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OpenTrials
Completed

NCT Number: NCT02986841

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Drug Abuse Screening Test (DAST-10)

    Time frame: 12 Months

    10-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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • Massachusetts General Hospital

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2016
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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