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
2 other identifiers
observational
113,123
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2016
CompletedFirst Posted
Study publicly available on registry
November 15, 2016
CompletedStudy Start
First participant enrolled
February 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2019
CompletedAugust 29, 2022
August 1, 2022
1.5 years
November 10, 2016
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Adoption of screening
% patients presenting for primary care visits who were screened in the past 12 months
12 Months
Provider adoption of CDS
% patients with positive screens for which CDS was launched and completed
12 Months
Referral of high risk patients
% patients with high risk use who received referral to specialty care
12 Months
Study Arms (6)
Clinic A1
Clinic A2
Clinic B1
Clinic B2
Clinic B3
Clinic B4
Interventions
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 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.
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
Eligibility Criteria
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.
You may qualify if:
- English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.
You may not qualify if:
- Inability to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Icahn School of Medicine at Mount Sinaicollaborator
- Massachusetts General Hospitalcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
McNeely J, Adam A, Rotrosen J, Wakeman SE, Wilens TE, Kannry J, Rosenthal RN, Wahle A, Pitts S, Farkas S, Rosa C, Peccoralo L, Waite E, Vega A, Kent J, Craven CK, Kaminski TA, Firmin E, Isenberg B, Harris M, Kushniruk A, Hamilton L. Comparison of Methods for Alcohol and Drug Screening in Primary Care Clinics. JAMA Netw Open. 2021 May 3;4(5):e2110721. doi: 10.1001/jamanetworkopen.2021.10721.
PMID: 34014326RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer McNeely, PhD
New York University Medical School
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2016
First Posted
November 15, 2016
Study Start
February 28, 2018
Primary Completion
September 9, 2019
Study Completion
September 9, 2019
Last Updated
August 29, 2022
Record last verified: 2022-08