Drug Safety Clinical Trial
Official title:
Data-driven Quality Improvement in Primary Care: Cluster Randomised Controlled Trial to Test the Effectiveness of a Multifaceted Intervention in Reducing High Risk Prescribing of Non-steroidal Anti-inflammatory Drugs and Antiplatelet Agents
A cluster randomised controlled trial to test the effectiveness of an informatics tool, educational and financial incentives to reduce high risk prescribing of non-steroidal anti-inflammatory drugs and anti-platelet agents.
The trial described here is part of a programme which aimed to design a complex, primary
care prescribing safety improvement intervention and test its effectiveness in a randomised
controlled trial.
Non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet drugs such as low dose
aspirin and clopidogrel are responsible for a significant proportion of hospital admissions
due to preventable adverse drug events (ADE), and are the drugs most commonly associated
with fatal ADEs. Previous research has identified groups of patients and patterns of
co-prescription in which use of these drugs is particularly high-risk , and national
prescribing and safety guidance has embedded this research in clear recommendations to
either avoid prescribing or to do so only when there is no alternative, and with caution. In
previous epidemiological work, we have shown that high-risk use of NSAIDs, aspirin and
clopidogrel is common, and pilot work in four practices has shown that focused review of
prescribing by the practice reduced the targeted high-risk NSAID prescribing by
approximately 40% after one round of feedback. This effect size is consistent with the
PINCER trial where the intervention was a pharmacist facilitated review process.
We hypothesise that a multi-faceted intervention comprising of (1) educational outreach, (2)
use of an informatics tool to monitor prescribing patterns at practice level and to prompt
and facilitate the review of individual patients at risk of ADEs and (3) a small financial
incentive to review patients will reduce rates of high-risk prescribing.
The specific research questions addressed by the trial are:
1. Does the intervention reduce the specified primary outcome of a composite measure of
high risk non-steroidal anti-inflammatory drug, aspirin and clopidogrel prescribing?
2. Does the intervention reduce the specified secondary outcomes of: the nine individual
measures constituting the composite; related admissions to hospital; repeat vs new
prescribing?
3. If found to be effective, then is the intervention cost-effective?
The trial will use a stepped-wedge design, which is particularly suited to a sequential
roll-out of an intensive and informatics based intervention focusing on patient safety. In
this design, all participating practices receive the intervention, but are randomised to a
starting time. At the point of entering the intervention phase of the trial, all practices
will receive an educational outreach visit which will include training in the use of the
informatics tool.
The informatics tool will provide regular feedback of any change in rates of high-risk
prescribing for each individual measure and the composite measure, with the ability to
drill-down to individual patient level and review a summary of each patient's relevant
conditions and prescribing.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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