Trial Outcomes & Findings for Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients (NCT NCT04630093)
NCT ID: NCT04630093
Last Updated: 2023-10-04
Results Overview
The primary feasibility outcome will be change in patient treatment satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) to synthesize a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.
COMPLETED
NA
100 participants
6 months
2023-10-04
Participant Flow
Participant milestones
| Measure |
Panel-based Pharmacogenetic Genotyping
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot of Preemptive Pharmacogenetics in Medically Underserved Patients
Baseline characteristics by cohort
| Measure |
Panel-based Pharmacogenetic Genotyping
n=99 Participants
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
|
Reported annual household income
Less than $25,000
|
28 Participants
n=5 Participants
|
|
Reported annual household income
$25,001-$50,000
|
20 Participants
n=5 Participants
|
|
Reported annual household income
$50,001-$75,000
|
3 Participants
n=5 Participants
|
|
Reported annual household income
$75,001-$100,000
|
3 Participants
n=5 Participants
|
|
Reported annual household income
Greater than $100,000
|
1 Participants
n=5 Participants
|
|
Reported annual household income
Unknown
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe primary feasibility outcome will be change in patient treatment satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) to synthesize a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.
Outcome measures
| Measure |
Panel-based Pharmacogenetic Genotyping
n=99 Participants
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Baseline
|
59.9 score on a scale
Standard Deviation 16.9
|
|
Change in Global Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
6 months
|
64.4 score on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: 6 monthsChange in patient treatment effectiveness satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.
Outcome measures
| Measure |
Panel-based Pharmacogenetic Genotyping
n=99 Participants
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
baseline
|
59.6 score on a scale
Standard Deviation 14.4
|
|
Change in Patient Treatment Effectiveness Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
6 months
|
63.3 score on a scale
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 6 monthsChange in patient treatment side effect satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.
Outcome measures
| Measure |
Panel-based Pharmacogenetic Genotyping
n=99 Participants
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
baseline
|
84.2 score on a scale
Standard Deviation 24.0
|
|
Change in Patient Treatment Side Effect Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
6 months
|
85.5 score on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: 6 monthsChange in patient treatment convenience satisfaction between baseline and 6 months after pharmacogenetic testing. This patient reported outcome will be measured via the TSQM. The TSQM is a validated tool that assesses three medication-related domains (effectiveness, side effects, and convenience) and a global satisfaction score. TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that each domain.
Outcome measures
| Measure |
Panel-based Pharmacogenetic Genotyping
n=99 Participants
All patients will receive clinical preemptive pharmacogenetic testing. Genotype results and consult notes will returned in the EHR pre-emptively. Data on implementation success metrics and PROs via patient report and TSQM measures will be collected. In addition, data on effectiveness outcomes and socioeconomic measures will be collected via the EHR and patient report, respectively.
Panel-based pharmacogenetic genotyping: A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
|
|---|---|
|
Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
baseline
|
67.7 score on a scale
Standard Deviation 13.2
|
|
Change in Patient Treatment Convenience Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
6 months
|
70.1 score on a scale
Standard Deviation 11.7
|
Adverse Events
Panel-based Pharmacogenetic Genotyping
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place