Data-driven Quality Improvement in Primary Care - Trial

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: Does the intervention reduce the specified primary outcome of a composite measure of high risk non-steroidal anti-inflammatory drug, aspirin and clopidogrel prescribing? Does the intervention reduce the specified secondary outcomes of: the nine individual measures constituting the composite; related admissions to hospital; repeat vs new prescribing? 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.

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

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Behavioral: DQIP Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: General medical practices in NHS Fife and NHS Tayside with a compatible clinical IT system and agreeing to participate. Practices that agree to have relevant medication related data to be automatically extracted from their electronic clinical information systems from 1/10/10 to 30/9/13 (ie 12 months before first practice starts till 12 months after last practice starts). Exclusion Criteria: Practices that use General Practice Administration System for Scotland (GPASS) or Egton Medicine Information System (EMIS) on the date of randomisation, since data extraction for the informatics requires Vision practice IT system.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All practices<br>The design is a stepped-wedge cluster randomised trial. All participating practices therefore receive the intervention at a start time which is randomised. | Behavioral: DQIP Intervention<br>* The DQIP intervention comprises of: Educational outreach Information technology application Financial incentives<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite: Proportion of patients with any risk factor as defined in secondary outcome measures to 9, who have received any high risk prescriptions of anti-inflammatory drugs or antiplatelets as defined in secondary outcome measures 1 to 9 | The primary and all secondary outcome measures will be measured in each practice at 8 weekly intervals (reflecting that all measures assess high risk prescriptions for NSAIDs and antiplatelets in the last 8 weeks). At the time of initial data extraction, 8 weekly intervals will be constructed for the 12 months before the intervention start date. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Proportion of patients with a history of peptic ulcer (risk factor), who have been prescribed a traditional* oral non-steroidal anti-inflammatory drug (NSAID) without gastro-protection (high risk prescription) | * a 'traditional' NSAID refers to any agent within this class except Cox 2 selective agents ('coxibs') | 8 weeks | 
| 2. Proportion of patients aged 75 or over (risk factor), who have been prescribed a traditional* NSAID without gastro-protection (high risk prescription) |  | 8 weeks | 
| 3. Proportion of patients aged 65 or over and prescribed low dose aspirin (risk factor), who have been prescribed a traditional oral NSAID without gastro-protection (high risk prescription) |  | 8 weeks | 
| 4. Proportion of patients aged 65 or over and prescribed low dose aspirin (risk factor), who have been co-prescribed clopidogrel without gastro-protection (high risk prescription) |  | 8 weeks | 
| 5. Proportion of patients prescribed warfarin (risk factor), who have been co-prescribed a traditional NSAID without gastro-protection (high risk prescription) |  | 8 weeks | 
| 6. Proportion of patients prescribed warfarin (risk factor), who have been co-prescribed low dose aspirin or clopidogrel without gastro-protection (high risk prescription) |  | 8 weeks | 
| 7. Proportion of patients with a documented diagnosis of heart failure (risk factor), who have been prescribed an analgesic dose NSAID (high risk prescription) |  | 8 weeks | 
| 8. Proportion of patients prescribed both a diuretic and an ACE inhibitor/ Angiotensin Receptor Blocker (risk factor), who have been prescribed an analgesic dose NSAID (high risk prescription) |  | 8 weeks | 
| 9. Proportion of patients with a documented diagnosis of chronic kidney disease stage 3,4 or 5, who have been prescribed an analgesic dose NSAID (high risk prescription) |  | 8 weeks | 
| 10. Proportion of patients with any risk factor listed in secondary outcomes measures 1 to 6, who have been prescribed any high risk prescription listed in secondary outcome measures 1 to 6 |  | 8 weeks | 
| 11. Proportion of patients with any risk factor listed in secondary outcome measures 8 to 9, who have been prescribed any high risk prescription listed in secondary outcome measures 8 to 9 |  | 8 weeks | 
| 12. No. of patients admitted to hospital for gastro-intestinal bleeding AND high risk prescription as defined in secondary outcome measure 10, divided by patient months with gastro-intestinal risk factors as defined in secondary outcome measure 10 |  | 48 weeks | 
| 13. No. of patients admitted to hospital for heart failure exacerbation AND high risk prescription as defined in secondary outcome measure 7, divided by patient months with documented heart failure as defined in secondary outcome measure 7 |  | 48 weeks | 
| 14. No. of patients admitted to hospital for acute renal failure, dehydration or diarrhoea AND high risk prescription as defined in secondary outcome measure 11, divided by patient months with renal risk factors as defined in outcome measure 11 |  | 48 weeks | 
| 15. No. of patients admitted to hospital for gastro-intestinal bleeding, divided by patient months with gastro-intestinal risk factors as defined in secondary outcome measure 10 |  | 48 weeks | 
| 16. No. of patients admitted to hospital for heart failure exacerbation, divided by patient months with documented heart failure as defined in secondary outcome measure 7 |  | 48 weeks | 
| 17. No. of patients admitted to hospital for acute renal failure or with dehydration or diarrhoea (both defined as potentially inappropriate/ambulatory care sensitive admissions), divided by patient months with renal risk factors as defined in measure 11 |  | 48 weeks | 
| 18. No. of patients with any emergency admission to hospital, divided by patient months with gastro-intestinal risk factors as defined in secondary outcome measure 10 |  | 48 weeks | 
| 19. No. of patients with any emergency admission to hospital, divided by patient months with documented heart failure as defined in secondary outcome measure 7 |  | 48 weeks | 
| 20. No. of patients with any emergency admission to hospital, divided by patient months with renal risk factors as defined in secondary outcome measure 11 |  | 48 weeks | 
| 21. Total NSAID volume (PRISMS) in participating compared to non-participating practices |  | 8 weeks | 
| 22. Proportion of patients prescribed an NSAID (HIC data) stratified by age in participating compared to non-participating practices |  | 8 weeks | 
| 23. Proportion of patients with risk factors as defined in secondary outcome measure 1 to 9, who have been prescribed a high risk prescription as defined in outcome measure 1 to 9 and have received such a prescription within the previous 12 months |  | 8 weeks | 
| 24. Proportion of patients with risk factors as defined in secondary outcome measure 1 to 9, who have been prescribed a high risk prescription as defined in outcome measure 1 to 9 and have NOT received such a prescription within the previous 12 months |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High risk prescribing, Primary care, Non-steroidal anti-inflammatory drugs, Anti-platelet agents, Stepped wedge design, Cluster randomised controlled trial, United Kingdom