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

Substance Abuse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963948
• Other study ID #: 16-01373
• Secondary ID: CTN-0062Ot
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: September 9, 2019

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113123
• Est. completion date: September 9, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
NYU Langone Health	Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adoption of screening	% patients presenting for primary care visits who were screened in the past 12 months	12 Months
Primary	Provider adoption of CDS	% patients with positive screens for which CDS was launched and completed	12 Months
Primary	Referral of high risk patients	% patients with high risk use who received referral to specialty care	12 Months