Communication DisabilitiesDECANCT07656584
Implementation of Communication Disability Collection and Accommodations in Primary Care Settings
A study testing Implementation Support Package in people with Communication Disabilities, run by NYU Langone Health at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication Disabilities
- What is being tested?
- Implementation Support Package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126,870 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Sep 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
The University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Christina Studts, PhD
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Jennifer Duffecy, MD
- Recruiting
Denver Health
Denver, Colorado, 80204
Alicia Wong, MD
- Recruiting
Northwestern University
Evanston, Illinois, 60611
Carol Haywood, PhD
- Recruiting
NYU Langone Health
New York, New York, 10016
Meghan Morris, PhD
About this study
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
- Being tested
- Implementation Support Package
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Support PackageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Support Package Clinics | Experimental | Clinics will receive an implementation support package, designed to integrate patients' disability status into the EHR and provide accommodations for patients with CD Receives: Behavioral: Implementation Support Package |
| Control Clinics | No intervention | Clinics will not receive the implementation support package for patients with CD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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.
Measured: 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.
Measured: Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Sep 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication DisabilitiesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126,870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Morris, PhD, Principal investigator, megan.morris@nyulangone.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656584
- Sponsor's protocol ID
- 25-00040
- Acronym
- DECA
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Communication Disability Collection and Accommodations in Primary Care Settings
- ClinicalTrials.gov ID
- NCT07656584
- Acronym / sponsor ID
- DECA / 25-00040
- Conditions
- Communication Disabilities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126,870 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation Support Package Clinics | Experimental | Behavioral: Implementation Support PackageClinics 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 intervention | –Clinics will not receive the implementation support package for patients with CD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Support PackageThe 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. | Behavioural | Implementation Support Package Clinics |
Primary outcome
(Aim 2) Patient Reach
Time frame: Baseline, Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
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.
(Aim 3) Adoption
Time frame: Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Morris, PhD principal investigator
megan.morris@nyulangone.org
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Support Package in people with Communication Disabilities, run by NYU Langone Health at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Morris, PhD (646-501-0027, megan.morris@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Aim 2) Patient Reach (time frame: Baseline, Implementation Follow Up (Approximately Month 9), Maintenance Follow Up (Approximately Month 21)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.