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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

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ClinicalTrials.gov Identifier: NCT02986841
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Massachusetts General Hospital
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
New York University School of Medicine

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.


Condition or disease
Substance Abuse

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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 2
Actual Study Start Date : May 10, 2016
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : December 1, 2018



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 50 end-user participants will be enrolled. Approximately 5 to 8 end-user participants are required for each cycle of usability testing.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986841


Contacts
Contact: Christine Chollack 646 501 2580 christine.chollack@nyumc.org
Contact: Sarah Farkas sarah.farkas@nyumc.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States
Contact: Melanie Harris         
Sponsors and Collaborators
New York University School of Medicine
Massachusetts General Hospital
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Jennifer McNeely, MD, MS New York University Medical School

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02986841     History of Changes
Other Study ID Numbers: 15-01099
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders