Diagnostic Errors
Conditions
Keywords
Depression, Blood Pressure, Anemias, Iron-Deficiency, Streptococcal Infections, Sexually Transmitted Diseases, Lead Poisoning, Nervous System, Childhood, Thyrotropin
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.
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.
Interventions
BEHAVIORALQuality Improvement Collaborative
1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams
Sponsors
American Academy of Pediatrics
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
26 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | 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 |
| Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Patients \>=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record |
| Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above. |
| Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | 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 |
| Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns. |
| Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs | Collected at 4 months | Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. |
| Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits | Collected monthly for 8 months when practice is intervening on this topic | Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. |
| Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits | Collected until 2 months | Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months. |
Countries
United States
Participant flow
Pre-assignment details
Of note, initial control data were collected prior to the first Intervention Period
Participants by arm
| Arm | Count |
|---|---|
| Reduce Elevated Blood Pressure Errors A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. | 3,562 |
| Reduce Depression Errors A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. | 7,508 |
| Reduce Lab Related Errors A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts. | 2,783 |
| Total | 13,853 |
Baseline characteristics
| Characteristic | Reduce Elevated Blood Pressure Errors | Reduce Depression Errors | Reduce Lab Related Errors | Total |
|---|---|---|---|---|
| Age, Categorical Control Group <=18 years | 1695 Participants | 3277 Participants | 1282 Participants | 6254 Participants |
| Age, Categorical Control Group >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Control Group Between 18 and 65 years | 33 Participants | 117 Participants | 75 Participants | 225 Participants |
| Age, Categorical Intervention Group <=18 years | 1805 Participants | 3967 Participants | 1332 Participants | 7104 Participants |
| Age, Categorical Intervention Group >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Intervention Group Between 18 and 65 years | 29 Participants | 147 Participants | 94 Participants | 270 Participants |
| Insurance Status Control Group Non-private Insurance | 1251 Participants | 2383 Participants | 1035 Participants | 4669 Participants |
| Insurance Status Control Group Private Insurance | 477 Participants | 1011 Participants | 322 Participants | 1810 Participants |
| Insurance Status Intervention Group Non-private Insurance | 1368 Participants | 3028 Participants | 1104 Participants | 5500 Participants |
| Insurance Status Intervention Group Private Insurance | 466 Participants | 1086 Participants | 322 Participants | 1874 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Control Group Female | 836 Participants | 1677 Participants | 693 Participants | 3206 Participants |
| Sex: Female, Male Control Group Male | 892 Participants | 1717 Participants | 664 Participants | 3273 Participants |
| Sex: Female, Male Intervention Group Female | 880 Participants | 2094 Participants | 742 Participants | 3716 Participants |
| Sex: Female, Male Intervention Group Male | 954 Participants | 2020 Participants | 684 Participants | 3658 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Adolescents Diagnosed With Depression Seen in Well Child Visits
Patients \>=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | 233 Participants |
| Intervention Group | Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | 443 Participants |
p-value: <0.000195% CI: [2.4, 5.3]Mixed Models Analysis
Primary
Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay
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
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | 1273 Participants |
| Intervention Group | Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | 1329 Participants |
p-value: 0.30295% CI: [-1, 3.1]Mixed Models Analysis
Primary
Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers
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
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | 969 Participants |
| Intervention Group | Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | 1378 Participants |
p-value: <0.000195% CI: [12.3, 20]Mixed Models Analysis
Secondary
Number of Adolescents With Mental Health Addressed During Their Well Child Visit
Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Adolescents With Mental Health Addressed During Their Well Child Visit | 1782 Participants |
| Intervention Group | Number of Adolescents With Mental Health Addressed During Their Well Child Visit | 3075 Participants |
p-value: <0.000195% CI: [22.4, 30.7]Mixed Models Analysis
Secondary
Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider
Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above.
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | 1292 Participants |
| Intervention Group | Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | 1339 Participants |
p-value: 0.92295% CI: [-1.8, 1.9]Mixed Models Analysis
Secondary
Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart
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.
Time frame: Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | 1233 Participants |
| Intervention Group | Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | 1681 Participants |
p-value: <0.000195% CI: [16.2, 24.1]Mixed Models Analysis
Secondary
Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider
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
Time frame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | 1013 Participants |
| Intervention Group | Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | 1394 Participants |
p-value: <0.000195% CI: [10.3, 17.7]Mixed Models Analysis
Other Pre-specified
Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits
Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time frame: Collected monthly for 8 months when practice is intervening on this topic
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Control Group | Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits | Percent of Clinics meeting threshold at 5 months | 15 Clinics |
| Control Group | Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits | Percent of Clinics meeting threshold at 8 months | 21 Clinics |
Other Pre-specified
Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits
Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time frame: Collected until 2 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Control Group | Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits | 27 Clinics |
Other Pre-specified
Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs
Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time frame: Collected at 4 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Control Group | Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs | 27 Clinics |