NCT04388228

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?

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable diabetes-mellitus

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

29 days

First QC Date

May 11, 2020

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage registered diagnoses of DM 2 in the EHR

    Registered diagnosis of type II diabetes in GPs electronic health record

    12 months

Secondary Outcomes (2)

  • Percentage registered lifestyle factors

    12 months

  • percentage registered diagnoses of heart failure

    12 months

Other Outcomes (4)

  • CKD follow-up quality indicator

    12 months

  • CKD vaccination quality indicator

    12 months

  • Diabetes treatment quality indicator

    12 months

  • +1 more other outcomes

Study Arms (2)

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.

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.

Other: Extended audit and feedback in GPs electronic health record

Interventions

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.

Basic feedbackExtended audit and feedback

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency, ChronicHeart Failure

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Study Officials

  • Tine De Burghgraeve, PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tine De Burghraeve, PhD

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

January 30, 2022

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share