Menu
Recruiting NCT07656584

Implementation of Communication Disability Collection and Accommodations in Primary Care Settings

No phase Interventional Communication Disabilities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementation Support Package.
Who it may be relevant to
Registry conditions: Communication Disabilities. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • (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)]

Eligibility criteria

Inclusion criteria

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
  • 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

  • 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 5 centers
  • The University of Colorado Anschutz Medical Campus — Aurora
  • Denver Health — Denver
  • University of Illinois Chicago — Chicago
  • Northwestern University — Evanston
  • NYU Langone Health — New York

Identifiers

NCT: NCT07656584 · 25-00040

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗