Date Published: April 19, 2017
Publisher: Public Library of Science
Author(s): Sue Wells, Natasha Rafter, Timothy Kenealy, Geoff Herd, Kyle Eggleton, Rose Lightfoot, Kim Arcus, Angela Wadham, Yannan Jiang, Chris Bullen, Iratxe Puebla.
To 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.
We 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.
A 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.
Performance 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.
Australian New Zealand Clinical Trials Registry ACTRN12613000607774
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. According to CVD risk assessment performance, PHOs would receive modest incentive payments and would be benchmarked quarterly against others.
Of the 38 practices in the Northland region, 20 (53%) agreed to participate and were randomised. There were 13 rural practices outside of the main city (Whangarei) boundary and 13 practices were classified as being large (≥2 FTE doctors). Stratified randomisation ensured a balance of these characteristics with 6 control and 7 POC practices classified as being rural and 6 control and 7 POC practices classified as being large. Fig 1 shows the CONSORT diagram of participation. One practice discontinued the use of the cobas b 101 device but as all CVD risk assessments were captured electronically regardless of device use, all their data were included in the intervention group data at the end of the trial.
Having a POC device within NZ general practices made no discernible difference to the completion of CVD risk assessments and was neither superior nor inferior to usual practice. In addition we found no differences in completion by patient characteristics (such as ethnicity or deprivation). However, the context to this trial is important in interpreting these findings. Driven by the government target to undertake CVD risk assessments, practice staff had accelerated their systems and procedures so that 50–60 CVD risk assessments were being conducted on average per month per practice. Indeed by July 2014 (three months after the trial recommenced), both trial and non-trial practices in the region had conducted a CVD risk assessment in 90% of the eligible Northland population in the previous five years . Therefore there was a considerable ceiling effect. Benefits from interventions are more likely to be reported where there is a sizeable evidence-practice gap at baseline. Even if this trial had not been halted it is debatable whether we might have seen a difference given the enormous momentum generated from the national health target. Associated with other external pressures such as open benchmarking, the target was a powerful modifier of practice behaviours. Each practice had responded by extensive investment in staff time and resources with the whole practice team concentrating on getting their eligible adult population risk assessed.