Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-01-10
Brief Title:
A Prospective Evaluation of Colorados New Statutory PDMP Mandates Compliance and Patient Outcomes
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Prospective Evaluation of Colorados New Statutory PDMP Mandates Compliance and Patient Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to test the impact of a clinical decision support CDS tool to improve health care provider practices in line with state law requiring review of the Colorado prescription drug monitoring program PDMP before prescribing an opioid analgesic pain medications often called narcotics or benzodiazepine sedatives or muscle relaxants The PDMP is a statewide database of filled controlled medication allowing health care providers to review medications ordered by other health care providers in the state and identify high-risk factors for overdose
The CDS tool only appears when a relevant prescription is being written by a health care provider and is purely informational not dictating care or changes in treatment
The study will track how the tool is used by health care providers if an opioid or benzodiazepine prescription is signed and future opioid use by patients
The CDS tool only appears when a relevant prescription is being written by a health care provider and is purely informational not dictating care or changes in treatment
The study will track how the tool is used by health care providers if an opioid or benzodiazepine prescription is signed and future opioid use by patients
Detailed Description:
Improving prescription drug monitoring PDMP use and the safety of controlled medication prescribing is a pillar of the national response to the worsening opioid crisis The evidence base for PDMPs would benefit greatly from research producing high quality actionable data linking and measuring PDMP use and important patient outcomes Data silos commonly limit the measurement of PDMP utilization and the linkage of PDMP use to provider prescribing actions Best practice data linkage strategies can facilitate a robust evaluation of PDMP effectiveness and specifically the impact of Colorados new PDMP regulations which mandate PDMP checks prior to opioid and benzodiazepine prescriptions with certain exceptions
The objective of this project is to improve data architecture across Colorados largest hospital system to effectively measure clinician PDMP use to address gaps in data compliance with statutes and important outcomes associated with new PDMP regulations By facilitating robust evaluations of process eg PDMP use opioid prescribing and patient outcomes eg future opioid use co-prescribing death this data system will expedite the measurement of PDMP effectiveness on changing opioid prescribing Further evaluation of clinical decision support CDS to promote compliance with regulation can determine if mandates result in increased PDMP use decreased opioid exposures high-risk prescriptions morbidity and mortality This project will enhance the PDMP in three key ways
Address inefficiencies of collecting PDMP use data Improved collection of PDMP data at the patient visit level will allow for rapid analysis of PDMP use and interventions
Implement effective PDMP interventions PDMP CDS tools can accelerate the uptake of mandated PDMP actions while routine data collection can be used to assess outcomes
Address sustainability Health system wide implementation will strengthen capacity to rapidly evaluate the effectiveness of multiple new PDMP policy interventions
The proposed project will achieve this using a single system pragmatic cluster randomized trial of CDS to deliver new state mandated PDMP regulations compared to usual care to evaluate PDMP use regulatory compliance and associated patient outcomes This will be performed across the UCHealth system in collaboration with Colorado Department of Regulatory Agencies DORA to maximize the quality and impact of the work and generate novel generalizable knowledge to support the progress of PDMPs
The objective of this project is to improve data architecture across Colorados largest hospital system to effectively measure clinician PDMP use to address gaps in data compliance with statutes and important outcomes associated with new PDMP regulations By facilitating robust evaluations of process eg PDMP use opioid prescribing and patient outcomes eg future opioid use co-prescribing death this data system will expedite the measurement of PDMP effectiveness on changing opioid prescribing Further evaluation of clinical decision support CDS to promote compliance with regulation can determine if mandates result in increased PDMP use decreased opioid exposures high-risk prescriptions morbidity and mortality This project will enhance the PDMP in three key ways
Address inefficiencies of collecting PDMP use data Improved collection of PDMP data at the patient visit level will allow for rapid analysis of PDMP use and interventions
Implement effective PDMP interventions PDMP CDS tools can accelerate the uptake of mandated PDMP actions while routine data collection can be used to assess outcomes
Address sustainability Health system wide implementation will strengthen capacity to rapidly evaluate the effectiveness of multiple new PDMP policy interventions
The proposed project will achieve this using a single system pragmatic cluster randomized trial of CDS to deliver new state mandated PDMP regulations compared to usual care to evaluate PDMP use regulatory compliance and associated patient outcomes This will be performed across the UCHealth system in collaboration with Colorado Department of Regulatory Agencies DORA to maximize the quality and impact of the work and generate novel generalizable knowledge to support the progress of PDMPs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15PBJA-22-GK-03114-PDMP | OTHER_GRANT | BJA | None |