Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

NCT02798354 | Completed Results

• 1 other identifier: 2014-3980
• Study Type: interventional
• Target: 13,853
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Errors

Keywords

Depression; Blood Pressure; Anemias, Iron-Deficiency; Streptococcal Infections; Sexually Transmitted Diseases; Lead Poisoning, Nervous System, Childhood; Thyrotropin

Outcome Measures

Primary Outcomes (3)

• 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: 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

  Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Reduce Elevated Blood Pressure Errors First

EXPERIMENTAL

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

Reduce Depression Errors First

EXPERIMENTAL

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

Reduce Lab Related Errors First

EXPERIMENTAL

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

Interventions

Quality Improvement Collaborative BEHAVIORAL

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

Reduce Depression Errors First; Reduce Elevated Blood Pressure Errors First; Reduce Lab Related Errors First

Eligibility Criteria

• Age: 26 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

American Academy of Pediatrics

Elk Grove Village, Illinois, 60007, United States

Location

Related Publications (1)

• 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.

  PMID: 30720339 DERIVED

MeSH Terms

Conditions

Depression; Anemia, Iron-Deficiency; Streptococcal Infections; Sexually Transmitted Diseases; Lead Poisoning, Nervous System, Childhood

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Practices enrolled in a QIC are likely not representative of all practices. Appropriate actions broadly defined. No direct chart review verifications. No data on 11 practices who left the study. Quasi-random chart review strategy.

Results Point of Contact

• Title: Dr. Michael Rinke
• Organization: Children's Hospital at Montefiore and Albert Einstein College of Medicine

mrinke@montefiore.org

718-741-2597

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: December 16, 2019
• Results First Posted: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)