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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:
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.
Full description
Background and rationale:
In March 2020, the INTEGO group published a study on pneumococcal vaccination status in Flanders (De Burghgraeve et al. The incidence of lower respiratory tract infections and pneumococcal vaccination status in adults in Flemish primary care. 2020, Acta Clin Belg. (DOI: 10.1080/17843286.2020.1735113)). Unlike pediatric vaccination, there is a low pneumococcal vaccination coverage rate (VCR) in adults in Flanders (187/1000 risk patients), which is possibly a public health problem. Recently the Belgian Superior Health Council published a new scientific recommendation on pneumococcal vaccination in adults (https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/hgr_9562_vaccinatie_tegen_pneumokokken_vweb.pdf). It might be beneficial to use the INTEGO registry to monitor and improve the vaccination coverage rate. This could be done by including AUDIT and feedback (A&F) loops to evaluate and improve the quality of care provided to patients. A&F 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). Furthermore, the data generated by this study will also support the implementation of a Publicly Funded Program for pneumococcal vaccination for older adults in Flanders and generate the needed data and insights to prepare for the launches of future pneumococcal vaccines in Belgium. Therefore, this study will investigate the effect of A&F on pneumococcal vaccination coverage in adults at risk in general practice.
Design:
This study will be a cluster-randomized trial: primary care practices will be randomized and divided into a control and intervention group. Allocation of control and intervention groups will be done by simple balanced randomization (1:1).
Objectives:
The primary study objective will be to assess the effect of "clinical AUDIT and feedback" loops on the pneumococcal vaccination coverage rate in adults at risk in general practice. Secondary objectives will be to explore whether the increase in vaccination coverage rate (VCR) after implementation of A&F loops is different in specific subgroups (risk groups, male/female, age, smoking status).
Intervention:
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. Like this we will be able to see the effect of individualized extended feedback on pneumococcal vaccination coverage on top of a standardized automated clinical AUDIT. This is important to know because the organization of feedback takes much more effort and cannot be easily scaled up to practices outside the registration network. So when a significant effect of feedback is seen on vaccination coverage this would have an important impact on the policy of future pro-active care.
Intervention group:
the INTEGO practices that will be assigned to the intervention group will receive an extended electronic feedback report with multiple components, directly implemented in their EHR, 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. They will be able to see the performance of their GP center, benchmarked to the mean VCR of the 10% best performing centers in the INTEGO network. The pneumococcal VCR will be presented in the three risk groups as defined in the eligibility criteria. The aim of the push system is to involve participating GPs and to actively direct their attention to the task at hand.
The extended feedback report will be delivered in the form of action plans and goals consisting of multiple components:
Control group:
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.
Sample size:
In total, 36 GP centers will be included, or 18 centres in each group to measure an absolute increase of 100/1000 risk patients in our primary outcome (80% power, alpha of 0.05) starting from a baseline vaccination coverage rate of 200/1000.
Assignment of interventions
Sequence generation:
Allocation of control and intervention groups will be done by simple balanced randomization (1:1). Enrollment of practices based on the in- and exclusion criteria, will be performed by researcher A, who is part of the trial. This will generate a numbered list of the eligible practices. Researcher B will, independently, assign numbers (denoting a specific practice) to either the control or intervention groups by means of a computer-generated list of random numbers, i.e. simple randomization.
Concealment mechanism:
Researcher B will prepare sealed, opaque envelopes containing a paper that assigns a specific practice number to a study group, based on this randomly generated number sequence. The process of the envelope preparation up until sealing and storage in a locked compartment will be videotaped by researcher B, who will thereafter be excluded from every other aspect of the trial. Allocation papers should never be visible, only the envelopes and the numbers on them. The video will be stored on an external device, which will be put in the locked compartment.
After practice enrollment, researcher A will access the locked compartment with the envelopes and review the accompanying video to ensure proper envelope preparation. Without opening or tampering with the letters, researcher A will write the appropriate mailing address on the respective envelope, based on their numbered list of practices. The envelopes will only be opened by the practices if they have an unbroken seal. This protocol is adapted from Radford et al. (Radford JA et al. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial. BMC Musculoskelet Disord. 2006;7:64).
Statistical methods:
Statistical methods for primary and secondary outcomes SAS and R will be used for analysis and for the graphs of the feedback. For this study data will only be used on an aggregated level (per GP center). No analyses will be performed on the patient level.
To evaluate the effect of the intervention on the primary and secondary outcome measures, a logistic generalized estimating equations (GEE) model will be used. This model is chosen because it can investigate the average response of an intervention on a population level. The effect of the intervention will be presented as the difference in proportions together with its 95% confidence interval.
Conclusion:
The data generated by this study will also support the implementation of a Publicly Funded Program for pneumococcal vaccination for older adults in Flanders and generate the needed data and insights to prepare for the launches of future pneumococcal vaccines in Belgium.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
To be eligible for inclusion in the study, general practice (GP) centers must conform to the following conditions:
To be eligible for inclusion in the study, patients must conform to the following conditions:
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
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.
Exclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Central trial contact
Bert Vaes, MD, PhD; Arne Janssens, Msc
Data sourced from clinicaltrials.gov
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