Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04388228 |
Other study ID # |
S62753 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 30, 2022 |
Est. completion date |
February 28, 2022 |
Study information
Verified date |
March 2022 |
Source |
KU Leuven |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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?
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?