Medication SafetyP-DQIPNCT03747107
Pharmacist and Data Driven Quality Improvement in Primary Care
An observational study of Medication Safety, run by University of Dundee at 1 site in United Kingdom.
Trial summary
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in one National Health Service (NHS) board in Scotland (Tayside), and comprises the following components: i. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Safety
- What is being tested?
- P-DQIP
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2020to 30 Jun 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All general practices in NHS Tayside, who use the Vision electronic medical record software and agree to the extraction of data from medical records for monitoring and evaluation purposes
Who may be able to join
- General practices in NHS Tayside, who use the Vision electronic medical record software and agree to the extraction of data from medical records for monitoring and evaluation purposes
Who cannot join
- General practices using electronic medical record software other than Vision
Trial locations and contacts
1 site in 1 country.
About this study
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in one National Health Service (NHS) board in Scotland (Tayside), and comprises the following components:
- Case finding of patients with drug therapy risks via the P-DQIP informatics tool ii. Decision support for clinicians when conducting medication reviews via the P-DQIP informatics tool iii. Support from practice pharmacists in reviewing and managing targeted patients iv. Ongoing performance feedback via the P-DQIP informatics tool v. Promotion of the P-DQIP tool and intervention among general practices. The P-DQIP intervention will be evaluated in all NHS Tayside practices who agree to share their data for monitoring and evaluation purposes.
Read the detailed description
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in NHS Tayside. The study is therefore a service evaluation of an NHS Tayside-led initiative, which comprises the following components:
- Case finding. The P-DQIP informatics tool will be added to medicines management software (the Scottish Therapeutics Utility), which is already installed in all general practices in NHS Scotland. The P-DQIP tool can be accessed by General Practitioners (GPs) and other clinicians in the practice including Health Board employed primary care pharmacists 'attached' to practices. The core of the tool is a set of indicators of high-risk prescribing to identify patients at high risk of drug related harm. The indicators have been developed by The Scottish Government's Polypharmacy working group. ii. Decision support. The P-DQIP tool provides structured information on patients' medical and medication histories and highlights specific drug therapy risks for consideration by the reviewing clinician. All decision making remains at the discretion of the reviewing clinician. iii. Pharmacist support. Teams of practice pharmacists working in practices within the same locality will be invited to participate in a half-day workshop, in which they will be trained on the use of the P-DQIP informatics tool. A total of 8 to 12 workshops will be conducted. The workshop will be facilitated by the P-DQIP project team. As part of the workshop, locality pharmacist teams will be encouraged to plan the P-DQIP work and to agree targets. They will be instructed to introduce the P-DQIP pogramme in a stepwise fashion, targeting patients at risk of bleeding and hypoglycaemia first. iv. Ongoing performance feedback. Practices and locality pharmacists will be able to access reports on the number of reviews conducted and the numbers of patients with targeted high-risk prescribing via the P-DQIP informatics tool.
- Promotion of the P-DQIP tool and intervention among GP practices. GP clusters will be offered a visit by the lead pharmacist for the programme, who will provide background and rationale for the P-DQIP programme, demonstrate the functionalities of the P-DQIP informatics tool and encourage collaboration in reviewing and managing targeted drug therapy risks with pharmacists.
- Conditions
- Medication Safety
- Being tested
- P-DQIP
- Keywords
- primary care, prescribing safety, adverse drug event, drug therapy risk, pharmacist, general practice
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-DQIPBehavioural
The 'intervention' is a health board quality improvement programme to be implemented across all practices in one Scottish NHS health board and comprises the following components: (i) Case finding via the P-DQIP informatics tool to identify patients with drug therapy risks for review; (ii) Decision support via the P-DQIP informatics tool to facilitate medication reviews; (iii) Practice pharmacists will be trained on the use of the P-DQIP informatics tool and instructed to target patients at risk of bleeding and hypoglycaemia first (iv) Ongoing performance feedback. Practices and locality pharmacists will be able to access reports on review activity and targeted prescribing; (v) promotion of the P-DQIP tool and intervention among GP practices. The P-DQIP intervention will be evaluated in all NHS Tayside practices who agree to share their data for monitoring and evaluation purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Initially targeted drug therapy risks in patients aged 75 years or older
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011; Numerator definition: No. of denominator patients meeting one or more numerator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Secondary outcomes (12)
All targeted drug therapy risks in patients aged 75 years or older (patient count)
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046; Numerator definition: No. of denominator patients meeting one or more numerator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in patients aged 75 years or older (indicator count)
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046; Numerator definition: No. of indicators specified under 'Other Pre-specified Outcomes' P001 to P046 triggered by denominator patients
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Initially targeted drug therapy risks in younger patients
Denominator definition: No. of patients aged <75 years meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011; Numerator definition: No. of denominator patients meeting one or more numerator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011;
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in younger patients (patient count)
Denominator definition: No. of patients aged <75 years meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046; Numerator definition: No. of denominator patients meeting one or more numerator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in younger patients (indicator count)
Denominator definition: No. of patients aged <75 years meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P046; Numerator definition: No. of indicators specified under 'Other Pre-specified Outcomes' P001 to P046 triggered by denominator patients
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
'Ongoing' versus 'new' drug therapy risks ('Ongoing')
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions specified under 'Other Pre-specified Outcomes' P001 to P011, who have met one or more numerator definitions specified under 'Other Pre-specified Outcomes' P001 to P011 in the previous 57 to 364 days; Numerator definition (Old): No. of denominator patients meeting one or more numerator definitions specified under 'Other Pre-specified Outcomes' P001 to P011
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
'Ongoing' versus 'new' drug therapy risks ('New')
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions specified under 'Other Pre-specified Outcomes' P001 to P011, who have NOT met any numerator definitions specified under 'Other Pre-specified Outcomes' P001 to P011 in the previous 57 to 364 days; Numerator definition: No. of denominator patients meeting one or more numerator definitions specified under 'Other Pre-specified Outcomes' P001 to P011
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Electrolyte disturbances
Denominator definition: No. of patients aged <75 years meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P047 to P050; Numerator definition: No. of indicators specified under 'Other Pre-specified Outcomes' P047 to P050 triggered by denominator patients
Measured: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (1) - Bleeding
Denominator definition: No. of patients aged 75 years or older; Numerator definition: No. of denominator patients who had an unscheduled care event with bleeding in the previous 84 days
Measured: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (2) - Hypoglycaemia, falls, fractures
Denominator definition: No. of patients aged 75 years or older; Numerator definition: No. of denominator patients who had an unscheduled care event with hypoglycaemia, a fall or a fracture in the previous 84 days
Measured: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (3) - Any potentially drug related events
Denominator definition: No. of patients aged 75 years or older; Numerator definition: No. of denominator patients who had an unscheduled care event in the previous 84 days with any of the following: Hypoglycaemia, fall, fracture, bleeding, heart failure, bradycardia, acute kidney injury, constipation, dehydration, hyperkalaemia, hyponatraemia, urinary retention, delirium) in the previous 84 days
Measured: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Unrelated unscheduled care events
Denominator definition: No. of patients aged 75 years or older; Numerator definition: No. of denominator patients who had an unscheduled care event in the previous 84 days with an unrelated ambulatory care sensitive admission (Appendicitis, pancreatitis, cholecystitis, cancer, cellulitis)
Measured: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start16 Sep 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Principal investigator, Nicola Gray, University of Dundee
- Investigators
- Tobias Dreischulte, Principal investigator, University of Dundee/NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747107
- Sponsor's protocol ID
- 2018PS02
- Acronym
- P-DQIP
- Status last verified
- Sep 2021
- First submitted
- 12 Nov 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We cannot agree to sharing individual participant data, since we do not own the data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist and Data Driven Quality Improvement in Primary Care
- ClinicalTrials.gov ID
- NCT03747107
- Acronym / sponsor ID
- P-DQIP / 2018PS02
- Conditions
- Medication Safety
- Keywords
- primary care, prescribing safety, adverse drug event, drug therapy risk, pharmacist, general practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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.
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in one National Health Service (NHS) board in Scotland (Tayside), and comprises the following components:
- Case finding of patients with drug therapy risks via the P-DQIP informatics tool ii. Decision support for clinicians when conducting medication reviews via the P-DQIP informatics tool iii. Support from practice pharmacists in reviewing and managing targeted patients iv. Ongoing performance feedback via the P-DQIP informatics tool v. Promotion of the P-DQIP tool and intervention among general practices. The P-DQIP intervention will be evaluated in all NHS Tayside practices who agree to share their data for monitoring and evaluation purposes.
Detailed description
P-DQIP is an intervention to improve prescribing safety in primary care. The 'intervention' is a health board quality improvement programme that will be implemented across all practices in NHS Tayside. The study is therefore a service evaluation of an NHS Tayside-led initiative, which comprises the following components:
- Case finding. The P-DQIP informatics tool will be added to medicines management software (the Scottish Therapeutics Utility), which is already installed in all general practices in NHS Scotland. The P-DQIP tool can be accessed by General Practitioners (GPs) and other clinicians in the practice including Health Board employed primary care pharmacists 'attached' to practices. The core of the tool is a set of indicators of high-risk prescribing to identify patients at high risk of drug related harm. The indicators have been developed by The Scottish Government's Polypharmacy working group. ii. Decision support. The P-DQIP tool provides structured information on patients' medical and medication histories and highlights specific drug therapy risks for consideration by the reviewing clinician. All decision making remains at the discretion of the reviewing clinician. iii. Pharmacist support. Teams of practice pharmacists working in practices within the same locality will be invited to participate in a half-day workshop, in which they will be trained on the use of the P-DQIP informatics tool. A total of 8 to 12 workshops will be conducted. The workshop will be facilitated by the P-DQIP project team. As part of the workshop, locality pharmacist teams will be encouraged to plan the P-DQIP work and to agree targets. They will be instructed to introduce the P-DQIP pogramme in a stepwise fashion, targeting patients at risk of bleeding and hypoglycaemia first. iv. Ongoing performance feedback. Practices and locality pharmacists will be able to access reports on the number of reviews conducted and the numbers of patients with targeted high-risk prescribing via the P-DQIP informatics tool.
- Promotion of the P-DQIP tool and intervention among GP practices. GP clusters will be offered a visit by the lead pharmacist for the programme, who will provide background and rationale for the P-DQIP programme, demonstrate the functionalities of the P-DQIP informatics tool and encourage collaboration in reviewing and managing targeted drug therapy risks with pharmacists.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All general practices in NHS Tayside, who use the Vision electronic medical record software and agree to the extraction of data from medical records for monitoring and evaluation purposes
Key inclusion criteria (1 listed)
- General practices in NHS Tayside, who use the Vision electronic medical record software and agree to the extraction of data from medical records for monitoring and evaluation purposes
Key exclusion criteria (1 listed)
- General practices using electronic medical record software other than Vision
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 |
|---|---|---|
| P-DQIPThe 'intervention' is a health board quality improvement programme to be implemented across all practices in one Scottish NHS health board and comprises the following components: (i) Case finding via the P-DQIP informatics tool to identify patients with drug therapy risks for review; (ii) Decision support via the P-DQIP informatics tool to facilitate medication reviews; (iii) Practice pharmacists will be trained on the use of the P-DQIP informatics tool and instructed to target patients at risk of bleeding and hypoglycaemia first (iv) Ongoing performance feedback. Practices and locality pharmacists will be able to access reports on review activity and targeted prescribing; (v) promotion of the P-DQIP tool and intervention among GP practices. The P-DQIP intervention will be evaluated in all NHS Tayside practices who agree to share their data for monitoring and evaluation purposes. | Behavioural | – |
Primary outcome
Initially targeted drug therapy risks in patients aged 75 years or older
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Denominator definition: No. of patients aged 75 years or older meeting one or more denominator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011; Numerator definition: No. of denominator patients meeting one or more numerator definitions as specified under 'Other Pre-specified Outcomes' P001 to P011
12 secondary outcomes
All targeted drug therapy risks in patients aged 75 years or older (patient count)
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in patients aged 75 years or older (indicator count)
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Initially targeted drug therapy risks in younger patients
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in younger patients (patient count)
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
All targeted drug therapy risks in younger patients (indicator count)
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
'Ongoing' versus 'new' drug therapy risks ('Ongoing')
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
'Ongoing' versus 'new' drug therapy risks ('New')
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Electrolyte disturbances
Time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (1) - Bleeding
Time frame: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (2) - Hypoglycaemia, falls, fractures
Time frame: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Related unscheduled care events (3) - Any potentially drug related events
Time frame: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
Unrelated unscheduled care events
Time frame: Measured at intervals of 12 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018
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 10 Sep 2021.
- Individual participant dataSharing planned: No. We cannot agree to sharing individual participant data, since we do not own the data.
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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.
Tobias Dreischulte principal investigator
University of Dundee/NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Safety, run by University of Dundee at 1 site 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 1 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Initially targeted drug therapy risks in patients aged 75 years or older (time frame: Measured at intervals of 8 weeks over a period of 18 months prior to and subsequent to the start date. The measurement on the start date will be excluded from analyses to account for the availability of a test version of the P-DQIP tool since Sept 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2021.