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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01GM081416-08A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study aims to compare patient use of and satisfaction with community pharmacist-delivered pharmacogenetic (PGx) testing delivered along or as part of a medication therapy management (MTM) service. Pharmacist and patient outcome measures will be collected by surveys, interviews, and review of pharmacy records.
This study aims to investigate the delivery of pharmacogenetic (PGx) testing alone or in combination with Medication Therapy Management (MTM) in the community pharmacy setting in order to assess and compare the two delivery models. Using a clust randomized trial, these effects of these two models will be compared. Pharmacist and patient outcome measures will be collected by survey, interviews, and review of pharmacy records. The investigators intend to compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess impact on workflow/operations) and patient perspective (to assess acceptance of testing, understanding of results, medication adherence, and overall satisfaction with delivery model). In the PGx only arm, pharmacists will offer PGx testing to patients who are prescribed one of the 10 eligible drugs (aripiprazole, carisoprodol, celecoxib, citalopram, clopidogrel, metoprolol, nortriptyline, paroxetine, simvastatin, warfarin) and will return results to the patient and physician with any recommendations for drug or dosage changes based on results. In the PGx and MTM arm, pharmacists will offer PGx testing to patients prescribed one of the 10 eligible drugs and provide two MTM sessions: one at the time of testing, and one when results are returned. All patients will be surveyed before PGx testing and 3 months after receiving results. Pharmacists will be surveyed prior to their participation and following the conclusion of the study. Pharmacists will also conduct a chart review of patients and document all interactions with enrolled patients and their providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGx Only | Experimental | Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results. |
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| PGx + MTM | Experimental | Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Therapy Management | Other | Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting | Post-Study Survey question: "Now that you know your test results, would you have taken the test in the first place?" (Response: 'would definitely' have taken the test) | Post-study Survey (after test results received) |
| Number of Patient Participants Who Recalled All Test Results | Post-Study Survey Question: "As best you can, please choose the result of your drug response test for the following genes" (Response: Result selected for all 5 genes) | Post-study (after test results received) |
| Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile | Patient survey question - "Did you feel your time spent with the pharmacist was worthwhile?". Reported as number of participants who selected answer choice "Yes, definitely". | Post-study (after test results received) |
| Number of Patient Participants' With High Medication Adherence | Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree") | Baseline (prior to testing) |
| Number of Patient Participants With High Medication Adherence (Post-study) | Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree") | Post-Study (after test results received) |
| Number of Patient Participants Who Reported Understanding of Implications of Test Results | Post_Study Survey Question: Please indicate your level of agreement with the following statement: "I understood clearly my choices for prevention or early detection of side effects." (Response: "Sometimes/Often") |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing | Pharmacist Post-Survey Question: How likely are you to continue providing PGx testing in your pharmacy after the conclusion of the study? (Answer response: "definitely continue") | Post-study (3 months) |
| Average Score of PGx Knowledge Assessment by Pharmacist Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27708 | United States |
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Enrolled 154 patient participants and 36 pharmacist participants for a total of 190. Patients and pharmacists were assigned to the PGx only or PGx + MTM study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | PGx Only (Patients) | Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists. |
| FG001 | PGx + MTM (Patients) | Patients received pharmacogenetic testing along with medication therapy management (MTM). Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists made recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Data collected from both patients and pharmacists. Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing |
| FG002 | PGx Only (Pharmacists) | Patients received pharmacogenetic testing only. Participating pharmacist made recommendations for drug/dose changes based on PGx results. Data collected from both patients and pharmacists. |
| FG003 | PGx + MTM (Pharmacists) | Patients received pharmacogenetic testing plus medication therapy management (MTM). Participating pharmacist made recommendations for drug/dose changes based on PGx results and conducted MTM. Data collected from both patients and pharmacists. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participating patients who completed the study. No baseline data collected for participating pharmacists.
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| ID | Title | Description |
|---|---|---|
| BG000 | PGx Only (Patients) | Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results. Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing. |
| BG001 | PGx + MTM (Patients) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patient Participants' Acceptance of PGx Services Offered in Community Pharmacy Setting | Post-Study Survey question: "Now that you know your test results, would you have taken the test in the first place?" (Response: 'would definitely' have taken the test) | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Post-study Survey (after test results received) |
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Data collected from enrollment through 6 months follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PGx Only (Patients) | Patients will receive pharmacogenetic testing. Pharmacists will make recommendations for drug/dose changes based on PGx results. Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanne B Haga | Duke University School of Medicine | 919-684-0325 | susanne.haga@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2017 | May 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| C099588 | myotubularin |
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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| Pharmacogenetic testing | Other | Community pharmacist will provide pharmacogenetic testing. |
|
|
| Post-study (after test results received) |
7-question knowledge assessment of pharmacogenetics. Possible Score Range 0-7; actual range 3-7 (higher scores correspond to higher number of correct answers/higher knowledge) |
| Baseline (prior to start of study) |
| Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing | Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: "reimbursement") | Post-study (3 months) |
| Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing | Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree"). | Post-study (3 months) |
| Lost to Follow-up |
|
Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Number of Patient Participants Who Recalled All Test Results | Post-Study Survey Question: "As best you can, please choose the result of your drug response test for the following genes" (Response: Result selected for all 5 genes) | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Post-study (after test results received) |
|
|
|
| Primary | Number of Patient Participants Who Considered Time With Pharmacist to be Worthwhile | Patient survey question - "Did you feel your time spent with the pharmacist was worthwhile?". Reported as number of participants who selected answer choice "Yes, definitely". | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Post-study (after test results received) |
|
|
|
| Primary | Number of Patient Participants' With High Medication Adherence | Pre-study (baseline) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree") | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Baseline (prior to testing) |
|
|
|
| Primary | Number of Patient Participants With High Medication Adherence (Post-study) | Post-study (follow-up) survey question: "In the last 7 days, I took all doses as prescribed" (Response: "strongly agree") | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Post-Study (after test results received) |
|
|
|
| Primary | Number of Patient Participants Who Reported Understanding of Implications of Test Results | Post_Study Survey Question: Please indicate your level of agreement with the following statement: "I understood clearly my choices for prevention or early detection of side effects." (Response: "Sometimes/Often") | Participants who completed the pre/post-study surveys. | Posted | Count of Participants | Participants | Post-study (after test results received) |
|
|
|
| Secondary | Number of Pharmacist Participants Who Reported Strong Likelihood to Continue to Deliver PGx Testing | Pharmacist Post-Survey Question: How likely are you to continue providing PGx testing in your pharmacy after the conclusion of the study? (Answer response: "definitely continue") | Pharmacists who completed the survey. | Posted | Count of Participants | Participants | Post-study (3 months) |
|
|
|
| Secondary | Average Score of PGx Knowledge Assessment by Pharmacist Participants | 7-question knowledge assessment of pharmacogenetics. Possible Score Range 0-7; actual range 3-7 (higher scores correspond to higher number of correct answers/higher knowledge) | All participating pharmacists. | Posted | Mean | Full Range | score on a scale | Baseline (prior to start of study) |
|
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| Secondary | Number of Pharmacist Participants Who Reported 'Reimbursement' as Most Common Barrier to Delivery of PGx Testing | Pharmacist Post-Survey Question: Of the following potential barriers to providing PGx testing services, please indicate the greatest perceived barrier (most common response: "reimbursement") | Pharmacists who completed the study. | Posted | Count of Participants | Participants | Post-study (3 months) |
|
|
|
| Secondary | Number of Participating Pharmacists Who Feel Qualified to Deliver PGx Testing | Pharmacist Post-Study survey question: I feel qualified to provide PGx testing at my pharmacy (Answer response: "strongly agree/agree"). | Pharmacists who completed the survey. | Posted | Count of Participants | Participants | Post-study (3 months) |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | PGx + MTM (Patients) | Patients will receive pharmacogenetic testing along with medication therapy management. Two MTM sessions will be conducted: one at the time testing is ordered and the testing sample is collected, and one when results are returned to the patient. Pharmacists will make recommendations for drug/dose changes based on medication action plan developed during MTM and the PGx results. Medication Therapy Management: Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing Pharmacogenetic testing: Community pharmacist will provide pharmacogenetic testing. | 0 | 83 | 0 | 83 | 0 | 83 |
| EG002 | PGx Only (Pharmacists) | Participating pharmacists provided participating patients with pharmacogenetic testing only | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | PGx + MTM (Pharmacists) | Participating pharmacists provided participating patients with pharmacogenetic testing along with medication therapy management (MTM) | 0 | 21 | 0 | 21 | 0 | 21 |
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| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |