An interventional study of Implementation Support Package in Communication Disabilities, sponsored by NYU Langone Health. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research
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.
149 studies on the registry are indexed under Communication Disorders; 44 are open to participants now.
This study's planned enrollment of 126,870 is above the median of 40 across 124 interventional studies indexed under Communication Disorders.
Browse Communication Disorders studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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EHR Data Extraction
Clinic Leadership, Providers \& Clinic Staff
Patients
Exclusion Criteria:
EHR Data Extraction
Clinic Leadership, Providers \& Clinic Staff Interviews and Focus Groups
Patient Interviews
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
Clinics will not receive the implementation support package for patients with CD.
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.
(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.
Time frame: 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.
Time frame: Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
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