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

NYU Langone Health

Status: Completed

Conditions: Substance Abuse

Treatments: Behavioral: Patient surveys; Behavioral: the SAAS survey; Behavioral: Meetings with implementation leader(s)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02963948

CTN-0062Ot (Other Identifier)

16-01373

Details and patient eligibility

About

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.

Full description

SPECIFIC AIMS

1. To program the NIDA CTN CDEs, the NIDA/ASAM 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).

Enrollment: 113,123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.

Exclusion criteria

• Inability to provide informed consent.

Trial design

113,123 participants in 6 patient groups

Clinic A1

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)

Clinic A2

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)

Clinic B1

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)

Clinic B2

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)

Clinic B3

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)

Clinic B4

Treatment:

Behavioral: the SAAS survey

Behavioral: Patient surveys

Behavioral: Meetings with implementation leader(s)