Dataset Information

Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial.

ABSTRACT:

Background

Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling off. Community based, intermediate care clinics for diabetes (ICCDs) were considered one solution and are functioning across the UK. However, there is no randomised trial evidence for the effectiveness of such clinics.

Trial design, methods and findings

This is a cluster-randomised trial, involving 3 primary care trusts, with 49 general practices randomised to usual care (n=25) or intervention (ICCDs; n=24). All eligible adult patients with T2D were invited; 1997 were recruited and 1280 followed-up after 18-months intervention.

Primary outcome

achievement of all three of the NICE targets [(HbA1c ? 7.0%/53 mmol/mol; Blood Pressure <140/80 mmHg; cholesterol <154 mg/dl (4 mmol/l)]. PRIMARY OUTCOME was achieved in 14.3% in the intervention arm vs. 9.3% in the control arm (p=0.059 after adjustment for covariates). The odds ratio (95% CI) for achieving primary outcome in the intervention group was 1.56 (0.98, 2.49). Primary care and community clinic costs were significantly higher in the intervention group, but there were no significant differences in hospital costs or overall healthcare costs. An incremental cost-effectiveness ratio (ICER) of +£7,778 per QALY gained, indicated ICCD was marginally more expensive at producing health gain.

Conclusions

Intermediate care clinics can contribute to improving target achievement in patients with diabetes. Further work is needed to investigate the optimal scale and organisational structure of ICCD services and whether, over time, their role may change as skill levels in primary care increase.

Trial registration

ClinicalTrials.gov NCT00945204; National Research Register (NRR) M0014178167.

SUBMITTER: Wilson A

PROVIDER: S-EPMC3988031 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial.

Wilson Andrew A O'Hare Joseph Paul JP Hardy Ainsley A Raymond Neil N Szczepura Ala A Crossman Ric R Baines Darrin D Khunti Kamlesh K Kumar Sudhesh S Saravanan Ponnusamy P

PloS one 20140415 4

<h4>Background</h4>Configuring high quality care for the rapidly increasing number of people with type 2 diabetes (T2D) is a major challenge worldwide for both providers and commissioners. In the UK, about two thirds of people with T2D are managed entirely in primary care, with wide variation in management strategies and achievement of targets. Pay for performance, introduced in 2004, initially resulted in improvements but disparities exist in ethnic minorities and the improvements are levelling ...[more]

PMID: 24736243

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Project description:World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs) rather than hospital specialists. Intermediate care clinics for diabetes (ICCD) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1) compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2) assess the cost-effectiveness of the intervention; and (3) explore the views and experiences of patients, health professionals and other stakeholders.This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study) is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention) or to hospital care (control). Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. orStandard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (?7.0%); blood pressure (<140/80); and cholesterol (<4 mmol/l), at the end of the 18-month intervention period. The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD) and stroke assessed by the United Kingdom Prospective Diabetes Study (UKPDS) risk engine. Other secondary outcomes include body mass index and waist circumference, use of medication, reported smoking, emotional adjustment, patient satisfaction and views on continuity, costs and health related quality of life. We aimed to randomize 50 practices and recruit 2,555 patients.Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012.[ClinicalTrials.gov: Identifier NCT00945204].

Project description:BackgroundAlthough evidence is accumulating that lifestyle modification may be cost-effective in patients with prediabetes, information is limited on the cost-effectiveness of interventions implemented in public health and primary health care settings. Evidence from well-conducted pragmatic trials is needed to gain insight into the realistic cost-effectiveness of diabetes prevention interventions in real-world settings. The aim of this study is to assess the cost-effectiveness of the SLIMMER lifestyle intervention targeted at patients at high risk of developing type 2 diabetes compared with usual health care in a primary care setting in the Netherlands.MethodsThree hundred and sixteen high-risk subjects were randomly assigned to the SLIMMER lifestyle intervention or to usual health care. Costs and outcome assessments were performed at the end of the intervention (12 months) and six months thereafter (18 months). Costs were assessed from a societal perspective. Patients completed questionnaires to assess health care utilisation, participant out-of-pocket costs, and productivity losses. Quality Adjusted Life Years (QALY) were calculated based on the SF-36 questionnaire. Cost-effectiveness planes and acceptability curves were generated using bootstrap analyses.ResultsThe cost-effectiveness analysis showed that the incremental costs of the SLIMMER lifestyle intervention were €547 and that the incremental effect was 0.02 QALY, resulting in an incremental cost-effectiveness ratio (ICER) of €28,094/QALY. When cost-effectiveness was calculated from a health care perspective, the ICER decreased to €13,605/QALY, with a moderate probability of being cost-effective (56% at a willingness to pay, WTP, of €20,000/QALY and 81% at a WTP of €80,000/QALY).ConclusionsThe SLIMMER lifestyle intervention to prevent type 2 diabetes had a low to moderate probability of being cost-effective, depending on the perspective taken.Trial registrationThe SLIMMER study is retrospectively registered with ClinicalTrials.gov (Identifier NCT02094911) since March 19, 2014.

Project description:BackgroundMedication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention.MethodsIn this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to researchers and statisticians involved in processing and analysing the data. The allocation was not masked to general practices, pharmacists, patients, or researchers who visited practices to extract data. [corrected]. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299.Findings72 general practices with a combined list size of 480,942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38-0·89); a β blocker if they had asthma (0·73, 0·58-0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34-0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months.InterpretationThe PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records.FundingPatient Safety Research Portfolio, Department of Health, England.

Project description:BACKGROUND:Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. AIMS AND OBJECTIVES:To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation. OBJECTIVES:1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff. METHODS:A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service. DISCUSSION:Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions. TRIAL REGISTRATION:ISRCTN17847169. Date registered: 15 December 2017.

Dataset Information

Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial.

Background

Trial design, methods and findings

Primary outcome

Conclusions

Trial registration

Publications

Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial.

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