Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT06608758

Conditions

Disabilities Multiple

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

Interventions

Electonic health record prompts with education

Standard of care

Study Details

Brief summary:

The goal of this study is to address the critical issue of diagnostic overshadowing by applying the Collective Impact Model40 to co-produce our End Diagnostic Overshadowing program with academic, health systems, health professional, PWDs, family members, and community stakeholders. Through this work, we will identify and address mechanisms that contribute to diagnostic overshadowing and diagnostic errors among people with disabilities. The main questions to answer are whether knowledge about diagnostic errors and confidence will improve with health care providers and professionals involved in diagnostic provesses, whether developed algorithms to identify patients at risk of diagnpstic error will be used, whether there will be change in time to diagnostic evaluation for PWD from the specified 5 population groups and with the specified diagnoses prone to error, and whether changes in usage of CPT Evaluation and Management codes will occur.

Conditions

Disabilities Multiple

Study ID

NCT06608758

Start date

Nov 22, 2024

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

• Patients aged 3-89 who received billed charges

Exclusion Criteria:

  • Patients under age 3 or over age 89.
  • Patients with secondary diagnosis of dementia as the population is already known to be at increased risk of diagnostic error

Study Design

Enrollment

120000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with disabilities

Cases with disabilities are patients aged 3 - 89 years old with one or more of 26 diagnoses prone to error and and have the following secondary (or primary) diagnoses (using associated ICD-10 codes)

Mobility impairments: Spinal cord diseases, Spinal cord injuries, Injury to spinal cord nerves, Multiple sclerosis, Cerebral palsy, Dependence on enabling machines or devices, Need for caregiver related to mobility impairments

Severe Vision impairments:

Severe Hearing impairments:

Mental health: Person history mental and behavioral disorders, Major Depression, Severe bipolar disorder, Severe schizophrenia, Paranoia, Psychosis

Intellectual Disabilities:

Autism

Patients without disabilities

Patients without disabilities are patients age 3-89 with one or more of 26 diagnoses prone to error and without the following secondary (or primary) diagnoses: Mobility impairments: Spinal cord diseases, Spinal cord injuries, Injury to spinal cord nerves, Multiple sclerosis, Cerebral palsy, Dependence on enabling machines or devices, Need for caregiver related to mobility impairments

Severe Vision impairments:

Severe Hearing impairments:

Mental health: Person history mental and behavioral disorders, Major Depression, Severe bipolar disorder, Severe schizophrenia, Paranoia, Psychosis

Intellectual Disabilities:

Autism

Interventions

Electonic health record prompts with education

1. . A baseline description of patients aged ≥ 3 to 89 years old with one or more of 26 diagnoses prone to error was developed to compare cases of patients with specific disabilities (major mobility impairments, severe mental health concerns, severe visual impairments, severe hearing loss, and IDD) versus cases of patients without the specific disabilities who have these diagnoses.
2. Initial manual chart reviews on PWDs with specific diagnoses of sepsis and metastatic breast cancer with two of the disability groups, patients with intellectual disabilities and/or autism and with severe mental illness were done.
3. We analyzed mammogram usage and factors related to usage among women ≥ 40 years old with IDD and with severe mental health issues

3\) We are working on algorithms to identify providers whose female patients age > 40 years old to encourage outreach and to identify the patients needing mammograms for outreach. Developing educational materials for both providers and patients.

Standard of care

Patients without disabilities will receive standard care related to electronic health record prompts, alerts, and decision supports.

Primary outcome measure

  • Descriptive data on use of electronic record (EHR) decision supports and prompts/alerts [ Time Frame: 1.5, 2.5, and 3.5 years ]
  • Complexity distribution of Evaluation and Management (E/M) Current Procedural Technology (CPT) codes [ Time Frame: 4 years ]
  • Knowledge questionnaires [ Time Frame: 3.5 years ]
  • Scores on Safer DX Checklist [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Director Research Affairs

312-942-3554Jennifer_Garcia@rush.edu

Tricia J Johnson, PhD

312-942-7107Tricia_J_Johnson@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Sarah H Ailey, PhD RN

3129423383Sarah_H_Ailey@rush.edu

Director Sponsored programs, CRA

312 942-3554

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 5, 2026

Last verified

Jul, 2026

Keywords

  • Disabilities
  • Diagnostic error
  • Diagnostic overshadowing
  • Algorithms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-05.