Trial · NCT02798354
Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
NCT02798354, Not applicable, Completed, Montefiore Medical Center; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE). Trials, record NCT02798354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02798354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)
- NCT number
- NCT02798354
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 13,853 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Diagnostic Errors
- Interventions
- Quality Improvement Collaborative
- First posted
- 2016-06-14
- Last updated
- 2019-12-16
- Results first posted
- 2019-12-16
- 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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | 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 |
| Primary | Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | 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 |
| Primary | Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | 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 | 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) | Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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 |
| Secondary | 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) | Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above. |
| Other | 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 | 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. |
| Other | 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 | 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. |
| Other | 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 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | 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 | Clinics | COUNT_OF_UNITS | |
| OTHER_PRE_SPECIFIED | 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 | Clinics | COUNT_OF_UNITS | |
| OTHER_PRE_SPECIFIED | 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 | Clinics | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Control Group | 233 | Participants | ||
| Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Intervention Group | 443 | Participants | ||
| Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Control Group | 969 | Participants | ||
| Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Intervention Group | 1378 | Participants | ||
| Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Control Group | 1273 | Participants | ||
| Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Intervention Group | 1329 | Participants | ||
| Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Control Group | 1782 | Participants | ||
| Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Intervention Group | 3075 | Participants | ||
| Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Control Group | 1233 | Participants | ||
| Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Intervention Group | 1681 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period | STARTED | Group 1: Blood Pressure, Depresion, Labs | 1,184 | 14 |
| First Intervention Period | STARTED | Group 2: Depression, Labs, Blood Pressure | 2,176 | 16 |
| First Intervention Period | STARTED | Group 3: Labs, Blood Pressure, Depression | 990 | 13 |
| First Intervention Period | Control Data Error 1 | Group 1: Blood Pressure, Depresion, Labs | 440 | 11 |
| First Intervention Period | Control Data Error 1 | Group 2: Depression, Labs, Blood Pressure | 549 | 10 |
| First Intervention Period | Control Data Error 1 | Group 3: Labs, Blood Pressure, Depression | 345 | 10 |
| First Intervention Period | Intervention Data Error 1 | Group 1: Blood Pressure, Depresion, Labs | 744 | 11 |
| First Intervention Period | Intervention Data Error 1 | Group 2: Depression, Labs, Blood Pressure | 1,627 | 10 |
| First Intervention Period | Intervention Data Error 1 | Group 3: Labs, Blood Pressure, Depression | 645 | 10 |
| First Intervention Period | COMPLETED | Group 1: Blood Pressure, Depresion, Labs | 1,184 | 11 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reduce Elevated Blood Pressure Errors | 0 | 0 |
| Total, all-cause mortality | Reduce Depression Errors | 0 | 0 |
| Total, all-cause mortality | Reduce Lab Related Errors | 0 | 0 |
| Total, other adverse events | Reduce Elevated Blood Pressure Errors | 0 | 0 |
| Total, other adverse events | Reduce Depression Errors | 0 | 0 |
| Total, other adverse events | Reduce Lab Related Errors | 0 | 0 |
| Total, serious adverse events | Reduce Elevated Blood Pressure Errors | 0 | 0 |
| Total, serious adverse events | Reduce Depression Errors | 0 | 0 |
| Total, serious adverse events | Reduce Lab Related Errors | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30720339 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Group vs Control Group: Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider | Trial comparisons |
| Intervention Group vs Control Group: Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay | Trial comparisons |
| Intervention Group vs Control Group: Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider | Trial comparisons |
| Intervention Group vs Control Group: Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers | Trial comparisons |
| Intervention Group vs Control Group: Number of Adolescents Diagnosed With Depression Seen in Well Child Visits | Trial comparisons |
| Intervention Group vs Control Group: Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart | Trial comparisons |
| Intervention Group vs Control Group: Number of Adolescents With Mental Health Addressed During Their Well Child Visit | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02798354
GET https://conductscience.org/api/trials/v1/NCT02798354/flow?page=2