End Diagnostic Overshadowing

ConditionDisabilities Multiple

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age3-89

SponsorRush University Medical Center

About this trial

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.

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 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
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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