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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS106560-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Children's National Research Institute | OTHER |
| Centro de Informática e Investigación Clínica (CIIC) | UNKNOWN |
| Washington State University | OTHER |
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Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.
Specific Aim 1: Determine the relationship between PEGASUS program implementation and TBI guideline adherence (Aim 1a), and assess system, provider, patient, implementation and guideline factors associated with TBI guideline adherence (Aim 1b). Hypothesis: Centers that receive the PEGASUS program have higher TBI guideline adherence (main outcome), as well as better discharge survival and 3-month Glasgow Outcome Scale-Extended (GOSE) score (secondary outcomes) than centers who receive usual care.
Specific Aim 2: Create a value stream map (VSM) to identify value-added processes of care associated with TBI guideline adherence. Hypothesis: ICU activity flows of TBI care during the first 72 hours will reveal value-added as well as non-value-added processes in severe TBI care. PEGASUS program implementation will result in more value-added TBI care processes and better TBI guideline adherence.
Specific Aim 3: Use computer simulation to develop and disseminate a real-world best practices blueprint for TBI guideline adherence. Hypothesis: This model will identify the impact of the PEGASUS program on key performance indicators (KPIs), outcomes (Aim 1), and process activities (Aim 2). Iterative computer simulations will then demonstrate the relationship among PEGASUS program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in TBI care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care, then Usual Care (Control) | No Intervention | All sites will collect usual care data during the baseline and post-randomization study periods. This arm (half of the sites) will maintain usual care. They will receive the opportunity for the PEGASUS program training (intervention) at the end of study. | |
| Usual Care, then PEGASUS Program (Intervention) | Experimental | All sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGASUS Program for Care | Other | This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention). | ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pathway Adoption | This outcome will be measured as yes/no for each participant at intervention sites to assess intervention delivery. In essence, the intervention started (use of PEGASUS program clinical pathway) within 24 hours of their eligibility and enrollment. Due to our intention-to-treat analysis plan, participants who enrolled after randomization but before intervention implementation at intervention sites are included in the analysis. Although they could not have implemented the intervention, sites were aware of their allocation status and were preparing and training during this interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention). Here, we stratified by extracranial injury status (isolated TBI vs. TBI and ext |
Inclusion Criteria:
Exclusion Criteria:
- none
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| Name | Affiliation | Role |
|---|---|---|
| Monica Vavilala, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sor Ludovica | La Plata | Buenos Aires | Argentina | |||
| Hospital Interzonal Especializado Materno Infantil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41891786 | Derived | Vavilala MS, Lujan S, Velonjara J, Bell MJ, Guadagnoli N, Wang J, Mock C, Weiner BJ, Petroni G; Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina study group. Results of the Pediatric Guideline Adherence and Outcomes (PEGASUS) Program Versus Usual Care Pragmatic Randomized Controlled Trial in Severe Traumatic Brain Injury. Crit Care Med. 2026 Jun 1;54(6):1442-1453. doi: 10.1097/CCM.0000000000007118. Epub 2026 Mar 27. | |
| 36471399 | Derived |
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De-identified data will be shared with Co-Investigators
Monthly as available
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Due to COVID-19, we reverted to a parallel-cluster design before randomization, resulting in a baseline period (9/1/19-7/13/20) with usual care data collected at all sites. Arm assignment and site notification was 7/13/20. Participants enrolled between 7/14/20-9/30/20 during intervention site training are included in the assigned arm (intention-to-treat) due to possible behavior change once assignment was known. Intervention implementation began for participants enrolled between 10/1/20-9/30/23.
Participants were screened based on ICU admission at 16 South American study hospitals between September 1, 2019 and September 30, 2023. The first participant was enrolled on September 9, 2019 and the last participant was enrolled September 26, 2023.
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care, Then Usual Care (Control) | All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study. |
| FG001 | Usual Care, Then PEGASUS Program (Intervention) | All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||||||||
| Post-Randomization |
|
16 sites contributed participants during baseline period. After randomization, 8 of those sites were assigned Control and 8 were assigned Intervention. Participants were allocated to the study arms based on their admission to either the control study hospitals or intervention study hospitals.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care, Then Usual Care (Control) | All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Participants recruited post-randomization are included in the post-randomization period. They will receive the opportunity for the PEGASUS program training (intervention) after the end of study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. |
| 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 | First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention). | We compared control and intervention arms post-randomization (07/13/20) in statistical analysis. Baseline period data contributed to other adjusted analyses. | Posted | Mean | Standard Deviation | mean percentage of guideline adherence | ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). |
Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study.
Our in-hospital complications form reported pneumonia, arrhythmia, shock, peritonitis, intraparenchymal hemorrhages, and other complications as free text. Severity was reported as severe, moderate, or mild. Severe events are reported here as serious adverse events and moderate/mild as other adverse events. More than one complication, complication type, and severity could be reported for the same participant.
Other was free text classified into organ system by investigators.
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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 | Usual Care at Baseline (Site That Was Later Assigned to the Control) | All participants received Usual Care. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Data for Adverse Events from the Baseline period (9/1/19-7/13/20) are listed here. See Outcomes for Mortality separated by study period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment | Pneumonia, severe |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment | Pneumonia, mild or moderate |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Monica S. Vavilala | University of Washington | 206-744-7235 | vavilala@uw.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2020 | Jan 2, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Jan 2, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2019 | Jan 2, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| National Institute of Neurological Disorders and Stroke (NINDS) |
| NIH |
Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.
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| Started within 24 hours of patient eligibility (at admission or deterioration) |
| Glasgow Outcome Scale (GOS) Score at Discharge | Participants' GOS score at hospital discharge from medical record: Death-1 (worse) Vegetative State-2 Severe Disability-3 Moderate Disability-4 Good Recovery-5 (better) The timing varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. | Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. |
| Discharge Survival | Number of survivors at intervention and control sites (descriptive and not powered for this outcome). | Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. |
| Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | We will examine participants' recovery using GOSE-Peds scores. These were assessed by site study staff either in-person, by telephone, or from medical record approximately 3 months after the admission date. Death-8 (worse) Vegetative State-7 Severe Disability lower-6 Severe Disability upper-5 Moderate Disability lower-4 Moderate Disability upper-3 Good Recovery lower-2 Good Recovery upper-1 (better) | 3 months post-admission |
| Mortality, 3-Month | We will examine participants' mortality at 3 months post discharge | 3 months post admission |
| ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). |
| Mar del Plata |
| Buenos Aires |
| Argentina |
| Hospital el Cruce | San Juan Bautista | Buenos Aires | Argentina |
| Hospital Municipal del Nino de San Justo | San Justo | Buenos Aires | Argentina |
| Hospital de Ninos Eva Peron | Catamarca | Catamarca Province | Argentina |
| Hospital Materno Infantil Dr. Hector Quintana | San Salvador de Jujuy | Jujuy Province | Argentina |
| Hospital Regional Reconquista | Reconquista | Santa Fe Province | Argentina |
| Hopital Victor J. Vilela | Rosario | Santa Fe Province | Argentina |
| Hospital del Nino Jesus | San Miguel de Tucumán | Tucumán Province | Argentina |
| Hospital de La Santisima Trinidad | Córdoba | Argentina |
| Hospital Humberto Notti | Mendoza | Argentina |
| Hospital Publico Materno Infantil | Salta | Argentina |
| Hospital Alassia | Santa Fe | Argentina |
| Centro Provincial de Salud Infantil Eva Peron | Santiago del Estero | Argentina |
| Hospital Carlos Van Buren | Valparaíso | Chile |
| Hospital de Trauma Manuel Giagni | Asunción | Paraguay |
| Velonjara J, Mills B, Lujan S, Petroni G, Bell MJ, Guadagnoli N, Mock C, Hughes JP, Vavilala MS, Rowhani-Rahbar A; PEGASUS Argentina Study Group. The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial. Trials. 2022 Dec 5;23(1):980. doi: 10.1186/s13063-022-06938-x. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Usual Care, Then PEGASUS Program (Intervention) | All sites collected usual care data from participants enrolled before randomization. This arm (8 sites) was randomized to receive the PEGASUS program (intervention) on 7/13/2020. Intervention site training occurred before the intervention was implemented for new participants beginning 10/1/2020. Participants recruited post-randomization but pre-implementation are included in the post-randomization period through end of recruitment 9/30/2023. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Total Glasgow Coma Scale (GCS) score <=8 | GCS score extracted from patient medical record as assessed by a provider. Used to measure changes in consciousness, including coma. The total score is made up of the sum of three components: eye response (1-4), verbal response (1-5), and motor response (1-6). The range is 3-15, with 15 being fully responsive in all component categories and 3 being fully non-responsive in all categories. A score less than or equal to 8 is typically classified as a severe traumatic brain injury when used in connection with a head injury. | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Count of Participants | Participants |
|
| Any extracranial injury | Non-head Abbreviated Injury Scale (AIS) score >0 indicates extracranial injury (1-6). Non-head AIS score=0 indicates isolated TBI (0). AIS is a scale assessing injury severity for different body regions, 0=uninjured, 1=minor to 6=unsurvivable. Non-head AIS is the highest value of any non-head region AIS. | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Count of Participants | Participants |
|
| Injury Severity Scale (ISS) | ISS range (0-75) The sum of the square of the highest three body region Abbreviated Injury Scale (AIS) scores. AIS range is 0-6, with 0=uninjured, 1=minor to 6=unsurvivable. If any body region has AIS=6, then ISS=75, regardless of other body region AIS scores. Higher score indicates higher total injury severity. | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Mean | Standard Deviation | units on a scale |
|
|
|
|
|
| Secondary | Clinical Pathway Adoption | This outcome will be measured as yes/no for each participant at intervention sites to assess intervention delivery. In essence, the intervention started (use of PEGASUS program clinical pathway) within 24 hours of their eligibility and enrollment. Due to our intention-to-treat analysis plan, participants who enrolled after randomization but before intervention implementation at intervention sites are included in the analysis. Although they could not have implemented the intervention, sites were aware of their allocation status and were preparing and training during this interval. | Analysis was intention-to-treat. Patients enrolled to the intervention arm after randomization, but before intervention implementation were still included because site investigators and sites were aware of their arm assignment from that date and could have altered behavior during the training interval before implementation start. | Posted | Count of Participants | Participants | Started within 24 hours of patient eligibility (at admission or deterioration) |
|
|
|
| Secondary | Glasgow Outcome Scale (GOS) Score at Discharge | Participants' GOS score at hospital discharge from medical record: Death-1 (worse) Vegetative State-2 Severe Disability-3 Moderate Disability-4 Good Recovery-5 (better) The timing varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Posted | Count of Participants | Participants | Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. |
|
|
|
| Secondary | Discharge Survival | Number of survivors at intervention and control sites (descriptive and not powered for this outcome). | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Posted | Count of Participants | Participants | Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study. |
|
|
|
| Secondary | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | We will examine participants' recovery using GOSE-Peds scores. These were assessed by site study staff either in-person, by telephone, or from medical record approximately 3 months after the admission date. Death-8 (worse) Vegetative State-7 Severe Disability lower-6 Severe Disability upper-5 Moderate Disability lower-4 Moderate Disability upper-3 Good Recovery lower-2 Good Recovery upper-1 (better) | 3-month outcome assessment among those who survived (enrolled participants less those who died in-hospital) and reached for follow-up. Lost-to-follow-up noted in Participant Flow. | Posted | Count of Participants | Participants | 3 months post-admission |
|
|
|
| Secondary | Mortality, 3-Month | We will examine participants' mortality at 3 months post discharge | The two row titles encompass two participant recruitment periods with patients participating in only one period. The sum of the rows equals the overall. Participants enrolled during baseline (study start through randomization on 7/13/20) provided usual care data. Participants enrolled during post-randomization (beginning 7/14/20 through study end) provided either usual care or intervention implementation data. This period was the population used in the primary analysis. | Posted | Count of Participants | Participants | 3 months post admission |
|
|
|
| Other Pre-specified | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention). Here, we stratified by extracranial injury status (isolated TBI vs. TBI and ext | We compared control and intervention arms post-randomization (07/13/20) in statistical analysis by extracranial injury status. | Posted | Mean | Standard Deviation | mean percentage of guideline adherence | ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). |
|
|
|
|
| 3 |
| 55 |
| 6 |
| 55 |
| 21 |
| 55 |
| EG001 | Usual Care at Post-Randomization Control Site | All participants received Usual Care. This arm (8 sites) was randomized to maintain usual care (control) on 7/13/2020. Data for Adverse Events from the Post-Randomization period (7/14/20-9/30/23) are listed here. See Outcomes for Mortality separated by study period. Sites will receive the opportunity for the PEGASUS program training (intervention) after the end of study. | 12 | 208 | 34 | 208 | 72 | 208 |
| EG002 | Usual Care at Baseline (Site That Was Later Assigned to the Intervention) | All participants received Usual Care. This arm (8 sites) was randomized to PEGASUS (intervention) on 7/13/2020. Data for Adverse Events from the Baseline period (9/1/19-7/13/20) are listed here. See Outcomes for Mortality separated by study period. | 6 | 61 | 7 | 61 | 16 | 61 |
| EG003 | PEGASUS Program at Post-Randomization Intervention Site | All participants received the PEGASUS Program in addition to Usual Care. This arm (8 sites) was randomized to PEGASUS (intervention) on 7/13/2020. Data for Adverse Events from the Post-Randomization period (7/14/20-9/30/23) are listed here. See Outcomes for Mortality separated by study period. Intervention site training occurred before the intervention was implemented for participants admitted beginning 10/1/2020. Participants in the Post-Randomization were intention-to-treat once site arm was assigned. Participants in this study period received Usual Care while site were receiving pre-implementation training, after implementation, participants received Usual Care and the PEGASUS Program. See Outcomes for Mortality separated by study period. PEGASUS Program for Care: This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care. | 13 | 181 | 17 | 181 | 78 | 181 |
| Arrhythmia | Cardiac disorders | Systematic Assessment | Arrhythmia, severe |
|
| Shock | General disorders | Systematic Assessment | Shock, severe |
|
| Peritonitis | Infections and infestations | Systematic Assessment | Peritonitis, severe |
|
| Intraparenchymal hemorrhage | Nervous system disorders | Systematic Assessment | Intraparenchymal hemorrhage, severe |
|
| Other: Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Other severe complications free text, classified by investigators as associated with Respiratory System |
|
| Other: Neurological | Nervous system disorders | Systematic Assessment | Other severe complications free text, classified by investigators as associated with Neurologic/Nervous System |
|
| Other: Electrolyte/Metabolic | Metabolism and nutrition disorders | Systematic Assessment |
|
| Other: Cardiac | Cardiac disorders | Systematic Assessment |
|
| Other: Hematology | Blood and lymphatic system disorders | Systematic Assessment |
|
| Other: Infectious | Infections and infestations | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Systematic Assessment | Arrhythmia, mild or moderate |
|
| Shock | General disorders | Systematic Assessment | Shock, mild or moderate |
|
| Peritonitis | Infections and infestations | Systematic Assessment | Peritonitis, mild or moderate |
|
| Intraparenchymal hemorrhage | Nervous system disorders | Systematic Assessment | Intraparenchymal hemorrhage, mild or moderate |
|
| Other: Infectious | Infections and infestations | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Infections |
|
| Other: Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Respiratory System |
|
| Other: Neurological | Nervous system disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Neurologic/Nervous System |
|
| Other: Gastrointestinal | Gastrointestinal disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Gastrointestinal System |
|
| Other: Hematology | Blood and lymphatic system disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Hematology |
|
| Other: Cardiac | Cardiac disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Cardiology |
|
| Other: Electrolyte/Metabolic | Metabolism and nutrition disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Electrolytes/Metabolic |
|
| Other: Ophthalmalogical | Eye disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Ophthalmology |
|
| Other: Kidney | Renal and urinary disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Kidney/Nephrology |
|
| Other: Dermatological | Skin and subcutaneous tissue disorders | Systematic Assessment | Other mild or moderate complications free text, classified by investigators as associated with Dermatology |
|
Not provided
Not provided
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| Male |
|
| Total GCS >8 (but motor<=5) |
|
| Deteriorated <=8 |
|
| Total GCS >8 (but motor<=5) |
|
| Yes |
|
| Vegetative state |
|
| Severe disability |
|
| Moderate disability |
|
| Good recovery |
|
| Post-Randomization |
|
|
| Survived |
|
| Post-Randomization |
|
|
| Vegetative state |
|
| Severe disability-lower |
|
| Severe disability-upper |
|
| Moderate disability-lower |
|
| Moderate disability-upper |
|
| Good recovery-lower |
|
| Good recovery-upper |
|
| Post-Randomization |
|
|
| Survived |
|
| Post-Randomized |
|
|
| Baseline, Extracranial injury (non-head AIS>0) |
|
|
| Post-Randomization, Isolated TBI (non-head AIS=0) |
|
|
| Post-Randomization, Extracranial injury (non-head AIS>0) |
|
|