Data-driven Quality Improvement in Primary Care - Trial

NCT01425502 | Completed DMC

• 2 other identifiers: 2011PS05ARPG/07/2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Drug Safety

Keywords

High risk prescribing; Primary care; Non-steroidal anti-inflammatory drugs; Anti-platelet agents; Stepped wedge design; Cluster randomised controlled trial; United Kingdom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• 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)

  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

Study Arms (1)

All practices

OTHER

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

Interventions

DQIP Intervention BEHAVIORAL

The DQIP intervention comprises of: * Educational outreach * Information technology application * Financial incentives

All practices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dundee: lead
• NHS Tayside: collaborator
• NHS Fife: collaborator

Study Sites (2)

NHS Fife

General Practices Across Fife, United Kingdom

Location

NHS Tayside

General Practices Across Tayside, United Kingdom

Location

Related Publications (18)

• 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.

  PMID: 16803468 BACKGROUND

• 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.

  PMID: 17896831 BACKGROUND

• 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.

  PMID: 17698822 BACKGROUND

• 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.

  PMID: 19709095 BACKGROUND

• 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.

  PMID: 15676048 BACKGROUND

• 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.

  PMID: 19832117 BACKGROUND

• 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.

  PMID: 21693525 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17092344 BACKGROUND

• 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.

  PMID: 33246496 DERIVED

• 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.

  PMID: 29306877 DERIVED

• 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.

  PMID: 28283493 DERIVED

• 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.

  PMID: 28061794 DERIVED

• 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.

  PMID: 26981935 DERIVED

• 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.

  PMID: 24448848 DERIVED

• 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.

  PMID: 23311722 DERIVED

• 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.

  PMID: 22929598 DERIVED

• 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.

  PMID: 22444945 DERIVED

Study Officials

• Bruce Guthrie, PhD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Primary Care Medicine

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: September 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 2, 2016

Record last verified: 2016-01

Locations

GB (2)