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

NCT02986841 | Completed

• 1 other identifier: 15-01099
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (1)

• Drug Abuse Screening Test (DAST-10)

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• NYU Langone Health: lead
• Massachusetts General Hospital: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jennifer McNeely, MD, MS

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: December 8, 2016
• Study Start: May 10, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

US (2)