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Audit and Feedback for General Practitioners in the Intego Network

Primary Purpose

Diabetes Mellitus, Chronic Kidney Diseases, Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extended audit and feedback in GPs electronic health record
Sponsored by
Tine De Burghraeve
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

inclusion criteria:

  • 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.

Exclusion criteria:

- 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Extended audit and feedback

    Basic feedback

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    percentage registered diagnoses of DM 2 in the EHR
    Registered diagnosis of type II diabetes in GPs electronic health record

    Secondary Outcome Measures

    Percentage registered lifestyle factors
    Registration of lifestyle habits such as alcohol and tobacco use
    percentage registered diagnoses of heart failure
    Registered diagnosis of heart failure in GPs electronic health record

    Full Information

    First Posted
    May 11, 2020
    Last Updated
    March 8, 2022
    Sponsor
    Tine De Burghraeve
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04388228
    Brief Title
    Audit and Feedback for General Practitioners in the Intego Network
    Official Title
    Audit and Feedback for General Practitioners in the Intego Network
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study is not applicable anymore due to the Covid pandemic.
    Study Start Date
    January 30, 2022 (Actual)
    Primary Completion Date
    February 28, 2022 (Actual)
    Study Completion Date
    February 28, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Tine De Burghraeve

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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?
    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?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Chronic Kidney Diseases, Heart Failure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Extended audit and feedback
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Basic feedback
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Extended audit and feedback in GPs electronic health record
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    percentage registered diagnoses of DM 2 in the EHR
    Description
    Registered diagnosis of type II diabetes in GPs electronic health record
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Percentage registered lifestyle factors
    Description
    Registration of lifestyle habits such as alcohol and tobacco use
    Time Frame
    12 months
    Title
    percentage registered diagnoses of heart failure
    Description
    Registered diagnosis of heart failure in GPs electronic health record
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    CKD follow-up quality indicator
    Description
    Percentage of patients with CKD in whom the GFR, albuminuria and total protein is determined at least once a year
    Time Frame
    12 months
    Title
    CKD vaccination quality indicator
    Description
    Percentage of patients with CKD who received a pneumococcal vaccination
    Time Frame
    12 months
    Title
    Diabetes treatment quality indicator
    Description
    Percentage of patients with diabetes and CKD who no longer receive metformin
    Time Frame
    12 months
    Title
    Diabetes follow-up quality indicator
    Description
    Percentage of patients with diabetes whose HbA1c level is measured at least once every 6 months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    inclusion criteria: 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. Exclusion criteria: - 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tine De Burghgraeve, PhD
    Organizational Affiliation
    KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33947448
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Audit and Feedback for General Practitioners in the Intego Network

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