Using pharmacogenomic testing in primary care: Protocol for a pilot randomized controlled study

Beatriz Manzor Mitrzyk, Reema Kadri, Karen B. Farris, Vicki L. Ellingrod, Michael S. Klinkman, Mack T. Ruffin, Melissa A. Plegue, Lorraine R. Buis

Research output: Contribution to journalArticle

Abstract

Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care.

Original languageEnglish (US)
Article numbere13848
JournalJournal of medical Internet research
Volume21
Issue number8
DOIs
StatePublished - Jan 1 2019

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Primary Health Care
Antidepressive Agents
Physicians
Demography
Depression
Medication Adherence
Pharmacogenomic Testing
Primary Care Physicians
Health Surveys
Anxiety Disorders
Hospital Emergency Service
Anxiety
Pharmacokinetics
Medicine
Safety
Health
Therapeutics
Pharmaceutical Preparations
Population
Genes

All Science Journal Classification (ASJC) codes

  • Health Informatics

Cite this

Mitrzyk, B. M., Kadri, R., Farris, K. B., Ellingrod, V. L., Klinkman, M. S., Ruffin, M. T., ... Buis, L. R. (2019). Using pharmacogenomic testing in primary care: Protocol for a pilot randomized controlled study. Journal of medical Internet research, 21(8), [e13848]. https://doi.org/10.2196/13848
Mitrzyk, Beatriz Manzor ; Kadri, Reema ; Farris, Karen B. ; Ellingrod, Vicki L. ; Klinkman, Michael S. ; Ruffin, Mack T. ; Plegue, Melissa A. ; Buis, Lorraine R. / Using pharmacogenomic testing in primary care : Protocol for a pilot randomized controlled study. In: Journal of medical Internet research. 2019 ; Vol. 21, No. 8.
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Mitrzyk, BM, Kadri, R, Farris, KB, Ellingrod, VL, Klinkman, MS, Ruffin, MT, Plegue, MA & Buis, LR 2019, 'Using pharmacogenomic testing in primary care: Protocol for a pilot randomized controlled study', Journal of medical Internet research, vol. 21, no. 8, e13848. https://doi.org/10.2196/13848

Using pharmacogenomic testing in primary care : Protocol for a pilot randomized controlled study. / Mitrzyk, Beatriz Manzor; Kadri, Reema; Farris, Karen B.; Ellingrod, Vicki L.; Klinkman, Michael S.; Ruffin, Mack T.; Plegue, Melissa A.; Buis, Lorraine R.

In: Journal of medical Internet research, Vol. 21, No. 8, e13848, 01.01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Using pharmacogenomic testing in primary care

T2 - Protocol for a pilot randomized controlled study

AU - Mitrzyk, Beatriz Manzor

AU - Kadri, Reema

AU - Farris, Karen B.

AU - Ellingrod, Vicki L.

AU - Klinkman, Michael S.

AU - Ruffin, Mack T.

AU - Plegue, Melissa A.

AU - Buis, Lorraine R.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care.

AB - Background: Antidepressants are used by primary care providers to treat a variety of conditions, including (but not limited to) depression and anxiety. A trial-and-error approach is typically used to identify effective therapy, as treatment efficacy and safety can vary based on the response, which is affected by certain gene types. Pharmacokinetic pharmacogenomic (PGx) testing provides phenotypic classification of individuals as poor, intermediate, extensive, and ultrarapid CYP450 metabolizers, providing information for optimal drug selection. Objective: The objective of this pilot study is to examine the feasibility, acceptability, and preliminary effectiveness of PGx testing when used after starting a new antidepressant medication. Methods: We are conducting a pilot study with physicians from 6 Department of Family Medicine clinics at the University of Michigan who are willing to use PGx test results to manage antidepressant medication use. From enrolled physicians, patients were recruited to participate in a 6-month randomized, wait-list controlled trial in which patient participants newly prescribed an antidepressant had PGx testing and were randomized equally to have the results released to their primary care physician as soon as results were available or after 3 months. Patients were excluded if they had been taking the antidepressant for more than 4 weeks or if they had undergone PGx testing in the past. Physician participants completed a baseline survey to assess demographics, as well as knowledge, feasibility, and acceptability of PGx testing for this population. At the conclusion of the study, physician participants will complete a survey to assess knowledge, satisfaction, feasibility, acceptability, perceived effectiveness, and barriers to widespread adoption of PGx testing. Patient participants will complete a baseline, 3-month, and 6-month assessment, and control patient participants will have an additional 9-month assessment. Data collected will include the reason for antidepressant use, self-reported medication adherence, side effects, patient health questionnaire 8-item depression scale, generalized anxiety disorder 7-item scale, 12-Item Short-Form Health Survey, work status or changes, and physician and emergency department visits. PGx knowledge and perceptions (including acceptability and feasibility) as well as demographic information will also be obtained. Results: We recruited 23 physician participants between November 2017 and January 2019, and 52 patient participants between January 2018 and April 2019. Currently, all physician and patient participants have been recruited, and we expect data collection to conclude in January 2020. Conclusions: This study will examine the preliminary effectiveness of PGx testing after treatment initiation and determine the feasibility and acceptability of PGx testing for use in primary care. Through this study, we expect to demonstrate the benefit of PGx testing and lay the foundation for translating this approach into use within primary care.

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