Brief Summary
The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients, often due to inaccurate application of blood pressure parameters that change based on age, gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to harm and malpractice claims.
The investigators propose to conduct a multisite, prospective, stepped wedge cluster randomized trial testing a quality improvement collaborative (QIC) intervention within the American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over 300 primary care practices, ranging from tertiary care academic medical centers to single practitioner private practices, interested in and experienced with QICs. Because many processes are likely to be common across diagnostic errors in outpatient settings, a multifaceted intervention, such as a QIC, has a high likelihood of success and broad applicability across populations. Preparatory inquiries to QuIIN primary care providers suggest high interest in reducing these 3 diagnostic errors and provider agreement with randomization to evaluate diagnostic error interventions. Practices will be randomized to one of three groups, with each group collecting retrospective baseline data on one error above, and then intervening to reduce that error during the first eight months. Each group will concurrently collect control data on an error they are not intervening on during those eight months. Following those eight months, the groups will continue intervening on their first error, begin intervening on the error they were a control site for, and begin collecting data on the third error for which they will be a control site for. Finally, in the final eight months, all groups will intervene on all three errors. A second wave of practices will be recruited to join the groups after eight months and will only intervene on two of the three errors.
The investigators propose to conduct a multisite, prospective, stepped wedge cluster randomized trial testing a quality improvement collaborative (QIC) intervention within the American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over 300 primary care practices, ranging from tertiary care academic medical centers to single practitioner private practices, interested in and experienced with QICs. Because many processes are likely to be common across diagnostic errors in outpatient settings, a multifaceted intervention, such as a QIC, has a high likelihood of success and broad applicability across populations. Preparatory inquiries to QuIIN primary care providers suggest high interest in reducing these 3 diagnostic errors and provider agreement with randomization to evaluate diagnostic error interventions. Practices will be randomized to one of three groups, with each group collecting retrospective baseline data on one error above, and then intervening to reduce that error during the first eight months. Each group will concurrently collect control data on an error they are not intervening on during those eight months. Following those eight months, the groups will continue intervening on their first error, begin intervening on the error they were a control site for, and begin collecting data on the third error for which they will be a control site for. Finally, in the final eight months, all groups will intervene on all three errors. A second wave of practices will be recruited to join the groups after eight months and will only intervene on two of the three errors.
Brief Title
Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
Detailed Description
Objectives:
Primary
• To determine whether a QIC consisting of evidence-based best-practice methodologies, mini-root cause analyses, data sharing, and behavior change techniques, is associated with a reduction in 3 specific diagnostic error rates in a national group of pediatric primary care practices.
* Hypothesis 1: Implementation of a QIC will lead to a 40% reduction in missed diagnosis of adolescent depression.
* Hypothesis 2: Implementation of a QIC will lead to a 30% reduction in missed diagnosis of pediatric elevated blood pressure.
* Hypothesis 3: Implementation of a QIC will lead to a 45% reduction in delayed diagnosis of actionable laboratory results.
Secondary
* To determine if a QIC's effect changes for wave 1 versus wave 2 participants, or for the second versus the first error a practice intervenes on.
* To further investigate the epidemiology of three ambulatory pediatric diagnostic errors: missed diagnosis of adolescent depression, missed diagnosis of pediatric elevated blood pressure, and delayed diagnosis of actionable laboratory results.
* To evaluate patient outcomes related to these diagnoses including outcomes after positive depression screening, missed elevated blood pressure screening and delayed diagnosis of actionable laboratory values.
Primary
• To determine whether a QIC consisting of evidence-based best-practice methodologies, mini-root cause analyses, data sharing, and behavior change techniques, is associated with a reduction in 3 specific diagnostic error rates in a national group of pediatric primary care practices.
* Hypothesis 1: Implementation of a QIC will lead to a 40% reduction in missed diagnosis of adolescent depression.
* Hypothesis 2: Implementation of a QIC will lead to a 30% reduction in missed diagnosis of pediatric elevated blood pressure.
* Hypothesis 3: Implementation of a QIC will lead to a 45% reduction in delayed diagnosis of actionable laboratory results.
Secondary
* To determine if a QIC's effect changes for wave 1 versus wave 2 participants, or for the second versus the first error a practice intervenes on.
* To further investigate the epidemiology of three ambulatory pediatric diagnostic errors: missed diagnosis of adolescent depression, missed diagnosis of pediatric elevated blood pressure, and delayed diagnosis of actionable laboratory results.
* To evaluate patient outcomes related to these diagnoses including outcomes after positive depression screening, missed elevated blood pressure screening and delayed diagnosis of actionable laboratory values.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Diagnostic Errors
Eligibility Criteria
Inclusion Criteria:
* The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.
* Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study
* The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.
* Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study
Inclusion Criteria
Inclusion Criteria:
* The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.
* Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study
* The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.
* Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study
Gender
All
Gender Based
false
Keywords
Depression
Blood Pressure
Anemias, Iron-Deficiency
Streptococcal Infections
Sexually Transmitted Diseases
Lead Poisoning, Nervous System, Childhood
Thyrotropin
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
26 Years
NCT Id
NCT02798354
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2014-3980
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Reducing Diagnostic Errors in Primary Care Pediatrics
Primary Outcomes
Outcome Description
Patients \>=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record
Outcome Measure
Number of Adolescents Diagnosed With Depression Seen in Well Child Visits
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Description
Systolic or Diastolic Blood Pressure \>= 90th percentile for age, gender and height or \>=120/80 in \>=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure
Outcome Measure
Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Description
Documented action step for first positive within 30 days:
1. Hemoglobin (Hgb) less than 11 and mean corpuscular volume (MCV) less than 75 in 1 or 2 year old without documentation of beginning iron, sending iron studies or family conversation
2. Lead greater than 5 without documentation of family conversation on lead remediation or plan to retest
Documented action step for first positive within 7 days:
1. Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist
2. Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation
3. Thyroid stimulating hormone (TSH) less than 0.5 or greater than 4.5 in greater than 1 year old without plan to repeat lab values or referral to endocrinologist
1. Hemoglobin (Hgb) less than 11 and mean corpuscular volume (MCV) less than 75 in 1 or 2 year old without documentation of beginning iron, sending iron studies or family conversation
2. Lead greater than 5 without documentation of family conversation on lead remediation or plan to retest
Documented action step for first positive within 7 days:
1. Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist
2. Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation
3. Thyroid stimulating hormone (TSH) less than 0.5 or greater than 4.5 in greater than 1 year old without plan to repeat lab values or referral to endocrinologist
Outcome Measure
Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Secondary Outcomes
Outcome Description
Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Measure
Number of Adolescents With Mental Health Addressed During Their Well Child Visit
Outcome Description
Systolic or Diastolic Blood Pressure \>= 90th percentile for age, gender and height or \>=120/80 in \>=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report.
Outcome Time Frame
Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Measure
Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart
Outcome Description
Systolic or Diastolic Blood Pressure \>= 90th percentile for age, gender and height or \>=120/80 in \>=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Measure
Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider
Outcome Description
Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above.
Outcome Time Frame
Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Outcome Measure
Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
26
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Rinke
Investigator Email
mrinke@montefiore.org
Investigator Phone
718-741-2524
Categories Mesh Debug
Mental Health & Behavioral Research --- DEPRESSION
Psychiatry & Behavioral Sciences --- DEPRESSION
Blood Disorders --- ANEMIA, IRON-DEFICIENCY
HIV/AIDS --- SEXUALLY TRANSMITTED DISEASES
Infectious Disease --- SEXUALLY TRANSMITTED DISEASES
Mental Health & Behavioral Research --- BEHAVIORAL SYMPTOMS
Psychiatry & Behavioral Sciences --- BEHAVIORAL SYMPTOMS
Blood Disorders --- ANEMIA
Blood & Bone Marrow Cancers --- ANEMIA
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Diabetes --- METABOLIC DISEASES
Diabetes & Endocrine System --- METABOLIC DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Substance Use and Addiction --- CHEMICALLY-INDUCED DISORDERS
MeSH Terms
DEPRESSION
ANEMIA, IRON-DEFICIENCY
STREPTOCOCCAL INFECTIONS
SEXUALLY TRANSMITTED DISEASES
LEAD POISONING, NERVOUS SYSTEM, CHILDHOOD
BEHAVIORAL SYMPTOMS
BEHAVIOR
ANEMIA, HYPOCHROMIC
ANEMIA
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IRON DEFICIENCIES
IRON METABOLISM DISORDERS
METABOLIC DISEASES
NUTRITIONAL AND METABOLIC DISEASES
GRAM-POSITIVE BACTERIAL INFECTIONS
BACTERIAL INFECTIONS
BACTERIAL INFECTIONS AND MYCOSES
INFECTIONS
COMMUNICABLE DISEASES
GENITAL DISEASES
UROGENITAL DISEASES
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
LEAD POISONING, NERVOUS SYSTEM
HEAVY METAL POISONING, NERVOUS SYSTEM
NEUROTOXICITY SYNDROMES
NERVOUS SYSTEM DISEASES
LEAD POISONING
HEAVY METAL POISONING
POISONING
CHEMICALLY-INDUCED DISORDERS