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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 2

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 2

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02986841
Enrollment
72
Registered
2016-12-08
Start date
2016-05-10
Completion date
2018-09-01
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse

Brief summary

This is a 4-phase study to implement the NIDA (Common Data Elements) Common Data Elements (CDEs) in primary care settings. The study will be conducted at three adult primary care clinics, in two 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. Phase 2 prepares for implementation of the screening and CDS tools as part of routine clinical practice. A key component of this phase is tailoring the screening and CDS tools through an iterative process of usability testing and adaptation of their design. In the KTA framework, this phase corresponds to the 'select, tailor, and implement interventions' step. Simultaneously, investigators will plan for implementation in one clinic of the MSHS system by identifying clinical champions, educating clinic leadership and staff, and conducting a workflow analysis to identify barriers and facilitators of implementation.

Interventions

None listed

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* English speaking adult individuals aged 18 years or older, and employee at a Wave 1 clinic. * Clinical implementation leaders Clinical implementation leaders are practicing 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 clinic site to advise the research team on implementation and to serve as a resource for their colleagues.

Exclusion criteria

* Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Drug Abuse Screening Test (DAST-10)12 Months10-item brief screening tool that can be administered by a clinician or self-administered. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026