Trial Outcomes & Findings for Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE) (NCT NCT02798354)

Results Overview

Patients \>=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13853 participants

Primary outcome timeframe

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

Results posted on

2019-12-16

Participant Flow

Of note, initial control data were collected prior to the first Intervention Period

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Group 1: Blood Pressure, Depresion, Labs A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.	Group 2: Depression, Labs, Blood Pressure A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.	Group 3: Labs, Blood Pressure, Depression A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.
First Intervention Period STARTED	1184 14	2176 16	990 13
First Intervention Period Control Data Error 1	440 11	549 10	345 10
First Intervention Period Intervention Data Error 1	744 11	1627 10	645 10
First Intervention Period COMPLETED	1184 11	2176 10	990 10
First Intervention Period NOT COMPLETED	0 3	0 6	0 3
Second Intervention Period STARTED	2617 11	1047 10	1368 10
Second Intervention Period Control Data Error 2	1378 11	593 10	668 9
Second Intervention Period Intervention Data Error 2	1239 11	454 9	700 10
Second Intervention Period COMPLETED	2617 11	1047 9	1368 10
Second Intervention Period NOT COMPLETED	0 0	0 1	0 0
Third Intervention Period STARTED	746 11	1010 9	2715 10
Third Intervention Period Control Data Error 3	419 11	620 9	1467 10
Third Intervention Period Intervention Data Error 3	327 11	390 9	1248 10
Third Intervention Period COMPLETED	746 11	1010 9	2715 10
Third Intervention Period NOT COMPLETED	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Each error had an intervention and control group

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=3394 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=4114 Participants Patients included at all practices during pratices' depression intervention phase
Number of Adolescents Diagnosed With Depression Seen in Well Child Visits	233 Participants	443 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=1728 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=1834 Participants Patients included at all practices during pratices' depression intervention phase
Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers	969 Participants	1378 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=1357 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=1426 Participants Patients included at all practices during pratices' depression intervention phase
Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay	1273 Participants	1329 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=3394 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=4114 Participants Patients included at all practices during pratices' depression intervention phase
Number of Adolescents With Mental Health Addressed During Their Well Child Visit	1782 Participants	3075 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=1728 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=1834 Participants Patients included at all practices during pratices' depression intervention phase
Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart	1233 Participants	1681 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Control Group n=1728 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=1834 Participants Patients included at all practices during pratices' depression intervention phase
Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider	1013 Participants	1394 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=1357 Participants Patients included at all practices during practices' depression control phase	Intervention Group n=1426 Participants Patients included at all practices during pratices' depression intervention phase
Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider	1292 Participants	1339 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=30 Clinics Patients included at all practices during practices' depression control phase	Intervention Group Patients included at all practices during pratices' depression intervention phase
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	27 Clinics	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=30 Clinics Patients included at all practices during practices' depression control phase	Intervention Group Patients included at all practices during pratices' depression intervention phase
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	27 Clinics	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=31 Clinics Patients included at all practices during practices' depression control phase	Intervention Group Patients included at all practices during pratices' depression intervention phase
Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits Percent of Clinics meeting threshold at 5 months	15 Clinics	—
Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits Percent of Clinics meeting threshold at 8 months	21 Clinics	—

Adverse Events

Reduce Elevated Blood Pressure Errors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reduce Depression Errors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reduce Lab Related Errors

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Rinke

Children's Hospital at Montefiore and Albert Einstein College of Medicine

Phone: 718-741-2597

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Reduce Elevated Blood Pressure Errors n=3562 Participants A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	Reduce Depression Errors n=7508 Participants A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	Reduce Lab Related Errors n=2783 Participants A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	Total n=13853 Participants Total of all reporting groups
Age, Categorical Intervention Group · <=18 years	1805 Participants n=1834 Participants • Each error had an intervention and control group	3967 Participants n=4114 Participants • Each error had an intervention and control group	1332 Participants n=1426 Participants • Each error had an intervention and control group	7104 Participants n=7374 Participants • Each error had an intervention and control group
Age, Categorical Intervention Group · Between 18 and 65 years	29 Participants n=1834 Participants • Each error had an intervention and control group	147 Participants n=4114 Participants • Each error had an intervention and control group	94 Participants n=1426 Participants • Each error had an intervention and control group	270 Participants n=7374 Participants • Each error had an intervention and control group
Age, Categorical Intervention Group · >=65 years	0 Participants n=1834 Participants • Each error had an intervention and control group	0 Participants n=4114 Participants • Each error had an intervention and control group	0 Participants n=1426 Participants • Each error had an intervention and control group	0 Participants n=7374 Participants • Each error had an intervention and control group
Age, Categorical Control Group · <=18 years	1695 Participants n=1728 Participants • Each error had an intervention and control group	3277 Participants n=3394 Participants • Each error had an intervention and control group	1282 Participants n=1357 Participants • Each error had an intervention and control group	6254 Participants n=6479 Participants • Each error had an intervention and control group
Age, Categorical Control Group · Between 18 and 65 years	33 Participants n=1728 Participants • Each error had an intervention and control group	117 Participants n=3394 Participants • Each error had an intervention and control group	75 Participants n=1357 Participants • Each error had an intervention and control group	225 Participants n=6479 Participants • Each error had an intervention and control group
Age, Categorical Control Group · >=65 years	0 Participants n=1728 Participants • Each error had an intervention and control group	0 Participants n=3394 Participants • Each error had an intervention and control group	0 Participants n=1357 Participants • Each error had an intervention and control group	0 Participants n=6479 Participants • Each error had an intervention and control group
Sex: Female, Male Intervention Group · Female	880 Participants n=1834 Participants • Each error had an intervention and control group	2094 Participants n=4114 Participants • Each error had an intervention and control group	742 Participants n=1426 Participants • Each error had an intervention and control group	3716 Participants n=7374 Participants • Each error had an intervention and control group
Sex: Female, Male Intervention Group · Male	954 Participants n=1834 Participants • Each error had an intervention and control group	2020 Participants n=4114 Participants • Each error had an intervention and control group	684 Participants n=1426 Participants • Each error had an intervention and control group	3658 Participants n=7374 Participants • Each error had an intervention and control group
Sex: Female, Male Control Group · Female	836 Participants n=1728 Participants • Each error had an intervention and control group	1677 Participants n=3394 Participants • Each error had an intervention and control group	693 Participants n=1357 Participants • Each error had an intervention and control group	3206 Participants n=6479 Participants • Each error had an intervention and control group
Sex: Female, Male Control Group · Male	892 Participants n=1728 Participants • Each error had an intervention and control group	1717 Participants n=3394 Participants • Each error had an intervention and control group	664 Participants n=1357 Participants • Each error had an intervention and control group	3273 Participants n=6479 Participants • Each error had an intervention and control group
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Insurance Status Intervention Group · Private Insurance	466 Participants n=1834 Participants • Each error had an intervention and control group	1086 Participants n=4114 Participants • Each error had an intervention and control group	322 Participants n=1426 Participants • Each error had an intervention and control group	1874 Participants n=7374 Participants • Each error had an intervention and control group
Insurance Status Intervention Group · Non-private Insurance	1368 Participants n=1834 Participants • Each error had an intervention and control group	3028 Participants n=4114 Participants • Each error had an intervention and control group	1104 Participants n=1426 Participants • Each error had an intervention and control group	5500 Participants n=7374 Participants • Each error had an intervention and control group
Insurance Status Control Group · Private Insurance	477 Participants n=1728 Participants • Each error had an intervention and control group	1011 Participants n=3394 Participants • Each error had an intervention and control group	322 Participants n=1357 Participants • Each error had an intervention and control group	1810 Participants n=6479 Participants • Each error had an intervention and control group
Insurance Status Control Group · Non-private Insurance	1251 Participants n=1728 Participants • Each error had an intervention and control group	2383 Participants n=3394 Participants • Each error had an intervention and control group	1035 Participants n=1357 Participants • Each error had an intervention and control group	4669 Participants n=6479 Participants • Each error had an intervention and control group