Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06215560
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-27
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Evaluation of Colorado's New Statutory PDMP Mandates: Compliance and Patient Outcomes
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
A Prospective Evaluation of Colorado's New Statutory PDMP Mandates: Compliance and Patient Outcomes
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
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 Colorado's 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 Colorado's 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 (e.g., PDMP use, opioid prescribing) and patient outcomes (e.g., 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 Colorado's 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 (e.g., PDMP use, opioid prescribing) and patient outcomes (e.g., 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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 15PBJA-22-GK-03114-PDMP | OTHER_GRANT | BJA | View |