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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 3

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ClinicalTrials.gov Identifier: NCT02963948
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : December 6, 2018
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York University School of Medicine

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 medical staff to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. Investigators 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.


Condition or disease Intervention/treatment
Substance Abuse Behavioral: Meetings with implementation leader(s) Behavioral: the SAAS survey Behavioral: Patient surveys

Detailed Description:

SPECIFIC AIMS

  1. To program the NIDA CTN CDEs, the NIDA/ASAM electronic Clinical Quality Measure (eCQM), and a lean decision support module into Epic.
  2. To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics / practices, including defining potential barriers and facilitators to their adoption.
  3. To evaluate the impact of implementation on:

    • Patient level outcomes (diagnosis, treatment referral);
    • Medical staff level outcomes (screening and assessment, clinical interventions including counseling and treatment referral); and
    • Systems level outcomes (logistics and costs of introducing the CDEs, feasibility).

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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Other
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 3
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Medical Staff
Approximately 40 medical staff will be enrolled for the focus groups
Behavioral: Meetings with implementation leader(s)
The perceived appropriateness of the intervention to medical staff will affect an intervention's initial adoption as well as sustainability. We will assess this through focus groups with staff, conducted approximately 1-2 months after implementation of the screening and CDS tools.

Medical staff surveyed using SAAS
Approximately 100 medical staff will be surveyed using the Substance Abuse Attitude Survey (SAAS)
Behavioral: the SAAS survey
Medical staff will be surveyed using the Substance Abuse Attitude Survey (SAAS) to gather information about attitudes from medical staff who do not participate in the focus groups, or may be uncomfortable sharing negative attitudes in a group of their peers. The SAAS is a validated multidimensional instrument that evaluates physician attitudes toward substance-using patients. It includes specific measures of attitudes toward permissiveness, treatment intervention, stereotypes, treatment optimism, and moralism, and has been used in prior studies of primary care physicians. Collecting information on staff attitudes toward substance users and substance use interventions will be helpful to inform about any sources for low adoption of the tools, and any needs for additional provider education and training.

Wave 1 Patients
Approximately 200 patients at a Wave 1 clinic
Behavioral: Patient surveys
Patient surveys regarding attitudes toward substance use screening and interventions in the primary care clinic will be distributed to patients presenting for care, regardless of whether they completed screening, at regular time periods throughout this study phase. The survey will be conducted for 1 week at the following approximate intervals following successful implementation: 1 month, 4 months, 7 months, and 10 months




Primary Outcome Measures :
  1. Adoption of screening [ Time Frame: 12 Months ]
    % patients presenting for primary care visits who were screened in the past 12 months

  2. Provider adoption of CDS [ Time Frame: 12 Months ]
    % patients with positive screens for which CDS was launched and completed

  3. Referral of high risk patients [ Time Frame: 12 Months ]
    % patients with high risk use who received referral to specialty care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Number of subjects:

  • Approximately 40 medical staff will be enrolled for the focus groups
  • Approximately 100 medical staff will be surveyed using Substance Abuse Attitude Survey (SAAS)
  • Approximately 200 patients at a Wave 1 clinic

Clinical implementation leaders Clinical implementation leaders are practicing primary care physicians (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 participating clinic will advise the research team on implementation and to serve as a resource for their colleagues.

Criteria

Inclusion Criteria:

  • English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.

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): NCT02963948


Contacts
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Contact: Christine Chollack 646 754 4795 Christine.Chollack@nyumc.org
Contact: Sarah Farkas 646 754 4795 Sarah.Farkas@nyumc.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Nicholas Carrellas       Ncarrellas@mgh.harvard.edu   
Contact: Lindsay Rosenthal       Lrosenthal@mgh.harvard.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Melanie Harris       Melanie.Harris@mountsinai.org   
Sponsors and Collaborators
New York University School of Medicine
Icahn School of Medicine at Mount Sinai
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jennifer McNeely, PhD New York University Medical School

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02963948     History of Changes
Other Study ID Numbers: 16-01373
CTN-0062Ot ( Other Identifier: NIDA )
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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