Ignite Creation Date:
2024-05-06 @ 9:22 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02963948
Status:
COMPLETED
Last Update Posted:
2022-08-29
First Post:
2016-11-10
Brief Title:
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements CDEs Into the Electronic Health Record EHR in Large Primary Care Settings CDE-EHR-PC Study Phase 3
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements CDEs Into the Electronic Health Record EHR in Large Primary Care Settings CDE-EHR-PC Study Phase 3
Status:
COMPLETED
Status Verified Date:
2022-08
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:
This is a 4-phase study to implement the NIDA CDEs in primary care settings Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs and assisting primary care medical staff to offer appropriate interventions by providing clinical decision support CDS and a mechanism for making referrals to addiction treatment Investigators aim to maximize the efficient adoption of screening CDS and treatment referrals by integrating all of these activities into the electronic health record EHR
The study will be conducted at three sites representing three large health systems Each phase will include deliverables essential to move to the next phase and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase Based on progress during earlier phases the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4
The study will be conducted at three sites representing three large health systems Each phase will include deliverables essential to move to the next phase and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase Based on progress during earlier phases the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4
Detailed Description:
SPECIFIC AIMS
1 To program the NIDA CTN CDEs the NIDAASAM electronic Clinical Quality Measure eCQM and a lean decision support module into Epic
2 To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics practices including defining potential barriers and facilitators to their adoption
3 To evaluate the impact of implementation on
Patient level outcomes diagnosis treatment referral
Medical staff level outcomes screening and assessment clinical interventions including counseling and treatment referral and
Systems level outcomes logistics and costs of introducing the CDEs feasibility
1 To program the NIDA CTN CDEs the NIDAASAM electronic Clinical Quality Measure eCQM and a lean decision support module into Epic
2 To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics practices including defining potential barriers and facilitators to their adoption
3 To evaluate the impact of implementation on
Patient level outcomes diagnosis treatment referral
Medical staff level outcomes screening and assessment clinical interventions including counseling and treatment referral and
Systems level outcomes logistics and costs of introducing the CDEs feasibility
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTN-0062Ot | OTHER | NIDA | None |