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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Nationwide Children's Hospital | OTHER |
| Providence Health & Services | OTHER |
| University of Pittsburgh |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Admission | Experimental | Referring providers contact the hospital to arrange for a child to be admitted directly into the pediatric hospital medicine unit. |
|
| ED Admission | Active Comparator | Children initially present at the Emergency Department and are then admitted to the pediatric hospital medicine unit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct admission | Behavioral | Process of pediatric admission is through admission directly into the pediatric hospital medicine unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 6 hours of hospital admission |
| 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 | within 6 hours of hospital admission |
| 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 | within 6 hours of hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Deterioration | Transfer for pediatric intensive care or rapid response calls | within 6 hours of arrival on the inpatient unit |
| Pediatric Hospitalization Admission Survey of Experience (PHASE) |
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Inclusion Criteria
Child has one of the following presenting diagnoses:
Exclusion Criteria
Ineligible children include those:
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| Name | Affiliation | Role |
|---|---|---|
| JoAnna K Leyenaar, MD, PhD | Dartmouth-Hitchcock Medical Center; Geisel School of Medicine at Dartmouth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States | ||
| UPMC Children's Hospital of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33256850 | Derived | Leyenaar JK, McDaniel CE, Acquilano SC, Schaefer AP, Bruce ML, O'Malley AJ. Comparative effectiveness of direct admission and admission through emergency departments for children: a randomized stepped wedge study protocol. Trials. 2020 Nov 30;21(1):988. doi: 10.1186/s13063-020-04889-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Step 1: Months 1-6 |
| |||||||||||||||||||
| Step 2: Months 7-12 |
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| Step 3: Months 13-21 |
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| Step 4: Months 22-39 |
|
The above numbers reflect admissions that occurred following each clinic's respective DA program start date and which were included in the patient-level analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | ED Admission |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained. | Posted | Median | Inter-Quartile Range | minutes | within 6 hours of hospital admission |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | Non-systematic Assessment | No SAEs expected |
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This study was implemented six weeks prior to the COVID-19 pandemic, which led to unprecedented changes to healthcare. Early in the pandemic, closures of primary care clinics, transitions to telehealth, and low ED volumes may have decreased DA access and improved relative timeliness of ED care. Throughout the study, pandemic-associated staffing challenges, shortages of bed availability, and pediatric unit closures (which were observed nationally) continued to impact the project.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Acquilano, Research Project Director | The Dartmouth Institute for Health Policy & Clinical Practice | 603-646-5937 | stephanie.acquilano@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Jul 26, 2024 | Prot_SAP_000.pdf |
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| OTHER |
| Dartmouth College | OTHER |
| Seattle Children's Hospital | OTHER |
stepped-wedge cluster randomized controlled trial
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| ED admission | Behavioral | Process of pediatric admission is through the emergency department |
|
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
| Within 72 hours of hospital admission |
| Pittsburgh |
| Pennsylvania |
| 15224 |
| United States |
| Providence Regional Medical Center - Everett | Everett | Washington | 98201 | United States |
| Patient Directly Admitted |
|
| Patient Admitted Through ED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Patient Directly Admitted |
|
| Patient Admitted Through ED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Patient Directly Admitted |
|
| Patient Admitted Through ED |
|
| COMPLETED |
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| NOT COMPLETED |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Payor | Type of insurance | Count of Participants | 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 |
|
|
|
| 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 | These analyses include all admissions that occurred following each clinic's respective DA program start date. | Posted | Median | Inter-Quartile Range | minutes | within 6 hours of hospital admission |
|
|
|
|
| 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 | These analyses include only those admissions that occurred following each clinic's respective DA program start date and for whom data were obtained. | Posted | Median | Inter-Quartile Range | minutes | within 6 hours of hospital admission |
|
|
|
|
| Secondary | Number of Participants With Clinical Deterioration | Transfer for pediatric intensive care or rapid response calls | These analyses include 145 DAs and 1852 ED admissions that occurred following each clinic's respective DA program start date. | Posted | Count of Participants | Participants | within 6 hours of arrival on the inpatient unit |
|
|
|
|
| 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 | As a secondary, self-reported outcome measure, we only obtained data from the subsample of families who completed a PHASE survey. | Posted | Mean | Standard Deviation | score on a scale | Within 72 hours of hospital admission |
|
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| 0 |
| 145 |
| EG001 | 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 | 0 | 1,852 | 0 | 1,852 | 0 | 1,852 |
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