- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States
- Massachusetts General Hospital
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New York
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New York, New York, United States
- Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer McNeely, MD, MS, New York University Medical School
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-01099
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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