Assessment of pharmacogenetic guided prescribing across a range of commonly prescribed medicine classes, initiated in primary care. Other
Conditions
Interventions
The PROGRESS trial is designed to assess the viability and utility of a pharmacogenetic-guided prescribing service in Primary Care. Potential participants attending their GP practice for a routine app
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be a registered patient at one of the recruiting GP practices. 2. Participants must have capacity to independently consent. 3. Participants must be 18 years of age or over. 4. Participants must be being considered for a new prescription of one of four medicines classes, or participants being considered for an agent change within one of the four medicine classes. The eligible medicine classes (and specific medicines) are: 4.1. Selective Serotonin Reuptake Inhibitors [citalopram, escitalopram, fluvoxamine, paroxetine, sertraline] 4.2. Tricyclic Antidepressants (prescribed for pain or depression) [amitriptyline, clomipramine, doxepin, imipramine, nortriptyline, trimipramine] 4.3. Statin Therapy [atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin] 4.4. Proton Pump Inhibitors [esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole]
Exclusion criteria
Exclusion criteria: 1. Patients unable to independently consent. 2. Patients under the age of 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Pharmacogenetic Clinical Utility Metric (Defined as the proportion of patients across the study cohort with a CPIC Level 1A variant related to the medicine which triggered recruitment to the study) – determined through genetic testing as part of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients recruited to the study who had their pharmacogenetic results returned within 10 working days (Monday – Friday) of enrolment. The day of enrolment represents day 0. Collected from patient records. 2. Average turnaround time from enrolment to PGx results being available on GPAS. Collected from patient records. 3. The proportion of enrolled patients whose GPAS system record was accessed by a member of the clinical team. Collected from patient records. 4. The proportion of participants who had a prescription issued before the pharmacogenetic results were available. Collected from patient records. 5. Average time from recruitment to prescription. Collected from patient records. 6. The proportion of patients who had at least one prescription amended over the course of the study based on the pharmacogenetic data. Collected from patient records. 7. Average turnaround time from enrolment to results being integrated into the Electronic Health Record (EHR). Collected from patient records. 8. Proportion of participants who have a delay (more than 10 working days) in results being integrated into the EHR. Collected from patient records. 9. The proportion of enrolled participants for whom a clinical decision support notification was triggered. Collected from patient records. 10. The average number of clinical decision support notifications which triggered over the course of the study (expressed as per month/visit/prescription). Collected from patient records. 11. The proportion of participants who had a prescription issued before the pharmacogenetic results were available. Collected from patient records. 12. The proportion of patients on a given class of medicine who had their index medicine (i.e., the medicine which precipitated recruitment) changed at 1 and 6 months following prescription. This outcome will be compared against anonymized historical (non-genotyped) comparators, matched for demographics, from the Greater Manchester Care Record | — |
Countries
England, United Kingdom
Contacts
Public ContactAmy Ingham
Outcome results
None listed