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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT03137303
Collaborator
Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
402
Enrollment
2
Locations
2
Arms
27
Actual Duration (Months)
201
Patients Per Site
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the use of spirometry in identifying Diagnostic Error in COPD and Asthma patients.

Condition or Disease Intervention/Treatment Phase
  • Device: Spirometry at initial visit
  • Drug: Albuterol
  • Device: Spirometry at 12-month follow-up
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Reducing Diagnostic Error to Improve Patient Safety in COPD and Asthma (REDEFINE Study)
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Sep 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Patient Subject Usual Care

On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit. The following will be performed. Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale Quality of life measures Subjects will be advised to go to their clinics and be managed by their PCP thereafter. At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry and undergo the same spirometry protocol as the intervention group.

Drug: Albuterol
The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
Other Names:
  • Albuterol, Ventolin, Proventil, Accuneb

    • Device: Spirometry at 12-month follow-up
    At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
    Other Names:
  • KoKo Spirometer (Model 313120)
  • 3 Liter Calibration Syringe

    		•
    Experimental: Patient-Subject Intervention

    On the day of the outpatient visit, subjects will be advised to arrive 90 minutes prior to their clinic visit in the same building as the clinic site. The following information will be collected and procedures will be performed: Subject demographic and contact information Co-morbid conditions Smoking history Medication history from patient and also from pharmacy used by subjects A respiratory exacerbation history in the past year Modified Medical Research Counsel (mMRC) dyspnea scale Quality of life measures Pre and post-bronchodilator using Albuterol (BD) spirometry

    Device: Spirometry at initial visit
    Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.
    Other Names:
  • KoKo Spirometer (Model 313120)
  • 3 Liter Calibration Syringe

    • Drug: Albuterol
    The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
    Other Names:
  • Albuterol, Ventolin, Proventil, Accuneb

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total Number of Healthcare Visits [1 year]

      Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups

    Secondary Outcome Measures

    1. Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results [1 year]

      determine differences in the accuracy of diagnosis between groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 1.Age >40 years of age

      1. Use of a maintenance respiratory medication and one of the following in the past year:
      1. Diagnosis of asthma and/or COPD
      1. No spirometry test performed in the past 3 years
      1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CCHHS Chicago Illinois United States 60612
    2 UI Health Chicago Illinois United States 60612

    Sponsors and Collaborators

    • University of Illinois at Chicago
    • Agency for Healthcare Research and Quality (AHRQ)

    Investigators

    • Principal Investigator: Min Joo, MD MPH, University of Illinois at Chicago

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Min Joo, MD MPH, Associate Professor, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT03137303
    Other Study ID Numbers:
    • 2016-1209
    First Posted:
    May 2, 2017
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Asthma
    Albuterol

    Study Results

    Participant Flow

    Recruitment Details Subjects who met the preliminary eligibility criteria were mailed a recruitment letter with the option to opt out. A phone screen was conducted to confirm eligibility. If eligible, we obtained verbal consent to participate in the study. Their scheduled appointment date was confirmed. They were asked to arrive 90 minutes before their clinic visit for enrollment. Recruitment took place from 07/2017 to 09/2019.
    Pre-assignment Detail
    Arm/Group Title Patient Subject Usual Care Patient-Subject Intervention
    Arm/Group Description Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
    Period Title: T0: Time of Enrollment - Baseline Visit
    STARTED 231 171
    COMPLETED 231 171
    NOT COMPLETED 0 0
    Period Title: T0: Time of Enrollment - Baseline Visit
    STARTED 231 171
    COMPLETED 225 161
    NOT COMPLETED 6 10
    Period Title: T0: Time of Enrollment - Baseline Visit
    STARTED 230 167
    COMPLETED 225 162
    NOT COMPLETED 5 5
    Period Title: T0: Time of Enrollment - Baseline Visit
    STARTED 230 167
    COMPLETED 225 163
    NOT COMPLETED 5 4
    Period Title: T0: Time of Enrollment - Baseline Visit
    STARTED 229 167
    COMPLETED 222 162
    NOT COMPLETED 7 5

    Baseline Characteristics

    Arm/Group Title Patient Subject Usual Care Patient-Subject Intervention Total
    Arm/Group Description Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit. Total of all reporting groups
    Overall Participants 231 171 402
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.6
    (10.4)
    57.5
    (10.1)
    57.6
    (10.2)
    Age, Customized (Count of Participants)
    40-64 years
    181
    78.4%
    135
    78.9%
    316
    78.6%
    65+ years
    50
    21.6%
    36
    21.1%
    86
    21.4%
    Sex: Female, Male (Count of Participants)
    Female
    170
    73.6%
    119
    69.6%
    289
    71.9%
    Male
    61
    26.4%
    52
    30.4%
    113
    28.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    17
    7.4%
    20
    11.7%
    37
    9.2%
    Not Hispanic or Latino
    214
    92.6%
    149
    87.1%
    363
    90.3%
    Unknown or Not Reported
    0
    0%
    2
    1.2%
    2
    0.5%
    Race/Ethnicity, Customized (Count of Participants)
    African-American/Black
    193
    83.5%
    139
    81.3%
    332
    82.6%
    White
    21
    9.1%
    20
    11.7%
    41
    10.2%
    Other
    15
    6.5%
    11
    6.4%
    26
    6.5%
    Missing
    2
    0.9%
    1
    0.6%
    3
    0.7%
    Marital Status (Count of Participants)
    Single/Widowed
    169
    73.2%
    128
    74.9%
    297
    73.9%
    Co-habiting/Married
    62
    26.8%
    43
    25.1%
    105
    26.1%
    Household Income (Count of Participants)
    < $10,000
    92
    39.8%
    71
    41.5%
    163
    40.5%
    $10,000-19,999
    41
    17.7%
    31
    18.1%
    72
    17.9%
    $20,000-29,999
    26
    11.3%
    9
    5.3%
    35
    8.7%
    $30,000+
    65
    28.1%
    51
    29.8%
    116
    28.9%
    Unknown or Not Reported
    7
    3%
    9
    5.3%
    16
    4%
    Education (Count of Participants)
    High school or less
    107
    46.3%
    80
    46.8%
    187
    46.5%
    Vocational/Technical School or Some College
    83
    35.9%
    61
    35.7%
    144
    35.8%
    Bachelor and above
    40
    17.3%
    30
    17.5%
    70
    17.4%
    Unknown or Not Reported
    1
    0.4%
    0
    0%
    1
    0.2%
    Health Plan (participants) [Number]
    Medicaid
    127
    55%
    87
    50.9%
    214
    53.2%
    Medicare
    60
    26%
    45
    26.3%
    105
    26.1%
    HMO
    36
    15.6%
    30
    17.5%
    66
    16.4%
    PPO
    26
    11.3%
    21
    12.3%
    47
    11.7%
    Self-pay
    23
    10%
    13
    7.6%
    36
    9%
    Other
    1
    0.4%
    0
    0%
    1
    0.2%
    Number of Health Plans per Patient (Count of Participants)
    0-1
    190
    82.3%
    146
    85.4%
    336
    83.6%
    ≥2
    41
    17.7%
    25
    14.6%
    66
    16.4%
    Coexisting Conditions (participants) [Number]
    Hypertension
    158
    68.4%
    116
    67.8%
    274
    68.2%
    Diabetes
    76
    32.9%
    53
    31%
    129
    32.1%
    Dyslipidemia
    70
    30.3%
    47
    27.5%
    117
    29.1%
    Osteoarthritis
    84
    36.4%
    66
    38.6%
    150
    37.3%
    Depression
    58
    25.1%
    37
    21.6%
    95
    23.6%
    Anxiety
    28
    12.1%
    23
    13.5%
    51
    12.7%
    Obstructive/sleep apnea
    21
    9.1%
    16
    9.4%
    37
    9.2%
    Congestive Heart Failure
    20
    8.7%
    9
    5.3%
    29
    7.2%
    Coronary Artery Disease
    11
    4.8%
    11
    6.4%
    22
    5.5%
    Arrhythmia
    21
    9.1%
    7
    4.1%
    28
    7%
    Autoimmune Disease
    11
    4.8%
    15
    8.8%
    26
    6.5%
    Cancer
    12
    5.2%
    13
    7.6%
    25
    6.2%
    Osteoporosis
    10
    4.3%
    7
    4.1%
    17
    4.2%
    Stroke
    8
    3.5%
    5
    2.9%
    13
    3.2%
    End Stage Kidney Disease
    0
    0%
    1
    0.6%
    1
    0.2%
    Other
    6
    2.6%
    9
    5.3%
    15
    3.7%
    Number of Coexisting Conditions (Count of Participants)
    0
    28
    12.1%
    16
    9.4%
    44
    10.9%
    1
    41
    17.7%
    29
    17%
    70
    17.4%
    2
    48
    20.8%
    47
    27.5%
    95
    23.6%
    3
    53
    22.9%
    37
    21.6%
    90
    22.4%
    4
    30
    13%
    23
    13.5%
    53
    13.2%
    5+
    31
    13.4%
    19
    11.1%
    50
    12.4%
    Respiratory Diagnosis (Count of Participants)
    Asthma
    171
    74%
    127
    74.3%
    298
    74.1%
    COPD
    28
    12.1%
    14
    8.2%
    42
    10.4%
    Asthma and COPD
    32
    13.9%
    30
    17.5%
    62
    15.4%
    Respiratory Medications (participants) [Number]
    Short-acting Bronchodilator
    226
    97.8%
    169
    98.8%
    395
    98.3%
    Inhaled Corticosteroids (ICS)
    145
    62.8%
    107
    62.6%
    252
    62.7%
    Long-acting muscarinic antagonists (LAMA)
    17
    7.4%
    11
    6.4%
    28
    7%
    Long-acting beta agonist (LABA)
    2
    0.9%
    2
    1.2%
    4
    1%
    ICS + LABA
    77
    33.3%
    60
    35.1%
    137
    34.1%
    LAMA + LABA
    1
    0.4%
    1
    0.6%
    2
    0.5%
    Respiratory Symptoms (participants) [Number]
    In the past yr., have you had worsened breathing symptoms that caused a change in your medications?
    52
    22.5%
    29
    17%
    81
    20.1%
    In the past year, have you been hospitalized for breathing problems?
    37
    16%
    14
    8.2%
    51
    12.7%
    In the past year, have you had the a cough continually for a long time (≥ 3 months)?
    133
    57.6%
    90
    52.6%
    223
    55.5%
    In the past year, have you had the a shortness of breath continually for a long time (≥ 3 months)?
    132
    57.1%
    78
    45.6%
    210
    52.2%
    In the past year, have you had the a sputum continually for a long time (≥ 3 months)?
    115
    49.8%
    70
    40.9%
    185
    46%
    Number of Respiratory Symptoms (Count of Participants)
    0
    62
    26.8%
    54
    31.6%
    116
    28.9%
    1
    42
    18.2%
    38
    22.2%
    80
    19.9%
    2
    43
    18.6%
    37
    21.6%
    80
    19.9%
    3
    84
    36.4%
    42
    24.6%
    126
    31.3%
    Tobacco Exposure (Count of Participants)
    Past
    86
    37.2%
    62
    36.3%
    148
    36.8%
    Current
    63
    27.3%
    50
    29.2%
    113
    28.1%
    Never
    82
    35.5%
    59
    34.5%
    141
    35.1%
    Second-Hand Smoke Exposure (Count of Participants)
    Yes
    172
    74.5%
    132
    77.2%
    304
    75.6%
    No
    59
    25.5%
    39
    22.8%
    98
    24.4%
    Illicit Substance Use (participants) [Number]
    Yes
    26
    11.3%
    26
    15.2%
    52
    12.9%
    Would rather not say
    1
    0.4%
    0
    0%
    1
    0.2%
    Modified Medical Research Council Dyspnea Scale (Count of Participants)
    0 = only breathless with strenuous exercise
    49
    21.2%
    35
    20.5%
    84
    20.9%
    1 = short of breath when hurrying or walking up a slight hill
    73
    31.6%
    60
    35.1%
    133
    33.1%
    2 = walk slower or have to stop for breath when walking
    48
    20.8%
    34
    19.9%
    82
    20.4%
    3 = stop for breath after walking about 100 yards or a few minutes
    50
    21.6%
    34
    19.9%
    84
    20.9%
    4 = too breathless to leave the house or when dressing
    11
    4.8%
    8
    4.7%
    19
    4.7%

    Outcome Measures

    1. Primary Outcome
    Title Total Number of Healthcare Visits
    Description Determine differences in healthcare visits which include all-cause and respiratory related, acute care outpatient visits, emergency department visits, and hospitalizations between groups
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    Intention to treat. Once randomized, patients were included in the analysis.
    Arm/Group Title Patient Subject Usual Care Patient-Subject Intervention
    Arm/Group Description Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
    Measure Participants 231 171
    Yes
    111
    48.1%
    76
    44.4%
    No
    119
    51.5%
    93
    54.4%
    Missing
    1
    0.4%
    2
    1.2%
    Yes
    48
    20.8%
    17
    9.9%
    No
    182
    78.8%
    152
    88.9%
    Missing
    1
    0.4%
    2
    1.2%
    Yes
    61
    26.4%
    35
    20.5%
    No
    169
    73.2%
    134
    78.4%
    Missing
    1
    0.4%
    2
    1.2%
    Yes
    198
    85.7%
    138
    80.7%
    No
    32
    13.9%
    31
    18.1%
    Missing
    1
    0.4%
    2
    1.2%
    Yes
    126
    54.5%
    72
    42.1%
    No
    104
    45%
    97
    56.7%
    Missing
    1
    0.4%
    2
    1.2%
    2. Secondary Outcome
    Title Total With Diagnosis of COPD and/or Asthma Consistent With Spirometry Results
    Description determine differences in the accuracy of diagnosis between groups
    Time Frame 1 year

    Outcome Measure Data

    Analysis Population Description
    This analysis was only done for patients who had clear yes or no diagnosis accuracy from spirometry. This also excluded those did not have missing spirometry either due to withdraw or lost to follow-up. Two patients with yes or no diagnosis accuracy from spirometry withdrew, but they were either qualified for "Correct initial diagnosis" or "Ever remove wrong initial diagnosis" and thus lead to no missing in this table.
    Arm/Group Title Patient Subject Usual Care Patient-Subject Intervention
    Arm/Group Description Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
    Measure Participants 176 128
    Correct initial diagnosis
    76
    32.9%
    55
    32.2%
    Stayed with wrong initial diagnosis
    92
    39.8%
    64
    37.4%
    Ever removed wrong initial diagnosis
    8
    3.5%
    9
    5.3%

    Adverse Events

    Time Frame T0-T4. From the enrollment time until the end of the 12-month follow-up visit.
    Adverse Event Reporting Description
    Arm/Group Title Patient Subject Usual Care Patient-Subject Intervention
    Arm/Group Description Patients were assigned to the arm group based on the randomization of their primary care provider. The usual care group completed the spirometry test (pre and post BD) during the T4 - 12-month follow-up visit (following the same spirometry protocol as the intervention group did at T0 - baseline visit). Patients were assigned to the arm group based on the randomization of their primary care provider. The intervention group completed the spirometry test (pre and post BD) during T0 - baseline visit.
    All Cause Mortality
    Patient Subject Usual Care Patient-Subject Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/231 (0.4%) 0/171 (0%)
    Serious Adverse Events
    Patient Subject Usual Care Patient-Subject Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/231 (0%) 0/171 (0%)
    Other (Not Including Serious) Adverse Events
    Patient Subject Usual Care Patient-Subject Intervention
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/231 (0%) 0/171 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Min J. Joo, MD MPH
    Organization University of Illinois at Chicago
    Phone 312-996-8039
    Email joo@uic.edu
    Responsible Party:
    Min Joo, MD MPH, Associate Professor, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT03137303
    Other Study ID Numbers:
    • 2016-1209
    First Posted:
    May 2, 2017
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021