Ignite Creation Date:
2024-05-06 @ 9:24 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02974335
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 1
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 1
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 providers to offer appropriate interventions by providing clinical decision support CDS and a mechanism for making referrals to addiction treatment We 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:
Phase 1 involves identifying the optimal screening tools and approaches for capturing CDE data programming the screening tools and CDEs into the Epic EHR and soliciting stakeholder input regarding implementation strategies for screening and clinical interventions including treatment referrals to address substance use
In the KTA framework Phase 1 addresses the first steps in the action cycle which are to identify review and select the tools that are to be implemented adapt tools to the local context assess barriers to use of the tools and begin the process of implementation by programming these tools into the Epic EHR We will accomplish these steps primarily through interviews and focus groups with key stakeholders The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients and to build the EHR tools CDEs and CDS that will be further tailored and tested in Phase 2 and then implemented in one clinic in Phase 3
Research Questions and Aims
The research questions that Phase 1 seeks to address are
1 Where should screening and initial assessment occur and who should administer the screening and assessment questionnaires
2 Is it better to screen for drugs only or for drugs and alcohol or for drugs alcohol and tobacco Should screening also include depression eg PHQ2 and PHQ9 Should screening be embedded in a broad behavioral health screen eg a comprehensive health risk assessment such as My Own Health Report 30
The specific aim that corresponds to Phase 1 is Aim 1 To program the NIDA CTN CDEs and a lean decision support module into Epic This phase will also define potential barriers and facilitators to the adoption of the CDEs and CDS which is a component of Specific Aim 2
In the KTA framework Phase 1 addresses the first steps in the action cycle which are to identify review and select the tools that are to be implemented adapt tools to the local context assess barriers to use of the tools and begin the process of implementation by programming these tools into the Epic EHR We will accomplish these steps primarily through interviews and focus groups with key stakeholders The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients and to build the EHR tools CDEs and CDS that will be further tailored and tested in Phase 2 and then implemented in one clinic in Phase 3
Research Questions and Aims
The research questions that Phase 1 seeks to address are
1 Where should screening and initial assessment occur and who should administer the screening and assessment questionnaires
2 Is it better to screen for drugs only or for drugs and alcohol or for drugs alcohol and tobacco Should screening also include depression eg PHQ2 and PHQ9 Should screening be embedded in a broad behavioral health screen eg a comprehensive health risk assessment such as My Own Health Report 30
The specific aim that corresponds to Phase 1 is Aim 1 To program the NIDA CTN CDEs and a lean decision support module into Epic This phase will also define potential barriers and facilitators to the adoption of the CDEs and CDS which is a component of Specific Aim 2
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