Drug SafetyDQIPNCT01425502
Data-driven Quality Improvement in Primary Care - Trial
A study testing DQIP Intervention in people with Drug Safety, run by University of Dundee at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Safety
- What is being tested?
- DQIP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Fife
General Practices Across Fife
NHS Tayside
General Practices Across Tayside
About this study
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
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.
Read the 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:
- Does the intervention reduce the specified primary outcome of a composite measure of high risk non-steroidal anti-inflammatory drug, aspirin and clopidogrel prescribing?
- Does the intervention reduce the specified secondary outcomes of: the nine individual measures constituting the composite; related admissions to hospital; repeat vs new prescribing?
- 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
- Drug Safety
- Being tested
- DQIP Intervention
- Keywords
- High risk prescribing, Primary care, Non-steroidal anti-inflammatory drugs, Anti-platelet agents, Stepped wedge design, Cluster randomised controlled trial, United Kingdom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DQIP InterventionBehavioural
The DQIP intervention comprises of:
- Educational outreach
- Information technology application
- Financial incentives
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: DQIP Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
- a 'traditional' NSAID refers to any agent within this class except Cox 2 selective agents ('coxibs')
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 8 weeks
5. Proportion of patients prescribed warfarin (risk factor), who have been co-prescribed a traditional NSAID without gastro-protection (high risk prescription)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 weeks
21. Total NSAID volume (PRISMS) in participating compared to non-participating practices
Measured: 8 weeks
22. Proportion of patients prescribed an NSAID (HIC data) stratified by age in participating compared to non-participating practices
Measured: 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
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Drug SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside, NHS Fife
- Responsible party
- Principal investigator, Bruce Guthrie, University of Dundee
- Investigators
- Bruce Guthrie, PhD, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425502
- Sponsor's protocol ID
- 2011PS05
- Other IDs
- ARPG/07/2
- Acronym
- DQIP
- Status last verified
- Jan 2016
- First submitted
- 26 Aug 2011
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 16803468Zullo 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.
PubMed 17896831Delaney 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.
PubMed 17698822Hart 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.
PubMed 19709095Loboz 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.
PubMed 15676048Harirforoosh 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.
PubMed 19832117Guthrie 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.
PubMed 21693525Avery 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.
PubMed 17092344Grant 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.
PubMed 33246496Dreischulte 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.
PubMed 29306877Grant 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.
PubMed 28283493Grant 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.
PubMed 28061794Dreischulte 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.
PubMed 26981935Grant 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.
PubMed 24448848
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01425502
- Acronym / sponsor ID
- DQIP / 2011PS05
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside, NHS Fife
- Study start
- Sep 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the intervention reduce the specified primary outcome of a composite measure of high risk non-steroidal anti-inflammatory drug, aspirin and clopidogrel prescribing?
- Does the intervention reduce the specified secondary outcomes of: the nine individual measures constituting the composite; related admissions to hospital; repeat vs new prescribing?
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All practices | Other | Behavioral: DQIP InterventionThe design is a stepped-wedge cluster randomised trial. All participating practices therefore receive the intervention at a start time which is randomised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DQIP InterventionThe DQIP intervention comprises of: * Educational outreach * Information technology application * Financial incentives | Behavioural | All practices |
Primary outcome
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.
24 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Background: PubMed 16803468Howard 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.
- Background: PubMed 17896831Zullo 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.
- Background: PubMed 17698822Delaney 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.
- Background: PubMed 19709095Hart 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.
- Background: PubMed 15676048Loboz 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.
- Background: PubMed 19832117Harirforoosh 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.
- Background: PubMed 21693525Guthrie 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.
- BackgroundAvery 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: PubMed 17092344Brown 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.
- Derived from this study: PubMed 33246496Grant 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.
- Derived from this study: PubMed 29306877Dreischulte 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.
- Derived from this study: PubMed 28283493Grant 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.
- Individual participant dataSharing planned: Undecided. 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.
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Focal Onset Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Guthrie, PhD principal investigator
University of Dundee
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DQIP Intervention in people with Drug Safety, run by University of Dundee at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425502, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.