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.
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
- Conditions the study is for
- Diabetes Mellitus, Chronic Kidney Diseases, Heart Failure
- 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?
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases, Heart Failure
- 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 group | Role | What they receive |
|---|---|---|
| Extended audit and feedback | Experimental | 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. Receives: Other: Extended audit and feedback in GPs electronic health record |
| Basic feedback | Active comparator | In 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.
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)
Percentage registered lifestyle factors
Registration of lifestyle habits such as alcohol and tobacco use
Measured: 12 months
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.
- First posted14 May 2020
- Study start30 Jan 2022
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: Study is not applicable anymore due to the Covid pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tine De Burghraeve
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tine De Burghraeve, KU Leuven
- Investigators
- Tine De Burghgraeve, PhD, Principal investigator, KU Leuven
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit and Feedback for General Practitioners in the Intego Network
- ClinicalTrials.gov ID
- NCT04388228
- Acronym / sponsor ID
- S62753
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases, Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is not applicable anymore due to the Covid pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tine De BurghraeveUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended audit and feedback | Experimental | Other: Extended audit and feedback in GPs electronic health recordThe 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. |
| Basic feedback | Active comparator | Other: Extended audit and feedback in GPs electronic health recordIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended audit and feedback in GPs electronic health recordThe 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. | Other | Basic feedback, Extended audit and feedback |
Primary outcome
percentage registered diagnoses of DM 2 in the EHR
Time frame: 12 months
Registered diagnosis of type II diabetes in GPs electronic health record
2 secondary outcomes
Percentage registered lifestyle factors
Time frame: 12 months
percentage registered diagnoses of heart failure
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 33947448Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine De Burghgraeve, PhD principal investigator
KU Leuven
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.