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

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.

Study Overview

• Status: Recruiting
• Conditions: Communication Disabilities
• Intervention / Treatment: Behavioral: Implementation Support Package

• Study Type: Interventional
• Enrollment (Estimated): 126870
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Morris, PhD; Phone Number: 646-501-0027; Email: megan.morris@nyulangone.org
• Study Contact Backup: Name: Sankeerth Jinna; Phone Number: 2122630844; Email: sankeerth.jinna@nyulangone.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • The University of Colorado Anschutz Medical Campus
      • Principal Investigator: Christina Studts, PhD
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health
      • Principal Investigator: Alicia Wong, MD
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Chicago
      • Principal Investigator: Jennifer Duffecy, MD
    • Evanston, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Principal Investigator: Carol Haywood, PhD
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Meghan Morris, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
No Intervention: Control Clinics; Clinics will not receive the implementation support package for patients with CD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Aim 2) Patient Reach	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	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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Megan Morris, PhD, megan.morris@nyulangone.org

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Communication Disorders
• Other Study ID Numbers: 25-00040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 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 Sharing Access Criteria: 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No