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Data-driven Quality Improvement in Primary Care - Trial (DQIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01425502
Recruitment Status : Completed
First Posted : August 30, 2011
Last Update Posted : February 2, 2016
Sponsor:
Collaborators:
NHS Tayside
NHS Fife
Information provided by (Responsible Party):
Bruce Guthrie, University of Dundee

Tracking Information
First Submitted Date  ICMJE August 26, 2011
First Posted Date  ICMJE August 30, 2011
Last Update Posted Date February 2, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
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 [ Time Frame: 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2011)
  • 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) [ Time Frame: 8 weeks ]
    * a 'traditional' NSAID refers to any agent within this class except Cox 2 selective agents ('coxibs')
  • 2. Proportion of patients aged 75 or over (risk factor), who have been prescribed a traditional* NSAID without gastro-protection (high risk prescription) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 8 weeks ]
  • 5. Proportion of patients prescribed warfarin (risk factor), who have been co-prescribed a traditional NSAID without gastro-protection (high risk prescription) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 weeks ]
  • 21. Total NSAID volume (PRISMS) in participating compared to non-participating practices [ Time Frame: 8 weeks ]
  • 22. Proportion of patients prescribed an NSAID (HIC data) stratified by age in participating compared to non-participating practices [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Data-driven Quality Improvement in Primary Care - Trial
Official Title  ICMJE 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
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Drug Safety
Intervention  ICMJE Behavioral: DQIP Intervention

The DQIP intervention comprises of:

  • Educational outreach
  • Information technology application
  • Financial incentives
Study Arms  ICMJE 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.
Intervention: Behavioral: DQIP Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2016)
33
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2011)
40
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01425502
Other Study ID Numbers  ICMJE 2011PS05
ARPG/07/2 ( Other Grant/Funding Number: Chief Scientist Office )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Follow up data is routinely collected clinical data. The trial team are data processors not data controllers, so cannot make the decision to share, although an application to share can be made to the National Health Service data controllers.
Responsible Party Bruce Guthrie, University of Dundee
Study Sponsor  ICMJE University of Dundee
Collaborators  ICMJE
  • NHS Tayside
  • NHS Fife
Investigators  ICMJE
Principal Investigator: Bruce Guthrie, PhD University of Dundee
PRS Account University of Dundee
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP