Data-driven Quality Improvement in Primary Care - Trial
NCT ID: NCT01425502
Last Updated: 2016-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2012-09-30
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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All practices
The design is a stepped-wedge cluster randomised trial. All participating practices therefore receive the intervention at a start time which is randomised.
DQIP Intervention
The DQIP intervention comprises of:
* Educational outreach
* Information technology application
* Financial incentives
Interventions
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DQIP Intervention
The DQIP intervention comprises of:
* Educational outreach
* Information technology application
* Financial incentives
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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NHS Tayside
OTHER_GOV
NHS Fife
OTHER_GOV
University of Dundee
OTHER
Responsible Party
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Bruce Guthrie
Professor of Primary Care Medicine
Principal Investigators
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Bruce Guthrie, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Locations
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NHS Fife
General Practices Across Fife, , United Kingdom
NHS Tayside
General Practices Across Tayside, , United Kingdom
Countries
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References
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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. doi: 10.1111/j.1365-2125.2006.02698.x. Epub 2006 Jun 26.
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. doi: 10.2165/00002512-200724100-00003.
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. doi: 10.1503/cmaj.070186.
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.
Loboz KK, Shenfield GM. Drug combinations and impaired renal function -- the 'triple whammy'. Br J Clin Pharmacol. 2005 Feb;59(2):239-43. doi: 10.1111/j.0306-5251.2004.2188.x.
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.
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.
Avery A, Rodgers S. The PINCER trial ('A cluster randomised trial to determine the effectiveness, costs/benefits and acceptability of a pharmacist-led, IT-based intervention compared with simple feedback in reducing rates of clinically important instances of potentially hazardous prescribing and medicines management in general practice'): final report. Nottingham, University of Nottingham 2010.
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
Grant A, Bugge C, Wells M. Designing process evaluations using case study to explore the context of complex interventions evaluated in trials. Trials. 2020 Nov 27;21(1):982. doi: 10.1186/s13063-020-04880-4.
Dreischulte T, Grant A, Hapca A, Guthrie B. Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: quantitative examination of variation between practices in recruitment, implementation and effectiveness. BMJ Open. 2018 Jan 5;8(1):e017133. doi: 10.1136/bmjopen-2017-017133.
Grant A, Dreischulte T, Guthrie B. Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: case study evaluation of adoption and maintenance of a complex intervention to reduce high-risk primary care prescribing. BMJ Open. 2017 Mar 10;7(3):e015281. doi: 10.1136/bmjopen-2016-015281.
Grant A, Dreischulte T, Guthrie B. Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing. Implement Sci. 2017 Jan 7;12(1):4. doi: 10.1186/s13012-016-0531-2.
Dreischulte T, Donnan P, Grant A, Hapca A, McCowan C, Guthrie B. Safer Prescribing--A Trial of Education, Informatics, and Financial Incentives. N Engl J Med. 2016 Mar 17;374(11):1053-64. doi: 10.1056/NEJMsa1508955.
Grant AM, Guthrie B, Dreischulte T. Developing a complex intervention to improve prescribing safety in primary care: mixed methods feasibility and optimisation pilot study. BMJ Open. 2014 Jan 21;4(1):e004153. doi: 10.1136/bmjopen-2013-004153.
Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.
Grant A, Dreischulte T, Treweek S, Guthrie B. Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care. Trials. 2012 Aug 28;13:154. doi: 10.1186/1745-6215-13-154.
Dreischulte T, Grant A, Donnan P, McCowan C, Davey P, Petrie D, Treweek S, Guthrie B. A cluster randomised stepped wedge trial to evaluate the effectiveness of a multifaceted information technology-based intervention in reducing high-risk prescribing of non-steroidal anti-inflammatory drugs and antiplatelets in primary medical care: the DQIP study protocol. Implement Sci. 2012 Mar 23;7:24. doi: 10.1186/1748-5908-7-24.
Other Identifiers
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ARPG/07/2
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2011PS05
Identifier Type: -
Identifier Source: org_study_id
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