Background Antiretroviral therapy has transformed human immunodeficiency virus infection intoa chronic condition associated with normal life expectancy. In the United Kingdom, the uptake of antiretroviral therapy is generally high, but a delay in starting antiretroviral therapy and non-adherence compromise the health and well-being of people living with human immunodeficiency virus, increase the risk of transmission of human immunodeficiency virus and increase National Health Service costs. Objectives The overall aim was to improve antiretroviral therapy uptake and adherence by addressing perceptual and practical barriers. The objectives were to (1) identify culturally specific beliefs and other factors influencing uptake of and adherence to antiretroviral therapy that have not emerged in previous research; (2) refine existing methods for assessing perceptual and practical barriers to antiretroviral therapy uptake and adherence; (3) develop an intervention to increase antiretroviral therapy uptakeand adherence; (4) determine intervention feasibility and acceptability; (5) evaluate intervention efficacy;(6) assess the short- and long-term costs and cost-effectiveness of the interventions and (7) prepare for implementation within the National Health Service. Design Objective 1 – in-depth interviews with Black African and Black Caribbean people living with human immunodeficiency virus ( n = 52); objective 2 – adaptation of the Beliefs about Medicines Questionnaire; objective 3 – development of the Supporting UPtake and Adherence to antiretroviral therapy service intervention; objective 4 – feasibility study ( n = 213) and acceptability/process interviews ( n = 24); objective 5 – observational study ( n = 484) and randomised controlled trial ( n = 143); objective 6 – systematic review, cost-effectiveness analysis ( n = 210) and economic modelling; and objective 7 – preparatory implementation work with people living with human immunodeficiency virus and human immunodeficiency virus clinic staff. Setting National Health Service human immunodeficiency virus clinics in England with a high proportion of ethnic minority populations. Participants People living with human immunodeficiency virus. Interventions Adherence support – cognitive–behavioural therapy plus care as usual. Main outcome measures Workstream 1 – adapted Beliefs about Medicines Questionnaire–antiretroviral therapy. Workstream 2 – feasibility study: participant recruitment and withdrawal rates. Workstream 3 – randomised controlled trial – primary outcome: medication event monitoring system adherence. Workstream 4 – incremental cost-effectiveness ratio. Results Workstream 1 – qualitative studies were used to refine the Beliefs about Medicines Questionnaire – antiretroviral therapy and, together with our preparatory research, to inform the cognitive–behavioural therapy-based intervention. Workstream 2 – recruitment to the randomised controlled trial and observational study was deemed feasible. Thematic analysis of exit interviews with recipients of the SUPA intervention demonstrated that the intervention was acceptable and addressed perceptual and practical barriers to antiretroviral therapy. In Workstream 3, we did not meet the recruitment targets and our trial was underpowered for the primary outcome: 143 participants met the inclusion criteria and were randomised (care as usual, n = 72; care as usual plus cognitive–behavioural therapy, n = 71). There was no significant effect of cognitive–behavioural therapy on the primary end point. Of the 112 participants (care as usual, n = 55; cognitive–behavioural therapy, n = 57) for whom sufficient data for primary end-point analysis were available, 17 (15.2%) met the primary end point (> 80% of months with an average monthly adherence of ≥ 90%) [9 (16.4%) in the care-as-usual group and 8 (14.0%) in the cognitive–behavioural therapy group ( p = 0.94)]. Secondary end points: median Medication Event Monitoring System adherence at 12 months was 61.9% in the care-as-usual group and 66.5% in the cognitive–behavioural therapy group ( p = 0.40), representing a 7.5% uplift in adherence. Participants who were randomised to receive the intervention, based on perceptions of antiretroviral therapy at baseline (low antiretroviral therapy necessity beliefs, and/or high antiretroviral therapy concerns), experienced a greater decrease in antiretroviral therapy concerns [care as usual −0.9 (95% confidence interval −1.4 to −0.5) vs. cognitive–behavioural therapy −0.6 (95% confidence interval −0.8 to −0.3); p = 0.03], treatment intrusiveness [median change in highly active antiretroviral treatment (antiretroviral therapy) Intrusiveness Scale scores: care as usual −0.5 (95% confidence interval −5.6 to 18.0) vs. cognitive–behavioural therapy −5.6 (95% confidence interval −20.4 to 1.2); p = 0.03] and depression scores [median change in depression score: care as usual 0 (95% confidence interval −1.5 to 2.0) vs. cognitive–behavioural therapy −1 (95% confidence interval −3 to 0); p = 0.02] between baseline and 12 months. Workstream 4 – cognitive–behavioural therapy resulted in 0.056 more quality-adjusted life-years than care as usual (95% confidence interval 0.0029 to 0.083). The incremental cost-effectiveness ratio was £11,189 per quality-adjusted life-year. At a threshold of £20,000 per quality-adjusted life-year, there was > 90% likelihood that the intervention would be more cost-effective than care as usual. There was a 13% likelihood that the intervention would produce more quality-adjusted life-years and result in lower health and social care costs than care as usual. A Markov model showed that, over the longer term, cognitive–behavioural therapy results in fewer quality-adjusted life-years and higher costs and, therefore, care as usual would be the more cost-effective option. Limitations Our primary outcome of full Medication Event Monitoring System adherence was problematic, our randomised controlled trial was underpowered and we were unable to demonstrate a significant difference in our primary outcome. Conclusions Patients who received the Supporting UPtake and Adherence to antiretroviral therapy service intervention benefited from a reduction in antiretroviral therapy concerns, a reduction in antiretroviral therapy intrusiveness and reduced depressive symptoms, and from improved quality of life. The intervention was likely to be cost-effective for the National Health Service within 12 months. Future work Given the difficulty in recruiting people at a high risk of non-engagement with human immunodeficiency virus care, future work assessing the effectiveness of adherence interventions may require alternative, non-standard randomised controlled trial designs. Further studies are necessary to recalibrate our understanding of the levels of antiretroviral therapy adherence necessary to achieve viral load suppression. Study registration The trial is registered as ISRCTN35514212 and the study is registered as CRD42019072431. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0109-10047) and is published in full in Programme Grants for Applied Research ; Vol. 13, No. 8. See the NIHR Funding and Awards website for further award information.

Background Transitions from hospital to home are a risky time for older people (aged 75 years and older). Unplanned and often avoidable hospital re-admissions are therefore high in this group. This research aimed to understand if increased involvement of older people in their care in hospital would improve the safety and experience of care transitions. Objectives In six work packages we set out to: understand patient and carer involvement in and experience of care transitions explore staff experiences of delivering good transitional care develop and validate a new measure (the Partners at Care Transitions Measure) to assess patient experience and safety during care transitions create a theory and logic model to inform the co-designed transitions intervention followed by a formative evaluation test the feasibility of delivering a trial to evaluate the intervention evaluate the clinical- and cost-effectiveness of the transitions intervention with a parallel process evaluation. Design Qualitative methods (1 and 2), literature reviewing, Delphi techniques and validation testing (3), co-design (4), cluster feasibility trial (5) and cluster randomised controlled trial (6). Settings National Health Service acute hospital trusts, general practices, patients and carer homes across the north of England, United Kingdom. Participants Patients aged 75 years and older and their caregivers. National Health Service staff working in acute National Health Service trusts on wards delivering the intervention. Intervention ‘Your Care Needs You’ intervention to support patient and carer involvement in hospital care in preparation for returning home. This comprised fixed components: a booklet, an advice sheet for managing at home and a film; and flexible components: ongoing staff involvement of patients through multiple approaches. Implementation included a nominated lead, staff training and posters. Main outcome measures Primary outcome was unplanned 30-day hospital re-admissions. Secondary outcomes included: unplanned 60- and 90-day hospital re-admissions; quality of transition; health-related quality of life (EuroQol-5 Dimensions, five-level version); and self-reported healthcare resource use. Data sources National Health Service Secondary Use Services data and Hospital Episodes data for work package 2 and routinely recorded National Health Service acute trust hospital data on re-admissions for work packages 5 and 6. Review methods Systematic narrative review for preparatory work on patient involvement; narrative meta review of transitions interventions; scoping review of transitions measures. Results Work package 1: Six themes relating to patient experience of care transitions. Patient involvement in hospital care found to be challenging ‘work’ that was often invisible to staff. Work package 2: National Health Service staff reported that high-quality care transitions were facilitated primarily through trust and strong relationships. Work package 3: A measure of quality and safety of care transitions (Partners at Care Transitions Measure) developed and validated with good internal reliability and internal consistency. Work package 4: An intervention called ‘Your Care Needs You’ that required revisions to support implementation. Work package 5: Primary outcome data were collected for 90% of participants. Follow-up questionnaire response rates were lower than anticipated (75% vs. 85%). Information on the acceptability, usability and implementation of the intervention informed iterations to the intervention and implementation package. Work package 6: 4947 participants from 39 hospital wards took part in the main trial. Six hundred and thirteen participants from 35 wards took part in the nested cohort. No differences were observed in the primary outcome of unplanned re-admission (Y/N) at 30 days post discharge [17% experienced re-admission within 30 days in the ‘Your Care Needs You’ group, 18% in care-as-usual, odds ratio: (0.93; 95% confidence interval, 0.78 to 1.10; p = 0.372)], and also at 60 and 90 days post discharge but all results were in favour of the intervention with a reduction in total re-admissions of 13% over 90 days [incidence rate ratio: 0.87 (0.76 to 0.99), p = 0.039]. There was a statistically significant reduction in Partners at Care Transitions Measure safety concerns at 30 days post discharge. The intervention is likely to be cost-effective. Limitations The main trial was conducted during the COVID-19 pandemic which exacerbated staffing challenges and limited opportunities to enhance and support implementation of the intervention. Participant recruitment to the nested study was challenging, resulting in fewer patients than planned and a less diverse sample than that included in the primary cohort. Therefore, while our primary cohort is representative of the patients in the hospital during the trial period, the nested cohort may suffer from some bias. Conclusions The ‘Your Care Needs You’ intervention offers a way to support staff and patients/families to facilitate greater involvement in care. This research demonstrates that increased involvement in hospital care has the potential to improve safety at transitions. Finding ways to support staff to encourage better patient involvement could lead to even more benefits being realised. Future work Hospitals could consider involving volunteers in supporting greater patient and family involvement. There was some indication that the component of the intervention most favoured was the patient advice for discharge. Trial registration This trial is registered as Current Controlled Trials ISRCTN51154948 (WP5) and ISRCTN17062524 (WP6). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-1214-20017) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 4. See the NIHR Funding and Awards website for further award information.

Background Eczema is a common condition with significant impact on quality of life. The main cause of treatment failure is non-use of prescribed treatments because treatments are time-consuming to apply; they may sting when first applied to inflamed skin; there are concerns about the safety of some treatments; and because people often receive conflicting advice about how and when to use them. Objectives Objectives of the present study are to: (1) explore the self-care support needs of children with eczema and their parents/carers, and young people with eczema, (2) review current best evidence about the safest and best ways to use topical corticosteroids for eczema, (3) develop theory-, evidence- and person-based online interventions to support eczema self-management in young people with eczema and parents/carers of children with eczema, (4) evaluate the clinical and cost-effectiveness of the interventions in two randomised controlled trials and (5) conduct a process evaluation and implementation planning. Design Five qualitative studies, four systematic reviews (one qualitative) and two parallel randomised controlled trials with nested process evaluation and economic evaluation. Setting Primary care. Participants Children and young people aged 13–25 years with eczema, and parents/carers of children aged 0–12 years with eczema. Participants with very mild or inactive eczema were excluded. Interventions We developed and evaluated two online behavioural interventions to support eczema management in: (1) young people and (2) parents/carers of children. Participants were not blinded to group allocation. Main outcome measures Primary outcome measure in the randomised controlled trials was participant-reported eczema severity measured by the patient-oriented eczema measure over 24 weeks. Secondary outcomes included patient-oriented eczema measures over 52 weeks, quality of life and patient enablement. Results Qualitative reviews and interviews provided in-depth understanding of the views, experiences and contexts within which young people and families manage eczema and identified barriers and facilitators to key behaviours. Systematic literature reviews on topical corticosteroid safety and effectiveness found no evidence of harm when topical corticosteroids were used intermittently to treat or prevent eczema flares. Our Cochrane review, which included 104 trials (8443 participants), found that potent and moderate topical corticosteroids are probably more effective than mild topical corticosteroids for treating moderate or severe eczema and that effectiveness is similar between once and twice daily use. Findings informed development of two online interventions, which were evaluated in two randomised controlled trials comparing intervention plus usual care to usual care only. Three hundred and forty parents/carers (169 usual care; 171 intervention) and 337 young people (169 usual care; 168 intervention) were randomised [mean baseline patient-oriented eczema measure 12.8 (standard deviation 5.3) and 15.2 (standard deviation 5.4), respectively]. An intention-to-treat analysis approach to the analysis was taken. Follow-up rates were: 92.4% (314/340) parents/carers and 90.2% (304/337) young people at 24 weeks. Compared with usual care over 24 weeks, eczema severity (patient-oriented eczema measure) improved in the intervention groups: adjusted mean difference −1.5 (95% confidence interval −2.5 to −0.6) for parents/carers, and −1.9 (95% confidence interval −3.0 to −0.8) for young people. Effects were sustained for 52 weeks in both groups. Enablement showed an important difference favouring the intervention group in both trials [adjusted mean difference at 24 weeks −0.7 (95% confidence interval −1.0 to −0.4) for parents/carers and −0.9 (95% confidence interval −1.3 to −0.6) for young people]. No harms were identified in either group. Economic analysis found both interventions were low cost and cost-effective with almost all analyses (with the exception of the complete-case cost–utility analysis for the parent/carer trial) estimating the interventions to be dominant (cost saving and effective). Process evaluation demonstrated that both groups found the interventions usable, relatable and trustworthy, and perceived that they helped to manage their eczema. The interventions have been redeveloped into an English and Welsh product ready for dissemination and an implementation strategy has been developed. Limitations This research was conducted during the COVID-19 pandemic. While this did not have a major impact on our research plans or delivery, it may have had impacts (positive and negative) on people’s eczema, their eczema management and access to health care. Conclusions Eczema Care Online is effective and acceptable to its target groups. Findings from this programme support the wide-scale implementation of the interventions, available at www.eczemacareonline.org.uk. Future work Future work may explore how Eczema Care Online can be implemented in different settings and contexts and adapted for severe eczema. More research is also needed on the long-term safety of topical corticosteroids. Trial registration This trial is registered as Current Controlled Trials ISRCTN79282252. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0216-20007) and is published in full in Programme Grants for Applied Research; Vol. 13, No. 3. See the NIHR Funding and Awards website for further award information.

Background Hip fracture has a substantial impact on the health, well-being and independence of patients and their families. In the 12 months after fracture, patients are at increased risk of cognitive and functional decline, admission to long-term care institutions and higher mortality. People with cognitive impairment are among the most vulnerable in acute hospital settings. They have lower short-term survival, with 24% mortality during admission. They are susceptible to suboptimal and inconsistent care standards that contribute to cognitive deterioration, increase risk of postoperative complications, prolong their length of stay and cause loss of independence. Objectives Establish best-practice from a systematic review of literature, observations of practice, perspectives of service users, carers, healthcare professionals, health service managers and experts in the field. Design the care pathway. Determine cultural/organisational changes necessary to implement and maximise adherence to the enhanced recovery pathway in hospital settings. Develop staff training and a training manual. Undertake a feasibility randomised controlled trial and collect outcomes to identify potential clinical and cost-effectiveness of the enhanced recovery pathway. Disseminate the findings and develop a definitive trial bid. Design A programme to develop an enhanced recovery pathway for people with hip fracture and cognitive impairment, tested for implementation and refined in the clinical environment. This refined enhanced recovery pathway was then tested in a feasibility study in 10 hospitals across the UK. Setting Acute care. Participants Hospital staff, people with cognitive impairment and hip fracture, carers and national and international experts in hip fracture or dementia. Interventions An enhanced recovery care pathway with checklist and an implementation process. Main outcome measures Mortality, patient and carer quality of life, cognition, activities of daily living. Data sources Clinical trial. Results A total of 284 participants were recruited, 132 to the PEFECT-ER intervention arm and 150 to the control arm, had good retention in the study and provided data for analysis. There was no evidence of any systematic between group difference at either the point of discharge from hospital or at 1-month follow-up. However, at 3 months, a relatively small effect of around one quarter of a standard deviation (0.071 units), was evidenced with respect to the health-related quality of life of the patient based on the EuroQol-5 Dimensions, five-level version by proxy in the intervention group (95% confidence interval 0.018 to 0.124; p = 0.009). A difference of 0.099 units in favour of the intervention group was also seen at the 6-month follow-up (95% confidence interval 0.001 to 0.198; p = 0.047). ‘Timed Up and Go’ and the Suitable Informant EuroQol-5 Dimensions, five-level version showed a no statistically significant difference except the model for length of stay. Those individuals in the intervention group had significantly longer lengths of stay, on average 1.22 times longer (95% confidence interval 1.02 to 1.45; p = 0.028). Mortality was similar in both groups, with a 6.1% mortality rate by 30 days post surgery. The process evaluation found that patients and carers were unable to comment on receiving the intervention. Limitations This was a feasibility study and was not designed as a definitive evaluation of the intervention. Lack of direct access to patient notes meant that researchers were unable to verify the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery check listing results. The relationship between changes in documentation of practices and changes in care practices is also unclear. Patient and suitable informants did not assist understandings of implementation, mechanisms of action or experiences of interacting with the intervention. Client Services Receipt Inventory data collection burden was an issue. Conclusions The Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery feasibility trial demonstrated mean recruitment of 1.87 participant per centre per month. Retention at 1 month was over 80% and at 6 months approximately 50%. This information is useful for those wishing to design a definitive clinical trial. Although 30-day mortality was the same in both groups, the potential for reduction, by Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery being implemented, exists from cumulatively increased good practices across a range of care domains. To compare longer-term survival of patients who received the intervention, we would recommend measuring 3-month (110-day) mortality in addition to 30-day mortality. These data are readily available from National Hip Fracture Database and are thus ideal for efficient trial design. Client Services Receipt Inventory can be reduced for a definitive trial, removing equipment questions and some community health use questions. Qualitative interviews with Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery trial patient and carer should not take place. Future work Work to date shows that the intervention pathway for Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery required considerable input from champions for delivery. We are exploring further funding options to facilitate work to understand these mechanisms and further test, pilot and produce the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery manual. Trial registration This trial is registered as Current Controlled Trials ISRCTN99336264. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: DTC-RP-PG-0311-12004) and is published in full in Programme Grants for Applied Research ; Vol. 13, No. 1. See the NIHR Funding and Awards website for further award information.