TBI (Traumatic Brain Injury)
Conditions
Keywords
guideline adherence, implementation fidelity, pediatric
Brief summary
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.
Detailed description
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.
Interventions
OTHERPEGASUS 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.
Sponsors
Children's National Research Institute
Centro de Informática e Investigación Clínica (CIIC)
Washington State University
National Institute of Neurological Disorders and Stroke (NINDS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Mechanism or head CT consistent with TBI * \<18 years old * Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated
Exclusion criteria
\- none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pathway Adoption | Started within 24 hours of patient eligibility (at admission or deterioration) | 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. |
| Glasgow Outcome Scale (GOS) Score at Discharge | 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. | 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. |
| Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | 3 months post-admission | 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) |
| Mortality, 3-Month | 3 months post admission | We will examine participants' mortality at 3 months post discharge |
| Discharge Survival | 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. | Number of survivors at intervention and control sites (descriptive and not powered for this outcome). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days). | 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 |
Countries
Argentina, Chile, Paraguay
Participant flow
Recruitment details
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.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 263 |
| 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. | 242 |
| Total | 505 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline | Death | 3 | 6 |
| Baseline | Lost to Follow-up | 1 | 2 |
| Post-Randomization | Death | 12 | 13 |
| Post-Randomization | Lost to Follow-up | 12 | 11 |
Baseline characteristics
| Characteristic | Total | Usual Care, Then Usual Care (Control) | Usual Care, Then PEGASUS Program (Intervention) |
|---|---|---|---|
| Age, Continuous Baseline | 7.0 years STANDARD_DEVIATION 5.3 | 6.2 years STANDARD_DEVIATION 4.7 | 7.7 years STANDARD_DEVIATION 5.7 |
| Age, Continuous Post-Randomization | 7.3 years STANDARD_DEVIATION 4.7 | 6.9 years STANDARD_DEVIATION 4.5 | 7.8 years STANDARD_DEVIATION 4.8 |
| Any extracranial injury Baseline No | 39 Participants | 20 Participants | 19 Participants |
| Any extracranial injury Baseline Yes | 77 Participants | 35 Participants | 42 Participants |
| Any extracranial injury Post-Randomization No | 92 Participants | 61 Participants | 31 Participants |
| Any extracranial injury Post-Randomization Yes | 297 Participants | 147 Participants | 150 Participants |
| Injury Severity Scale (ISS) Baseline | 27.3 units on a scale STANDARD_DEVIATION 20 | 26.9 units on a scale STANDARD_DEVIATION 20.8 | 28.8 units on a scale STANDARD_DEVIATION 18.7 |
| Injury Severity Scale (ISS) Post-Randomization | 27.8 units on a scale STANDARD_DEVIATION 17.9 | 26.3 units on a scale STANDARD_DEVIATION 18.8 | 29.6 units on a scale STANDARD_DEVIATION 16.7 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Baseline Female | 42 Participants | 19 Participants | 23 Participants |
| Sex: Female, Male Baseline Male | 74 Participants | 36 Participants | 38 Participants |
| Sex: Female, Male Post-Randomization Female | 135 Participants | 77 Participants | 58 Participants |
| Sex: Female, Male Post-Randomization Male | 254 Participants | 131 Participants | 123 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Baseline At admission <=8 | 83 Participants | 35 Participants | 48 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Baseline Deteriorated <=8 | 31 Participants | 18 Participants | 13 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Baseline Total GCS >8 (but motor<=5) | 2 Participants | 2 Participants | 0 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Post-Randomization At admission <=8 | 284 Participants | 146 Participants | 138 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Post-Randomization Deteriorated <=8 | 105 Participants | 62 Participants | 43 Participants |
| Total Glasgow Coma Scale (GCS) score <=8 Post-Randomization Total GCS >8 (but motor<=5) | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 55 | 12 / 208 | 6 / 61 | 13 / 181 |
| other Total, other adverse events | 21 / 55 | 72 / 208 | 16 / 61 | 78 / 181 |
| serious Total, serious adverse events | 6 / 55 | 34 / 208 | 7 / 61 | 17 / 181 |
Outcome results
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).
Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Population: We compared control and intervention arms post-randomization (07/13/20) in statistical analysis. Baseline period data contributed to other adjusted analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Baseline | 81.7 mean percentage of guideline adherence | Standard Deviation 12.9 |
| Usual Care, Then Usual Care (Control) | First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Post-Randomization | 83.7 mean percentage of guideline adherence | Standard Deviation 11.5 |
| Usual Care, Then PEGASUS Program (Intervention) | First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Baseline | 81.0 mean percentage of guideline adherence | Standard Deviation 13.2 |
| Usual Care, Then PEGASUS Program (Intervention) | First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall | Post-Randomization | 84.4 mean percentage of guideline adherence | Standard Deviation 12.8 |
Comparison: Null hypothesis: Assuming no difference between usual care (control) and PEGASUS (intervention).~We used 2011-2012 results from prior pilot work in Argentina (58.6% TBI guideline adherence) to determine a sample size of 432 eligible patients (216 per arm) for the planned parallel cluster RCT, which would have 80% power to detect a 18.7% higher ICU TBI guideline adherence rate with programme implementation, with a two-sided alpha of 5%, and an intraclass coefficient of 0.05.p-value: 0.9595% CI: [-3.3, 3.5]Mixed Models Analysis
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.
Time frame: Started within 24 hours of patient eligibility (at admission or deterioration)
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Clinical Pathway Adoption | Post-Randomization, Pre-Implementation | 11 Participants |
| Usual Care, Then Usual Care (Control) | Clinical Pathway Adoption | Post-Randomization, Post-Implementation Implemented Clinical Pathway | 170 Participants |
| Usual Care, Then Usual Care (Control) | Clinical Pathway Adoption | Post-Randomization, Post-Implementation Did Not Implement Clinical Pathway | 0 Participants |
Secondary
Discharge Survival
Number of survivors at intervention and control sites (descriptive and not powered for this outcome).
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Discharge Survival | Baseline | Died in-hospital | 3 Participants |
| Usual Care, Then Usual Care (Control) | Discharge Survival | Post-Randomization | Died in-hospital | 12 Participants |
| Usual Care, Then Usual Care (Control) | Discharge Survival | Baseline | Survived | 52 Participants |
| Usual Care, Then Usual Care (Control) | Discharge Survival | Post-Randomization | Survived | 196 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Discharge Survival | Baseline | Survived | 55 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Discharge Survival | Baseline | Died in-hospital | 6 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Discharge Survival | Post-Randomization | Survived | 168 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Discharge Survival | Post-Randomization | Died in-hospital | 13 Participants |
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)
Time frame: 3 months post-admission
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Severe disability-lower | 27 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Severe disability-upper | 11 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Death | 0 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Vegetative state | 0 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Severe disability-lower | 5 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Severe disability-upper | 7 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Moderate disability-lower | 0 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Moderate disability-upper | 4 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Good recovery-lower | 3 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Good recovery-upper | 32 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Death | 0 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Vegetative state | 6 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Moderate disability-lower | 4 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Moderate disability-upper | 9 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Good recovery-lower | 26 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Good recovery-upper | 101 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Severe disability-upper | 17 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Severe disability-lower | 25 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Good recovery-lower | 4 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Good recovery-lower | 26 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Moderate disability-upper | 8 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Death | 0 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Good recovery-upper | 27 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Vegetative state | 2 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Moderate disability-lower | 4 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Severe disability-lower | 8 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Death | 0 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Severe disability-upper | 10 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Good recovery-upper | 68 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Moderate disability-lower | 1 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Post-Randomization | Vegetative state | 9 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds) | Baseline | Moderate disability-upper | 1 Participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Death (all-cause) | 3 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Vegetative state | 0 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Severe disability | 5 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Moderate disability | 3 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Good recovery | 44 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Death (all-cause) | 12 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Vegetative state | 15 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Severe disability | 18 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Moderate disability | 24 Participants |
| Usual Care, Then Usual Care (Control) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Good recovery | 139 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Severe disability | 17 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Death (all-cause) | 6 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Death (all-cause) | 13 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Vegetative state | 2 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Good recovery | 100 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Severe disability | 4 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Vegetative state | 9 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Moderate disability | 19 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Post-Randomization | Moderate disability | 42 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Glasgow Outcome Scale (GOS) Score at Discharge | Baseline | Good recovery | 30 Participants |
Secondary
Mortality, 3-Month
We will examine participants' mortality at 3 months post discharge
Time frame: 3 months post admission
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Mortality, 3-Month | Baseline | Died | 0 Participants |
| Usual Care, Then Usual Care (Control) | Mortality, 3-Month | Baseline | Survived | 51 Participants |
| Usual Care, Then Usual Care (Control) | Mortality, 3-Month | Post-Randomized | Died | 0 Participants |
| Usual Care, Then Usual Care (Control) | Mortality, 3-Month | Post-Randomized | Survived | 184 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Mortality, 3-Month | Post-Randomized | Survived | 157 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Mortality, 3-Month | Baseline | Died | 0 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Mortality, 3-Month | Post-Randomized | Died | 0 Participants |
| Usual Care, Then PEGASUS Program (Intervention) | Mortality, 3-Month | Baseline | Survived | 53 Participants |
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
Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Population: We compared control and intervention arms post-randomization (07/13/20) in statistical analysis by extracranial injury status.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care, Then Usual Care (Control) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Baseline, Isolated TBI (non-head AIS=0) | 80.2 mean percentage of guideline adherence | Standard Deviation 12.1 |
| Usual Care, Then Usual Care (Control) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Baseline, Extracranial injury (non-head AIS>0) | 83.0 mean percentage of guideline adherence | Standard Deviation 13.4 |
| Usual Care, Then Usual Care (Control) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Post-Randomization, Isolated TBI (non-head AIS=0) | 81 mean percentage of guideline adherence | Standard Deviation 13.9 |
| Usual Care, Then Usual Care (Control) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Post-Randomization, Extracranial injury (non-head AIS>0) | 84.8 mean percentage of guideline adherence | Standard Deviation 10.2 |
| Usual Care, Then PEGASUS Program (Intervention) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Post-Randomization, Extracranial injury (non-head AIS>0) | 84.0 mean percentage of guideline adherence | Standard Deviation 12.9 |
| Usual Care, Then PEGASUS Program (Intervention) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Baseline, Isolated TBI (non-head AIS=0) | 84.3 mean percentage of guideline adherence | Standard Deviation 12.2 |
| Usual Care, Then PEGASUS Program (Intervention) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Post-Randomization, Isolated TBI (non-head AIS=0) | 86.2 mean percentage of guideline adherence | Standard Deviation 12.4 |
| Usual Care, Then PEGASUS Program (Intervention) | Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status | Baseline, Extracranial injury (non-head AIS>0) | 79.6 mean percentage of guideline adherence | Standard Deviation 13.4 |
p-value: 0.0195% CI: [1.9, 13.8]Mixed Models Analysis