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:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	7/19/2018
Start Date:	July 25, 2017
End Date:	June 2020
Contact:	Christine Chollack
Email:	christine.chollack@nyumc.org
Phone:	646 501 2580

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.

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 (e.g., PHQ2 and PHQ9)? Should
screening be embedded in a broad behavioral health screen (e.g., 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.

Inclusion Criteria:

- Must be a current primary care clinic patient

Exclusion Criteria:

- Inability to provide informed consent

We found this trial at

sites

Massachusettes General Hospital

Boston, Massachusetts 02114

from

Boston, MA