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 1

NCT02974335 | Completed

• 1 other identifier: 14-01948
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs, and assisting primary care providers to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. We aim to maximize the efficient adoption of screening, CDS, and treatment referrals by integrating all of these activities into the electronic health record (EHR). The study will be conducted at three sites, representing three 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.

Conditions

Addiction

Outcome Measures

Primary Outcomes (3)

• Patient level outcomes: diagnosis, and treatment referral

  1 Year

• Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.

  1 year

• Systems level outcomes: logistics and costs of introducing the CDEs.

  1 year

Study Arms (3)

Primary Care Providers (PCPs)

Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.

Behavioral: Interviews with Stakeholders

Medical Assistants (MAs) + Registered Nurses (RNs)

Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.

Behavioral: Interviews with Stakeholders

Patients

Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems.

Behavioral: Interviews with Stakeholders

Interventions

Interviews with Stakeholders BEHAVIORAL

The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.

Medical Assistants (MAs) + Registered Nurses (RNs); Patients; Primary Care Providers (PCPs)

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

Patients will be recruited from the three clinics where we plan to implement study Phases 2-4. Clinic staff will give recruitment flyers to all patients registering for appointments in the week prior to each focus group. Potential participants who are interested in participating will call the Research Coordinator, who will assess eligibility and schedule them for the appropriate group. Groups will be divided based on age; one group will include participants under age 50, and a second group will include those age 50 and over. This grouping strategy is chosen because individuals in these age groups are anticipated to differ in their substance use patterns, medical needs, and concerns about screening procedures.

You may qualify if:

• Must be a current primary care clinic patient

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

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

Study Sites (3)

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: a qualitative study of patients, providers, and staff. Addict Sci Clin Pract. 2018 Apr 9;13(1):8. doi: 10.1186/s13722-018-0110-8.

  PMID: 29628018 RESULT

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennifer McNeely

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 28, 2016
• Study Start: July 25, 2017
• Primary Completion: April 5, 2019
• Study Completion: April 5, 2019
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (3)