Supporting general practitioner-based care for poorly controlled type 2 diabetes mellitus (the DECIDE study): feasibility study and protocol for a pilot cluster randomised controlled trial

Murphy, Mark; Byrne, Molly; Boland, Fiona; Corrigan, Derek; Gillespie, Paddy; Fahey, Tom; Smith, Susan M.

doi:10.1186/s40814-018-0352-y

Cited by 4 publications

(6 citation statements)

References 34 publications

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“… 16 DECIDE is a trailblazing randomised pragmatic clinical effectiveness trial, involving a three-way partnership between academia, industry and CPRD, which recruited patients with type 2 diabetes in a routine primary care setting, randomised to the licenced intervention or standard of care. 17 The study involved centralised searches of CPRD’s primary care data to enable GPs in the CPRD network across all four UK nations to readily enrol suitable patients into the study when they presented for their routine diabetes checks. The novelty of this pragmatic clinical effectiveness study was that the study clinical data were captured directly from the patient’s primary care EHR and flowed into CPRD’s interventional research services platform (IRSP).…”

Section: Resultsmentioning

confidence: 99%

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Realising the full potential of data-enabled trials in the UK: a call for action

2021

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RationaleClinical trials are the gold standard for testing interventions. COVID-19 has further raised their public profile and emphasised the need to deliver better, faster, more efficient trials for patient benefit. Considerable overlap exists between data required for trials and data already collected routinely in electronic healthcare records (EHRs). Opportunities exist to use these in innovative ways to decrease duplication of effort and speed trial recruitment, conduct and follow-up.ApproachThe National Institute of Health Research (NIHR), Health Data Research UK and Clinical Practice Research Datalink co-organised a national workshop to accelerate the agenda for ‘data-enabled clinical trials’. Showcasing successful examples and imagining future possibilities, the plenary talks, panel discussions, group discussions and case studies covered: design/feasibility; recruitment; conduct/follow-up; collecting benefits/harms; and analysis/interpretation.ReflectionSome notable studies have successfully accessed and used EHR to identify potential recruits, support randomised trials, deliver interventions and supplement/replace trial-specific follow-up. Some outcome measures are already reliably collected; others, like safety, need detailed work to meet regulatory reporting requirements. There is a clear need for system interoperability and a ‘route map’ to identify and access the necessary datasets. Researchers running regulatory-facing trials must carefully consider how data quality and integrity would be assessed. An experience-sharing forum could stimulate wider adoption of EHR-based methods in trial design and execution.DiscussionEHR offer opportunities to better plan clinical trials, assess patients and capture data more efficiently, reducing research waste and increasing focus on each trial’s specific challenges. The short-term emphasis should be on facilitating patient recruitment and for postmarketing authorisation trials where research-relevant outcome measures are readily collectable. Sharing of case studies is encouraged. The workshop directly informed NIHR’s funding call for ambitious data-enabled trials at scale. There is the opportunity for the UK to build upon existing data science capabilities to identify, recruit and monitor patients in trials at scale.

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Section: Resultsmentioning

confidence: 99%

“…Trials like the Salford Lung Studies and DECIDE serve as vanguards demonstrating the application of real-world evidence in fully data-enabled clinical trials. 17 21 22 …”

Section: Discussionmentioning

confidence: 99%

Realising the full potential of data-enabled trials in the UK: a call for action

2021

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“…Details of the DECIDE intervention, including a description of content in terms of behaviour change techniques,40 have been outlined previously 25 29. In brief, the components of the DECIDE intervention included:…”

Section: Methodsmentioning

confidence: 99%

“…The first stage of the UK Medical Research Council (MRC) framework was used, in conjunction with the behaviour change wheel (BCW) as a theoretical guide to intervention development 26–28. The process of intervention development,25 the results of the non-randomised pilot study29 and the protocol for the DECIDE intervention have been reported previously29 (online supplementary file 1). We aimed to examine the feasibility and potential clinical impact of the DECIDE intervention through a pilot cluster randomised control trial (RCT).…”

Section: Introductionmentioning

confidence: 99%

Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial

et al. 2020

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ObjectivesWe developed a complex intervention called DECIDE (ComputeriseD dECisIonal support for suboptimally controlleD typE 2 Diabetes mellitus in Irish General Practice) which used a clinical decision support system to address clinical inertia and support general practitioner (GP) intensification of treatment for adults with suboptimally controlled type2 diabetes mellitus (T2DM). The current study explored the feasibility and potential impact of DECIDE.DesignA pilot cluster randomised controlled trial.SettingConducted in 14 practices in Irish General Practice.ParticipantsThe DECIDE intervention was targeted at GPs. They applied DECIDE to patients with suboptimally controlled T2DM, defined as a glycated haemoglobin (HbA1c) ≥70 mmol/mol and/or blood pressure ≥150/95 mmHg.InterventionThe intervention incorporated training and a web-based clinical decision support system which supported; (i) medication intensification actions; and (ii) non-pharmacological actions to support care. Control practices delivered usual care.Primary and secondary outcome measuresFeasibility and acceptability was determined using thematic analysis of semi-structured interviews with GPs, combined with data from the DECIDE website. Clinical outcomes included HbA1c, medication intensification, blood pressure and lipids.ResultsWe recruited 14 practices and 134 patients. At 4-month follow-up, all practices and 114 patients were followed up. GPs reported finding decision support helpful navigating increasingly complex medication algorithms. However, the majority of GPs believed that the target patient group had poor engagement with GP and hospital services for a range of reasons. At follow-up, there was no difference in glycaemic control (−3.6 mmol/mol (95% CI −11.2 to 4.0)) between intervention and control groups or in secondary outcomes including, blood pressure, total cholesterol, medication intensification or utilisation of services. Continuation criteria supported proceeding to a definitive randomised trial with some modifications.ConclusionThe DECIDE study was feasible and acceptable to GPs but wider impacts on glycaemic and blood pressure control need to be considered for this patient population going forward.Trial registration numberISRCTN69498919

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“…The limitations of Irish general practice coding have impacted on the ability to conduct trials. For example, in the DECIDE trial (Murphy et al, 2018), it was necessary to fund the development of a software tool to identify individuals with poorly controlled T2DM. Even so, difficulties arose in many practices due to lack of standardisation of data entry for chronic disease (Collins & Janssens, 2012).…”

Section: Introductionmentioning

confidence: 99%

Development of a primary care research network focused on chronic disease: a feasibility study for both practices and research networks

et al. 2021

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Background: High quality data should be a key resource for research and planning of healthcare, but low quality general practice data has been documented internationally. This study assessed the feasibility of collecting reliable chronic disease data in Irish general practice, using a program of training and feedback to improve the quality of coding for chronic conditions in practice information systems. Methods: Training in chronic disease coding and reporting was provided to a purposive sample of general practices in Ireland. From July to December 2020, practices reported the number of patients receiving free medical care, and the number of patients coded with each of eight chronic conditions: type 2 diabetes mellitus (T2DM), asthma, chronic obstructive pulmonary disease (COPD), ischaemic heart disease (IHD), heart failure (HF), atrial fibrillation (ATF), transient ischaemic attack (TIA) and cerebrovascular accident/stroke (CVA). Calculated prevalences were compared with national and international estimates. Results: We recruited and trained 16 practices with 65.5 full-time equivalent GPs and a study-eligible patient population of 36,327. There was a large degree of variation across practices for all conditions. For example, in July, reported prevalence of IHD ranged from 0.3% to 10.2% (a 34-fold difference), and reported prevalence of HF ranged from 0.2% to 4.0% (a 20-fold difference). No single practice had high or low prevalences across all conditions. Changes over time across all practices were minimal, averaging between 0.1% and 0.3% for all conditions. By December, a large degree of variation across practices remained. Across all conditions, average prevalences were higher than previously published estimates. Conclusions: Although hampered by the COVID-19 pandemic, it was feasible to implement this programme of training and feedback to report on chronic disease data recorded in general practice. Coding quality in Irish general practice is highly varied, and improvement would require a greater degree of intervention, including audit.

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Supporting general practitioner-based care for poorly controlled type 2 diabetes mellitus (the DECIDE study): feasibility study and protocol for a pilot cluster randomised controlled trial

Cited by 4 publications

References 34 publications

Realising the full potential of data-enabled trials in the UK: a call for action

Realising the full potential of data-enabled trials in the UK: a call for action

Supporting care for suboptimally controlled type 2 diabetes mellitus in general practice with a clinical decision support system: a mixed methods pilot cluster randomised trial

Development of a primary care research network focused on chronic disease: a feasibility study for both practices and research networks

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