The impact of a point-of-care testing device on CVD risk assessment completion in New Zealand primary-care practice: A cluster randomised controlled trial and qualitative investigation.

Sue Wells,Angela Wadham,Yannan Jiang,Kim Arcus,Kyle Eggleton,Natasha Rafter,Chris Bullen,Geoff Herd,Rose Lightfoot,Timothy Kenealy

doi:10.1371/journal.pone.0174504

Abstract

ObjectivesTo assess the effect of a point of care (POC) device for testing lipids and HbA1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice.MethodsWe conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme.ResultsA CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61–1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA1c test assay performance. The trial restarted after the manufacturing issue was rectified but this affected the end use of the device.ConclusionsPerformance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion. The promise of combining risk assessment, communication and management within one consultation was not realised. With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12613000607774

Highlights

Diabetes and cardiovascular disease (CVD) are major causes of death and disability in New Zealand[1,2] with Māori, Pacific and South Asian people bearing a disproportionate burden.[3,4] To address this population health issue, in 2011, the government made CVD risk assessments and screening for diabetes a national priority, setting a target of 90% of eligible adults to be screened by Primary Health Organisations (PHOs) by July 2014.[5]
A CVD risk assessment entry was recorded for 7421 patients in 10 point of care (POC) practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both
With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting

Summary

Introduction

Diabetes and cardiovascular disease (CVD) are major causes of death and disability in New Zealand[1,2] with Māori (indigenous people of New Zealand), Pacific and South Asian people bearing a disproportionate burden.[3,4] To address this population health issue, in 2011, the government made CVD risk assessments and screening for diabetes a national priority, setting a target of 90% of eligible adults to be screened by Primary Health Organisations (PHOs) by July 2014.[5] According to CVD risk assessment performance, PHOs would receive modest incentive payments and would be benchmarked quarterly against others.[6]. The uptake of screening tests has been reported as being more of a problem in rural areas, for high risk ethnic groups and for those who are most socio-economically deprived.[8,9,10,11,12,13]

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Methods

Conclusion