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
- Conditions
- Substance Abuse
- Interventions
- Behavioral: Meetings with implementation leader(s)Behavioral: the SAAS surveyBehavioral: 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
- English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.
- Inability to provide informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinic A1 Meetings with implementation leader(s) - Clinic A2 Patient surveys - Clinic B2 Patient surveys - Clinic B1 the SAAS survey - Clinic B2 the SAAS survey - Clinic B4 Patient surveys - Clinic A1 the SAAS survey - Clinic A2 Meetings with implementation leader(s) - Clinic B1 Meetings with implementation leader(s) - Clinic B2 Meetings with implementation leader(s) - Clinic B3 the SAAS survey - Clinic B3 Patient surveys - Clinic A1 Patient surveys - Clinic A2 the SAAS survey - Clinic B1 Patient surveys - Clinic B3 Meetings with implementation leader(s) - Clinic B4 Meetings with implementation leader(s) - Clinic B4 the SAAS survey -
- Primary Outcome Measures
Name Time Method Adoption of screening 12 Months % patients presenting for primary care visits who were screened in the past 12 months
Referral of high risk patients 12 Months % patients with high risk use who received referral to specialty care
Provider adoption of CDS 12 Months % patients with positive screens for which CDS was launched and completed
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States