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Published on: August 30, 2018
A qualitative process evaluation of a clinical trial on bedside model-informed precision dosing of vancomycin in
Lise-Marie Kinnaer1, Anca Amza2, Pieter De Cock3,4,5
1Department of Public Health and Primary Care, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
Introduction:
Model-Informed Precision Dosing (MIPD) is increasingly used to optimize vancomycin therapy in critically ill patients. However, process evaluations randomized controlled trials (RCTs) of MIPD remain rare, particularly in neonatal and pediatric intensive care. They provide however valuable insights about how and why interventions work.
Aim:
This study explored healthcare professionals' (HCPs) experiences with using the MIPD software for vancomycin during the BENEFICIAL-RCT in critically ill children and examined contextual factors influencing its use.
Method:
A qualitative descriptive exploratory study was conducted after the BENEFICIAL-RCT in 8 Belgian hospitals. Semi-structured interviews and focus groups were held between January and May 2025 with physicians, clinical pharmacists, clinical biologists, and trial nurses. Data were analyzed thematically.
Results:
Twenty-one HCPs participated. Four overarching themes emerged: enhanced clinical confidence and professional empowerment, experienced workflow barriers, clinical and healthcare-system implications and conditions for sustained MIPD-adoption. Participants described that beyond faster attainment of target AUC, the software fostered professional empowerment through its visualizations and the ability to retain final decision authority. Experiences also underscored how infrequent clinical exposure to adopting MIPD hindered continuity of MIPD expertise. This was pertinent in settings with low vancomycin case volumes or frequent rotating medical staff. As experienced workflow barriers especially the pivotal role of nurses in ensuring accurate documentation of sampling and infusion times was mentioned. These documentation uncertainties were perceived as affecting trust in the dosing workflow. Participants also highlighted night-time operational challenges for which workarounds set up during the RCT would not be feasible for routine practice. Concerning conditions for sustained MIPD-implementation, HCPs emphasized the importance of MIPD integration in electronic health records and automated dose calculation. The need for local MIPD champions was recurrently emphasized, particularly to support onboarding of new HCPs in MIPD.
Conclusion:
The results highlight that to support broader implementation of MIPD in pediatric critical care, hospitals should prioritize electronic record integration, streamline workflows, and appoint internal MIPD champions. These measures may reduce workload and errors, and support sustainable use in daily practice.
Insights
Model-Informed Precision Dosing (MIPD) software improved clinician confidence in vancomycin therapy for critically ill children. Streamlining workflows and integrating MIPD into electronic health records are key for sustained adoption in pediatric critical care.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacometrics and Pharmacokinetics
- Health Services Research
Background:
- Model-Informed Precision Dosing (MIPD) is vital for optimizing vancomycin therapy in critically ill patients.
- Process evaluations of MIPD randomized controlled trials (RCTs) are scarce, especially in pediatric intensive care settings.
- Understanding the 'how' and 'why' of MIPD interventions is crucial for successful implementation.
Purpose of the Study:
- To explore healthcare professionals' (HCPs) experiences using MIPD software for vancomycin during a pediatric RCT.
- To identify contextual factors influencing the adoption and sustained use of MIPD in critically ill children.
- To gather insights for improving MIPD implementation strategies in pediatric critical care.
Main Methods:
- A qualitative descriptive exploratory study was conducted post-BENEFICIAL-RCT in 8 Belgian hospitals.
- Semi-structured interviews and focus groups were held with physicians, pharmacists, biologists, and nurses.
- Thematic analysis was used to analyze data collected between January and May 2025.
Main Results:
- Four themes emerged: enhanced clinical confidence, workflow barriers, clinical/system implications, and conditions for sustained adoption.
- HCPs reported increased professional empowerment and confidence due to MIPD's visualizations and retained decision authority.
- Workflow barriers included documentation uncertainties, infrequent exposure hindering expertise, and operational challenges, particularly at night.
Conclusions:
- Prioritizing electronic health record integration and automated dose calculation is essential for broader MIPD implementation.
- Streamlining workflows and appointing local MIPD champions are crucial for reducing workload and errors.
- These measures will support the sustainable use of MIPD in daily pediatric critical care practice.
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