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

NCT ID: NCT02986841

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-10

Study Completion Date

2018-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Abuse

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer McNeely, MD, MS

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-01099

Identifier Type: -

Identifier Source: org_study_id

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