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

Addiction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974335
• Other study ID #: 14-01948
• Status: Completed
• Start date: July 25, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be a current primary care clinic patient

Exclusion Criteria:

• Inability to provide informed consent

Related Conditions & MeSH terms

• Addiction
• Behavior, Addictive

Intervention

Behavioral:
• Interviews with 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.

Locations

Country	Name	City	State
United States	Massachusettes General Hospital	Boston	Massachusetts
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient level outcomes: diagnosis, and treatment referral		1 Year
Primary	Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.		1 year
Primary	Systems level outcomes: logistics and costs of introducing the CDEs.		1 year