Computerised decision support for poorly-controlled type 2 diabetes mellitus in Irish General Practice

• Register: ISRCTN
• Last refreshed on: 15 March 2021
• Main ID: ISRCTN69498919
• Date of registration: 26/07/2017
• Prospective Registration: Yes
• Primary sponsor: HRB Centre for Primary Care Research
• Public title: Computerised decision support for poorly-controlled type 2 diabetes mellitus in Irish General Practice
• Scientific title: Supporting General Practitioners intensify medications for patients with poorly-controlled type 2 diabetes mellitus with computerised decision support: a cluster randomised controlled trial in Irish General Practice (the DECIDE study)
• Date of first enrolment: 01/10/2018
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN69498919
• Study type: Interventional
• Study design: Pilot study and cluster randomised control trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Mark Murphy

Key inclusion & exclusion criteria

Inclusion criteria:
GPs will be the target of the intervention and will be unit of randomisation. All GPs who are part of the HRB Clinical Trials Network will be eligible for inclusion.

1. Only patients with poorly controlled T2DM will be targeted by the GP with the DECIDE intervention
2. Patients must have a diagnosis of T2DM
3. They must be aged over 18 years and less than 75, as there is less evidence about treatment intensification in patients aged above 75 years
4. There is no validated cut-off which defines poor control of T2DM for targeted interventions. For the purposes of this study, the trialists have selected HbA1C or BP levels for which there would be consensus on the importance of intervention and treatment and have clinical face validity in terms of intervention. In the DECIDE study only patients with a HbA1c reading of 8.5% (70 mmol/mol) or above and/or a blood pressure reading over 150/95mmHg will be included
5. Not all patients will be suitable for treatment intensification and individual decisions on treatment changes will be made by each patient’s GP.

Exclusion criteria:
1. All GPs will be included
2. Patients are excluded if they do not fulfill the inclusion criteria


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Poorly controlled type 2 diabetes mellitus (T2DM)
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus

Intervention(s)

A theory-based complex intervention to target GPs’ prescribing behaviour in the treatment of patients with poorly controlled T2DM was developed using the first stage of the UK Medical Research Council (MRC) framework. The study utilised the Behaviour Change Wheel (BCW) to provide a theoretical guide to intervention development. The DECIDE study has three components:

1. Finding poorly controlled type 2 diabetes mellitus (T2DM) patients: Though GPs could use existing electronic health record search functions to find target patients (e.g. with a HbA1c > 70mmol/mol), the research team has worked with the Irish Primary Care Research Network (IPCRN) and Irish College of General Practitioners (ICGP) to develop an automated finder function, permitting the rapid retrieval of all target patients in each practice. These patients can then be logged and recorded securely on a local database in each practice.
2. The DECIDE clinical decision support system (CDSS). A web-based decision CDSS was created which delivers patient-specific recommendations to the GP on what medication intensifications could be recommended, if any. The algorithms in the CDSS are based on ICGP guidance for management of hypertension and T2DM.
3. A training module was developed for intervention group GPs to explain all the steps in the intervention. A practice-based training session on the use of IPCRN DECIDE finder tool and web-based DECIDE treatment algorithms was created. The training session explains that either the practice nurse or GP can insert the patient specific information into the DECIDE website, either at a chart review or with the patient during the Diabetes Cycle of Care visit. In the second step of the CDSS, the GP is offered with

Primary Outcome(s)

HbA1c, a measure of glycaemic control, collected from medical records at baseline and at 6 months follow up

Secondary Outcome(s)

Medications, blood pressure and lipids collected from medical records at baseline and at 6 months follow up

Secondary ID(s)

HRBDECIDE

Source(s) of Monetary Support

HRB Centre for Primary Care Research, HRB Clinical Trials Network, Ireland, HRB-funded SPHeRE Programme (structured PhD programme in Health Services Research), Irish College of General Practitioners, WestREN Network, National University of Ireland, Galway

Ethics review

Status:
Approval date:
Contact:

Irish College of General Practitioners Research Ethics Committee, approval on the 16/06/2016 for the DECIDE study to pilot the study. An extension ethics approval to perform the study as an exploratory trial will be issued on completion of the pilot.

Results

• Results available: Yes
• Date Completed: 30/04/2019