Implementation of Communication Disability Collection and Accommodations in Primary Care Settings
DECA
1 other identifier
interventional
126,870
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 15, 2026
CompletedFirst Posted
Study publicly available on registry
June 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
July 8, 2026
July 1, 2026
1.6 years
June 15, 2026
July 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
(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)
Study Arms (2)
Implementation Support Package Clinics
EXPERIMENTALClinics will receive an implementation support package, designed to integrate patients' disability status into the EHR and provide accommodations for patients with CD
Control Clinics
NO INTERVENTIONClinics will not receive the implementation support package for patients with CD.
Interventions
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.
Eligibility Criteria
You may qualify if:
- EHR Data Extraction
- Adults 18+ years
- Patients who had at least one visit within the 21-month EHR data collection period at participating study clinics.
- Clinic Leadership, Providers \& Clinic Staff
- Adults 18+ years
- Patients
- Adults 18+ years
- Patients with communication disabilities seen at least once at participating study clinics during the 21-month study period.
- 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.
You may not qualify if:
- EHR Data Extraction
- Patients whose records are unavailable due to technical issues.
- Patients who are not seen at least once at participating study clinics during the 21-month data collection period.
- Duplicate records (e.g., duplicative EHR records marked for deletion).
- Patients who have opted-out of research participation.
- Clinic Leadership, Providers \& Clinic Staff Interviews and Focus Groups
- Being \<18 years old
- Not an employed member of a participating study clinic or potential end user of the study implementation strategy.
- Patient Interviews
- Being \<18 years old
- Patients without communication disabilities.
- Patients with communication disabilities seen outside of participating study clinics.
- Patients who are unable to provide consent for themselves.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
The University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Denver Health
Denver, Colorado, 80204, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60611, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Megan Morris, PhD
megan.morris@nyulangone.org
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2026
First Posted
June 18, 2026
Study Start
September 1, 2025
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
July 8, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.