Trial Outcomes & Findings for Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children (NCT NCT04192799)

NCT ID: NCT04192799

Last Updated: 2024-10-21

Results Overview

Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1997 participants
• Primary outcome timeframe: within 6 hours of hospital admission
• Results posted on: 2024-10-21

Participant Flow

Unit of analysis: Clinical practices

Participant milestones

Measure	Sequence 1: Periods 1-4 With Direct Admission Intervention Intervention: clinical practices received training in direct admissions for patients. Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	Sequence 2: Periods 2-4 With Direct Admission Intervention Intervention: clinical practices received training in direct admissions for patients. Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit ED admission: Process of pediatric admission is through the emergency department	Sequence 3: Periods 3-4 With Direct Admission Intervention Intervention: clinical practices received training in direct admissions for patients. Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit ED admission: Process of pediatric admission is through the emergency department	Sequence 4: Period 4 With Direct Admission Intervention Intervention: clinical practices received training in direct admissions for patients. Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit ED admission: Process of pediatric admission is through the emergency department
Step 1: Months 1-6 STARTED	134 18	0 0	0 0	0 0
Step 1: Months 1-6 Patient Directly Admitted	8 18	0 0	0 0	0 0
Step 1: Months 1-6 Patient Admitted Through ED	126 18	0 0	0 0	0 0
Step 1: Months 1-6 COMPLETED	134 18	0 0	0 0	0 0
Step 1: Months 1-6 NOT COMPLETED	0 0	0 0	0 0	0 0
Step 2: Months 7-12 STARTED	98 18	60 17	0 0	0 0
Step 2: Months 7-12 Patient Directly Admitted	8 18	3 17	0 0	0 0
Step 2: Months 7-12 Patient Admitted Through ED	90 18	57 17	0 0	0 0
Step 2: Months 7-12 COMPLETED	98 18	60 17	0 0	0 0
Step 2: Months 7-12 NOT COMPLETED	0 0	0 0	0 0	0 0
Step 3: Months 13-21 STARTED	239 18	146 17	164 17	0 0
Step 3: Months 13-21 Patient Directly Admitted	23 18	13 17	9 17	0 0
Step 3: Months 13-21 Patient Admitted Through ED	216 18	133 17	155 17	0 0
Step 3: Months 13-21 COMPLETED	239 18	146 17	164 17	0 0
Step 3: Months 13-21 NOT COMPLETED	0 0	0 0	0 0	0 0
Step 4: Months 22-39 STARTED	344 18	246 17	259 17	307 17
Step 4: Months 22-39 Patient Directly Admitted	28 18	17 17	18 17	18 17
Step 4: Months 22-39 Patient Admitted Through ED	316 18	229 17	241 17	289 17
Step 4: Months 22-39 COMPLETED	344 18	246 17	259 17	307 17
Step 4: Months 22-39 NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Effectiveness of Direct Admission & Admission Through Emergency Departments for Children

Baseline characteristics by cohort

Measure	Direct Admission n=145 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1852 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department	Total n=1997 Participants Total of all reporting groups
Age, Continuous	2.8 years n=5 Participants	2.8 years n=7 Participants	2.8 years n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	929 Participants n=7 Participants	994 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	923 Participants n=7 Participants	1003 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	154 Participants n=7 Participants	162 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	137 Participants n=5 Participants	1645 Participants n=7 Participants	1782 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	53 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	130 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	670 Participants n=7 Participants	699 Participants n=5 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	819 Participants n=7 Participants	912 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	110 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	120 Participants n=7 Participants	124 Participants n=5 Participants
Region of Enrollment United States	145 participants n=5 Participants	1852 participants n=7 Participants	1997 participants n=5 Participants
Primary Payor Medicaid	68 Participants n=5 Participants	1256 Participants n=7 Participants	1324 Participants n=5 Participants
Primary Payor Commercial	72 Participants n=5 Participants	564 Participants n=7 Participants	636 Participants n=5 Participants
Primary Payor Other	5 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 6 hours of hospital admission

Population: These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained.

Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications

Outcome measures

Measure	Direct Admission n=139 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1786 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
Timeliness of Clinical Care - Initial Therapeutic Management	142 minutes Interval 96.5 to 209.5	153 minutes Interval 85.0 to 258.0

PRIMARY outcome

Timeframe: within 6 hours of hospital admission

Population: These analyses include all admissions that occurred following each clinic's respective DA program start date.

Length of time from arrival at the hospital until first time when at least 3 vital signs were documented; if missing, time of initial brief nursing assessment

Outcome measures

Measure	Direct Admission n=145 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1852 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
Timeliness of Clinical Care - Initial Clinical Assessment	25 minutes Interval 19.0 to 31.0	13 minutes Interval 7.0 to 30.0

PRIMARY outcome

Timeframe: within 6 hours of hospital admission

Population: These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained.

Length of time from arrival at the hospital until time of initial labs and/or imaging, including "standing orders" for diagnostic testing in emergency departments

Outcome measures

Measure	Direct Admission n=141 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
Timeliness of Clinical Care - Initial Diagnostic Testing	120.5 minutes Interval 83.0 to 171.0	99 minutes Interval 48.0 to 186.0

SECONDARY outcome

Timeframe: within 6 hours of arrival on the inpatient unit

Population: These analyses include 145 DAs and 1852 ED admissions that occurred following each clinic's respective DA program start date.

Transfer for pediatric intensive care or rapid response calls

Outcome measures

Measure	Direct Admission n=145 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1852 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
Number of Participants With Clinical Deterioration	1 Participants	15 Participants

SECONDARY outcome

Timeframe: Within 72 hours of hospital admission

Population: As a secondary, self-reported outcome measure, we only obtained data from the subsample of families who completed a PHASE survey.

Standardized closed-ended survey questions regarding parent-reported experience of hospital admission with respect to the admission process, communication with families, communication between providers, and the hospital space; composite measure on 0-1 scale, with higher scores indicating better family experience

Outcome measures

Measure	Direct Admission n=67 Participants Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=805 Participants Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
Pediatric Hospitalization Admission Survey of Experience (PHASE)	0.75 score on a scale Standard Deviation 0.22	0.71 score on a scale Standard Deviation 0.22

Adverse Events

Direct Admission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ED Admission

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Direct Admission n=145 participants at risk Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. Direct admission: Process of pediatric admission is through admission directly into the pediatric hospital medicine unit	ED Admission n=1852 participants at risk Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. ED admission: Process of pediatric admission is through the emergency department
General disorders	0.00% 0/145 • 6 hours (first 6 hours post inpatient admission) This study was deemed minimal risk by the IRB and reviewed as an expedited study. We did not expect any mortality or serious adverse events; possible adverse events included discomfort with completing the survey and loss of confidentiality.	0.00% 0/1852 • 6 hours (first 6 hours post inpatient admission) This study was deemed minimal risk by the IRB and reviewed as an expedited study. We did not expect any mortality or serious adverse events; possible adverse events included discomfort with completing the survey and loss of confidentiality.

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Acquilano, Research Project Director

The Dartmouth Institute for Health Policy & Clinical Practice

Phone: 603-646-5937

Email: stephanie.acquilano@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place