Clinical trial NCT02798354: Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
Official title: Reducing Diagnostic Errors in Primary Care Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Errors
Keywords: Depression
Blood Pressure
Anemias, Iron-Deficiency
Streptococcal Infections
Sexually Transmitted Diseases
Lead Poisoning, Nervous System, Childhood
Thyrotropin
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: American Academy of Pediatrics
First posted: 2016-06-14
Enrollment: 13853
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Adolescents Diagnosed With Depression Seen in Well Child Visits
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
measure: Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
measure: Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Secondary outcomes:
measure: Number of Adolescents With Mental Health Addressed During Their Well Child Visit
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
measure: Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart
timeFrame: Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)
measure: Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
measure: Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider
timeFrame: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Other outcomes:
measure: 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
timeFrame: Collected at 4 months
measure: 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
timeFrame: Collected until 2 months
measure: Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits
timeFrame: Collected monthly for 8 months when practice is intervening on this topic
Locations:
city: Elk Grove Village
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
References:
citation: 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.