Supporting High-impAct useRs in Emergency Departments (SHarED) quality improvement: a mixed-method evaluation.

BACKGROUND: The need to better manage frequent attenders or high-impact users (HIUs) in hospital emergency departments (EDs) is widely recognised. These patients often have complex medical needs and are also frequent users of other health and care services. The West of England Academic Health Science Network launched its Supporting High impAct useRs in Emergency Departments (SHarED) quality improvement programme to spread a local HIU intervention across six other EDs in five Trusts. AIM: SHarED aimed to reduce ED attendance and hospital admissions by 20% for enrolled HIUs. To evaluate the implementation of SHarED, we sought to learn about the experience of staff with HIU roles and their ED colleagues and assess the impact on HIU attendance and admissions. METHODS: We analysed a range of data including semistructured interviews with 10 HIU staff; the number of ED staff trained in HIU management; an ED staff experience survey; and ED attendances and hospital admissions for 148 HIUs enrolled in SHarED. RESULTS: Staff with HIU roles were unanimously positive about the benefits of SHarED for both staff and patients. SHarED contributed to supporting ED staff with patient-centred recommendations and provided the basis for more integrated case management across the health and care system. 55% of ED staff received training. There were improvements in staff views relating to confidence, support, training and HIUs receiving more appropriate care. The mean monthly ED attendance per HIU reduced over time. Follow-up data for 86% (127/148) of cases showed a mean monthly ED attendances per HIU reduced by 33%, from 2.1 to 1.4, between the 6 months pre-enrolment and post-enrolment (p<0.001). CONCLUSION: SHarED illustrates the considerable potential for a quality improvement programme to promote more integrated case management by specialist teams across the health and care system for particularly vulnerable individuals and improve working arrangements for hard-pressed staff.

Improved health-related quality of life after hepatitis C viraemic clearance among people who inject drugs may not be durable.

BACKGROUND AND AIMS: Chronic infection with the hepatitis C virus (HCV) has a detrimental impact on health-related quality of life (QoL). Scale-up of HCV direct-acting antiviral (DAA) therapy among people who inject drugs (PWID) is underway in several countries since the introduction of interferon-free regimens. This study aimed to assess the impact of DAA treatment success on QoL for PWID. DESIGN: Cross-sectional study using two rounds of the Needle Exchange Surveillance Initiative, a national anonymous bio-behavioural survey and a longitudinal study involving PWID who underwent DAA therapy. SETTING: The setting for the cross-sectional study was Scotland (2017-2018, 2019-2020). The setting for the longitudinal study was the Tayside region of Scotland (2019-2021). PARTICIPANTS: In the cross-sectional study PWID were recruited from services providing injecting equipment (n = 4009). In the longitudinal study, participants were PWID on DAA therapy (n = 83). MEASUREMENTS: In the cross-sectional study, the association between QoL (measured using the EQ-5D-5L quality of life instrument) and HCV diagnosis and treatment was assessed using multilevel linear regression. In the longitudinal study, QoL was compared at four timepoints using multilevel regression, from treatment commencement until 12 months following commencement. FINDINGS: In the cross-sectional study, 41% (n = 1618) were ever chronically HCV infected, of whom 78% (n = 1262) were aware of their status and of whom 64% (n = 704) had undergone DAA therapy. There was no evidence for a marked QoL improvement associated with viral clearance among those treated for HCV (B = 0.03; 95% CI, -0.03 to 0.09). In the longitudinal study, improved QoL was observed at the sustained virologic response test timepoint (B = 0.18; 95% CI, 0.10-0.27), but this was not maintained at 12 months following start of treatment (B = 0.02; 95% CI, -0.05 to 0.10). CONCLUSIONS: Successful direct-acting antiviral therapy for hepatitis C infection may not lead to a durable improvement in quality of life among people who inject drugs, although there may be a transient improvement around the time of sustained virologic response. Economic models of the impact of scaling-up treatment may need to include more conservative quality of life benefits over and above reductions in mortality, disease progression and transmission of infection.

Impact of rapid near-patient STI testing on service delivery outcomes in an integrated sexual health service in the United Kingdom: a controlled interrupted time series study.

OBJECTIVES: To evaluate the impact of a new clinic-based rapid sexually transmitted infection testing, diagnosis and treatment service on healthcare delivery and resource needs in an integrated sexual health service. DESIGN: Controlled interrupted time series study. SETTING: Two integrated sexual health services (SHS) in UK: Unity Sexual Health in Bristol, UK (intervention site) and Croydon Sexual Health in London (control site). PARTICIPANTS: Electronic patient records for all 58 418 attendances during the period 1 year before and 1 year after the intervention. INTERVENTION: Introduction of an in-clinic rapid testing system for gonorrhoea and chlamydia in combination with revised treatment pathways. OUTCOME MEASURES: Time-to-test notification, staff capacity, cost per episode of care and overall service costs. We also assessed rates of gonorrhoea culture swabs, follow-up attendances and examinations. RESULTS: Time-to-notification and the rate of gonorrhoea swabs significantly decreased following implementation of the new system. There was no evidence of change in follow-up visits or examination rates for patients seen in clinic related to the new system. Staff capacity in clinics appeared to be maintained across the study period. Overall, the number of episodes per week was unchanged in the intervention site, and the mean cost per episode decreased by 7.5% (95% CI 5.7% to 9.3%). CONCLUSIONS: The clear improvement in time-to-notification, while maintaining activity at a lower overall cost, suggests that the implementation of clinic-based testing had the intended impact, which bolsters the case for more widespread rollout in sexual health services.

An analysis of the construct validity and responsiveness of the ICECAP-SCM capability wellbeing measure in a palliative care hospice setting.

BACKGROUND: For outcome measures to be useful in health and care decision-making, they need to have certain psychometric properties. The ICECAP-Supportive Care Measure (ICECAP-SCM), a seven attribute measure (1. Choice, 2. Love and affection, 3. Physical suffering, 4. Emotional suffering, 5. Dignity, 6. Being supported, 7. Preparation) developed for use in economic evaluation of end-of-life interventions, has face validity and is feasible to use. This study aimed to assess the construct validity and responsiveness of the ICECAP-SCM in hospice inpatient and outpatient settings. METHODS: A secondary analysis of data collated from two studies, one focusing on palliative care day services and the other on constipation management, undertaken in the same national hospice organisation across three UK hospices, was conducted. Other quality of life and wellbeing outcome measures used were the EQ-5D-5L, McGill Quality of Life Questionnaire - Expanded (MQOL-E), Patient Health Questionnaire-2 (PHQ-2) and Palliative Outcomes Scale Symptom list (POS-S). The construct validity of the ICECAP-SCM was assessed, following hypotheses generation, by calculating correlations between: (i) its domains and the domains of other outcome measures, (ii) its summary score and the other measures' domains, (iii) its summary score and the summary scores of the other measures. The responsiveness of the ICECAP-SCM was assessed using anchor-based methods to understand change over time. Statistical analysis consisted of Spearman and Pearson correlations for construct validity and paired t-tests for the responsiveness analysis. RESULTS: Sixty-eight participants were included in the baseline analysis. Five strong correlations were found with ICECAP-SCM attributes and items on the other measures: four with the Emotional suffering attribute (Anxiety/depression on EQ-5D-5L, Psychological and Burden on MQOL-E and Feeling down, depressed or hopeless on PHQ-2), and one with Physical suffering (Weakness or lack of energy on POS-S). ICECAP-SCM attributes and scores were most strongly associated with the MQOL-E measure (0.73 correlation coefficient between summary scores). The responsiveness analysis (n = 36) showed the ICECAP-SCM score was responsive to change when anchored to changes on the MQOL-E over time (p < 0.05). CONCLUSIONS: This study provides initial evidence of construct validity and responsiveness of the ICECAP-SCM in hospice settings and suggests its potential for use in end-of-life care research.

Exploring the costs, consequences and efficiency of three types of palliative care day services in the UK: a pragmatic before-and-after descriptive cohort study.

BACKGROUND: Palliative Care Day Services (PCDS) offer supportive care to people with advanced, progressive illness who may be approaching the end of life. Despite the growth of PCDS in recent years, evidence of their costs and effects is scarce. It is important to establish the value of such services so that health and care decision-makers can make evidence-based resource allocation decisions. This study examines and estimates the costs and effects of PCDS with different service configurations in three centres across the UK in England, Scotland and Northern Ireland. METHODS: People who had been referred to PCDS were recruited between June 2017 and September 2018. A pragmatic before-and-after descriptive cohort study design analysed data on costs and outcomes. Data on costs were collected on health and care use in the 4 weeks preceding PCDS attendance using adapted versions of the Client Service Receipt Inventory (CSRI). Outcomes, cost per attendee/day and volunteer contribution to PCDS were also estimated. Outcomes included quality of life (MQOL-E), health status (EQ-5D-5L) and capability wellbeing (ICECAP-SCM). RESULTS: Thirty-eight attendees were recruited and provided data at baseline and 4 weeks (centre 1: n = 8; centre 2: n = 8, centre 3: n = 22). The cost per attendee/day ranged from £121-£190 (excluding volunteer contribution) to £172-£264 (including volunteer contribution) across the three sites. Volunteering constituted between 28 and 38% of the total cost of PCDS provision. There was no significant mean change at 4 week follow-up from baseline for health and care costs (centre 1: £570, centre 2: -£1127, centre 3: £65), or outcomes: MQOL-E (centre 1: - 0.48, centre 2: 0.01, centre 3: 0.24); EQ-5D-5L (centre 1: 0.05, centre 2: 0.03, centre 3: - 0.03) and ICECAP-SCM (centre 1:0.00, centre 2: - 0.01, centre 3: 0.03). Centre costs variation is almost double per attendee when attendance rates are held constant in scenario analysis. CONCLUSIONS: This study highlights the contribution made by volunteers to PCDS provision. There is insufficient evidence on whether outcomes improved, or costs were reduced, in the three different service configurations for PCDS. We suggest how future research may overcome some of the challenges we encountered, to better address questions of cost-effectiveness in PCDS.

A group intervention to improve quality of life for people with advanced dementia living in care homes: the Namaste feasibility cluster RCT.

BACKGROUND: People with advanced dementia who live and die in nursing homes experience variable quality of life, care and dying. There is a need to identify appropriate, cost-effective interventions that facilitate high-quality end-of-life care provision. OBJECTIVES: To establish the feasibility and acceptability to staff and family of conducting a cluster randomised controlled trial of the Namaste Care intervention for people with advanced dementia in nursing homes. DESIGN: The study had three phases: (1) realist review and (2) intervention refinement to inform the design of (3) a feasibility cluster randomised controlled trial with a process evaluation and economic analysis. Clusters (nursing homes) were randomised in a 3 : 1 ratio to intervention or control (usual care). The nature of the intervention meant that blinding was not possible. SETTING: Nursing homes in England providing care for people with dementia. PARTICIPANTS: Residents with advanced dementia (assessed as having a Functional Assessment Staging Test score of 6 or 7), their informal carers and nursing home staff. INTERVENTION: Namaste Care is a complex group intervention that provides structured personalised care in a dedicated space, focusing on enhancements to the physical environment, comfort management and sensory engagement. MAIN OUTCOME MEASURES: The two contender primary outcome measures were Comfort Assessment in Dying - End of Life Care in Dementia for quality of dying (dementia) and Quality of Life in Late Stage Dementia for quality of life. The secondary outcomes were as follows: person with dementia, sleep/activity (actigraphy), neuropsychiatric symptoms, agitation and pain; informal carers, satisfaction with care at the end of life; staff members, person-centred care assessment, satisfaction with care at the end of life and readiness for change; and other data - health economic outcomes, medication/service use and intervention activity. RESULTS: Phase 1 (realist review; 86 papers) identified that a key intervention component was the activities enabling the development of moments of connection. In phase 2, refinement of the intervention enabled the production of a user-friendly 16-page A4 booklet. In phase 3, eight nursing homes were recruited. Two homes withdrew before the intervention commenced; four intervention and two control homes completed the study. Residents with advanced dementia (n = 32) were recruited in intervention (n = 18) and control (n = 14) homes. Informal carers (total, n = 12: intervention, n = 5; control, n = 7) and 97 staff from eight sites (intervention, n = 75; control, n = 22) were recruited over a 6-month period. Recruitment is feasible. Completion rates of the primary outcome questionnaires were high at baseline (100%) and at 4 weeks (96.8%). The Quality of Life in Late Stage Dementia was more responsive to change over 24 weeks. Even where economic data were missing, these could be collected in a full trial. The intervention was acceptable; the dose varied depending on the staffing and physical environment of each care home. Staff and informal carers reported changes for the person with dementia in two ways: increased social engagement and greater calm. No adverse events related to the intervention were reported. CONCLUSIONS: A subsequent definitive trial is feasible if there are amendments to the recruitment process, outcome measure choice and intervention specification. FUTURE WORK: In a full trial, consideration is needed of the appropriate outcome measure that is sensitive to different participant responses, and of clear implementation principles for this person-centred intervention in a nursing home context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14948133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 6. See the NIHR Journals Library website for further project information.

Namaste Care is a programme of respectful stimulation for nursing home residents who have advanced dementia. It is person-focused and reflects residents' individual likes and interests. It is claimed that Namaste Care improves quality of life for residents, family and staff, and quality of dying for residents, and can be provided without additional cost. This study explored how feasible it would be to conduct a large study in the future to understand the effects of Namaste Care on people with advanced dementia. Our literature review showed that Namaste Care enables people with advanced dementia to have moments of connection with others. We refined some Namaste Care resources through working with care home staff, family and volunteers to create a user-friendly booklet. Eight care homes were recruited to our 6-month trial; four homes were supported to introduce Namaste Care, two continued as usual and two withdrew. In the four intervention homes, residents with advanced dementia received Namaste Care. Staff used standard measures to assess (1) residents' responses and (2) the economic costs and benefits of Namaste Care. Researchers made observation visits. Records of activity in Namaste Care sessions were completed, and interviews were held with staff and family. Residents wore an ActiGraph (Activinsights Ltd, Kimbolton, UK) device that recorded their levels of sleep and activity. The length and frequency of Namaste Care sessions varied. Nursing homes incurred additional costs but could see ways to reduce those. All residents accepted wearing an ActiGraph device. Staff completed the data collection tools; some measures were more informative than others. Data from interviews showed that most people had positive experiences of Namaste Care. The findings support the view that Namaste Care has benefits for people with advanced dementia in nursing homes. We consider that, with some changes, this trial offers a model for a large study to show whether or not Namaste Care could be promoted more widely.

Evaluating the population impact of hepatitis C direct acting antiviral treatment as prevention for people who inject drugs (EPIToPe) - a natural experiment (protocol).

INTRODUCTION: Hepatitis C virus (HCV) is the second largest contributor to liver disease in the UK, with injecting drug use as the main risk factor among the estimated 200 000 people currently infected. Despite effective prevention interventions, chronic HCV prevalence remains around 40% among people who inject drugs (PWID). New direct-acting antiviral (DAA) HCV therapies combine high cure rates (>90%) and short treatment duration (8 to 12 weeks). Theoretical mathematical modelling evidence suggests HCV treatment scale-up can prevent transmission and substantially reduce HCV prevalence/incidence among PWID. Our primary aim is to generate empirical evidence on the effectiveness of HCV 'Treatment as Prevention' (TasP) in PWID. METHODS AND ANALYSIS: We plan to establish a natural experiment with Tayside, Scotland, as a single intervention site where HCV care pathways are being expanded (including specialist drug treatment clinics, needle and syringe programmes (NSPs), pharmacies and prison) and HCV treatment for PWID is being rapidly scaled-up. Other sites in Scotland and England will act as potential controls. Over 2 years from 2017/2018, at least 500 PWID will be treated in Tayside, which simulation studies project will reduce chronic HCV prevalence among PWID by 62% (from 26% to 10%) and HCV incidence will fall by approximately 2/3 (from 4.2 per 100 person-years (p100py) to 1.4 p100py). Treatment response and re-infection rates will be monitored. We will conduct focus groups and interviews with service providers and patients that accept and decline treatment to identify barriers and facilitators in implementing TasP. We will conduct longitudinal interviews with up to 40 PWID to assess whether successful HCV treatment alters their perspectives on and engagement with drug treatment and recovery. Trained peer researchers will be involved in data collection and dissemination. The primary outcome - chronic HCV prevalence in PWID - is measured using information from the Needle Exchange Surveillance Initiative survey in Scotland and the Unlinked Anonymous Monitoring Programme in England, conducted at least four times before and three times during and after the intervention. We will adapt Bayesian synthetic control methods (specifically the Causal Impact Method) to generate the cumulative impact of the intervention on chronic HCV prevalence and incidence. We will use a dynamic HCV transmission and economic model to evaluate the cost-effectiveness of the HCV TasP intervention, and to estimate the contribution of the scale-up in HCV treatment to observe changes in HCV prevalence. Through the qualitative data we will systematically explore key mechanisms of TasP real world implementation from provider and patient perspectives to develop a manual for scaling up HCV treatment in other settings. We will compare qualitative accounts of drug treatment and recovery with a 'virtual cohort' of PWID linking information on HCV treatment with Scottish Drug treatment databases to test whether DAA treatment improves drug treatment outcomes. ETHICS AND DISSEMINATION: Extending HCV community care pathways is covered by ethics (ERADICATE C, ISRCTN27564683, Super DOT C Trial clinicaltrials.gov: NCT02706223). Ethical approval for extra data collection from patients including health utilities and qualitative interviews has been granted (REC ref: 18/ES/0128) and ISCRCTN registration has been completed (ISRCTN72038467). Our findings will have direct National Health Service and patient relevance; informing prioritisation given to early HCV treatment for PWID. We will present findings to practitioners and policymakers, and support design of an evaluation of HCV TasP in England.