Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01600846 |
| Other study ID # |
Pro00031122 |
| Secondary ID |
2R01GM081416-04 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 15, 2012 |
| Last updated |
July 27, 2017 |
| Start date |
December 2012 |
| Est. completion date |
July 2013 |
Study information
| Verified date |
August 2014 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to further integrate pharmacogenetic (PGx) testing into clinical
practice by educating physicians about pharmacogenetics and offering testing to their
patients. Pharmacogenetic testing may help physicians choose the best drug and dosage for
their patients which can reduce side effects, increase effectiveness, and improve patient
adherence.
Two clinics will be involved. One clinic will have a pharmacist on-site as a resource to
physicians and to advise what patients may benefit from PGx testing; the other clinic will
have a pharmacist on call.
Patient and physician perspectives about PGx testing and their utilization will be examined
via surveys.
The investigators hypothesize that with education about PGx testing, more physicians will
utilize testing.
Description:
This study aims to assess two delivery models of PGx testing (physician-initiated and
pharmacist-initiated) for commonly prescribed drugs in primary care practices and evaluate
the delivery of testing from three perspectives: physician, patient, and practice setting. We
hypothesize that greater utilization will be influenced by increased physician knowledge and
awareness of drugs with PGx testing, comfort in discussing PGx testing with patients and
applying results to therapeutic decision-making and positive attitudes towards the testing
process. We hypothesize that the pharmacist-initiated approach will result in the most
effective use and rapid uptake of PGx testing given the hands-on educational approach with
the pharmacist providing expert guidance. We also hypothesize that having a pharmacist with
PGx testing expertise as part of the medical team will result in greater physician comfort
with test ordering and application of results as compared with the physician-initiated model.
In addition, an economic analysis will be conducted to evaluate and compare the costs of each
model.
We will also examine patient perspectives about PGx testing and their utilization of test
results. We hypothesize that patients who have experienced adverse responses or a poor drug
outcome (no response) in the past, are taking chronic medications, and those who are older
will be more likely to consent to PGx testing. We hypothesize that patients' increased
awareness about their genetic predisposition to adverse responses will result in greater
discussion with prescribing physicians and pharmacists about the PGx results when new
treatments are prescribed, with greater attention to adverse effects of new drugs and
potentially greater medication compliance.
We will implement and evaluate two delivery models of PGx testing into primary care
practices: physician-initiated testing and pharmacist-initiated testing. Each practice will
be provided an educational intervention and will be surveyed prior to the seminar and
following the intervention period to assess primary care practitioner (PCP) knowledge and
attitudes about PGx testing. These surveys will take about 10-15 minutes to complete and will
be available through an online system like SurveyMonkey.
In the pharmacist-initiated group, a pharmacist based within the practice will identify
prescribed drugs with available PGx testing through chart review and provide specific
information and recommendations about PGx testing to the ordering physician. In the
physician-initiated group, physicians will order testing as they deem necessary, but will
also have on-call pharmacist support to consult.
Patients who are offered PGx testing will also be surveyed: once after deciding whether or
not to pursue PGx testing and then, if they consent to testing, after they receive their test
results. These surveys will take about 10-15 minutes to complete and will be on paper
(pretest) and online through a system like SurveyMonkey (post-test). The pretest survey will
have 3 sections: demographics, perceived risks and benefits of PGx testing, and satisfaction
with test results. The post-test will assess information-seeking behavior, medication
adherence, and knowledge of adverse drug reactions.
Chart reviews will be conducted throughout the study to collect various data-points. All
extracted data-points will be coded; the key will be stored in a separate file to minimize
any breach of privacy. In summary, the medical records of patients scheduled to be seen at
either clinic during the first or second phase of the study (see Figure 1) will be reviewed
to identify those patients that were prescribed a drug from Table 1. A post-intervention (the
third and final phase of the study) chart review will be conducted to monitor the number of
new prescriptions for drugs listed in Table 1, the frequency with which PGx testing is
ordered, by which physicians, and for which drugs.
We will conduct chart reviews at the end of each phase of the study (pre-intervention period,
intervention period, and post intervention period) of patients prescribed targeted
medications. No HIPAA (Health Insurance Portability and Accountability Act) identifiers will
be recorded.
All PCPs practicing at the two clinics involved in the study are eligible to participate. All
physicians who participate in the educational intervention in either arm will be invited to
participate in the pre and post-intervention surveys.
The patient survey population will include patients who were offered and consented or
declined testing. All patients 18 years and older who were prescribed a drug for which PGx
testing is available and offered a PGx test by their physician during the intervention period
will be asked to participate in the initial survey. Patients must be English-speaking and
able to complete the survey without assistance.
Chart review will include all patients who were scheduled an appointment at either of the
clinics within the designed study period. Data abstracted (full chart review) will be limited
to those patients who were prescribed a target drug during the designated period.
