Trial Outcomes & Findings for Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool (NCT NCT03936985)
NCT ID: NCT03936985
Last Updated: 2024-07-11
Results Overview
To assess the validity of the PDMP Narcotic Score, the AUC (Area Under the Curve) was used. AUC ranges in value from 0 to 1. A model whose predictions are 100% wrong has an AUC of 0.0; one whose predictions are 100% correct has an AUC of 1.0. And when AUC is 0.5, it means the model has no means of separating between the different groups. For this study, the closer to 1.0 the more similar the PDMP Narcotic Score is to the WHO ASSIST.
COMPLETED
1464 participants
The ASSIST was administered once at Day 1.
2024-07-11
Participant Flow
Participant milestones
| Measure |
All Participants
Study participants were patients of one of the 19 study pharmacies, completed the survey, and had sufficient data in the prescription drug monitoring program to generate the Narcotic Score (NS)
|
|---|---|
|
Overall Study
STARTED
|
1464
|
|
Overall Study
COMPLETED
|
1464
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
Baseline characteristics by cohort
| Measure |
All Participants
n=1464 Participants
Study participants were patients of one of the 19 study pharmacies, completed the survey, and had sufficient data in the prescription drug monitoring program to generate the Narcotic Score (NS)
|
|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
911 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
553 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1447 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Prescription Opioids
Low
|
772 Participants
n=5 Participants
|
|
Prescription Opioids
Moderate
|
623 Participants
n=5 Participants
|
|
Prescription Opioids
High
|
33 Participants
n=5 Participants
|
|
Prescription Opioids
Unknown/Not responded
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The ASSIST was administered once at Day 1.Population: Participants who complete the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST).
To assess the validity of the PDMP Narcotic Score, the AUC (Area Under the Curve) was used. AUC ranges in value from 0 to 1. A model whose predictions are 100% wrong has an AUC of 0.0; one whose predictions are 100% correct has an AUC of 1.0. And when AUC is 0.5, it means the model has no means of separating between the different groups. For this study, the closer to 1.0 the more similar the PDMP Narcotic Score is to the WHO ASSIST.
Outcome measures
| Measure |
High to Moderate Risk
n=33 Participants
High- compared to moderate-risk for prescription opioid use on the ASSIST
|
Moderate to Low Risk
n=1395 Participants
Moderate- compared to low-risk for prescription opioid use on the ASSIST
|
|---|---|---|
|
Validity of the PDMP Narcotic Score Versus the WHO ASSIST
|
.70 probability
Interval 0.59 to 0.8
|
.74 probability
Interval 0.71 to 0.76
|
Adverse Events
All Participants
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