End Diagnostic Overshadowing: Understanding and Reducing Diagnostic Error in Patients With Disabilities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120,000
- Locations
- 1
- Primary Endpoint
- Descriptive data on use of electronic record (EHR) decision supports and prompts/alerts
Study Overview
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.
Detailed Description
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 diagnoses prone to error 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 diagnostic error, 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.
Aim 1: Identify and create understanding of mechanisms underlying diagnostic overshadowing. We will conduct baseline and post-analysis of CPT codes related to diagnostic processes to examine differences between patients aged ≥3 years with and without the specific disabilities listed above, along with demographic and clinical characteristics associated with health outcomes (e.g., race, ethnicity, gender, insurance type, specific diagnoses). Based on differences identified in baseline CPT analyses, we will conduct follow-up chart reviews and targeted interviews and develop Joint Commission-style individual mock tracers, following the care of the listed specific populations of PWD, and systems-of-care tracers focused on evaluating the extent to which care systems incorporate accessibility, effective communication, reasonable accommodations, trauma-informed care, and other processes that support timely and accurate diagnosis of conditions prone to diagnostic error. Mock tracer teams will provide formative evaluation of care to involved staff. Using inductive thematic analysis45 of notes from chart reviews, interviews, and mock tracers, we will identify mechanisms underlying diagnostic overshadowing. We will evaluate CPT codes (quantitative), chart reviews (mixed methods), and interview and tracer results (qualitative) at Year 5 compared with Year 1 to determine changes.
Our hypothesis is that there will be statistical difference in diagnostic processes between people with the specified disabilities and people without the specified disabilities.
Aim 2: Co-produce a framework of mechanisms underlying diagnostic overshadowing to develop educational programs and EHR decision supports. We will collaborate with stakeholders to refine, confirm, and prioritize mechanisms underlying diagnostic overshadowing identified in Aim 1 and use these findings for the co-production of educational programs and EHR decision supports. We will evaluate these mitigation efforts through: (1) pre- and post-knowledge assessments related to use of the educational programs; and (2) descriptive pre- and post-data on the use of specific EHR decision supports.47 Our hypothesis is that we will have information that can be used to develop algorithms for identifying PWD from the specific populations at risk of DO/DE as evidenced by diagnostic process data from the Safer DX Checklist and usage of CPT E/M code.
Our Hypotheses are that there will be statistical change in time to diagnostic evaluation for PWD from the specified 5 population groups and with the specified diagnoses prone to error. We will Evaluate for change after implementation of algorithms to identify patients with the specified disabilities at risk for DO/DE.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Years to 89 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged 3-89 who received billed charges
Exclusion Criteria
- •Patients under age 3 or over age
- •Patients with secondary diagnosis of dementia as the population is already known to be at increased risk of diagnostic error
Arms & Interventions
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
Intervention: Electonic health record prompts with education (Behavioral)
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
Intervention: Standard of care (Other)
Outcomes
Primary Outcomes
Descriptive data on use of electronic record (EHR) decision supports and prompts/alerts
Time Frame: 1.5, 2.5, and 3.5 years
After implementation of EHR prompts/alerts and decision supports related to diagnostic error, descriptive data will be collected and analyzed on usage.
Complexity distribution of Evaluation and Management (E/M) Current Procedural Technology (CPT) codes
Time Frame: 4 years
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.
Knowledge questionnaires
Time Frame: 3.5 years
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.
Scores on Safer DX Checklist
Time Frame: 4 years
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.
Secondary Outcomes
- Mock tracer qualitative analysis(Years 4 and 5)
Investigators
Sarah Ailey
Professor
Rush University Medical Center
