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NCT Number: NCT06322238

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

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').

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location status: Recruiting

Location contact

Elisa Houwink, MD, PhD

CONTACT

[email protected]

5073192037

Jessica Wright, PharmD

SUB_INVESTIGATOR

Mary Johnson

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria:

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

  • 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
  • Subject has signed informed consent
  • Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email

Exclusion criteria

  • 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.
  • Current inpatients
  • Unable to consent to the study
  • Unwilling to take part
  • Subject has no permanent address
  • Subject has no current primary care provider
  • Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
  • Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
  • Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
  • History of a liver transplant or an allogeneic hematopoietic stem cell transplant
  • DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory

Treatment and study plan

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.

Primary outcomes

  1. Adverse Drug Reaction (ADR)

    Time frame: 48 weeks

    The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes

Secondary outcomes

  1. PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.

    Time frame: 48 weeks

    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.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire

    Time frame: 48 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: PREPARE-Mayo

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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