Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02963948
Enrollment
113123
Registered
2016-11-15
Start date
2018-02-28
Completion date
2019-09-09
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse

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.

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).

Interventions

BEHAVIORALMeetings 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.

BEHAVIORALthe 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.

BEHAVIORALPatient 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

Sponsors

Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
Massachusetts General Hospital
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Referral of high risk patients12 Months% patients with high risk use who received referral to specialty care
Adoption of screening12 Months% patients presenting for primary care visits who were screened in the past 12 months
Provider adoption of CDS12 Months% patients with positive screens for which CDS was launched and completed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026