Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)

Asthma and chronic obstructive pulmonary disease (COPD) are common chronic lung diseases that
are diagnosed in more than 30 million adults in the United States. However, diagnostic error
(DE), is considered one of the most common and harmful of patient-safety problems by the
Institute of Medicine, occur frequently with asthma and/or COPD and disproportionately affect
minorities and the under-served. DE leads to lost opportunities to identify other chronic
conditions, avoidable morbidity and mortality, unnecessary costs to patients and health
systems, and poor quality of care. Shortness of breath or dyspnea, which is a common symptom
in asthma and COPD, is also common for many other chronic conditions such as cardiovascular
disease and obesity. A better understanding of the impact of DE and interventions to improve
diagnostic accuracy in asthma and COPD are of particular importance for minorities and the
under-served that are disproportionately affected by conditions leading to dyspnea.

Spirometry is a simple, mobile, and essential test that is recommended by all major national
and international guidelines for the diagnosis of asthma and COPD. However it is well known
that spirometry is not routinely used in the ambulatory primary care setting and minorities
and the underserved population are less likely to have spirometry leading to greater
prevalence of DE. It has been estimated that 30-50% of people with an existing diagnosis of
asthma and COPD were found to be misdiagnosed. Many of these patients misdiagnosed with
asthma and/or COPD receive unnecessary respiratory pharmacotherapy which can pose serious
risks including pneumonia, cardiovascular events, and mortality. In the setting of DE, these
are considered avoidable and unnecessary respiratory pharmacotherapy use in minorities and
the underserved that are already disproportionately affected by cardiovascular disease
increases the risk of poorer outcomes. There is also DE in the diagnosis of asthma versus
COPD, as these are both clinically distinct respiratory disorders with nuances in treatment
recommendations. It is reported that African-Americans are considered to have increasing COPD
mortality and are disproportionately affected by asthma death rates. However, as spirometry
is not routinely performed and DE is prevalent in asthma and COPD, a component of these poor
outcomes may be attributable to missed or delayed diagnoses of other chronic conditions or
misdiagnosis within asthma and COPD.

Barriers to the use of spirometry in primary care exist at provider and health systems
levels. Previous studies show that primary care providers (PCPs) lack knowledge in existing
guidelines and in implementing spirometry into primary care clinics. Beyond these barriers,
PCPs struggle with logistical challenges such as time and workflow constraints with clinic
visits lasting 15 minutes or less in patients with multiple chronic medical conditions. These
predisposing and enabling factors explain why prior studies that included interventions to
educate PCPs and incorporate spirometry by training personnel in primary care clinics have
had limited results.

A new paradigm to improve guideline based care for asthma and COPD which includes spirometry
is needed and can lead to a better understanding of DE and improved patient safety and
patient-centered outcomes. Health Promoters or Community health workers (CHWs) have been
supplementing medical care by disseminating appropriate health care practices for underserved
minority populations. However, studies which include diagnostic evaluations with spirometry
for asthma and COPD have not been performed. The REDEFINE program (Reducing Diagnostic Error
to Improve PatieNt SafEty in COPD and Asthma) will incorporate health promoters working
collaboratively with PCPs to address identified barriers to guideline based care which
includes spirometry for the diagnosis of asthma and COPD for patients at risk for DE. We
propose a comparative effectiveness study to better understand the epidemiology of DE and to
evaluate the effectiveness and economic impact of providing the REDEFINE program to an
underserved, predominantly minority population with a diagnosis of asthma and/or COPD at risk
for DE.

Inclusion Criteria:

- 1.Age >40 years of age

- 2. Use of a maintenance respiratory medication and one of the following in the past
year:

- 3. Diagnosis of asthma and/or COPD

- 4. No spirometry test performed in the past 3 years

- 5. Past or current smoker or is exposed to tobacco

Exclusion Criteria:

- Unable to perform adequate spirometry

- Non-English speaking

- Pregnancy

- Plans to move from the Chicago Area within the next year

- Seen by pulmonary specialist in the past 3 years

- Any terminal illness with a life expectancy of <6 months

- Life threatening (e.g. intensive care admission and/or use of mechanical ventilation)
respiratory failure event in the past year.