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

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.

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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusettes General Hospital, Boston, Massachusetts, United States

About this study

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:

Where should screening and initial assessment occur, and who should administer the screening and assessment questionnaires?
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Must be a current primary care clinic patient

Exclusion criteria

Inability to provide informed consent

Treatment and study plan

Interviews with Stakeholders

Behavioral

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.

Primary outcomes

Patient level outcomes: diagnosis, and treatment referral

Time frame: 1 Year
Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.

Time frame: 1 year
Systems level outcomes: logistics and costs of introducing the CDEs.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

Icahn School of Medicine at Mount Sinai
Massachusetts General Hospital
Oregon Health and Science University

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Nov 28, 2016
Registry last updated: Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed