Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT07656584

Conditions

Communication Disabilities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implementation Support Package

Study Details

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.

Conditions

Communication Disabilities

Study ID

NCT07656584

Start date

Sep 1, 2025

Status verified date

Jul, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126870 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

no intervention: Control Clinics

Clinics will not receive the implementation support package for patients with CD.

Interventions

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.

Primary outcome measure

  • (Aim 2) Patient Reach [ Time Frame: Baseline, Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21) ]
  • (Aim 3) Adoption [ Time Frame: Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21) ]

Central Contacts and Locations

Locations

The University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Christina Studts, PhD

Denver Health

Recruiting

Denver, Colorado, United States, 80204

Principal Investigator:

Alicia Wong, MD

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Jennifer Duffecy, MD

Northwestern University

Recruiting

Evanston, Illinois, United States, 60611

Principal Investigator:

Carol Haywood, PhD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Meghan Morris, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-08.