature (24 articles on medication management exploring causality); 2) Realist Evaluation (50 realist-informed interviews with older people, family carers and health and care practitioners, explaining their experiences); and 3) data synthesis and theorising from 1) and 2). RESULTS: Medication management was viewed from the perspective of 'implementation' and structured into five stages: identifying a problem (Stage 1), getting a diagnosis and/or medications (Stage 2), starting, changing or stopping medications (Stage 3), continuing to take medications (Stage 4), and reviewing/reconciling medications (Stage 5). Three individual stages (1, 3 and 4) are conducted by the older person sometimes with family carer support when they balance routines, coping and risk. Stages 2 and 5 are interpersonal where the older person works with a practitioner-prescriber-reviewer, perhaps with carer involvement. Applying Normalisation Process Theory, four steps were identified within each stage: 1) sense making: information, clarification; 2) action: shared-decision-making; 3) reflection/monitoring; and 4) enduring relationships, based on collaboration and mutual trust. In a detailed analysis of Stage 5: Reviewing/reconciling medications, adopting the lens of 'burden', MEMORABLE identified five burdens amenable to mitigation: ambiguity, concealment, unfamiliarity, fragmentation and exclusion. Two initial improvement propositions were identified for further research: a risk screening tool and individualised information. CONCLUSIONS: Older people and family carers often find medication management challenging and burdensome particularly for complex regimens. Practitioners need to be aware of this potential challenge, and work with older people and their carers to minimise the burden associated with medication management. TRIAL REGISTRATION: PROSPERO 2016:CRD42016043506.

The AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT.

BACKGROUND: Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. OBJECTIVE: To optimise the design of and determine the feasibility of a pragmatic, multicentre, cluster randomised controlled trial of the AMBER care bundle compared with best standard care. DESIGN: A feasibility cluster randomised controlled trial including semistructured interviews with patients and relatives, focus groups with health-care professionals, non-participant observations of multidisciplinary team meetings, a standard care survey, heat maps and case note reviews. Retrospective data were collected from the family or close friends of deceased patients via a bereavement survey. SETTING: Four general medical wards at district general hospitals in England. PARTICIPANTS: There were 65 participants (control, n = 36; intervention, n = 29). There were 24 interviews, four focus groups, 15 non-participant meeting observations, six case note reviews and three heat maps, and 15 of out 23 bereavement, standard care surveys were completed. INTERVENTION: The AMBER care bundle is implemented by a nurse facilitator. It includes the development and documentation of a medical plan, consideration of outcomes, resuscitation and escalation status and daily plan revisiting. The AMBER care bundle encourages staff, patients and families to talk openly about their preferences and priorities should the worst happen. MAIN OUTCOME MEASURES: Two 'candidate' primary outcomes were selected to be evaluated for a future definitive trial: Integrated Palliative care Outcome Scale patient/family anxiety and communication subscale and 'howRwe'. The secondary outcome measures were Integrated Palliative care Outcome Scale symptoms, Australian-modified Karnofsky Performance Status scale, EuroQol-5 Dimensions, five-level version, Client Service Receipt Inventory, recruitment rate, intervention fidelity and intervention acceptability. RESULTS: Data were collected for 65 patients. This trial was not powered to measure clinical effectiveness, but variance and changes observed in the Integrated Palliative care Outcome Scale subscale indicated that this measure would probably detect differences within a definitive trial. It was feasible to collect data on health, social and informal care service use and on quality of life at two time points. The AMBER care bundle was broadly acceptable to all stakeholders and was delivered as planned. The emphasis on 'clinical uncertainty' prompted health-care professional awareness of often-overlooked patients. Reviewing patients' AMBER care bundle status was integrated into routine practice. Refinements included simplifying the inclusion criteria and improving health-care professional communication training. Improvements to trial procedures included extending the time devoted to recruitment and simplifying consent procedures. There was also a recommendation to reduce data collected from patients and relatives to minimise burden. LIMITATIONS: The recruitment rate was lower than anticipated. The inclusion criteria for the trial were difficult to interpret. Information sheets and consent procedures were too detailed and lengthy for the target population. Health-care professionals' enthusiasm and specialty were not considered while picking trial wards. Participant recruitment took place later during hospital admission and the majority of participants were lost to follow-up because they had been discharged. Those who participated may have different characteristics from those who did not. CONCLUSIONS: This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36040085. National Institute for Health Research (NIHR) Portfolio registration number 32682. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 55. See the NIHR Journals Library website for further project information.

Unwell hospital patients who are approaching the end of their lives and may die at any moment receive inconsistent care and often do not have opportunities to discuss their future care preferences. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to help identify such patients, train health-care professionals to better communicate their concerns with them and their families and, where possible, to realise their preferences for place of care and death. The Liverpool Care Pathway for the Dying Patient, previously used across England, was designed to provide the best possible quality of care to those at the end of life. However, an independent review identified that it often was not used appropriately, leading to poor patient outcomes. A number of the criticisms of the Liverpool Care Pathway for the Dying Patient, such as reports of quickened deaths from the withdrawal of hydration/nutrition, as well as poor communication with patients and families, may have been identified earlier if it had been thoroughly evaluated. The AMBER care bundle, developed at Guy's and St Thomas' Hospital, aims to provide better outcomes for patients with clinically uncertain recovery and their families. It is important that the AMBER care bundle is properly investigated before wider use. A bigger study of the AMBER care bundle would be complex and expensive, so we examined whether or not this would be possible and acceptable to patients cared for in four wards across four hospitals, before deciding whether or not to go ahead with this bigger study. Two wards used the care bundle and two did not. We interviewed participants, their families and staff, and examined participants' clinical notes. We found that the AMBER care bundle was largely acceptable to patients, relatives and staff, and generally delivered as intended. We successfully collected information from 65 unwell patients at the beginning of the trial and again 3­5 and 10­15 days later. However, a limited number of data were collected at the final time point (10­15 days) due to many participants being discharged from the hospital. Group discussions with staff and interviews with participants and relatives identified important changes required to improve the AMBER care bundle and views on how the trial was conducted. These included simplifying the type of patients who may be appropriate for the AMBER care bundle and improving communication training for staff. Although we identified that a further study was technically possible, it is currently impractical. Future solutions that would require further testing include focusing on clinical need rather than trying to guess how the patient's condition will develop to identify potential trial participants and using questions completed by the patients as part of their routine care as a source of information. In the meantime, the AMBER care bundle continues to be used in over 40 hospitals in England.

Recommendations for services for people living with chronic breathlessness in advanced disease: Results of a transparent expert consultation.

Chronic breathlessness is highly distressing for people with advanced disease and their informal carers, yet health services for this group remain highly heterogeneous. We aimed to generate evidence-based stakeholder-endorsed recommendations for practice, policy and research concerning services for people with advanced disease and chronic breathlessness. We used transparent expert consultation, comprising modified nominal group technique during a stakeholder workshop, and an online consensus survey. Stakeholders, representing multiple specialities and professions, and patient/carers were invited to participate. Thirty-seven participants attended the stakeholder workshop and generated 34 separate recommendations, rated by 74 online survey respondents. Seven recommendations had strong agreement and high levels of consensus. Stakeholders agreed services should be person-centred and flexible, should cut across multiple disciplines and providers and should prioritize breathlessness management in its own right. They advocated for wide geographical coverage and access to expert care, supported through skills-sharing among professionals. They also recommended recognition of informal carers and their role by clinicians and policymakers. Overall, stakeholders' recommendations reflect the need for improved access to person-centred, multi-professional care and support for carers to provide or access breathlessness management interventions. Future research should test the optimal models of care and educational strategies to meet these recommendations.

Taking patient and public involvement online: qualitative evaluation of an online forum for palliative care and rehabilitation research.

PLAIN ENGLISH SUMMARY: Patient and public involvement (PPI) is increasingly recognised as important in research. Most PPI takes place face-to-face, but this can be difficult for people who are unwell or have caring responsibilities. As these challenges are particularly common in palliative care and rehabilitation research, we developed an online forum for PPI: www.csipublicinvolvement.co.uk. In this study, we explored how well the online forum worked, if it is a suitable method for PPI, and how PPI members and researchers reacted to using it. We used an existing theory about online interventions to help choose the 'right' questions to ask participants. We invited PPI members and researchers who had used the online forum to participate in focus groups, and identified the most important themes discussed. Within this study, PPI members have helped with the interview questions, analysis, and write up. Overall, four PPI members and five researchers participated in the focus groups. Participants felt the online forum worked well and had multiple benefits. From the discussions, we identified four key questions to consider when developing online methods for PPI: how does the forum work, how does it engage people, how does it empower people, and what is the impact? Participants suggested the forum could be improved by being more PPI and less researcher focused. We conclude that when developing online methods of PPI, a functioning forum is not enough: it also needs to be engaging and empowering to have an impact. Future work can use these four domains when developing their own online PPI methods. BACKGROUND: Patient and public involvement (PPI) in research is increasingly recognised as important. Most PPI activities take place face-to-face, yet this can be difficult for people with ill health or caring responsibilities, and may exclude people from hard-to-reach populations (e.g. living in vulnerable social circumstances and/or remote geographical locations). These challenges are particularly pertinent in palliative care and rehabilitation research where people often live with, or care for someone with, advanced illness. In response to this, we aimed to test the functionality, feasibility, and acceptability of an online forum for PPI for palliative care and rehabilitation research (www.csipublicinvolvement.co.uk). METHODS: We conducted separate focus groups with PPI members and researchers who had used the online forum. Data collection was underpinned by DeLone and Mclean's model of information systems success. Focus groups were recorded, transcribed, and analysed using inductive thematic analysis. Dual coding by two authors ensured rigour, and attention was paid to divergent cases. RESULTS: Four PPI members and five researchers participated in the focus groups (two PPI focus groups, one researcher focus group). The online forum was perceived as functional, feasible, and acceptable. Our analysis identified four key questions to consider when developing online methods for PPI: (1) how does the forum work, (2) how does it engage people, (3) how does it empower people, and (4) what is the impact? PPI members felt that the online forum was too researcher led, and needed to be more PPI focussed. CONCLUSIONS: When developing online methods of PPI, a functioning forum is not enough: it also needs to be engaging and empowering to have an impact. To optimise online involvement, future work should refer to these four domains and balance the needs of researchers and PPI members.

Developing a framework for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens (MEMORABLE)--a realist synthesis.

BACKGROUND: Medication-related adverse events have been estimated to be responsible for 5700 deaths and cost the UK £750 million annually. This burden falls disproportionately on older people. Outcomes from interventions to optimise medication management are caused by multiple context-sensitive mechanisms. The MEdication Management in Older people: REalist Approaches BAsed on Literature and Evaluation (MEMORABLE) project uses realist synthesis to understand how, why, for whom and in what context interventions, to improve medication management in older people on complex medication regimes residing in the community, work. METHOD: This realist synthesis uses secondary data and primary data from interviews to develop the programme theory. A realist logic of analysis will synthesise data both within and across the two data sources to inform the design of a complex intervention(s) to help improve medication management in older people. 1. Literature review The review (using realist synthesis) contains five stages to develop an initial programme theory to understand why processes are more or less successful and under which situations: focussing of the research question; developing the initial programme theory; developing the search strategy; selection and appraisal based on relevance and rigour; and data analysis/synthesis to develop and refine the programme theory and context, intervention and mechanism configurations. 2. Realist interviews Realist interviews will explore and refine our understanding of the programme theory developed from the realist synthesis. Up to 30 older people and their informal carers (15 older people with multi-morbidity, 10 informal carers and 5 older people with dementia), and 20 care staff will be interviewed. 3. Developing framework for the intervention(s) Data from the realist synthesis and interviews will be used to refine the programme theory for the intervention(s) to identify: the mechanisms that need to be 'triggered', and the contexts related to these mechanisms. Intervention strategies that change the contexts so the mechanisms are triggered to produce desired outcomes will be developed. Feedback on these strategies will be obtained. DISCUSSION: This realist synthesis aims to develop a framework (underpinned by our programme theory) for a novel multi-disciplinary, multi-agency intervention(s), to improve medication management in community-dwelling older people on complex medication regimens. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016043506.