Effects and costs of implementing predictive risk stratification in primary care: a randomised stepped wedge trial.

AIM: We evaluated the introduction of a predictive risk stratification model (PRISM) into primary care. Contemporaneously National Health Service (NHS) Wales introduced Quality and Outcomes Framework payments to general practices to focus care on those at highest risk of emergency admission to hospital. The aim of this study was to evaluate the costs and effects of introducing PRISM into primary care. METHODS: Randomised stepped wedge trial with 32 general practices in one Welsh health board. The intervention comprised: PRISM software; practice-based training; clinical support through two 'general practitioner (GP) champions' and technical support. The primary outcome was emergency hospital admissions. RESULTS: Across 230 099 participants, PRISM implementation increased use of health services: emergency hospital admission rates by 1 % when untransformed (while change in log-transformed rate ΔL=0.011, 95% CI 0.010 to 0.013); emergency department (ED) attendance rates by untransformed 3 % (while ΔL=0.030, 95% CI 0.028 to 0.032); outpatient visit rates by untransformed 5 % (while ΔL=0.055, 95% CI 0.051 to 0.058); the proportion of days with recorded GP activity by untransformed 1 % (while ΔL=0.011, 95% CI 0.007 to 0.014) and time in hospital by untransformed 3 % (while ΔL=0.029, 95% CI 0.026 to 0.031). Thus NHS costs per participant increased by £76 (95% CI £46 to £106). CONCLUSIONS: Introduction of PRISM resulted in a statistically significant increase in emergency hospital admissions and use of other NHS services without evidence of benefits to patients or the NHS.

Predictive risk stratification model: a progressive cluster-randomised trial in chronic conditions management (PRISMATIC) research protocol.

BACKGROUND: An ageing population increases demand on health and social care. New approaches are needed to shift care from hospital to community and general practice. A predictive risk stratification tool (Prism) has been developed for general practice that estimates risk of an emergency hospital admission in the following year. We present a protocol for the evaluation of Prism. METHODS/DESIGN: We will undertake a mixed methods progressive cluster-randomised trial. Practices begin as controls, delivering usual care without Prism. Practices will receive Prism and training randomly, and thereafter be able to use Prism with clinical and technical support. We will compare costs, processes of care, satisfaction and patient outcomes at baseline, 6 and 18 months, using routine data and postal questionnaires. We will assess technical performance by comparing predicted against actual emergency admissions. Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers. We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups. We will take account of covariates and explanatory factors. In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis. We will also examine changes in quality of life of patients across the risk spectrum. We will record and transcribe focus groups and interviews and analyse them thematically. We have received full ethical and R and D approvals for the study and Information Governance Review Panel (IGRP) permission for the use of routine data. We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals. DISCUSSION: The proposed study will provide information on costs and effects of Prism; how it is used in practice, barriers and facilitators to its implementation; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions. TRIAL REGISTRATION: Controlled Clinical Trials ISRCTN no. ISRCTN55538212.

Exploring the role of economics in prioritization in public health: what do stakeholders think?

BACKGROUND: Debates surrounding the use of conventional approaches in public health and the existence of perceived barriers to using the results of economic evaluations have led to questions posed as to how to establish priorities within public health schemes. The aims of this study were therefore to explore the feasibility and validity of economic evaluation techniques in developing priorities within public health programmes and consider the extent to which different presentational approaches are likely to be incorporated into decision-making, from perspectives of relevant stakeholders. METHODS: An advisory board, representative of potential users of economic evaluations, was set up to identify preferences for how findings from economic evaluations might be presented to decision makers and to test the impact of different approaches, different outputs and different presentational styles. The board was divided into two groups, each of which was given three hypothetical 'scenarios' to consider. The scenarios comprised descriptions of methods and outputs, with costs, effects, target population and context of intervention constant across all scenarios. RESULTS: The perceived validity of estimates of effectiveness was vitally important, along with sufficient information to gauge whether designs were appropriate and to assess implementation practicalities. Cost-benefit analysis and cost-utility analysis were the preferred approaches despite their complexity, although participants required benchmarks to place net-benefit estimates from cost-benefit analyses into context. CONCLUSION: Further research is required to substantiate and build on these preliminary findings and collaborations between economists and policy makers are needed to develop clear, rigorous and standard guidance relating to economic evaluation, recognizing the diversity of public health strategies.

Home telemonitoring and quality of life in stable, optimised chronic obstructive pulmonary disease.

We conducted a six-month randomised controlled trial of home telemonitoring for patients with chronic obstructive pulmonary disease (COPD). A total of 40 stable patients with moderate to severe COPD who had completed pulmonary rehabilitation took part. They were randomised to receive standard care (controls) or standard care plus home telemonitoring (intervention). During the monitoring period, patients in the telemonitoring group recorded their symptoms and physical observations twice daily. The data were transmitted automatically at night via the home telephone line. Nurses could access the data through a website and receive alerting email messages if certain conditions were detected. The patients completed the St George's Respiratory Questionnaire, Hospital Anxiety and Depression and the EuroQoL EQ-5D quality of life scores before and after pulmonary rehabilitation, and then periodically during the trial. There were significant and clinically important improvements in the scores immediately following pulmonary rehabilitation, but thereafter there were no differences in quality of life scores between the groups at any time, or consistently within either group over time. The study showed that telemonitoring was safe but, despite being well used, it was not associated with changes in quality of life in patients who had stable COPD.

Does home telemonitoring after pulmonary rehabilitation reduce healthcare use in optimized COPD? A pilot randomized trial.

AIM: To see if home telemonitors reduce healthcare use in those with optimized chronic obstructive pulmonary disease (COPD). METHODS: We randomized 40 stable patients with moderate to severe COPD, who had completed at least 12 sessions of outpatient pulmonary rehabilitation (PR), to receive standard care (Controls) for 52 weeks or standard care plus Docobo HealthHUB monitors at home for 26 weeks followed by 26 weeks standard care (Tm Group). During the monitoring period, the Tm Group completed symptoms and physical observations twice daily which were stored and then uploaded at 2 am through a freephone landline. Nurses could access the data through a secure web site and received alerting e-mails if certain combinations of data occurred. RESULTS: There were fewer primary care contacts for chest problems (p < 0.03) in the Tm group, but no differences between the groups in emergency room visits, hospital admissions, days in hospital or contacts to the specialist COPD community nurse team, during the monitoring period. After the monitors were removed, there were no differences between the groups for any of the health care contacts (p > 0.20 throughout). CONCLUSION: In stable, optimized COPD patients who have already completed PR, telemonitoring in addition to best care, reduces primary care chest contacts but not hospital or specialist team utilization.

Randomised controlled factorial trial of dietary advice for patients with a single high blood pressure reading in primary care.

OBJECTIVE: To assess the effect of brief interventions during the "watchful waiting" period for hypertension. DESIGN: Factorial trial. SETTING: General practice. METHODS: 296 patients with blood pressure > 160/90 mm Hg were randomised to eight groups defined by three factors: an information booklet; low sodium, high potassium salt; prompt sheets for high fruit, vegetable, fibre; and low fat. MAIN OUTCOME MEASURES: Blood pressure (primary outcome); secondary outcomes of diet, weight, and dietary biomarkers (urinary sodium:potassium (Na:K) ratio; carotenoid concentrations). RESULTS: Blood pressure was not affected by the booklet (mean difference (diastolic blood pressure) at one month 0.2, 95% confidence interval 1.6 to 2.0), salt (0.13; 1.7 to 2.0), or prompts (0.52; 1.3 to 2.4). The salt decreased Na:K ratio (difference 0.32; 0.08 to 0.56, P = 0.01), and the prompts helped control weight (difference 0.39 (0.85 to 0.05) kg at one month, P = 0.085; 1.2 (0.1 to 2.25) kg at six months, P = 0.03). Among those with lower fruit and vegetable consumption (< 300 g per day), prompts increased fruit and vegetable consumption and also carotenoid concentrations (difference 143 (16 to 269) mmol/l, P < 0.03) but did not decrease blood pressure. CONCLUSION: During watchful waiting, over and above the effect of brief advice and monitoring, an information booklet, lifestyle prompts, and low sodium salt do not reduce blood pressure. Secondary analysis suggests that brief interventions-particularly lifestyle prompts-can make useful changes in diet and help control weight, which previous research indicates are likely to reduce the long term risk of stroke.

Development, validation and utilisation of food-frequency questionnaires - a review.

OBJECTIVE: The purpose of this review is to provide guidance on the development, validation and use of food-frequency questionnaires (FFQs) for different study designs. It does not include any recommendations about the most appropriate method for dietary assessment (e.g. food-frequency questionnaire versus weighed record). METHODS: A comprehensive search of electronic databases was carried out for publications from 1980 to 1999. Findings from the review were then commented upon and added to by a group of international experts. RESULTS: Recommendations have been developed to aid in the design, validation and use of FFQs. Specific details of each of these areas are discussed in the text. CONCLUSIONS: FFQs are being used in a variety of ways and different study designs. There is no gold standard for directly assessing the validity of FFQs. Nevertheless, the outcome of this review should help those wishing to develop or adapt an FFQ to validate it for its intended use.