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Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

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ClinicalTrials.gov Identifier: NCT02798354
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : December 16, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
American Academy of Pediatrics
Information provided by (Responsible Party):
Michael Rinke, Montefiore Medical Center

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.


Condition or disease Intervention/treatment Phase
Diagnostic Errors Behavioral: Quality Improvement Collaborative Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13853 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Reducing Diagnostic Errors in Primary Care Pediatrics
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reduce Elevated Blood Pressure Errors First

Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values.

Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.

Behavioral: Quality 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

Experimental: Reduce Depression Errors First

Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis.

Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.

Behavioral: Quality 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

Experimental: Reduce Lab Related Errors First

Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis.

Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.

Behavioral: Quality 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




Primary Outcome Measures :
  1. Number of Adolescents Diagnosed With Depression Seen in Well Child Visits [ Time Frame: 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

  2. Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers [ Time Frame: 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

  3. Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay [ Time Frame: 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 Outcome Measures :
  1. Number of Adolescents With Mental Health Addressed During Their Well Child Visit [ Time Frame: 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.

  2. Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart [ Time Frame: 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.

  3. Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider [ Time Frame: 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

  4. Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider [ Time Frame: 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.


Other Outcome Measures:
  1. 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 [ Time Frame: 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.

  2. 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 [ Time Frame: 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.

  3. Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   26 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798354


Locations
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United States, Illinois
American Academy of Pediatrics
Elk Grove Village, Illinois, United States, 60007
Sponsors and Collaborators
Montefiore Medical Center
American Academy of Pediatrics
  Study Documents (Full-Text)

Documents provided by Michael Rinke, Montefiore Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Rinke, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02798354    
Other Study ID Numbers: 2014-3980
First Posted: June 14, 2016    Key Record Dates
Results First Posted: December 16, 2019
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Rinke, Montefiore Medical Center:
Depression
Blood Pressure
Anemias, Iron-Deficiency
Streptococcal Infections
Sexually Transmitted Diseases
Lead Poisoning, Nervous System, Childhood
Thyrotropin