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. 2018 Jun 8;7(6):e152.
doi: 10.2196/resprot.9588.

The General Practitioner Prompt Study to Reduce Cardiovascular and Renal Complications in Patients With Type 2 Diabetes and Renal Complications: Protocol and Baseline Characteristics for a Cluster Randomized Controlled Trial

Andrew Willis  1 , Winston Crasto #  2 , Laura Gray  3 , Helen Dallosso  1 , Ghazala Waheed  1 , Geri Gray  1 , Melanie J Davies  4 , Kamlesh Khunti  1
Affiliations

The General Practitioner Prompt Study to Reduce Cardiovascular and Renal Complications in Patients With Type 2 Diabetes and Renal Complications: Protocol and Baseline Characteristics for a Cluster Randomized Controlled Trial

Andrew Willis et al. JMIR Res Protoc. .

Abstract

Background: Adherence to evidence-based cardiovascular risk factor targets in patients with type 2 diabetes and microalbuminuria has shown long-term reduction in mortality and morbidity. Strategies to achieve such adherence have been delivered at individual patient level and are not cost-effective. Health care professional-level intervention has the potential to promote better adherence at lower cost.

Objective: The aim of this study was to assess the effectiveness of a multifactorial technology-driven intervention comprising health care professional training, a software prompt installed on practice systems, clinician email support, and enhanced performance and feedback reporting.

Methods: A cluster randomized trial will be performed where the primary outcome is the proportion of eligible patients meeting tight cardiovascular risk factor targets, including systolic and diastolic blood pressure (BP; BP<130/80 mm Hg) and total cholesterol (TC; TC<3.5 mmol/L) at 24 months. Secondary outcomes include proportion of patients with glycated hemoglobin (HbA1c) <58 mmol/mol (7.5%), change in medication prescribing, changes in microalbuminuria and renal function (estimated glomerular filtration rate, eGFR), incidence of major adverse CV events and mortality, and coding accuracy. Cost-effectiveness of the intervention will also be assessed.

Results: Among 2721 eligible patients, mean age was 62.9 (SD 10.0) years, and duration of diabetes was 10.46 (SD 7.22) years. Mean HbA1c was 59.3 (SD 17.4) mmol/mol; mean systolic and diastolic BP (mm Hg) were 134.3 (SD 14.6) and 76.1 (SD 9.5) mm Hg, respectively; and mean TC was 4.1 (SD 0.98) mmol/L. Overall, 131 out of 2721 (4.81%) patients achieved all 3 "tight" cardiovascular risk factor targets. Cardiovascular risk factor burden increased two-fold in those with eGFR<60 mL/min/1.73 m2 compared with those with eGFR≥60 mL/min/1.73 m2. Prevalence of microalbuminuria was 22.76%. In total, 1076 out of 2721 (39.54%) patients were coded for microalbuminuria or proteinuria on their primary care medical record.

Conclusions: The general practitioner prompt study is the largest UK primary care-based, technology-driven, randomized controlled trial to support intensive intervention in high-risk group of multiethnic individuals with type 2 diabetes and microalbuminuria. This paper provides contemporary estimates for prevalent cardiovascular disease and adherence to evidence-based cardiovascular risk factor targets at baseline in a population with type 2 diabetes and microalbuminuria. The main trial results, including cost-effectiveness data, will be submitted for publication in 2018.

Trial registration: International Standard Randomized Controlled Trial Number ISRCTN14918517; http://www.isrctn.com/ISRCTN14918517 (Archived by WebCite at http://www.webcitation.org/6zqm53wNA).

Registered report identifier: RR1-10.2196/9588.

Keywords: diabetes mellitus, type 2; primary health care.

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Conflict of interest statement

Conflicts of Interest: MJD has acted as a consultant, advisory board member, and speaker for Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca and Janssen; an advisory board member for Servier; and as a speaker for Mitsubishi Tanabe Pharma Corporation and Takeda Pharmaceuticals International Inc. She has received grants in support of investigator and investigator-initiated trials from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, and Janssen. KK has been a consultant, speaker, and advisory board member for Amgen, AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Merck Sharp and Dohme, Janssen, and Boehringer Ingelheim. He has also received grants in support of investigator-initiated trials from AstraZeneca, Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Merck Sharp and Dohme, and Roche. WC has received speaker fees, education and grants from Sanofi-Aventis, Novo Nordisk, Boehringer Ingelheim, Lilly, and Internis Pharmaceuticals limited. AW, LG, HD, WG, and GG have no conflicts of interests to declare.

Figures

Figure 1
Figure 1
Recruitment flowchart. T2DM: type 2 diabetes; MA: microalbuminuria.
See this image and copyright information in PMC

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