This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors’ needs, including barriers and facilitators to intervention success. Review evidence ( N = 49 papers) informed the intervention’s Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews ( N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers ( N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

IntroductionLoneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations.Methods and analysisThe PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context.Ethics and disseminationThis study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners.Trial registration numberISRCTN19193075

Background A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients’ home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. Methods One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients’ medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. Results Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. Conclusions This mixed-methods process evaluation provided novel insights into practitioners’ decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients’ readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. Trial registration (ISRCTN13790648). Registered 14 May 2015.

Background: The implementation of complex interventions experiences challenges that affect the extent to which they become embedded and scaled-up. Implementation at scale in complex environments like community settings defies universal replication. Planning for implementation in such environments requires knowledge of organisational capacity and structure. Pre-implementation work is an important element of the early phase of preparing the setting for the introduction of an intervention, and the factors contributing towards the creation of an optimal pre-implementation community context are under-acknowledged. Methods: To explore the factors contributing towards the creation of an optimal pre-implementation context, a quasi-ethnographic approach was taken. The implementation of a social network intervention designed to tackle loneliness in a community setting acts as the case in example. Observations (of meetings), interviews (with community partners) and documentary analysis (national and local policy documents and intervention resources) were conducted. Layder's adaptive theory approach was taken to data analysis, with the Consolidated Framework for Implementation Research (CFIR) and a typology of third-sector organisations used to interpret the findings. Results: Community settings were found to sit along a continuum with three broad categories defined as Fully Professionalised Organisations; Aspirational Community, Voluntary and Social Enterprises; and Non-Professionalised Community-Based Groups. The nature of an optimal pre-implementation context varied across these settings. Using the CFIR, the results illustrate that some settings were more influenced by political landscape (Fully professional and Aspirational setting) and others more influenced by their founding values and ethos (Non-Professionalised Community-Based settings). Readiness was achieved at different speeds across the categories with those settings with more resource availability more able to achieve readiness (Fully Professional settings), and others requiring flexibility in the intervention to help overcome limited resource availability (Aspirational and Non-Professionalised Community-Based settings).