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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Dundee.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
NHS Tayside
NHS Fife
Information provided by (Responsible Party):
Bruce Guthrie, University of Dundee
ClinicalTrials.gov Identifier:
NCT01425502
First received: August 26, 2011
Last updated: May 19, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Drug Safety
Behavioral: DQIP Intervention

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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    * 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 21. Total NSAID volume (PRISMS) in participating compared to non-participating practices [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 22. Proportion of patients prescribed an NSAID (HIC data) stratified by age in participating compared to non-participating practices [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: DQIP Intervention

    The DQIP intervention comprises of:

    • Educational outreach
    • Information technology application
    • Financial incentives
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425502

Locations
United Kingdom
NHS Fife
General practices across Fife, United Kingdom
NHS Tayside
General practices across Tayside, United Kingdom
Sponsors and Collaborators
University of Dundee
NHS Tayside
NHS Fife
Investigators
Principal Investigator: Bruce Guthrie, PhD University of Dundee
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruce Guthrie, Professor of Primary Care Medicine, University of Dundee
ClinicalTrials.gov Identifier: NCT01425502     History of Changes
Other Study ID Numbers: 2011PS05, ARPG/07/2
Study First Received: August 26, 2011
Last Updated: May 19, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University of Dundee:
High risk prescribing
Primary care
Non-steroidal anti-inflammatory drugs
Anti-platelet agents
Stepped wedge design
Cluster randomised controlled trial
United Kingdom

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014