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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113,123
- 试验地点
- 2
- 主要终点
- Adoption of screening
研究概览
简要总结
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.
详细描述
SPECIFIC AIMS
- To program the NIDA CTN CDEs, the NIDA/ASAM electronic Clinical Quality Measure (eCQM), and a lean decision support module into Epic.
- 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.
- 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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.
排除标准
- •Inability to provide informed consent.
结局指标
主要结局
Adoption of screening
时间窗: 12 Months
% patients presenting for primary care visits who were screened in the past 12 months
Referral of high risk patients
时间窗: 12 Months
% patients with high risk use who received referral to specialty care
Provider adoption of CDS
时间窗: 12 Months
% patients with positive screens for which CDS was launched and completed
次要结局
未报告次要终点