Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-06-30
Brief Title:
Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units a Stepped-wedge Cluster Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Telescope_2
Brief Summary:
The objective of this study is to assess whether an intervention package via telemedicine consisting of daily multidisciplinary rounds with a specialist in intensive care medicine an intervention package provided by a specialized multiprofessional team nursing physical therapy and clinical pharmacy and a management intervention package focused on quality and safety reduces the length of stay in ICU patients in Brazil Our hypothesis is that the intervention package via telemedicine has the potential to decrease the length of stay in ICU patients in Brazil
The study provides for the implementation of three interventions in association via telemedicine
Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine
Intervention package by specialized multidisciplinary team nursing physiotherapy and clinical pharmacy
Management intervention package quality and safety
The main questions it aims to answer are
Length of stay in ICU measured in days considering the time interval between admission to the ICU and the moment of physical transfer of the patient to another hospital admission area or external transfer
ICU mortality
Mechanical ventilation free time at 28 days
Ventilator-associated events
Patient Mobilization Density
Standard resource use
Standardized mortality rate
The study provides for the implementation of three interventions in association via telemedicine
Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine
Intervention package by specialized multidisciplinary team nursing physiotherapy and clinical pharmacy
Management intervention package quality and safety
The main questions it aims to answer are
Length of stay in ICU measured in days considering the time interval between admission to the ICU and the moment of physical transfer of the patient to another hospital admission area or external transfer
ICU mortality
Mechanical ventilation free time at 28 days
Ventilator-associated events
Patient Mobilization Density
Standard resource use
Standardized mortality rate
Detailed Description:
BACKGROUND
ICU beds represent a scarce and high cost resource This scenario is aggravated by the scarcity and heterogeneous distribution of specialists in intensive care medicine in Brazil Telemedicine is an innovative and promising technology with the possibility of making the daily multidisciplinary round accessible with the presence of intensive care medicine specialists throughout the national territory In a previous study Telescope Trial I it was demonstrated that daily multidisciplinary round conducted via telemedicine by a remotely located medical specialist is a safe and feasible practice However little is known about different modalities of telemedicine care in the ICU environment more specifically about the impact of interventions performed by a multidisciplinary team non-medical and management interventions quality and safety
SAMPLE SIZE CALCULATION
A total sample size of 18750 to 25000 patients will be considered to detect a reduction in the length of stay in the ICU on a logarithmic scale of 01479 equivalent to a 11-day reduction compared to the baseline resulting from the intervention package with a significance level of 5 and a minimum power of 95 This variation in total sample size is due to different estimates of patients per period in the 25 Brazilian ICUs in question It is estimated that there will be a variation of 30 to 40 patients recruited per month per ICU
PRIMARY OUTCOME
Length of stay in the ICU measured in days considering the time interval between admission to the ICU and the moment of physical transfer of the patient to another hospital admission area or external transfer
SECONDARY OUTCOMES
ICU mortality
Mechanical ventilation free time in 28 days
Ventilator-associated events
Patient Mobilization Density
Standard resource use
Standardized mortality rate
EXPLORATORY OUTCOMES
In-hospital mortality
Adherence to elevated bedside
Adequate prevention of venous thromboembolism
Accidental extubation rate
Rate of patients with adequate glycemic control defined as blood glucose 70mgdl to 180mgdl
Rate of patients - day receiving oral or enteral diet
Rate of patient-day under adequate sedation defined by Richmond agitation and sedation scale RASS -3 to
Rate of patients on oxygen therapy in normoxia defined as peripheral oxygen saturation SpO2 92 to 96
Rate of ICU readmission within 48 hours
Rate of early reintubation 48h after extubation
Rate of central venous catheter use
Rate of indwelling urinary catheter use
Central venous catheter use time
Time of indwelling urinary catheter use
STATISTICAL ANALYSIS
All analyses will be described in detail in a statistical analysis plan which will be finalized and submitted for publication before the database is closed and analyses begin The primary statistical analyses will be conducted according to the intention-to-treat principle Since ICUs will be randomized not patients and outcomes will be measured at the patient level all analyses will be adjusted for clustering of data
The primary outcome length of ICU stay will be analyzed at the individual level using a generalized linear mixed model including as fixed effect the group and considering distributions that can fit an expected right skewness such as truncated Poisson Gamma or inverse Gaussian distribution etc choosing the best fit according to model parameters The goal of the mixed model is to be able to fit random vectors taking into account the correlation of the observations of individuals in the same cluster Thus the model will have as random effect an intercept for each unit To consider an eventual lack of balance we will adjust the analysis model for the factors used in the stratification and for the outcome value at the unit level in the pre-randomization period ie mean length of stay in the ICU of each unit as suggested by the literature Additionally we will adjust for factors that have a correlation with length of stay aiming to decrease variability between units thus impacting intra cluster correlation and increasing the power of the study The adjustment factors will be defined after the pre-randomization period data collection and reported in a statistical analysis plan published before closing the study database as specified above These factors are about severity SAPS 3 and clinical or surgical profile In the event of a significant amount of missing data on the primary endpoint the analysis will be re-evaluated after using multiple imputation with chained equations assuming that the data will be missing at random Data collected during the transition period will not be analyzed for primary secondary or exploratory endpoints
Sensitivity analyses and subgroups for the primary outcome
We will define a priori the following subgroups for analysis of the primary outcome
A - ICU length of stay stratified by clinical vs elective surgical and emergency surgical patients
B - Length of stay in ICU stratified by three groups lower middle and upper thirds of severity determined by SAPS 3 score
C - ICU length of stay stratified by mechanically ventilated patients on admission invasive mechanical ventilation
Similarly in all other analyses generalized linear mixed models will be used Analyses of the pre-specified secondary outcomes and subgroup analyses will not be adjusted for multiple comparisons thus should be interpreted as exploratory
Due to the importance of the SAPS 3 severity score we will evaluate the calibration of the model with data from the pre-randomization period If necessary we will recalibrate the model for the study population
The significance level for all endpoints will be 005 All analyses will be performed with R software version 420 the version will be updated at the time of the analysis
REGULATORY STATUS
The study will be conducted in accordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Humans Act
APPROVAL FROM ETHICS AND REGULATORY AUTHORITIES
The study will be performed according to the national and international guidelines The Institutional Review Board of the Hospital Israelita Albert Einstein has approved this study CAAE 69575123010010071 The participating centers will not initiate the study until they have obtained approval from their respective local Institutional Review Boards The need for informed consent is determined by the Institutional Review Board of each participating center
ICU beds represent a scarce and high cost resource This scenario is aggravated by the scarcity and heterogeneous distribution of specialists in intensive care medicine in Brazil Telemedicine is an innovative and promising technology with the possibility of making the daily multidisciplinary round accessible with the presence of intensive care medicine specialists throughout the national territory In a previous study Telescope Trial I it was demonstrated that daily multidisciplinary round conducted via telemedicine by a remotely located medical specialist is a safe and feasible practice However little is known about different modalities of telemedicine care in the ICU environment more specifically about the impact of interventions performed by a multidisciplinary team non-medical and management interventions quality and safety
SAMPLE SIZE CALCULATION
A total sample size of 18750 to 25000 patients will be considered to detect a reduction in the length of stay in the ICU on a logarithmic scale of 01479 equivalent to a 11-day reduction compared to the baseline resulting from the intervention package with a significance level of 5 and a minimum power of 95 This variation in total sample size is due to different estimates of patients per period in the 25 Brazilian ICUs in question It is estimated that there will be a variation of 30 to 40 patients recruited per month per ICU
PRIMARY OUTCOME
Length of stay in the ICU measured in days considering the time interval between admission to the ICU and the moment of physical transfer of the patient to another hospital admission area or external transfer
SECONDARY OUTCOMES
ICU mortality
Mechanical ventilation free time in 28 days
Ventilator-associated events
Patient Mobilization Density
Standard resource use
Standardized mortality rate
EXPLORATORY OUTCOMES
In-hospital mortality
Adherence to elevated bedside
Adequate prevention of venous thromboembolism
Accidental extubation rate
Rate of patients with adequate glycemic control defined as blood glucose 70mgdl to 180mgdl
Rate of patients - day receiving oral or enteral diet
Rate of patient-day under adequate sedation defined by Richmond agitation and sedation scale RASS -3 to
Rate of patients on oxygen therapy in normoxia defined as peripheral oxygen saturation SpO2 92 to 96
Rate of ICU readmission within 48 hours
Rate of early reintubation 48h after extubation
Rate of central venous catheter use
Rate of indwelling urinary catheter use
Central venous catheter use time
Time of indwelling urinary catheter use
STATISTICAL ANALYSIS
All analyses will be described in detail in a statistical analysis plan which will be finalized and submitted for publication before the database is closed and analyses begin The primary statistical analyses will be conducted according to the intention-to-treat principle Since ICUs will be randomized not patients and outcomes will be measured at the patient level all analyses will be adjusted for clustering of data
The primary outcome length of ICU stay will be analyzed at the individual level using a generalized linear mixed model including as fixed effect the group and considering distributions that can fit an expected right skewness such as truncated Poisson Gamma or inverse Gaussian distribution etc choosing the best fit according to model parameters The goal of the mixed model is to be able to fit random vectors taking into account the correlation of the observations of individuals in the same cluster Thus the model will have as random effect an intercept for each unit To consider an eventual lack of balance we will adjust the analysis model for the factors used in the stratification and for the outcome value at the unit level in the pre-randomization period ie mean length of stay in the ICU of each unit as suggested by the literature Additionally we will adjust for factors that have a correlation with length of stay aiming to decrease variability between units thus impacting intra cluster correlation and increasing the power of the study The adjustment factors will be defined after the pre-randomization period data collection and reported in a statistical analysis plan published before closing the study database as specified above These factors are about severity SAPS 3 and clinical or surgical profile In the event of a significant amount of missing data on the primary endpoint the analysis will be re-evaluated after using multiple imputation with chained equations assuming that the data will be missing at random Data collected during the transition period will not be analyzed for primary secondary or exploratory endpoints
Sensitivity analyses and subgroups for the primary outcome
We will define a priori the following subgroups for analysis of the primary outcome
A - ICU length of stay stratified by clinical vs elective surgical and emergency surgical patients
B - Length of stay in ICU stratified by three groups lower middle and upper thirds of severity determined by SAPS 3 score
C - ICU length of stay stratified by mechanically ventilated patients on admission invasive mechanical ventilation
Similarly in all other analyses generalized linear mixed models will be used Analyses of the pre-specified secondary outcomes and subgroup analyses will not be adjusted for multiple comparisons thus should be interpreted as exploratory
Due to the importance of the SAPS 3 severity score we will evaluate the calibration of the model with data from the pre-randomization period If necessary we will recalibrate the model for the study population
The significance level for all endpoints will be 005 All analyses will be performed with R software version 420 the version will be updated at the time of the analysis
REGULATORY STATUS
The study will be conducted in accordance with the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Humans Act
APPROVAL FROM ETHICS AND REGULATORY AUTHORITIES
The study will be performed according to the national and international guidelines The Institutional Review Board of the Hospital Israelita Albert Einstein has approved this study CAAE 69575123010010071 The participating centers will not initiate the study until they have obtained approval from their respective local Institutional Review Boards The need for informed consent is determined by the Institutional Review Board of each participating center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None