NCT03747107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

November 12, 2018

Last Update Submit

September 9, 2021

Conditions

Keywords

primary careprescribing safetyadverse drug eventdrug therapy riskpharmacistgeneral practice

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • All targeted drug therapy risks in patients aged 75 years or older (patient count)

    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)

    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

    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)

    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)

    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

  • +7 more secondary outcomes

Other Outcomes (50)

  • Individual indicators (P001)

    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

  • Individual indicators (P002)

    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

  • Individual indicators (P003)

    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

  • +47 more other outcomes

Interventions

P-DQIPBEHAVIORAL

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.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • General practices using electronic medical record software other than Vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Tayside

Dundee, Scotland, DD2 4BF, United Kingdom

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Tobias Dreischulte

    University of Dundee/NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 20, 2018

Study Start

September 16, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

We cannot agree to sharing individual participant data, since we do not own the data.

Locations