Dementia care coordinators in primary care: a realist evaluation.

BACKGROUND: A dementia care coordinator (DCC) service has recently been implemented across Kent and Medway Integrated Care Board (ICB). DCCs are provided at the primary care network (PCN) level and work closely with GP practice teams. The service is intended to help service users navigate the care system and provide proactive support to mitigate crisis points. However, the value of this service from key stakeholder perspectives is not yet known. AIM: To understand: 1) how the DCC service works, for whom, and in what circumstances; and 2) identify outcomes, resource implications, and costs. METHOD: The study uses mixed-methods realist evaluation with an embedded economic component. Data collection includes: questionnaires, service provider metrics, and qualitative interviews with healthcare practitioners and service users. Interpretive comparative analysis and narrative synthesis including evaluation of service costs against outcomes will produce a refined final programme theory. Patient and public involvement have been consulted throughout. RESULTS: Preliminary results indicate that when embedded in a local practice, healthcare practitioners including GPs welcome DCC involvement. DCCs act as community lynchpins, bridging service users to appropriate care pathways. The service may be capable of increasing diagnosis rates and reducing crisis points. However, caseloads are currently untamed. Therefore, the service and its workforce are becoming over-stretched. CONCLUSION: This evaluation describes preliminary findings from a recently implemented DCC service in Kent and Medway ICB. There is a crucial need to enhance the support of this workforce in order to ensure sustainability of this service. These findings will inform service development and future investment decisions.

Team climate, job satsfaction and burnout: results from a national survey of staff in general practice in England.

BACKGROUND: Measures are needed to address recruitment and retention problems in general practice. A good team climate (relational processes of team working) can mitigate the effects of pressured work environments, but little is known about it in British general practice. AIM: To assess team climate, explore practice characteristics and workforce combinations associated with favourable team climates, and analyse associations between practice team climate and job satisfaction, intention to remain in post, burnout and measures of practice performance. METHOD: An online questionnaire distributed to practices (for all their staff) via Clinical Research Networks, mid 2022, comprising validated measures: 14 item Team Climate Inventory (TCI) and single items on job satisfaction and emotional exhaustion/burnout; a question on intention to remain in post; participant role, age group, gender. Anonymous completion; submission through the Oxford RCGP RSC. RESULTS: Responses received from 4.8% of national staff headcount, n = 9835, (21.6% GP, 22.9% nurse/direct patient care, 55.5% non-clinical). Mean TCI score, 3.73 (scale 1-5 best); 78.3% were satisfied in their jobs; 26.1% reported high burnout. GPs perceived significantly better team climate, and reported lower job satisfaction, higher burnout (especially male GPs) and lower intention to quit than other groups. After adjusting for practice and workforce characteristics, team climate was better in smaller practices and associated with more job satisfaction, less burnout, increased intention to remain and improved patient-reported experiences; climate was unrelated to QOF performance. CONCLUSION: Team climate could be used to improve morale and patient experience. Micro teams might be beneficial in larger practices.

Dementia care coordinator service in Kent and Medway: a realist evaluation protocol.

BACKGROUND: Dementia care is a key priority for both NHS England and the UK government. National guidelines highlight the importance of care coordination to address the challenges people living with dementia and their carers can encounter when trying to access the health and care system. To counter these challenges, Kent and Medway Integrated Care Board (ICB) have recently implemented a proactive dementia care coordinator (DCC) service to support people with dementia and their carers from pre-diagnosis to end-of-life care. AIM: To understand how the DCC service works (or does not work), for whom, and in what circumstances. The findings will inform service development and future investment decisions. DESIGN & SETTING: This study will use a realist approach to evaluate the DCC service in Kent and Medway ICB, south-east England, which has a population of 1.9 million, comprising 42 primary care networks (PCNs; groups of general practices) each having a DCC. METHOD: An initial programme theory will be developed from existing literature, and in collaboration with stakeholders. Mixed methods, including questionnaires to DCCs, service provider metrics, and qualitative interviews, will be used to collect data on service provider and service user experiences. Interpretive comparative analysis and narrative synthesis, including evaluation of service costs against outcomes, will produce a refined final programme theory. RESULTS: The results from this project will produce evidence-based recommendations to help improve service delivery and possible service expansion. CONCLUSION: This protocol describes a realist evaluation designed to investigate the recently implemented DCC service in Kent and Medway ICB.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Overweight/Obesity and Time Preference: Evidence from a Survey among Adults in the UK.

INTRODUCTION: Overweight and obesity is a global problem incurring substantial health and economic implications. This has also been highlighted by the ongoing COVID-19 pandemic which has disproportionately affected overweight and obese individuals. Most of the interventions have concentrated on promotion of physical activities and healthy eating which may involve current sacrifices for future health gains. The purpose of this study was to explore the relationship between bodyweight and how individuals state they would trade-off immediate income for higher amounts in the future (time preference). METHODS: An online survey was conducted targeting adults aged >16 years in the UK (England, Northern Ireland, Scotland, and Wales) from January 1, 2016 to July 31, 2016. Using paid online adverts, as well as personal and professional networks for distribution of links to the online survey, the questionnaire asked respondents to report socio-economic and demographic information, height, and weight and to complete a time preference exercise. Data were analysed using descriptive statistics; associations were explored between BMI and respondents' characteristics and time preference using Spearman rank-order correlation and χ2 tests as appropriate. We adopted STROBE guidelines for the reporting of the study. RESULTS: A total of 561 responses were analysed (female = 293, males = 268). The relationship between time preference and overweight/obesity, using BMI as the measure is highly significant (χ2 = 95.92: p < 0.001). Individuals of normal weight have low time preferences and are more likely to invest in activities in a bid to reap future health benefits. There are also significant relationships between BMI and employment status (χ2 = 37.03; p < 0.001), physical activities (p < 0.0001), income levels (χ2 = 6.68; p < 0.035), family orientation, i.e., with or without children (χ2 = 12.88; p < 0.012), and ethnicity (χ2 = 18.31; p < 0.001). These imply that individuals in employment and with children in their families are less likely to be overweight or obese compared to those who do not. People from black backgrounds are also more likely to be overweight or obese and have higher time preferences compared to people from white backgrounds. DISCUSSIONS/CONCLUSIONS: People's preventive behaviours today can be predicted by their time preference and this understanding could be vital in improving population's uptake and maintenance of overweight and obesity prevention actions. People who have low time preference are more likely to invest time and resources in physical activities and healthy lifestyles to reap future health benefits hence value utilities-in-anticipation. Public health programmes should therefore use the knowledge of the association between time preference and overweight/obesity to inform designs of intervention programmes.

A feasibility trial of an intervention in alcohol dependence for structured preparation before detoxification versus usual care: the SPADe trial results.

BACKGROUND: Individuals who are 'moderately' or 'severely' dependent consume alcohol at levels that are likely to have a severe impact on their own health and mortality, the health and behaviours of others (family members) and to have economic and social implications. Treatment guidelines suggest that treatment needs to be planned with medically assisted withdrawal (also referred to as detoxification), and aftercare support but outcomes are poor with low proportions engaging in after care and high relapse rates. An approach of structured preparation before alcohol detoxification (SPADe) puts an emphasis on introducing lifestyle changes, development of coping strategies for cravings, stress and emotions as well as introducing changes to the immediate family and social environment in advance of alcohol cessation. Such a pre-habilitation paradigm compliments the established treatment approach. The key research question was: can we design a large scale, randomised controlled trial (RCT) that will answer whether such an approach is more effective than usual care in helping individuals to maintain longer periods of alcohol abstinence? METHODS: This is a pragmatic, parallel, two-arm, feasibility RCT comparing SPADe and usual care against usual care only in maintaining alcohol abstinence in adults with alcohol dependence receiving care in two community addiction services in London. Feasibility outcomes, exploration of primary and secondary clinical outcomes and health economic outcomes are analysed. The trial follows the guidelines of phase 2 of the Medical Research Council (MRC) for complex interventions. RESULTS: We were able to recruit 48/50 participants during a period of 9 months. Retention in the trial for the whole period of the 12 months was 75%. Treatment compliance was overall 44%. Data completion for the primary outcome was 65%, 50% and 63% at 3, 6 and 12 months, respectively. The intervention group had more days abstinent in the previous 90 days at the 12 months (n = 54.5) versus control (n = 41.5). CONCLUSIONS: The results of this feasibility trial indicate that with the appropriate modifications, a full multicentred trial would be possible to test the effectiveness and cost-effectiveness of a pre-habilitation approach such as the SPADe group intervention in addition to usual care against usual care only. TRIAL REGISTRATION: Name of registry: ISRCTN; Trial Registration Number: 14621127 ; Date of Registration: 22/02/2017.

Feasibility and Utility of mHealth for the Remote Monitoring of Parkinson Disease: Ancillary Study of the PD_manager Randomized Controlled Trial.

BACKGROUND: Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. OBJECTIVE: We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. METHODS: PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored. RESULTS: Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. CONCLUSIONS: We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17396879; http://www.isrctn.com/ISRCTN17396879. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2767-4.

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis.

BACKGROUND: Palliative care remains suboptimal in end-stage liver disease. AIM: To inform a definitive study, we assessed palliative long-term abdominal drains in end-stage liver disease to determine recruitment, attrition, safety/potential effectiveness, questionnaires/interview uptake/completion and make a preliminary cost comparison. METHODS: A 12-week feasibility nonblinded randomised controlled trial comparing large-volume paracentesis vs long-term abdominal drains in refractory ascites due to end-stage liver disease with fortnightly home visits for clinical/questionnaire-based assessments. Study success criteria were attrition not >50%, <10% long-term abdominal drain removal due to complications, the long-term abdominal drain group to spend <50% ascites-related study time in hospital vs large-volume paracentesis group and 80% questionnaire/interview uptake/completion. RESULTS: Of 59 eligible patients, 36 (61%) were randomised, 17 to long-term abdominal drain and 19 to large-volume paracentesis. Following randomisation, median number (IQR) of hospital ascitic drains (long-term abdominal drain group vs large-volume paracentesis group) were 0 (0-1) vs 4 (3-7); week 12 serum albumin (g/L) and serum creatinine (µmol/L) were 29 (26.5-32.5) vs 30 (25-35) and 104.5 (81-115.5) vs 127 (63-158) respectively. Total attrition was 42% (long-term abdominal drain group 47%, large-volume paracentesis group 37%). Median (IQR) fortnightly community/hospital/social care ascites-related costs and percentage study time in hospital were lower in the long-term abdominal drain group, £329 (253-580) vs £843 (603-1060) and 0% (0-0.74) vs 2.75% (2.35-3.84) respectively. Self-limiting cellulitis/leakage occurred in 41% (7/17) in the long-term abdominal drain group vs 11% (2/19) in the large-volume paracentesis group; peritonitis incidence was 6% (1/17) vs 11% (2/19) respectively. Questionnaires/interview uptake/completion were ≥80%; interviews indicated that long-term abdominal drains could transform the care pathway. CONCLUSIONS: The REDUCe study demonstrates feasibility with preliminary evidence of long-term abdominal drain acceptability/effectiveness/safety and reduction in health resource utilisation. TRIAL REGISTRATION: ISRCTN30697116, date assigned: 07/10/2015.

Day case complex devices: the state of the UK.

Objective: Complex cardiac devices including implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy (CRT) devices can safely be implanted as a day case procedure as opposed to overnight stay. We assess how common day case complex device therapy is and the cost implications of more widespread adoption across the UK. Methods: A freedom of information request was sent to all centres performing complex cardiac devices across the UK to assess the adoption of this technique. Cost implications were assessed using Department of Health National Schedule of Reference Costs 2016-2017. Results: 100 UK centres were surveyed, 80% replied. Eighty per cent of UK centres already implant complex cardiac devices as a day case to some extent. 64.06% of centres have a protocol for this. 12.82% of centres do <25% of complex devices as a day case. 15.38% do 25%-50% as day case. 17.95% do 50%-75% as day case and 33.33% do >75% as day case. There was no relationship between centre volume and the proportion of devices done as a day case as opposed to overnight stay. The cost saving of performing a complex device as a day case as opposed to overnight stay was £412 per ICD, £525 per CRT-pacemaker and £2169 per CRT-defibrillator. Conclusions: Day case complex devices are already widespread across the UK, however, there is scope for increase. An increase in proportion of day case devices could translate to £5 583 265 in savings annually for the National Health Service if all centres performed 75% of devices as a day case.

Effectiveness of home or hospital initiation of treatment at diagnosis for children with type 1 diabetes (DECIDE trial): a multicentre individually randomised controlled trial.

OBJECTIVE: To determine whether, in children with newly diagnosed type 1 diabetes who were not acutely unwell, management at home for initiation of insulin treatment and education of the child and family, would result in improved clinical and psychological outcomes at 2 years postdiagnosis. DESIGN: A multicentre randomised controlled trial (January 2008/October 2013). SETTING: Eight paediatric diabetes centres in England, Wales and Northern Ireland. PARTICIPANTS: 203 clinically well children aged under 17 years, with newly diagnosed type 1 diabetes and their carers. INTERVENTION: Management of the initiation period from diagnosis at home, for a minimum of 3 days, to include at least six supervised injections and delivery of pragmatic educational care. MAIN OUTCOME MEASURES: Primary outcome was glycosylated haemoglobin (HbA1c) concentration at 24 months postdiagnosis. Secondary outcomes included coping, anxiety, quality of life and use of NHS resources. RESULTS: 203 children, newly diagnosed, were randomised to commence management at home (n=101) or in hospital (n=102). At the 24 month primary end point, there was one withdrawal and a follow-up rate of 194/202 (96%). Mean HbA1c in the home treatment arm was 72.1 mmol/mol and in the hospital treated arm 72.6 mmol/mol. There was a negligible difference between the mean HbA1c levels in the two arms adjusted for baseline (1.01, 95% CI 0.93 to 1.09). There were mostly no differences in secondary outcomes at 24 months, apart from better child self-esteem in the home-arm. No home-arm children were admitted to hospital during initiation and there were no adverse events at that time. The number of investigations was higher in hospital patients during the follow-up period. There were no differences in insulin regimens between the two arms. CONCLUSIONS: There is no evidence of a difference between home-based and hospital-based initiation of care in children newly diagnosed with type 1 diabetes across relevant outcomes. TRIAL REGISTRATION NUMBER: ISRCTN78114042.

Estimation of Quality-adjusted Life Years alongside clinical trials: the impact of 'time-effects' on trial results.

OBJECTIVES: The objectives were to investigate the impact of 'time-effect' on the estimation of quality-adjusted life years (QALYs) along prospective clinical trials' outcomes using an assumed fixed time duration versus the actual time durations for each case. The 'time' duration is the length of time in a health state. METHODS: Two methods were used in the estimation of QALYs based using EQ-5D 3L scores collected at specific time-point intervals. One method used the actual time durations for each case based on CRF records, and the other used an assumed time duration and globally applied it to all the cases. Using SPSS ® software program, we used paired-sample t-tests to assess whether the 'time-effect' can potentially affect trial results using CONSTRUCT trial data as reported in the trial results publications. The trial compared use of Infliximab with Cyclosporine for patients with Ulcerative Colitis and it involved some 270 participants. KEY FINDINGS: The results largely indicate statistically significant differences between the two methods of QALY estimations. QALYs at the respective time-points indicate no statistical difference between the two approaches. However, the difference in terms of total QALYs between the two QALY estimation approaches is statistically significant with considerable impact on costs/QALY. CONCLUSIONS: Considering the possible impact of the time-effect on QALY estimations, the result implies that it can have significant implications for resources allocations decisions. In this respect, researchers have to pay due considerations to the approach they use and where possible, actual time durations must be used in QALY estimations along prospective clinical trials.

Acceptability to patients, carers and clinicians of an mHealth platform for the management of Parkinson's disease (PD_Manager): study protocol for a pilot randomised controlled trial.

BACKGROUND: Parkinson's disease is a degenerative neurological condition causing multiple motor and non-motor symptoms that have a serious adverse effect on quality of life. Management is problematic due to the variable and fluctuating nature of symptoms, often hourly and daily. The PD_Manager mHealth platform aims to provide a continuous feed of data on symptoms to improve clinical understanding of the status of any individual patient and inform care planning. The objectives of this trial are to (1) assess patient (and family carer) perspectives of PD_Manager regarding comfort, acceptability and ease of use; (2) assess clinician views about the utility of the data generated by PD_Manager for clinical decision making and the acceptability of the system in clinical practice. METHODS/DESIGN: This trial is an unblinded, parallel, two-group, randomised controlled pilot study. A total of 200 persons with Parkinson's disease (Hoehn and Yahr stage 3, experiencing motor fluctuations at least 2 h per day), with primary family carers, in three countries (110 Rome, 50 Venice, Italy; 20 each in Ioannina, Greece and Surrey, England) will be recruited. Following informed consent, baseline information will be gathered, including the following: age, gender, education, attitudes to technology (patient and carer); time since Parkinson's diagnosis, symptom status and comorbidities (patient only). Randomisation will assign participants (1:1 in each country), to PD_Manager vs control, stratifying by age (1 ≤ 70 : 1 > 70) and gender (60% M: 40% F). The PD_Manager system captures continuous data on motor symptoms, sleep, activity, speech quality and emotional state using wearable devices (wristband, insoles) and a smartphone (with apps) for storing and transmitting the information. Control group participants will be asked to keep a symptom diary covering the same elements as PD_Manager records. After a minimum of two weeks, each participant will attend a consultation with a specialist doctor for review of the data gathered (by either means), and changes to management will be initiated as indicated. Patients, carers and clinicians will be asked for feedback on the acceptability and utility of the data collection methods. The PD_Manager intervention, compared to a symptom diary, will be evaluated in a cost-consequences framework. DISCUSSION: Information gathered will inform further development of the PD_Manager system and a larger effectiveness trial. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN17396879 . Registered on 15 March 2017.