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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

Completed
Conditions
Substance Abuse
Interventions
Behavioral: Meetings with implementation leader(s)
Behavioral: the SAAS survey
Behavioral: Patient surveys
Registration Number
NCT02963948
Lead Sponsor
NYU Langone Health
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 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.

Detailed 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).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
113123
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.
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Exclusion Criteria
  • Inability to provide informed consent.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Clinic A1Meetings with implementation leader(s)-
Clinic A2Patient surveys-
Clinic B2Patient surveys-
Clinic B1the SAAS survey-
Clinic B2the SAAS survey-
Clinic B4Patient surveys-
Clinic A1the SAAS survey-
Clinic A2Meetings with implementation leader(s)-
Clinic B1Meetings with implementation leader(s)-
Clinic B2Meetings with implementation leader(s)-
Clinic B3the SAAS survey-
Clinic B3Patient surveys-
Clinic A1Patient surveys-
Clinic A2the SAAS survey-
Clinic B1Patient surveys-
Clinic B3Meetings with implementation leader(s)-
Clinic B4Meetings with implementation leader(s)-
Clinic B4the SAAS survey-
Primary Outcome Measures
NameTimeMethod
Adoption of screening12 Months

% patients presenting for primary care visits who were screened in the past 12 months

Referral of high risk patients12 Months

% patients with high risk use who received referral to specialty care

Provider adoption of CDS12 Months

% patients with positive screens for which CDS was launched and completed

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

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