End Diagnostic Overshadowing:Addressing Ableism in Diagnoses

NCT06608758 | Recruiting

• 1 other identifier: R01HD116320
• Study Type: observational
• Target: 120,000
• Locations: 1 country
• Sites: 1

Brief Summary

People with disabilities (PWD) experience increased risk of diagnostic error-sometimes due to attributing symptoms to disability rather than a potentially new or co-morbid conditions. As well, some diagnoses are prone to error. Based on literature we identified the following twenty-six with ICD-10 codes: Aortic aneurysm and dissection I71.0 - I71.9; Arterial thromboembolism I74.0 - I74.9; Venous thromboembolism I82.0-I82.99 and I82.A-I82.C; Congestive heart failure I50.1-150.9; Stroke All I60, I61, I62, I63, I64; Myocardial infarction I21.0-I21.9 and I21.A-I21.B; Spinal abscess G06.0, G06.1 and G06.2; Meningitis and encephalitis G04 -G04.91; Endocarditis I33.0-I33.9 and I38; Sepsis A41.0-A41.9; Pneumonia J12.0-J95.851; Lung cancer C34.0-C34.92; Melanoma C43.0- C43.9; Colorectal cancer C18.0-C18.9; Breast cancer C50 to C50.929, and C79.81; Prostate cancer C61; Pediatric Arterial ischemic stroke I63.0-163.9xx; Appendicitis K35-K35.8xx; Asthma J45.2-J45.998; Retinal blastoma C69.20, C69.21, C60.22; Brain tumor C71.0-C71.9; Polyateritis M30.0-M30.8; Congenital heart disease Q20 - Q28 (Q24.9 particularly important); Duchense muscular dystrophy G71.0-G71.9; Inflammatory bowel disease K51.0-K51.9; Scleroderma M34.0-M34.9.The goal of this research is to identify and create understanding of what underlies and contributes to increased risk of diagnostic error with these diagnoses. The investigators plan to develop ways to reduce it, specifically ways to identify people with disabilities at risk of diagnostic error (DE). The investigators will also develop education programs and decision supports targeted to healthcare professionals. If it is effective, ways to reduce diagnostic error will have been developed among people with disabilities.

Conditions

Disabilities Multiple

Keywords

Disabilities; Diagnostic error; Diagnostic overshadowing; Algorithms

Outcome Measures

Primary Outcomes (4)

• Descriptive data on use of electronic record (EHR) decision supports and prompts/alerts

  After implementation of EHR prompts/alerts and decision supports related to diagnostic error, descriptive data will be collected and analyzed on usage.

  1.5, 2.5, and 3.5 years

• Complexity distribution of Evaluation and Management (E/M) Current Procedural Technology (CPT) codes

  The percentage of each complexity score for Current Procedural Technology (CPT) Evaluation and Management (E/M) codes will be measured by setting (ED, outpatient, inpatient, preventive care) for differences using Fisher'ss exact tests for patients with disabilities (PWD) aged 3-89 years old with specific disabilities (major mobility impairments, mental health concerns, severe visual impairments/ blindness, severe hearing loss/deafness, and IDD) versus patients aged 3-89 years old without the specific disabilities.

  4 years

• Knowledge questionnaires

  Knowledge questionnaires will be developed related to algorithms to detect people with disabilities from 5 specified groups at risk of diagnostic overshadowing, EHR prompts/alerts and decisions supports. Pre and post, the percentage of correct answers will be calculated and compared using ANCOVA.

  3.5 years

• Scores on Safer DX Checklist

  The Safer Dx Instrument uses a Likert scale to rate the degree of agreement with statement regarding diagnostic processes. Higher scores may indicate a greater likelihood of a diagnostic error or "missed opportunity" for diagnosis.

  4 years

Secondary Outcomes (1)

• Mock tracer qualitative analysis

  Years 4 and 5

Other Outcomes (1)

• Interaction effects pre and post diagnostic processes

  3.5 years

Study Arms (2)

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

Behavioral: Electonic health record prompts with education

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

Other: Standard of care

Interventions

Electonic health record prompts with education BEHAVIORAL

1). A baseline audit of diagnostic processes (including data from the Safer DX Checklist and CPT E/M code usage) for patients aged ≥ 3 to 89 years with one or more of 26 diagnoses prone to error to compare cases of PWD with specific disabilities (major mobility impairments,1 mental health concerns,2,3 severe visual impairments/ blindness,4 severe hearing loss/deafness,5 and IDD6,7) versus without the disabilities. Using analyses of data, chart reviews, staff interviews and mock tracers, a frame of themes underlying increased risk of DE will be co-produced to develop algorithms to identify patients with the specified disabilities at risk. Case studies for education on DE, and EHR prompts, alerts, and decision supports related to the algorithms will be co-produced along with education on the EHR materials. Evaluate for change in use of diagnostic processes among PWD post implementation of algorithms and EHR prompts, alerts and decision supports will be conducted post-intervention.

Patients with disabilities

Standard of care OTHER

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

Patients without disabilities

Eligibility Criteria

• Age: 3 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases: * Cases without disabilities are patients 3 - 89 years old without the following principal and secondary diagnoses (using associated ICD-10 codes): * Cases with disabilities are patients aged 3 - 89 years old with the following Principal and secondary 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

You may qualify if:

• Patients aged 3-89 who received billed charges

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• St. John Fisher College: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Educational Status; Standard of Care

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarah H Ailey, PhD RN

  Rush University College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director Research Affairs

CONTACT

312-942-3554; Jennifer_Garcia@rush.edu

Tricia J Johnson, PhD

CONTACT

312-942-7107; Tricia_J_Johnson@rush.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: End Diagnostic Overshadowing program information will be shared on clinicaltrials.gov upon funding. Information will be updated at least yearly. The information will be submitted according to policy in the NIH "Policy on the Dissemination of NIH-Funded Clinical Trial Information." RUSH University Medical Center has policies in place to ensure that research registration and results reporting occur in compliance the NIH policy. Data will be findable and identifiable via standard indexing tools available through clinicaltrials.gov. Data will be made available to other users at least by the time of associated publications or end of the performance period. performance period. Data will be available for a minimum of five years after the last publication. If there is a funded competitive application, data preservation and sharing will continue into the time of the new application and for at least five years after the last associated publication.
• Access Criteria: Access to data deposited in clinicaltrials.gov will not be limited. All data deposited will be stripped of identifying information. Efforts will be made to maximize sharing of data stripped of identifiers. This research is approved as exempt by the Rush University IRB. Consent will thus not be a consideration in data sharing. If consent is needed for any portion of this research, data sharing will be made clear in the consent.

Locations

US (1)