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Implementation of Communication Disability Collection and Accommodations in Primary Care Settings (DECA)

2026年7月6日 更新者：NYU Langone Health
This multi-methods-multi-site study aims to adapt and evaluate the effects of an implementation support package of strategies to assist primary care clinics in documenting patients' communication disability (CD) and accommodation needs in the electronic health record (EHR) and providing communication accommodations through EHR data extraction, surveys, focus groups, interviews, and clinical practice observations.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

126870

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • The University of Colorado Anschutz Medical Campus
        • 首席研究员：
          • Christina Studts, PhD
      • Denver、Colorado、美国、80204
        • 招聘中
        • Denver Health
        • 首席研究员：
          • Alicia Wong, MD
    • Illinois
      • Chicago、Illinois、美国、60612
        • 招聘中
        • University of Illinois Chicago
        • 首席研究员：
          • Jennifer Duffecy, MD
      • Evanston、Illinois、美国、60611
        • 招聘中
        • Northwestern University
        • 首席研究员：
          • Carol Haywood, PhD
    • New York
      • New York、New York、美国、10016
        • 招聘中
        • NYU Langone Health
        • 首席研究员：
          • Meghan Morris, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

EHR Data Extraction

  1. Adults 18+ years
  2. Patients who had at least one visit within the 21-month EHR data collection period at participating study clinics.

Clinic Leadership, Providers & Clinic Staff

  1. Adults 18+ years
  2. Individuals of all genders and members of all racial and ethnic categories employed at participating study clinics will be eligible for inclusion. NYULH study personnel will enroll providers and staff referred for study inclusion from all participating study clinics; not just NYULH staff exclusively.

Patients

  1. Adults 18+ years
  2. Patients with communication disabilities seen at least once at participating study clinics during the 21-month study period.
  3. Patients who self-identify as proficient in English communication as defined by English being a preferred language, or self-reported ability to participate in an interview in English without the support of an interpreter.

Exclusion Criteria:

EHR Data Extraction

  1. Patients whose records are unavailable due to technical issues.
  2. Patients who are not seen at least once at participating study clinics during the 21-month data collection period.
  3. Duplicate records (e.g., duplicative EHR records marked for deletion).
  4. Patients who have opted-out of research participation.

Clinic Leadership, Providers & Clinic Staff Interviews and Focus Groups

  1. Being <18 years old
  2. Not an employed member of a participating study clinic or potential end user of the study implementation strategy.

Patient Interviews

  1. Being <18 years old
  2. Patients without communication disabilities.
  3. Patients with communication disabilities seen outside of participating study clinics.
  4. Patients who are unable to provide consent for themselves.
  5. Patients who report not being proficient in English communication or self-reported inability to participate in an interview in English without the support of an interpreter.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Implementation Support Package Clinics
Clinics will receive an implementation support package, designed to integrate patients' disability status into the EHR and provide accommodations for patients with CD
行为的：Implementation Support Package
The implementation support package includes materials, activities, and procedures ready for use in diverse primary care practices and will facilitate each clinic's determination of how they will implement collection of disability status and provision of accommodations.
无干预：Control Clinics
Clinics will not receive the implementation support package for patients with CD.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
(Aim 2) Patient Reach
大体时间：Baseline, Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
Percent of patients who have a visit during the time of data collection and have the communication disability field completed in the EHR. A positive outcome for having the communication disability field completed in the EHR will be "no disability" "speech/language disability", "hearing disability", "decline", or "other" documented in the EHR, while a negative outcome will be the CD fields being left blank. All adult patients who are seen in each clinic are eligible to have their disability status documented, regardless of the type of visit.
Baseline, Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
(Aim 3) Adoption
大体时间：Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
Adoption assessed for all the patients with a recorded accommodation need; measured as the percentage of clinical encounters in which the accommodation was provided and used, as ascertained through the EHR.
Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NYU Langone Health

调查人员

  • 首席研究员：Megan Morris, PhD、megan.morris@nyulangone.org

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月1日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2027年5月31日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 25-00040

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The de-identified participant data from the final research dataset will be deposited to the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR) to ensure that the research community has long-term access to the data. These files may be accessed directly through the ICPSR website. After agreeing to Terms of Use, users with an ICPSR My Data account and an authorized IP address from a member institution may download the data, and non-members may purchase the files. The research data from this project will be supplied to ICPSR for permanent storage at the end of the project and incrementally; all data not otherwise published by the end of the grant period will be embargoed for one year to allow finalizations of manuscripts and data preparation for sharing. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

IPD 共享时间框架

The research data from this project will be supplied to ICPSR for permanent storage at the end of the project and incrementally; all data not otherwise published by the end of the grant period will be embargoed for one year to allow finalizations of manuscripts and data preparation for sharing.

IPD 共享访问标准

Users with an ICPSR My Data account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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