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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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').

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject must be ≥ 18 years old

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.

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

Subject is able to donate saliva

Disqualifiers

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

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

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PGx panel test

    Diagnostic test

    In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: PGx testing armExperimental treatment 1 intervention
Group B: Delayed PGx testing armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
48 weeks

Secondary outcomes

1

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.

Time frame
48 weeks
2

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.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

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