End Diagnostic Overshadowing:Addressing Ableism in Diagnoses

ConditionDisabilities Multiple

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age3-89

SponsorRush University Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

120,000 Participants

are divided into 2 treatment groups

Group A: Patients with disabilities1 intervention

Group B: Patients without disabilities1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

4 years

Secondary outcomes

Mock tracer qualitative analysis

Qualitative analysis of review notes from mock tracers pre-intervention will be compared to notes post intervention.

Time frame

Years 4 and 5

Other outcomes

Interaction effects pre and post diagnostic processes

Using pre-test measures and independent variables from year one, ANCOVA will be used to measure interaction effects on effects of the intervention. Age increments, gender, race/ethnicity, urban/rural, co-morbidities, disability type, insurance type, and severity of illness \[relevant to site\]), and the 10 issues suggested by stakeholders (singly or in composites) will be entered as covariates in ANCOVA and measured for variation by setting in post-test results of CPT E/M code complexity usage analysis, Safer DX Checklist scores, knowledge checks, descriptive data on use of EHR decision supports and prompts/alert.

Time frame

3.5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

St. John Fisher College

Collaborator

University of Minnesota

Collaborator

Source ClinicalTrials.gov

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