Child Health, Hospitalization
Conditions
Brief summary
At a national level, emergency departments (EDs) serve as the portal of hospital admission for 75% of hospitalized children. The remainder occur via direct admission, defined as admission to hospital without first receiving care in the hospital's ED. The overall goals of this research are to: (i) implement pediatric direct admission systems at 3 hospitals, (ii) compare the timeliness of healthcare delivery for children who are admitted directly and through emergency departments, (iii) determine which patient populations achieve the greatest benefits from direct admission, and (iv) identify barriers and facilitators of successful implementation.
Detailed description
The Specific Aims of this research are to: (i) Determine the effect of a pediatric direct admission system on timeliness of healthcare provision (the investigator's primary outcome), family experience of care, and rates of clinical deterioration compared to hospital admission beginning in the ED; (ii) Identify the pediatric populations and conditions that experience the greatest benefits from direct admission; and (iii) Through interviews with key informants, identify barriers to and facilitators of implementing standardized direct admission processes. To achieve these Aims, a stepped-wedge cluster randomized controlled trial at three geographically diverse hospitals in the United States will be conducted, randomizing primary and urgent care practices in the hospitals' catchment area to cross over to the direct admission intervention at four time points. Linear models with random effects for clusters and time period fixed effects will be used to evaluate outcomes associated with the direct admission intervention. To examine for heterogeneity of treatment effects, interactions between direct admission and a priori-specified subgroups will be examined.
Interventions
BEHAVIORALDirect admission
Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
BEHAVIORALED admission
Process of pediatric admission is through the emergency department
Sponsors
Dartmouth College
Patient-Centered Outcomes Research Institute
Nationwide Children's Hospital
Providence Health & Services
University of Pittsburgh
Seattle Children's Hospital
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
stepped-wedge cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
30 Days to 17 Years
Healthy volunteers
No
Inclusion criteria
Child has one of the following presenting diagnoses: * gastroenteritis * dehydration * skin and soft tissue infection * urinary tract infection/pyelonephritis * pneumonia * viral infection not otherwise specified * influenza
Exclusion criteria
Ineligible children include those: * with planned admissions (i.e., chemotherapy) * admitted to non-pediatric hospital medicine services (i.e., intensive care) * transferred from other hospitals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timeliness of Clinical Care - Initial Therapeutic Management | within 6 hours of hospital admission | Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications |
| Timeliness of Clinical Care - Initial Clinical Assessment | within 6 hours of hospital admission | 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 |
| Timeliness of Clinical Care - Initial Diagnostic Testing | within 6 hours of hospital admission | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Deterioration | within 6 hours of arrival on the inpatient unit | Transfer for pediatric intensive care or rapid response calls |
| Pediatric Hospitalization Admission Survey of Experience (PHASE) | Within 72 hours of hospital admission | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Direct Admission 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 | 145 |
| ED Admission 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 | 1,852 |
| Total | 1,997 |
Baseline characteristics
| Characteristic | Direct Admission | ED Admission | Total |
|---|---|---|---|
| Age, Continuous | 2.8 years | 2.8 years | 2.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 154 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 137 Participants | 1645 Participants | 1782 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 53 Participants | 53 Participants |
| Primary Payor Commercial | 72 Participants | 564 Participants | 636 Participants |
| Primary Payor Medicaid | 68 Participants | 1256 Participants | 1324 Participants |
| Primary Payor Other | 5 Participants | 32 Participants | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 130 Participants | 140 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 670 Participants | 699 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 110 Participants | 118 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 120 Participants | 124 Participants |
| Race (NIH/OMB) White | 93 Participants | 819 Participants | 912 Participants |
| Region of Enrollment United States | 145 participants | 1852 participants | 1997 participants |
| Sex: Female, Male Female | 65 Participants | 929 Participants | 994 Participants |
| Sex: Female, Male Male | 80 Participants | 923 Participants | 1003 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 1,852 |
| other Total, other adverse events | 0 / 145 | 0 / 1,852 |
| serious Total, serious adverse events | 0 / 145 | 0 / 1,852 |
Outcome results
Primary
Timeliness of Clinical Care - Initial Clinical Assessment
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
Time frame: within 6 hours of hospital admission
Population: These analyses include all admissions that occurred following each clinic's respective DA program start date.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Admission | Timeliness of Clinical Care - Initial Clinical Assessment | 25 minutes |
| ED Admission | Timeliness of Clinical Care - Initial Clinical Assessment | 13 minutes |
p-value: <0.00195% CI: [1.06, 1.19]Gamma Regression with Log Link Function
Primary
Timeliness of Clinical Care - Initial Diagnostic Testing
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
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Admission | Timeliness of Clinical Care - Initial Diagnostic Testing | 120.5 minutes |
| ED Admission | Timeliness of Clinical Care - Initial Diagnostic Testing | 99 minutes |
p-value: 0.3795% CI: [0.8, 1.09]Gamma Regression with Log Link Function
Primary
Timeliness of Clinical Care - Initial Therapeutic Management
Length of time from arrival at the hospital until time of first antibiotics, IV placement, fluid administration, or other medications
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Direct Admission | Timeliness of Clinical Care - Initial Therapeutic Management | 142 minutes |
| ED Admission | Timeliness of Clinical Care - Initial Therapeutic Management | 153 minutes |
p-value: <0.00195% CI: [0.65, 0.85]Gamma Regression with Log Link Function
Secondary
Number of Participants With Clinical Deterioration
Transfer for pediatric intensive care or rapid response calls
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Admission | Number of Participants With Clinical Deterioration | 1 Participants |
| ED Admission | Number of Participants With Clinical Deterioration | 15 Participants |
p-value: 0.8195% CI: [0.14, 12.27]Regression, Logistic
Secondary
Pediatric Hospitalization Admission Survey of Experience (PHASE)
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Admission | Pediatric Hospitalization Admission Survey of Experience (PHASE) | 0.75 score on a scale | Standard Deviation 0.22 |
| ED Admission | Pediatric Hospitalization Admission Survey of Experience (PHASE) | 0.71 score on a scale | Standard Deviation 0.22 |
p-value: 0.1295% CI: [-0.01, 0.11]Regression, Linear