Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

Side Effect of Drug Clinical Trial

— PREPARE-Mayo  

Official title:

A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mankato-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322238
• Other study ID #: 23-008706
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the

following criteria:

1. Subject must be = 18 years old

2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care.

3. Subject is able and willing to take part and willing to be followed up on for 48 weeks

4. Subject is able to donate saliva

5. Subject has signed informed consent

6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Exclusion Criteria:

1. For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel

2. Pregnant or lactating (to be verbally confirmed with the patient)

3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care

4. Duration of index drug total treatment length is planned to be less than seven consecutive days.

5. Current inpatients

6. Unable to consent to the study

7. Unwilling to take part

8. Subject has no permanent address

9. Subject has no current primary care provider

10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study

11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis

12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis

13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant

14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Related Conditions & MeSH terms

• Drug Metabolism, Poor, CYP2C19-Related
• Drug Metabolism, Poor, CYP2D6-Related
• Drug-Related Side Effects and Adverse Reactions
• Side Effect of Drug

Intervention

Diagnostic Test:
• PGx panel test
In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mankato), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Drug Reaction (ADR)	The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes	48 weeks
Secondary	PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.	The 29-item PREPARE-MAYO Clinicians' and pharmacists' Questionnaire measures the Experience and Attitude, Knowledge, Knowledge testing and Needs assessment of clinicians and pharmacists. Each item is scored from 1 (disagree) to 4 (agree). Total possible scores range from 29 to 116, with lower scores indicating less knowledge and higher scores indicating more knowledge.	48 weeks
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire	The 10-item PROMIS Global Health measures general, physical, mental and social health. Each item is scored from 1 (poor health) to 5 (excellent health). Total possible scores range from 10 to 50, with lower scores indicating worse state of health and higher scores indicating greater state of health.	48 weeks