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Diabetes MellitusNCT04388228

Audit and Feedback for General Practitioners in the Intego Network

A study testing Extended audit and feedback in GPs electronic health record in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Tine De Burghraeve.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Audit and feedback is an extensively investigated quality intervention, which according to the last Cochrane review leads to small but potentially important improvements in professional practice. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Extended audit and feedback in GPs electronic health record
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Jan 2022to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • This trial has the general practices as the level of allocation.
  • All GPs in the Intego network will be asked to participate in this trial.
  • For GPs working in a group, the whole group will be asked to collaborate.

Who cannot join

  • If not all GPs in a group practice want to collaborate in the intervention study, the whole GP practice will not be included in this study.

About this study

Audit and feedback is an extensively investigated quality intervention, which according to the last Cochrane review leads to small but potentially important improvements in professional practice. There is some evidence that feedback can improve EHR registration but the effect and important features of feedback are still the subject of debate. Previous work has identified some testable and theory-informed hypotheses for designing an audit and feedback intervention and suggestions to improve the effectiveness of the intervention are available in literature. There are several criteria feedback could meet to have an impact on the registration level of GP's in the EHR. The researchers now want to evaluate if the effort to make an extended feedback intervention has an effect on the registration behavior of the GP.

The research question is: Does an audit and extended feedback intervention improves the quality of registration in the EHR of the general physician compared to basic feedback?

Read the detailed description

Intego is a Belgian general practice-based morbidity registration network at the Department of General Practice of the University of Leuven. Intego collects data on health parameters, incidence and prevalence rates, laboratory results, and prescribed drugs for all relevant subgroups. It is unique in Belgium. These data are used as a basis for teaching, quality improvement interventions, and research, as well as for policy making by both physicians' organizations and governmental bodies. The health ministry of the Flemish government mainly funds the network. Ad hoc research projects serve as an additional funding source.

Up until 2017, 97 general practitioners (GP's) of 55 practices evenly spread throughout Flanders, Belgium, collaborated in Intego. GP's applied for inclusion in the registry. Before acceptance of their data, registration performance was audited using algorithms to compare their results with those of all other applicants. Only data of practices with optimal registration performance that met our three quality requirements were included in the database. First, the average number of new diagnoses per patient per year should be higher than one. Second, diagnoses have to be entered in the practice software using keywords. The Intego GP's prospectively and routinely registered all new diagnoses and new drug prescriptions, as well as laboratory test results and patient information. The registration made use of computer-generated keywords internally linked to codes [International Classification of Primary Care (ICPC-2) and International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) for diagnoses and WHO's Anatomical Therapeutic Chemical (ATC) classification system for drugs]. The percentage of diagnoses recorded without using keywords should be less than 5%. Finally, these parameters must remain stable for at least three years.

In 2017, Intego made a transition in data infrastructure and size of the network.

Further information technology development for the electronic health record (EHR) 'Medidoc' was terminated, and all its users were urged by the vendor to migrate to a new EHR, called CareConnect (Corilus), a cloud-based EHR. This transition marked the moment to redesign the data collection for this registry, which had not changed since its start. To comply with the new General Data Protection Regulation legislation, the Healthdata.be platform was identified as a partner for this task.

Moreover, the number of practices was increased and now counts 107 practices (410 GPs). However, new GP practices might not meet the quality requirements for good registration yet.

The data completeness of the EHR is thus an important factor to consider when reusing data stored in the EHR. Other pitfalls and sources of bias when using EHR data have also been identified. In order to improve registration, we want to implement extended electronically delivered feedback and evaluate its effects on correctly registering the diagnosis of chronic diseases and lifestyle habits in the EHR.

Audit and feedback is an extensively investigated quality intervention, which according to the last Cochrane review leads to small but potentially important improvements in professional practice. There is some evidence that feedback can improve EHR registration but the effect and important features of feedback are still the subject of debate. Previous work has identified some testable and theory-informed hypotheses for designing an audit and feedback intervention and suggestions to improve the effectiveness of the intervention are available in literature. There are several criteria feedback could meet to have an impact on the registration level of GP's in the EHR. We now want to evaluate if the effort to make an extended feedback intervention has an effect on the registration behavior of the GP.

The research question is: Does an audit and extended feedback intervention improves the quality of registration in the EHR of the general physician compared to basic feedback?

Being tested
Extended audit and feedback in GPs electronic health record
Medical subject headings
Diabetes Mellitus, Renal Insufficiency, Chronic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended audit and feedback in GPs electronic health recordOther

    The intervention consists of an extended electronically delivered feedback with multiple components which will be delivered 4 times electronically into general practices over 12 months.

    This extended feedback report consists of:

    • Benchmarking of the results of the audit versus peers, versus guidelines and versus disease specific laboratory results.
    • A low cognitive load of the feedback where the results will be presented with the help of graphs.
    • Action plans to improve the quality of registration
    • A push system to minimize the effort the GP must make to consult the feedback.
Study groups in NCT04388228
Study groupRoleWhat they receive
Extended audit and feedbackExperimentalThe intervention consists of an extended electronically delivered feedback with multiple components which will be delivered 4 times electronically into general practices over 12 months. This extended feedback report consists of: * Benchmarking of the results of the audit versus peers, versus guidelines and versus disease specific laboratory results. * A low cognitive load of the feedback where the results will be presented with the help of graphs. * Action plans to improve the quality of registration * A push system to minimize the effort the GP must make to consult the feedback.
Receives: Other: Extended audit and feedback in GPs electronic health record
Basic feedbackActive comparatorIn the past, all GPs received basic feedback on the level of registration in the EHR and this form of feedback will still be provided in the control group. By providing all GPs a basic level of feedback, we do not change the former protocol and all GPs will receive the opportunity to improve their registration performance. Only the way of receiving feedback is more straightforward, the GP needs to login to HealthStat.be.
Receives: Other: Extended audit and feedback in GPs electronic health record

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage registered diagnoses of DM 2 in the EHR

    Registered diagnosis of type II diabetes in GPs electronic health record

    Measured: 12 months

Secondary outcomes (2)
  1. Percentage registered lifestyle factors

    Registration of lifestyle habits such as alcohol and tobacco use

    Measured: 12 months

  2. percentage registered diagnoses of heart failure

    Registered diagnosis of heart failure in GPs electronic health record

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2020
  2. Study start30 Jan 2022
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Why it stopped: Study is not applicable anymore due to the Covid pandemic.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388228
Sponsor's protocol ID
S62753
Status last verified
Mar 2022
First submitted
11 May 2020
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Van den Bulck S, De Burghgraeve T, Raat W, Mamouris P, Coursier P, Vankrunkelsven P, Goderis G, Hermens R, Van Pottelbergh G, Vaes B. The effect of automated audit and feedback on data completeness in the electronic health record of the general physician: protocol for a cluster randomized controlled trial. Trials. 2021 May 4;22(1):325. doi: 10.1186/s13063-021-05259-9.

    PubMed 33947448

Questions about this trial

What is this clinical trial studying?

A study testing Extended audit and feedback in GPs electronic health record in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Tine De Burghraeve.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage registered diagnoses of DM 2 in the EHR (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04388228, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022; AzTrials last refreshed its copy on 29 Oct 2026.

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