Pharmacist and Data Driven Quality Improvement in Primary Care

Study Overview
=================
Brief 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. 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: i. 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. v. 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.

Official Title
-----------------
Pharmacist and Data Driven Quality Improvement in Primary Care

Conditions
-----------------
Medication Safety

Intervention / Treatment
-----------------
* Behavioral: P-DQIP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: General practices using electronic medical record software other than Vision
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: P-DQIP|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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 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 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 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 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 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 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 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 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 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, prescribing safety, adverse drug event, drug therapy risk, pharmacist, general practice