Future Health Today: A pragmatic stratified cluster randomised head-to-head trial of electronic quality improvement activities to reduce cardiovascular disease risk in people with chronic kidney disease in general practice compared to active control (Preprint)

Abstract

Future Health Today (FHT) is a program integrated with electronic medical record (EMR) systems in general practice and comprises a practice dashboard to identify people at risk of, or with, chronic disease who may benefit from intervention, active clinical decision support (CDS) at the point of care, and quality improvement activities. One module within FHT aims to facilitate cardiovascular disease (CVD) risk reduction in people with chronic kidney disease (CKD) through recommendation of ACE inhibitors (ACEI), angiotensin receptor blockers (ARB) or statins according to Australian guidelines (defined as appropriate pharmacological therapy).

To determine if the FHT program increases the proportion of general practice patients with CKD receiving appropriate pharmacological therapy to reduce CVD risk at 12 months post-randomisation compared to active control (usual care).

General practices recruited via practice-based research networks in Victoria and Tasmania were randomly allocated 1:1 to FHT CKD module or active control. The intervention was delivered to practices between 4th October 2021 and 30th September 2022. Data extracted from electronic medical records for eligible patients identified at baseline were used to evaluate the trial outcomes at the completion of the intervention period. Primary analysis used an intention to treat approach. The intervention effect for the primary outcome was estimated with a marginal logistic model using generalised estimating equations with robust standard errors.

Overall, of the 734 eligible patients from 19 intervention practices and 715 from 21 control practices, 82 (11.2%) and 70 (9.8%) respectively had received appropriate pharmacological therapy (ACEI/ARB and/or statins) at 12 months post-intervention to reduce CVD risk, with an estimated between-trial group difference (Diff) of 2.0% (95% CI: -1.6% to 5.7%) and odds ratio (OR) of 1.24 (95% CI: 0.85 to 1.81, P=0.26). There was no evidence to support between-group differences in secondary outcomes and general practice healthcare utilisation, except for proportion of patients with statin prescribing. Of the 470 intervention patients and 425 control patients that received a recommendation for statins, 61 (13%) and 38 (9.0%) were prescribed statins at follow-up (Diff=4.3% (95% CI 0 to 8.6%); OR 1.55 (95% CI 1.02 to 2.35) P =0.039).

FHT harnesses the data stored within electronic medical records to translate guidelines into practice through QI activities and active clinical decision support. In this instance, it did not result in a difference in prescribing or clinical outcomes except for small changes in statin prescribing. This may relate to COVID-19-related disruptions, technical implementation challenges and not meeting the sample size as the eligible number of patients per practice was less than anticipated. A separate process evaluation will further explore factors impacting implementation and engagement with FHT.

ACTRN12620000993998