Negotiating commissioning pathways for the successful implementation of innovative health technology in primary care.

BACKGROUND: Commissioning innovative health technologies is typically complex and multi-faceted. Drawing on the negotiated order perspective, we explore the process by which commissioning organisations make their decisions to commission innovative health technologies. The empirical backdrop to this discussion is provided by a case study exploring the commissioning considerations for a new photoplethysmography-based diagnostic technology for peripheral arterial disease in primary care in the UK. METHODS: The research involved an empirical case study of four Clinical Commissioning Groups (CCGs) involved in the commissioning of services in primary and secondary care. Semi-structured in-depth interviews (16 in total) and two focus groups (a total of eight people participated, four in each group) were conducted with key individuals involved in commissioning services in the NHS including (i) senior NHS clinical leaders and directors (ii) commissioners and health care managers across CCGs and (iii) local general practitioners. RESULTS: Commissioning of a new diagnostic technology for peripheral arterial disease in primary care involves high levels of protracted negotiations over funding between providers and commissioners, alliance building, conflict resolution and compromise of objectives where the outcomes of change are highly contingent upon interventions made across different care settings. Our evidence illustrates how reconfigurations of inter-organisational relations, and of clinical and related work practices required for the successful implementation of a new technology could become the major challenge in commissioning negotiations. CONCLUSIONS: Innovative health technologies such as the diagnostic technology for peripheral arterial disease are commissioned in care pathways where the value of such technology is realised by those delivering care to patients. The detail of how care pathways are commissioned is complex and involves high degrees of uncertainty concerning such issues as prioritisation decisions, patient benefits, clinical buy-in, value for money and unintended consequences. Recent developments in the new care models and integrated care systems (ICSs) in the UK offer a unique opportunity for the successful commissioning arrangements of innovative health technologies in primary care such as the new diagnostic technology for peripheral arterial disease.

Rapid evaluation for health and social care innovations: challenges for "quick wins" using interrupted time series.

BACKGROUND: Rapid evaluation was at the heart of National Health Service England's evaluation strategy of the new models of care vanguard programme. This was to facilitate the scale and spread of successful models of care throughout the health & social care system. The aim of this paper is to compare the findings of the two evaluations of the Enhanced health in Care Homes (EHCH) vanguard in Gateshead, one using a smaller data set for rapidity and one using a larger longitudinal data set and to investigate the implications of the use of rapid evaluations using interrupted time series (ITS) methods. METHODS: A quasi-experimental design study in the form of an ITS was used to evaluate the impact of the vanguard on secondary care use. Two different models are presented differing by timeframes only. The short-term model consisted of data for 11 months data pre and 20 months post vanguard. The long-term model consisted of data for 23 months pre and 34 months post vanguard. RESULTS: The cost consequences, including the cost of running the EHCH vanguard, were estimated using both a single tariff non-elective admissions methodology and a tariff per bed day methodology. The short-term model estimated a monthly cost increase of £73,408 using a single tariff methodology. When using a tariff per bed day, there was an estimated monthly cost increase of £14,315. The long-term model had, using a single tariff for non-elective admissions, an overall cost increase of £7576 per month. However, when using a tariff per bed-days, there was an estimated monthly cost reduction of £57,168. CONCLUSIONS: Although it is acknowledged that there is often a need for rapid evaluations in order to identify "quick wins" and to expedite learning within health and social care systems, we conclude that this may not be appropriate for quasi-experimental designs estimating effect using ITS for complex interventions. Our analyses suggests that care must be taken when conducting and interpreting the results of short-term evaluations using ITS methods, as they may produce misleading results and may lead to a misallocation of resources.

A polygenic risk score added to a QRISK®2 cardiovascular disease risk calculator demonstrated robust clinical acceptance and clinical utility in the primary care setting.

AIMS: The aim of the study was to assess the real-world feasibility, acceptability, and impact of an integrated risk tool for cardiovascular disease (CVD IRT, combining the standard QRISK®2 risk algorithm with a polygenic risk score), implemented within routine primary practice in the UK National Health Service. METHODS AND RESULTS: The Healthcare Evaluation of Absolute Risk Testing Study (NCT05294419) evaluated participants undergoing primary care health checks. Both QRISK2 and CVD IRT scores were returned to the healthcare providers (HCPs), who then communicated the results to participants. The primary outcome of the study was feasibility of CVD IRT implementation. Secondary outcomes included changes in CVD risk (QRISK2 vs. CVD IRT) and impact of the CVD IRT on clinical decision-making. A total of 832 eligible participants (median age 55 years, 62% females, 97.5% White ethnicity) were enrolled across 12 UK primary care practices. Cardiovascular disease IRT scores were obtained on 100% of the blood samples. Healthcare providers stated that the CVD IRT could be incorporated into routine primary care in a straightforward manner in 90.7% of reports. Participants stated they were 'likely' or 'very likely' to recommend the use of this test to their family or friends in 86.9% of reports. Participants stated that the test was personally useful (98.8%) and that the results were easy to understand (94.6%). When CVD IRT exceeded QRISK2, HCPs planned changes in management for 108/388 (27.8%) of participants and 47% (62/132) of participants with absolute risk score changes of >2%. CONCLUSION: Amongst HCPs and participants who agreed to the trial of genetic data for refinement of clinical risk prediction in primary care, we observed that CVD IRT implementation was feasible and well accepted. The CVD IRT results were associated with planned changes in prevention strategies.

When a standard cardiovascular risk tool, as currently used in National Health Service Health Checks, was expanded to include genetic risk information, it was well accepted by both participants and healthcare providers and generated impactful changes in planned clinical decision-making.Most participants found the test useful and easy to understand, and healthcare providers found it straightforward to use in most cases.When risk was increased by the addition of genetic information, this influenced planned management decisions.

Prospective Assessment of the Diagnostic Accuracy of Multi-site Photoplethysmography Pulse Measurements for Diagnosis of Peripheral Artery Disease in Primary Care.

Peripheral arterial disease (PAD) is associated with cerebral and coronary artery disease. Symptomatic PAD affects about 5% of people over 55 years; many more have asymptomatic PAD. Early detection enables modification of arterial disease risk factors. Diagnostically, assessment of symptoms or signs can be unreliable; ankle brachial pressure index (ABPI) testing is time-consuming and few healthcare professionals are properly trained. This study assessed the diagnostic accuracy of multi-site photoplethysmography (MPPG), an alternative non-invasive test for PAD, in primary care. PAD patients identified from general practice registers were age- and sex-matched with controls. Participants were assessed using MPPG, ABPI and duplex ultrasound (DUS). Outcome measures were sensitivity and specificity of MPPG and ABPI (relative to DUS) and concordance. MPPG test results were available in 249 of 298 eligible participants from 16 practices between May 2015 and November 2016. DUS detected PAD in 101/249 (40.6%). MPPG sensitivity was 79.8% (95% confidence interval [CI] 69.9-87.6%), with specificity 71.9% (95% CI 63.7-79.2%). ABPI sensitivity was 80.2% (95% CI 70.8-87.6%), with specificity 88.6% (95% CI 82-93.5%). With comparable sensitivity to ABPI, MPPG is quick, automated and simpler to do than ABPI; it offers the potential for rapid and accessible PAD assessments in primary care.

Enhancing research capacity across healthcare and higher education sectors: development and evaluation of an integrated model.

BACKGROUND: With current policy in healthcare research, in the United Kingdom and internationally, focused on development of research excellence in individuals and teams, building capacity for implementation and translation of research is paramount among the professionals who use that research in daily practice. The judicious use of research outcomes and evaluation of best evidence and practice in healthcare is integrally linked to the research capacity and capabilities of the workforce. In addition to promoting high quality research, mechanisms for actively enhancing research capacity more generally must be in place to address the complexities that both undermine and facilitate this activity. METHODS: A comprehensive collaborative model for building research capacity in one health professional group, speech and language therapy, was developed in a region within the UK and is presented here. The North East of England and the strong research ethos of this profession in addressing complex interventions offered a fertile context for developing and implementing a model which integrated the healthcare and university sectors. Two key frameworks underpin this model. The first addresses the individual participants' potential trajectory from research consciousness to research participative to research active. The second embeds a model developed for general practitioners into a broader framework of practice-academic partnership and knowledge and skills exchange, and considers external drivers and impacts on practice and patient outcomes as key elements. RESULTS AND DISCUSSION: The integration of practice and academia has been successful in building a culture of research activity within one healthcare profession in a region in the UK and has resulted, to date, in a series of research related outcomes. Understanding the key components of this partnership and the explicit strategies used has driven the implementation of the model and are discussed here. CONCLUSIONS: A strong, equitable collaboration between clinical and academic partners working towards a common outcome can enhance the use of research within the healthcare workforce and contribute actively to the research process. A set of propositions are specified to facilitate both transferability of this partnership model to other professional groups and clinical teams and evaluation of the model components.

Cardiovascular-related conditions and risk factors in primary care for deprived communities before and during the COVID-19 pandemic: an observational study in Northern England.

OBJECTIVES: The North East of England, ranked as having the highest poverty levels and the lowest health outcomes, has the highest cardiovascular disease (CVD) premature mortality. This study aimed to compare CVD-related conditions and risk factors for deprived practice populations with other general practice (GP) populations in Northern England to England overall, before and during COVID-19 to identify changes in recorded CVD-related risk factors and conditions and evidence-based lipid prescribing behaviour. DESIGN: A population-based observational study of aggregated practice-level data obtained from publicly accessible data sets. SETTING: 34 practices that fall into the 15% most deprived practice populations in England were identified as the most deprived communities in the North East and North Cumbria (Deep End). PARTICIPANTS: Patients aged ≥16 registered with GP and diagnosed with any form of CVD. PRIMARY AND SECONDARY OUTCOME MEASURES: CVD-related conditions and risk factors, statin prescribing. RESULTS: Deep End (n=263 830) had a smaller, younger and more deprived population with lower levels of employment and full-time education and higher smoking prevalence. They had some higher recorded CVD-related conditions than England but lower than the non-Deep End. Atrial fibrillation (-0.9, -0.5), hypertension (-3.7, -1.3) and stroke and transient ischaemic attack rates (-0.5, -0.1) appeared to be lower in the Deep End than in the non-Deep End but the optimal statin prescribing rate was higher (3.1, 8.2) than in England. CONCLUSION: Recorded CVD-related risk factors and conditions remained comparable before and during COVID-19. These are higher in the Deep End than in England and similar or lower than the non-Deep End, with a higher optimal statin prescribing rate. However, it was not possible to control for age and sex. More work is needed to estimate the consequences of the pandemic on disadvantaged communities and to compare whether the findings are replicated in other areas of deprivation.

Using care and support planning to implement routine falls prevention and management for people living with frailty: A qualitative evaluation.

BACKGROUND: Frailty is a key issue in current healthcare delivery and falls is an important component. Care and support planning (CSP) is an established approach to managing long term conditions (LTCs) and has potential to provide more person-centred care for those at risk of falling. This qualitative evaluation aimed to understand the barriers and success criteria involved in incorporating falls assessment and management into the CSP process. METHODS: CSP for falls prevention was implemented in eight general practices in the North of England. Six of the eight practices participated in the qualitative evaluation. Seven group interviews were undertaken with staff (n = 31) that included practice nurses, health care assistants, nurses, and administrative staff (n = 2-8 per group). Observations of the falls and CSP training provided additional data. Interviews covered experiences and potential impacts of training, and processes of implementation of the programme, and were informed by normalisation process theory. Thematic analysis was undertaken using a team-based approach. RESULTS: Although successfully implemented across the practices, how established CSP was and therefore 'organisational readiness' was an overarching theme that illustrated differences in how easily sites were able to implement the additional elements for frailty. The challenges, successes and impacts of implementation are demonstrated through this theme and four further themes: training resources and learning; positive impacts of the programme (including enabling easier conversations around 'frailty'); integrating work processes/work with patients; and dealing with uncertainty and complexity. CONCLUSIONS: Care and Support Planning services designed to target frailty and falls is feasible and can successfully be delivered in the primary care setting, if key enablers are promoted and challenges to implementation addressed from planning through to integration in practice.

Accuracy of Peripheral Arterial Disease Registers in UK General Practice: Case-Control Study.

BACKGROUND: Approximately 20% of the UK population aged 55 to 75 years have evidence of peripheral arterial disease (PAD). PAD affects quality of life and life expectancy if not appropriately diagnosed and managed. At risk patients require accurate diagnosis to ensure optimal treatment to slow disease progression and minimize adverse outcomes. AIM: To assess the accuracy of general practice (GP) registration of the diagnosis of peripheral arterial disease (PAD). DESIGN AND SETTING: An observational analytic case-control study. As part of a National Institute for Health Research-funded (ISRCTN13301188) project assessing novel diagnostic methods set in GP practice. METHODS: A total of 125 patients registered as having PAD and 125 age- and sex-matched controls were recruited from 15 general practices across North East England. The register was then assessed for accuracy of diagnosis. Duplex vascular ultrasound scanning (DUS) undertaken by vascular scientists was used as the gold standard reference for PAD. RESULTS: The PAD register had a sensitivity of 86% (95% CI 77%-92%) and specificity of 74% (95% CI 67%-81%) when compared with DUS. The positive predictive value, however, was 69.6% (95% CI 63%-75%) and negative predictive value 88.8% (95% CI 82%-92%). The overall diagnostic effectiveness of the PAD register was 79.2% (95% CI 73%-84%). CONCLUSION: This analysis indicates that while PAD is detected with reasonable sensitivity in primary care, many patients registered with a diagnosis of PAD lacked DUS-proven disease. Improved approaches to the objective diagnosis of PAD may improve diagnosis and management of PAD in primary care.

Breastfeeding peer support: are there additional benefits?

Anecdotal discussion among breastfeeding peer supporters and the infant-feeding co-ordinator suggested that breastfeeding peer support provided by breastfeeding peer supporters may offer benefits to breastfeeding women and their families other than increasing breastfeeding initiation and sustainability. The aim of this research was to determine whether there was evidence to support this. The research team used focus groups to obtain information from 16 local women who had received breastfeeding peer support from breastfeeding peer supporters. The key themes that emerged were--improved mental health, increased self-esteem or confidence, parenting skills, improved family diet, breastfeeding sustainability and poor hospital experience.The findings suggest that breastfeeding peer supporters supporting mothers to breastfeed, with the intention of increasing both breastfeeding rates and sustainability, may have additional benefits in several aspects of families' lives. Breastfeeding peer support may play an important role in helping to attain targets such as reducing obesity and postnatal depression.

A qualitative study to investigate why patients accept or decline a copy of their referral letter from their GP.

BACKGROUND: Our practice in Northumberland has offered patients copies of their clinical referral letters for almost 3 years. However, many patients declined this offer and this qualitative study was conducted to determine why almost 80% of patients offered a copy of their referral letter opted not to receive one. AIM: To discover why some patients accepted and others declined a copy of the letter written from GP to specialist. DESIGN OF STUDY: A qualitative focus-group study. SETTING: General practice in Northumberland. METHOD: Three focus groups of referred patients were created, and discussions were taped, transcribed and analysed for major themes. RESULTS: The patients chose to accept or decline a copy of their referral letter for diverse reasons. However, most felt that the ability to choose for themselves whether to have a copy or not was essential. CONCLUSIONS: The concept of trust in their GP was a major theme that patients related was often behind their decision to decline a copy of their letter. These results, if transferable, may have implications for the application of this policy.

Intervention to reduce excessive alcohol consumption and improve comorbidity outcomes in hypertensive or depressed primary care patients: two parallel cluster randomized feasibility trials.

BACKGROUND: Many primary care patients with raised blood pressure or depression drink potentially hazardous levels of alcohol. Brief interventions (BI) to reduce alcohol consumption may improve comorbid conditions and reduce the risk of future alcohol problems. However, research has not established their effectiveness in this patient population. This study aimed to establish the feasibility of definitive trials of BI to reduce excessive drinking in primary care patients with hypertension or mild to moderate depression. METHODS: Thirteen general practices in North East England were randomized to the intervention or control arm of one of two parallel pilot trials. Adult patients drinking excessively and diagnosed with hypertension or mild-to-moderate depression received the Alcohol Use Disorders Identification Test (AUDIT) by postal survey. Consenting respondents scoring more than 7 on AUDIT (score range 0 to 40) received brief alcohol consumption advice plus an information leaflet (intervention) or an information leaflet alone (control) with follow-up at six months. Measurements included the numbers of patients eligible, recruited, and retained, and the AUDIT score and systolic/diastolic blood pressure of each patient or the nine-item Patient Health Questionnaire (PHQ-9) score. Acceptability was assessed via practitioner feedback and patient willingness to be screened, recruited, and retained at follow-up. RESULTS: In the hypertension trial, 1709 of 33,813 adult patients (5.1%) were eligible and were surveyed. Among the eligible patients, 468 (27.4%) returned questionnaires; 166 (9.6% of those surveyed) screened positively on AUDIT and 83 (4.8% of those surveyed) were recruited (50.0% of positive screens). Sixty-seven cases (80.7% of recruited patients) completed follow-up at six months. In the depression trial, 1,044 of 73,146 adult patients (1.4%) were eligible and surveyed. Among these eligible patients, 215 (20.6%) responded; 104 (10.0% of those surveyed) screened positively on AUDIT and 29 (2.8% of those surveyed) were recruited (27.9% of positive screens). Nineteen cases (65.5% of recruited patients) completed follow-up at six months. CONCLUSIONS: Recruitment and retention rates were higher in the hypertension trial than in the depression trial. A full brief intervention trial appears feasible for primary care patients with hypertension who drink excessively. High AUDIT scores in the depression trial suggest the importance of alcohol intervention in this group. However, future work may require alternative screening and measurement procedures. TRIAL REGISTRATION: Current Controlled Trials ISRCTN89156543; registered 21 October 2013.