The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage

NCT05920499 | Not Yet Recruiting

• 1 other identifier: S66253
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this cluster-randomized trial is to study the effect of Audit and Feedback loops on pneumococcal vaccination coverage rate in adults at risk in general practice. The main questions it aims to answer are:

• To assess the effect of "clinical AUDIT and feedback" loops on the pneumococcal vaccination coverage rate in adults at risk in general practice.
• To explore whether the increase in vaccination coverage rate after implementation of Audit and Feedback loops is different in specific subgroups (risk groups, male/female, age, smoking status). Every general practice center assigned to the control or intervention group will have access to a clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. The general practice centers in the intervention group will also receive an individualized extended electronic feedback report, with multiple components like benchmarked performances and action plans, at baseline and each 2 months from baseline onwards.

Conditions

Pneumococcal Infections

Keywords

AUDIT; Feedback; general practice; pneumococcal vaccination rate

Outcome Measures

Primary Outcomes (1)

• Vaccination coverage rate (VCR)

  Vaccination coverage rate (VCR) in the three defined risk groups for pneumococcal infections.

  12 months

Secondary Outcomes (1)

• Vaccination coverage rate (VCR) in specific subgroups

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The INTEGO practices (INTEGO is a GP morbidity registry in Flanders Belgium) that will be assigned to the intervention group will receive an extended electronic feedback report with multiple components, directly implemented in their EHR (electronic health record), on the pneumococcal vaccination coverage in adults at risk in their practice ('push system'). There will be a direct connection between the EHR of the practice and a SAS visual analytics tool in the Healthdata environment (single-sign-on connection), that will show the extended feedback. This report will be available at baseline and updated every two months based on the current situation.

Other: AUDIT and Feedback

Control group

ACTIVE COMPARATOR

Every GP center assigned to the control group will only have access to the clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. GP centers in the control group will not receive an extended feedback report at baseline and every 2 months afterwards.

Other: AUDIT and Feedback

Interventions

AUDIT and Feedback OTHER

AUDIT and Feedback is a well-known quality intervention that according to the last Cochrane review leads to "small but potentially important improvements in professional practice" (Ivers N et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012, 6:Cd000259). Standardized automated AUDITs are available in most EHR systems in Belgium. Feedback, on the other hand, is only available in specific registration networks. At study baseline the performance in INTEGO practices will be measured. Afterwards a standardized clinical AUDIT to identify patients that may benefit from pneumococcal vaccination will be implemented in the EHR of all INTEGO practices. The Feedback will only be implemented in the intervention group.

Control group; Intervention group

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• It is a Flemish GP center in the INTEGO network.
• The GP center uses an electronic health record (EHR), automatically linked to the INTEGO database.
• The physician (one per center, in name of all GPs in that center) signs a specific study consent form.
• The patient belongs to a target group for pneumococcal vaccination (based on https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth\_theme\_file/hgr\_9562\_vaccinatie\_tegen\_pneumokokken\_vweb.pdf):
• A. Adults aged 16 - 85 years old with a high risk for a pneumococcal infection
• Adults with an immunity disorder
• Adults with anatomical and / or functional asplenia, sickle-cell disease or hemoglobinopathy
• Adults with cerebrospinal fluid or cochlear implant leakage B. Adults (aged 50 - 85 years old) with comorbidity
• Chronic cardiac disease
• Chronic pulmonary disease or smoker
• Chronic liver disease or ethylabusus
• Chronic kidney disease
• Chronic neurological or neuromuscular disorders with aspiration risk
• Diabetes mellitus C. Healthy persons aged 65 - 85 years old
• The patient has an electronic medical record (EMR) in the participating general practice centre. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.

You may not qualify if:

• Patients excluded from feedback: patients not belonging to one of the target groups for pneumococcal vaccination.
• Patients excluded from AUDIT: patients not belonging to one of the target groups for pneumococcal vaccination OR
• Correctly vaccinated high-risk patients (PPV23 less than 5 years ago AND PCV13 ever received)
• Correctly vaccinated adults with comorbidity (1) PCV13 ever received AND PPV23 less than 5 years ago, OR 2) PCV13 ever received AND 2x PPV23 vaccination more than 5 years ago)
• Correctly vaccinated healthy persons (PPV23 ever received)

Sponsors & Collaborators

• Bert Vaes: lead

Study Sites (1)

Academic Center of General Practice

Leuven, 3000, Belgium

Location

Related Publications (9)

• De Burghgraeve T, Henrard S, Verboven B, Van Pottelbergh G, Vaes B, Mathei C. The incidence of lower respiratory tract infections and pneumococcal vaccination status in adults in flemish primary care. Acta Clin Belg. 2021 Oct;76(5):335-345. doi: 10.1080/17843286.2020.1735113. Epub 2020 Mar 9.

  PMID: 32149595 BACKGROUND

• Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O'Brien MA, Johansen M, Grimshaw J, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012 Jun 13;2012(6):CD000259. doi: 10.1002/14651858.CD000259.pub3.

  PMID: 22696318 BACKGROUND

• Truyers C, Goderis G, Dewitte H, Akker Mv, Buntinx F. The Intego database: background, methods and basic results of a Flemish general practice-based continuous morbidity registration project. BMC Med Inform Decis Mak. 2014 Jun 6;14:48. doi: 10.1186/1472-6947-14-48.

  PMID: 24906941 BACKGROUND

• Delvaux N, Aertgeerts B, van Bussel JC, Goderis G, Vaes B, Vermandere M. Health Data for Research Through a Nationwide Privacy-Proof System in Belgium: Design and Implementation. JMIR Med Inform. 2018 Nov 19;6(4):e11428. doi: 10.2196/11428.

  PMID: 30455164 BACKGROUND

• Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.

  PMID: 23311722 BACKGROUND

• Brown B, Gude WT, Blakeman T, van der Veer SN, Ivers N, Francis JJ, Lorencatto F, Presseau J, Peek N, Daker-White G. Clinical Performance Feedback Intervention Theory (CP-FIT): a new theory for designing, implementing, and evaluating feedback in health care based on a systematic review and meta-synthesis of qualitative research. Implement Sci. 2019 Apr 26;14(1):40. doi: 10.1186/s13012-019-0883-5.

  PMID: 31027495 BACKGROUND

• Foster M, Presseau J, Podolsky E, McIntyre L, Papoulias M, Brehaut JC. How well do critical care audit and feedback interventions adhere to best practice? Development and application of the REFLECT-52 evaluation tool. Implement Sci. 2021 Aug 17;16(1):81. doi: 10.1186/s13012-021-01145-9.

  PMID: 34404449 BACKGROUND

• Littenberg B, MacLean CD. Intra-cluster correlation coefficients in adults with diabetes in primary care practices: the Vermont Diabetes Information System field survey. BMC Med Res Methodol. 2006 May 3;6:20. doi: 10.1186/1471-2288-6-20.

  PMID: 16672056 BACKGROUND

• Radford JA, Landorf KB, Buchbinder R, Cook C. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006 Aug 9;7:64. doi: 10.1186/1471-2474-7-64.

  PMID: 16895612 BACKGROUND

Related Links

• Belgian guidelines for pneumococcal vaccination
• Data platform that hosts the INTEGO data

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bert Vaes, MD, PhD

  Department of Public Health and Primary Care, KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bert Vaes, MD, PhD

CONTACT

+32 16 37 72 97; bert.vaes@kuleuven.be

Arne Janssens, Msc

CONTACT

+32 16 37 66 21; arne.janssens@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the study it is not possible to blind at the practice level. Physicians will always be aware to which group they belong. At Healthdata (data collection) practices included in the intervention group will be identified so the extended feedback report can be made available only to them.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 27, 2023
• Study Start: January 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)