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Recruiting NCT06608758

End Diagnostic Overshadowing

Observational Disabilities Multiple

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electonic health record prompts with education, Standard of care.
Who it may be relevant to
Registry conditions: Disabilities Multiple. Basic parameters: 3 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

End Diagnostic Overshadowing: Understanding and Reducing Diagnostic Error in Patients With Disabilities

Overview

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.

Our research is innovative and fills a critical need for improving health outcomes among PWD. We will integrate CPT code analysis with Joint Commission recommendations in a novel way to establish a system for identifying mechanisms underlying diagnostic overshadowing and developing and evaluating targeted educational programs and EHR decision supports to reduce diagnostic errors.

Evaluation of diagnostic processes

Safer DX Checklist

The Safer DX checklist was developed to guide chart reviews including patient history, examination, diagnostic test interpretation and follow-up, ordering of tests, referrals, and diagnostic assessment. The checklist is used to assess five main aspects of the diagnostic process (1) the patient-provider encounter; (2) use and interpretation of diagnostic tests; (3) follow-up and tracking of diagnostic information; (4) referrals and follow-up; and (5) patient-related factors. It is used in multiple studies addressing diagnostic error.We modified the Safer DX Checklist for use by nurses.

CPT Evaluation and Management codes

CPT codes were developed by the American Medical Association and undergo periodic revisions and ongoing maintenance. CPT codes are the universal way that providers document their services, providing standardized reporting needed for billing and reimbursement of healthcare providers, including physicians, nurse practitioners, physician assistants, other professionals.66 The system provides numeric codes for issues such as: 1. The site of service (e.g., Emergency Department, inpatient, outpatient, preventive services); 2. The service provided; 3. The complexity of clinical information-gathering and decision-making, and 4) Time spent. The accuracy of CPT codes can vary, as indicated in a study of CPT codes related to hip fractures in the National Surgical Quality Improvement Program.68 However, CPT codes provide a standardized database used to report aggregated outcomes and to highlight potential problem areas/issues needing further investigation. CPT E/M codes usage is a stage in the diagnostic process where errors can occur.

CPT E/M codes are used to bill for services by providers related to the diagnostic process in evaluating and managing the health of a patient. Each setting has a specific group of CPT E/M codes ranges from lowest time and complexity of decision making to highest time and complexity of decision making. A recent study used CPT E/M codes for video telehealth visits compared to in-person visits with established patients of a large urban public healthcare system above the 50th percentile in video telehealth utilization. Evaluation indicated lower complexity of E/M with telehealth visits.

Furthermore, use of CPT E/M codes at telehealth visits varied by specialty, but the authors noted that it was not known if the differences were due to the two types of visits or to the comfort level of providers and patients. In a small study using emergency department (ED) data at Rush University Medical Center (July 1, 2019 to December 1, 2020), differences in CPT E/M codes were found between patients with and without IDD visiting the ED for the same reasons and same level of severity. Moderate (99284) and high complexity (99285) evaluation and management codes, with no differences in time-intensive cases, were used with 25.7% of patients with IDD compared to 39.6% of patients without IDD, with statistical significance. Additionally, median professional charges for patients with IDD were lower. An analysis of differences in use of CPT E/M codes shows promise in using them to identify and understand mechanisms underlying diagnostic overshadowing and diagnostic error. In our chart reviews we will collect data on any use of CPT E/M codes including dates and specific codes used.

Mock tracers Mock tracers were developed by the Joint Commission for use in preparing for accreditation visits and are often used in healthcare systems as part of ongoing quality assurance and professional development efforts. Mock tracers provide information on patient experiences, quality of care, healthcare processes and products, and areas needing improvement. Tracers involve one-on-one and small group interviews with prompts for the questions that will be asked in addition to a review of patient charts and forms. For this project, questions will center around diagnostic processes (as evaluated using the Safer DX Checklist and evaluation of the use of CPT codes. Deeper inquiry is expected based on answers.

Algorithms

We recognize that lack of data on people with disabilities can lead to inadequate algorithms . People with disabilities expressed concerns of being denied life-saving health services during COVID related to crisis triage algorithms that didn't reflect their needs. Algorithms are already in use to address diagnostic error such as identifying patients at risk of delayed test results; delays in follow up of chest imaging results tests for hypothyroidism, and delayed/missed diagnoses related to abdominal pain. The study that addressed missed/delayed diagnoses related to abdominal pain was conducted in an ED. An algorithm was developed to identify patients at high risk of diagnostic error related to abdominal pain and then used for chart reviews to identify patients at high-risk for diagnostic error related to abdominal pain. In a randomized clinical trial, algorithms were used to prospectively identify patients at high risk of delayed/missed diagnoses of lung, colorectal or prostate cancer. Time to diagnostic evaluation was significantly reduced in the intervention group vs. control group for colorectal and prostate cancers, but not lung cancers. None of the research on algorithms specifically addressed diagnostic overshadowing as part of delayed/missed diagnoses and none addressed intersectionality. A 2009 study specifically on educing diagnostic overshadowing found case studies for educational purposes to be useful.

EHR prompts and alerts

The stage of the diagnostic process (e.g., obtaining clinical history, conducting exams, ordering specific tests, assessments, developing diagnoses, post-diagnostic referrals) requires different clinical decision supports; Furthermore, conditions that are not common require specific supports. Through standard order sets, alerts and reminders, and other means of diagnosticsupport (e.g., website), clinicians can access guidelines more easily. However, poorly designed EHR support can contribute to diagnostic error.82-84 Therefore, developing EHR decision supports requires attention to issues such as how the supports are accepted by clinicians, how they fit with workflow, time requirements, formatting, and how supports promote system-thinking. The EPIC EHR system, as an example, provides a means to improve decision support. Further, patient participation is important, and EHR systems can provide decision supports that can be used by both clinicians and patients.86

Co-production of healthcare programs

Involving impacted persons in co-production of services impacting them is considered an ethical issue in healthcare, transcending the traditional dichotomy between knowledge and program developers and users. Co-production involves building collaboration of people from impacted groups in the production and use of knowledge and programs from the start of the process. Participation of PWD impacted by the results of research and program planning is often

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Mock tracer qualitative analysis [Time frame: Years 4 and 5]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Publications

  • 163. Fram S. The constant comparative analysis method outside of grounded theory. Qualitative report. 2015. doi: 10.46743/2160-3715/2013.1569. 164. McMillan SS, Kelly F, Sav A, et al. Using the nominal group technique: How to analyse across multiple groups. Health Serv Outcomes Res Method. 2014;14(3):92-108. https://link.springer.com/article/10.1007/s10742-014-0121-1. doi: 10.1007/s10742-014-0121-
  • 156. How Rochester regional health is raising health equity in healthcare Rochester Regional Health Web site. https://hive.rochesterregional.org/2023/02/health-equity-rochester. Accessed November 21, 2023. 158. AMA: New 2023 CPT code set includes burden-reducing revisionsAmerican Medical Association Press releases Web site. https://www.ama-assn.org/press-center/press-releases/ama- new-2023-cpt-cod
  • 6692. doi: 10.1352/1934-9556-61.4.326. 148. Stancliffe RJ, Pettingell SL, Bershadsky J, Houseworth J, Tichá R. Community participation and staying home if you want: US adults with intellectual and developmental disabilities. Journal of Applied Research in Intellectual Disabilities. 2022;35(5):1199-1207. doi: 10.1111/jar.13014. 149. Pettingell SL, Houseworth J, Tichá R, Kramme JED, Hewitt AS. Incen
  • 143. Stancliffe RJ, Tichá R, Pettingell SL, Houseworth J, Bershadsky J. Current services and outcomes of formerly institutionalised and never-institutionalised US adults with intellectual and developmental disabilities: A propensity score matching analysis. Journal of applied research in intellectual disabilities. 2023;36(4):859-870. https://onlinelibrary.wiley.com/doi/abs/10.1111/jar.13103. doi:
  • 135. Bernadette Mazurek Melnyk, PhD, APRN-CNP, FAANP, FNAP, FAAN, Pamela Lusk, DNP, RN, PMHNP-BC, FAANP, FAAN / Bernadette Mazurek Melnyk, PhD, APRN-CNP, FAANP, FNAP, FAAN, Pamela Lusk, DNP, RN, PMHNP-BC, FAANP, FAAN. A practical guide to child and adolescent mental health screening, evidence-based assessment, intervention, https://www.perlego.com/book/2633732/a-practical-guide-to-child-and-adoles
  • 126. Weinberg DB, Cooney-Miner D, Perloff JN. Analyzing the relationship between nursing education and patient outcomes. J NURS REGUL. 2012;3(2):4-10. doi: 10.1016/S2155-8256(15)30212-X. 127. Weinberg DB, Cooney-Miner D, Perloff JN, Babington L, Avgar AC. Building collaborative capacity: Promoting interdisciplinary teamwork in the absence of formal teams. Med Care. 2011;49(8):716-723. doi: 10.1097
  • developmental disabilities . 2022. 118. Ailey SH, Johnson TJ, Fogg L, Friese TR. Factors related to complications among adult patients with intellectual disabilities hospitalized at an academic medical center. Intellect Dev Disabil. 2015;53(2):114-119. doi: 10.1352/1934-9556-53.2.114 [doi]. 119. Ailey SH, Johnson T, Fogg L, Friese TR. Hospitalizations of adults with intellectual disability in acad
  • 107. Ailey SH, Hart R. Hospital program for working with adult clients with intellectual and developmental disabilities. Intellect Dev Disabil. 2010;48(2):145-147. 108. Ailey SH, Brown PJ, Ridge CM. Improving hospital care of patients with intellectual and developmental disabilities. Disabil Health J. 2017;10(2):169-172. 109. Ailey SH, Johnson T, Fogg L, Friese TR. Hospitalizations of adults with

Identifiers

NCT: NCT06608758 · R01HD116320

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗