Diagnostic ErrorsNCT02798354
Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
A study testing Quality Improvement Collaborative in people with Diagnostic Errors, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Diagnostic Errors
- What is being tested?
- Quality Improvement Collaborative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,853 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 31 Oct 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Elk Grove Village, Illinois, 60007
About this study
Official title: 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.
Read the 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.
- Conditions
- Diagnostic Errors
- Being tested
- Quality Improvement Collaborative
- Keywords
- Depression, Blood Pressure, Anemias, Iron-Deficiency, Streptococcal Infections, Sexually Transmitted Diseases, Lead Poisoning, Nervous System, Childhood, Thyrotropin
- Medical subject headings
- Depression, Anemia, Iron-Deficiency, Streptococcal Infections, Sexually Transmitted Diseases, Lead Poisoning, Nervous System, Childhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Improvement CollaborativeBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Quality Improvement Collaborative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start1 Jun 2015
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,853 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, Michael Rinke, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798354
- Sponsor's protocol ID
- 2014-3980
- Status last verified
- Dec 2019
- First submitted
- 25 May 2016
- Last updated
- 16 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30720339