Clinical trial NCT02963948: 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
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 3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Abuse
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: Massachusetts General Hospital
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-11-15
Enrollment: 113123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Number of subjects:

* Approximately 40 medical staff will be enrolled for the focus groups
* Approximately 100 medical staff will be surveyed using Substance Abuse Attitude Survey (SAAS)
* Approximately 200 patients at a Wave 1 clinic

Clinical implementation leaders Clinical implementation leaders are practicing primary care physicians (PCPs) who provide feedback to the research team and support their colleagues on implementing screening, using the CDS, and carrying out clinical interventions and referrals to address unhealthy substance use. One or two primary care providers will be identified from each participating clinic will advise the research team on implementation and to serve as a resource for their colleagues.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Adoption of screening
timeFrame: 12 Months
measure: Provider adoption of CDS
timeFrame: 12 Months
measure: Referral of high risk patients
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: New York University Medical School
name: Jennifer McNeely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNeely J, Adam A, Rotrosen J, Wakeman SE, Wilens TE, Kannry J, Rosenthal RN, Wahle A, Pitts S, Farkas S, Rosa C, Peccoralo L, Waite E, Vega A, Kent J, Craven CK, Kaminski TA, Firmin E, Isenberg B, Harris M, Kushniruk A, Hamilton L. Comparison of Methods for Alcohol and Drug Screening in Primary Care Clinics. JAMA Netw Open. 2021 May 3;4(5):e2110721. doi: 10.1001/jamanetworkopen.2021.10721.