Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

Reducing Diagnostic Errors in Primary Care Pediatrics

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Errors
• Intervention / Treatment: Behavioral: Quality Improvement Collaborative

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.

• Study Type: Interventional
• Enrollment (Actual): 13853
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • American Academy of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
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	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay	Documented action step for first positive within 30 days: 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; 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: Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist; Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation; 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	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
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.	Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)
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	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
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.	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Collected at 4 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	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.	Collected until 2 months
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.	Collected monthly for 8 months when practice is intervening on this topic

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: American Academy of Pediatrics

Publications and helpful links

General Publications

• Bundy DG, Singh H, Stein RE, Brady TM, Lehmann CU, Heo M, O'Donnell HC, Rice-Conboy E, Rinke ML. The design and conduct of Project RedDE: A cluster-randomized trial to reduce diagnostic errors in pediatric primary care. Clin Trials. 2019 Apr;16(2):154-164. doi: 10.1177/1740774518820522. Epub 2019 Feb 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Blood Pressure; Sexually Transmitted Diseases; Streptococcal Infections; Anemias, Iron-Deficiency; Lead Poisoning, Nervous System, Childhood; Thyrotropin
• Other Study ID Numbers: 2014-3980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No