Pharmacogenomic TestingMPRINTNCT05037305
VICE-MPRINT: Maternal and Pediatric Pharmacogenetics Survey
A study testing Educational video in people with Pharmacogenomic Testing, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenomic Testing
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 798 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2022to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Provide consent in English or Spanish
- Primary care at VUMC
- Adult women aged 18 and older
- Currently pregnant 12 to 30 weeks gestational age
- Completed or scheduled first prenatal visit at VUMC clinic
- Intent to deliver at VUMC or affiliate
Show all 14Show fewer
- Agrees to receive findings from pharmacogenomic testing
- Allow access their medical record
- Provide consent (parent/guardian) and/or assent (child) in English or Spanish
- Primary care or subspecialty care at VUMC
- Aged 0 to 16
- Parent (0-16 years) and child (12-16 years) agree for both parent and child to receive findings from pharmacogenomic testing
- Parent (0-16 years) and child (12-16 years) allow access their medical record
- Have a chronic health condition.
Who cannot join
- Stem cell or solid organ transplant
- Recent transfusion within the previous 2 months
- Inability to provide DNA sample for testing
- Prior pharmacogenomic testing
- Pregnant women undergoing in vitro fertilization or assisted reproductive technologies
- Pediatric
Show all 10Show fewer
- Stem cell or solid organ transplant
- Recent transfusion within the previous 2 months
- Inability to provide DNA sample for testing
- Prior pharmacogenomic testing
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video.
Read the detailed description
This study will follow a two-arm unblinded research design. Study inclusion criteria include ability to provide a DNA sample for pharmacogenetic (PGx) testing and willingness to receive the test results. All participants will have PGx testing. Participants will complete a survey at study baseline, which will collect demographic information (age, race/ethnicity), contact and alternative contact information, primary care physician information, socioeconomic details (e.g. insurance information, education, occupation, marital status, and income) health data (e.g. chronic conditions, personal and family history of genetic diseases) and lifestyle data (e.g. smoking, drinking, and physical activity). Parents will complete enrollment surveys on behalf of children. Basic health and pregnancy history will also be collected for pregnant women. Survey questions regarding information and knowledge on PGx testing will be administered at enrollment and again after return of PGx results. Participants will be randomized to either the intervention group or the delayed intervention group. Individuals in the intervention group will be provided an educational video about PGx testing at the time that PGx results are available. Participants in the Delayed intervention group will be provided the educational video after they complete the first follow up survey. The investigators will include questions in the follow-up survey specific to the educational video in the first follow up survey (Intervention group) or the second follow up survey (Delayed intervention group).
- Conditions
- Pharmacogenomic Testing
- Being tested
- Educational video
- Keywords
- pharmacogenomic, PGx, pediatric, maternal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
The brief educational video provides information about pharmacogenetic testing, the results of pharmacogenetic testing, and how to find these results in the patient portal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | All individuals in the Intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Upon completion of the testing, they will be provided a link to an educational video about pharmacogenetic testing and results. Surveys will be performed before and after the pharmacogenetic testing. Receives: Other: Educational video |
| Delayed intervention arm | Other | All individuals in the Delayed intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Surveys will be performed before and after the pharmacogenetic testing. Upon completion of the first follow up survey, they will be provided a link to an educational video about pharmacogenetic testing and results. A second follow up survey will then be completed. Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' opinions of pharmacogenetic testing changes after results are received
- Opinion of Knowledge of Pharmacogenetics (PGx) and Related Terminology is being collected in 3 ways. Ten words or phrases will be assessed using a 5-variable ordinal scale ('Not at all familiar' to 'Extremely familiar'). One question will use a 4-variable ordinal scale (Very well, somewhat well, a little, not at all). Another question will use a 5-option Likert scale (A lot, somewhat, a little, not at all, don't know).
- Opinion of the Usefulness of PGx Testing is being collected using 12 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree').
- Opinion of What Can be Learned from PGx Test Results is being collected using 9 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree').
For all 3 above, responses reflect relative value, not absolute value, so are not additive and there are no total scores.
Measured: Baseline to post-return of PGx results, approximately 2- 4 weeks
Secondary outcomes (2)
Participants gain an improved knowledge of pharmacogenetics after educational intervention
- The 3 sections for Outcome 1 will also be asked to individuals who receive the educational video after they've received their PGx test results (as opposed to those who receive the results and video at the same time). These questions will be used in a pre-post analysis to investigate potential changes in knowledge after receiving the educational intervention.
- Opinion of the Educational Video: Participants will also be asked questions regarding the video to gauge their perceptions of the utility. These questions are being collected using a 5-variable ordinal scale. There are 4 statements in this section. Response options range from 'Strongly disagree' to 'Strongly agree'. Level of agreement with and understanding of terms is being measured, and responses reflect relative value, not absolute value, so are not additive and there is no total score.
Measured: Baseline to post-return of PGx results, approximately 2-4 weeks
Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions
- Preferences and Comfort on Their Healthcare Providers Accessing and Using Their PGx Test is assessed using 6 questions with 5-point Likert scales ('Strongly disagree' to 'Strongly agree').
- Attitudes Regarding PGx Testing and Benefits of the Study are being collected through a matrix block of 12 statements with 5-point Likert scales ('Strongly disagree' to 'Strongly agree').
- Factors Relating to Decision to Get PGx Testing is measured through a matrix of 8 questions with 5-point Likert scales ('Strongly disagree' to 'Strongly agree').
- Preference on Provider Who Orders, and Explains PGx Tests will be gauged using 2 "select all that apply" questions.
- Understanding of, Trust in, and Confidence in Prescriptions after PGx Test Results will be measured with 1 question each.
For all above, responses reflect relative value, not absolute value, so are not additive and there are no total scores.
Measured: Baseline to post-return of PGx results, approximately 2- 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 Jun 2022
- Primary completion31 Jan 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenomic TestingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All individuals in study will be undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenetic assay used at Vanderbilt University Medical Center. Upon completion of the pharmacogenetic testing, participants will be randomized to view an educational video immediately (intervention group), or after completion of a follow up survey (delayed intervention).
- Masking
- None (open label)
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Digna Velez Edwards, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037305
- Sponsor's protocol ID
- VUMCIRB:212241
- Acronym
- MPRINT
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets, including genomic data, will be made available upon request and review/approval of research purpose.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Attitudes Regarding Pharmacogenetic Testing Among Children With Chronic Conditions and Pregnant Women
- ClinicalTrials.gov ID
- NCT05037305
- Acronym / sponsor ID
- MPRINT / VUMCIRB:212241
- Conditions
- Pharmacogenomic Testing
- Keywords
- pharmacogenomic, PGx, pediatric, maternal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The field of pharmacogenetics has progressed from the discovery of genetic variants that cause variable function of drug metabolism enzymes to a cornerstone of clinical precision medicine. However, there are limited data supporting drug-gene associations for children and for women during and after pregnancy. The unique physiology of childhood and pregnancy demand validation of pharmacogenetic signals prior to clinical implementation. These knowledge gaps are compounded for individuals from minority populations, who have been underrepresented and thus underserved by genomic research and specifically pharmacogenetic studies. The primary objective of this project is to advance research and support clinical implementation in pharmacogenetics for children and pregnant women. This work will illuminate knowledge of, attitudes about, and priorities for pharmacogenetics, and will assess the impact of a brief educational video on knowledge and attitudes around pharmacogenetic testing. The investigators will assess the knowledge and attitudes regarding pharmacogenetic testing among diverse cohorts of children with chronic conditions and pregnant women, before and after receiving pharmacogenetic test results. Participants will be randomized to view an educational video about pharmacogenetic testing either at the time of receiving their pharmacogenetic test results, or at a later time. The investigators will perform surveys before and after pharmacogenomic testing and return of results, and before and after watching the educational video.
Detailed description
This study will follow a two-arm unblinded research design. Study inclusion criteria include ability to provide a DNA sample for pharmacogenetic (PGx) testing and willingness to receive the test results. All participants will have PGx testing. Participants will complete a survey at study baseline, which will collect demographic information (age, race/ethnicity), contact and alternative contact information, primary care physician information, socioeconomic details (e.g. insurance information, education, occupation, marital status, and income) health data (e.g. chronic conditions, personal and family history of genetic diseases) and lifestyle data (e.g. smoking, drinking, and physical activity). Parents will complete enrollment surveys on behalf of children. Basic health and pregnancy history will also be collected for pregnant women. Survey questions regarding information and knowledge on PGx testing will be administered at enrollment and again after return of PGx results. Participants will be randomized to either the intervention group or the delayed intervention group. Individuals in the intervention group will be provided an educational video about PGx testing at the time that PGx results are available. Participants in the Delayed intervention group will be provided the educational video after they complete the first follow up survey. The investigators will include questions in the follow-up survey specific to the educational video in the first follow up survey (Intervention group) or the second follow up survey (Delayed intervention group).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All individuals in study will be undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenetic assay used at Vanderbilt University Medical Center. Upon completion of the pharmacogenetic testing, participants will be randomized to view an educational video immediately (intervention group), or after completion of a follow up survey (delayed intervention).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: Educational videoAll individuals in the Intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Upon completion of the testing, they will be provided a link to an educational video about pharmacogenetic testing and results. Surveys will be performed before and after the pharmacogenetic testing. |
| Delayed intervention arm | Other | Other: Educational videoAll individuals in the Delayed intervention arm will undergo pharmacogenetic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center. Surveys will be performed before and after the pharmacogenetic testing. Upon completion of the first follow up survey, they will be provided a link to an educational video about pharmacogenetic testing and results. A second follow up survey will then be completed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Provide consent in English or Spanish
- Primary care at VUMC
- Adult women aged 18 and older
- Currently pregnant 12 to 30 weeks gestational age
- Completed or scheduled first prenatal visit at VUMC clinic
Key exclusion criteria (10 listed)
- Stem cell or solid organ transplant
- Recent transfusion within the previous 2 months
- Inability to provide DNA sample for testing
- Prior pharmacogenomic testing
- Pregnant women undergoing in vitro fertilization or assisted reproductive technologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoThe brief educational video provides information about pharmacogenetic testing, the results of pharmacogenetic testing, and how to find these results in the patient portal. | Other | Delayed intervention arm, Intervention arm |
Primary outcome
Participants' opinions of pharmacogenetic testing changes after results are received
Time frame: Baseline to post-return of PGx results, approximately 2- 4 weeks
* Opinion of Knowledge of Pharmacogenetics (PGx) and Related Terminology is being collected in 3 ways. Ten words or phrases will be assessed using a 5-variable ordinal scale ('Not at all familiar' to 'Extremely familiar'). One question will use a 4-variable ordinal scale (Very well, somewhat well, a little, not at all). Another question will use a 5-option Likert scale (A lot, somewhat, a little, not at all, don't know). * Opinion of the Usefulness of PGx Testing is being collected using 12 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). * Opinion of What Can be Learned from PGx Test Results is being collected using 9 statements with 5-variable ordinal scales ('Strongly disagree' to 'Strongly agree'). For all 3 above, responses reflect relative value, not absolute value, so are not additive and there are no total scores.
2 secondary outcomes
Participants gain an improved knowledge of pharmacogenetics after educational intervention
Time frame: Baseline to post-return of PGx results, approximately 2-4 weeks
Researchers gain a better understanding of the concerns about and perceptions of pharmacogenetic testing among pregnant women and parents of children with chronic conditions
Time frame: Baseline to post-return of PGx results, approximately 2- 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified datasets, including genomic data, will be made available upon request and review/approval of research purpose.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Pharmacogenomic Testing, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' opinions of pharmacogenetic testing changes after results are received (time frame: Baseline to post-return of PGx results, approximately 2- 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.