Data-driven Quality Improvement in Primary Care - Trial

Drug Safety Clinical Trial

— DQIP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425502
• Other study ID #: 2011PS05
• Secondary ID: ARPG/07/2
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: January 31, 2016
• Start date: September 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Drug Safety

Intervention

Behavioral:
• DQIP Intervention
The DQIP intervention comprises of: Educational outreach Information technology application Financial incentives

Locations

Country	Name	City	State
United Kingdom	NHS Fife	General practices across Fife
United Kingdom	NHS Tayside	General practices across Tayside

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	NHS Fife, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Avery AJ, Rodgers S, Cantrill JA, Armstrong S, Elliott R, Howard R, Kendrick D, Morris CJ, Murray SA, Prescott RJ, Cresswell K, Sheikh A. Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices. Trials. 2009 May 1;10:28. doi: 10.1186/1745-6215-10-28. Erratum in: Trials. 2010;11:23. — View Citation

Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. Review. — View Citation

Delaney JA, Opatrny L, Brophy JM, Suissa S. Drug drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding. CMAJ. 2007 Aug 14;177(4):347-51. — View Citation

Guthrie B, McCowan C, Davey P, Simpson CR, Dreischulte T, Barnett K. High risk prescribing in primary care patients particularly vulnerable to adverse drug events: cross sectional population database analysis in Scottish general practice. BMJ. 2011 Jun 21;342:d3514. doi: 10.1136/bmj.d3514. — View Citation

Harirforoosh S, Jamali F. Renal adverse effects of nonsteroidal anti-inflammatory drugs. Expert Opin Drug Saf. 2009 Nov;8(6):669-81. doi: 10.1517/14740330903311023. Review. — View Citation

Hart J, Hawkey CJ, Lanas A, Naesdal J, Talley NJ, Thomson AB, Yeomans ND. Predictors of gastroduodenal erosions in patients taking low-dose aspirin. Aliment Pharmacol Ther. 2010 Jan;31(1):143-9. doi: 10.1111/j.1365-2036.2009.04133.x. Epub . — View Citation

Howard RL, Avery AJ, Slavenburg S, Royal S, Pipe G, Lucassen P, Pirmohamed M. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol. 2007 Feb;63(2):136-47. Epub 2006 Jun 26. Review. — View Citation

Loboz KK, Shenfield GM. Drug combinations and impaired renal function -- the 'triple whammy'. Br J Clin Pharmacol. 2005 Feb;59(2):239-43. — View Citation

Zullo A, Hassan C, Campo SM, Morini S. Bleeding peptic ulcer in the elderly: risk factors and prevention strategies. Drugs Aging. 2007;24(10):815-28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	5. Proportion of patients prescribed warfarin (risk factor), who have been co-prescribed a traditional NSAID without gastro-protection (high risk prescription)		8 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	21. Total NSAID volume (PRISMS) in participating compared to non-participating practices		8 weeks	No
Secondary	22. Proportion of patients prescribed an NSAID (HIC data) stratified by age in participating compared to non-participating practices		8 weeks	No
Secondary	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	No
Secondary	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	No