Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-23
Brief Title:
Preventing Iatrogenic Dependence Linked to Hospitalisation in Elderly Patients Hospitalised in Acute Geriatrics
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Preventing Iatrogenic Dependence Linked to Hospitalisation in Elderly Patients Hospitalised in Acute Geriatrics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
TAKE CARE
Brief Summary:
Iatrogenic dependence linked to hospitalisation DILH is very frequent severe but avoidable in 80 of cases Extensive research has identified 6 main causes of DILH in the elderly which interact and have common risk factors immobilisation falls undernutrition de novo urinary incontinence confusion and drug side-effects
Our main hypothesis is that promoting access to knowledge of and implementation of good practice recommendations by healthcare staff medical and paramedical concerning DILH in the elderly based on graded interventions and targeting the 6 main causes of DILH via the TAKE CARE intervention could reduce the incidence of DILH in the population of patients aged 75 or over hospitalised in acute geriatric units excluding post-operative and post-resuscitation in the context of unscheduled hospitalizations
A Multicenter randomized cluster trial evaluating the effect of the TAKE CARE intervention compared with usual care in patients will be conducted across 11 acute geriatric services in France A total of 2200 patients will be needed for a total period of 6 months with a 6 months followup prior inclusion Data will be collected directly from the patients medical records and entered by an investigator or a clinical study technician in an electronic CRF CleanWeb managed by the URC PSL
The trial will also include a qualitative component to assess among other things the implementation aspects of this complex intervention individual interviews focus group A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention
The impact of the TAKE CARE intervention will be studied using a win-ratio approach based on a hierarchical composite criterion that takes into account vital status at D7 and the change in ADL score between D15 before admission and D7 The difference in ADL score between D-15 and D7 will be compared between the 2 randomisation groups using a mixed linear model with the randomisation arm as a fixed effect and a random effect on the cluster A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective
Our main hypothesis is that promoting access to knowledge of and implementation of good practice recommendations by healthcare staff medical and paramedical concerning DILH in the elderly based on graded interventions and targeting the 6 main causes of DILH via the TAKE CARE intervention could reduce the incidence of DILH in the population of patients aged 75 or over hospitalised in acute geriatric units excluding post-operative and post-resuscitation in the context of unscheduled hospitalizations
A Multicenter randomized cluster trial evaluating the effect of the TAKE CARE intervention compared with usual care in patients will be conducted across 11 acute geriatric services in France A total of 2200 patients will be needed for a total period of 6 months with a 6 months followup prior inclusion Data will be collected directly from the patients medical records and entered by an investigator or a clinical study technician in an electronic CRF CleanWeb managed by the URC PSL
The trial will also include a qualitative component to assess among other things the implementation aspects of this complex intervention individual interviews focus group A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention
The impact of the TAKE CARE intervention will be studied using a win-ratio approach based on a hierarchical composite criterion that takes into account vital status at D7 and the change in ADL score between D15 before admission and D7 The difference in ADL score between D-15 and D7 will be compared between the 2 randomisation groups using a mixed linear model with the randomisation arm as a fixed effect and a random effect on the cluster A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective
Detailed Description:
Hospitalization for an acute illness in older individuals is connected to a decline in functionality referred to as iatrogenic dependence linked to hospitalization DILH This is characterized by the inability to perform essential daily activities necessary for independent living The literature has identified six primary causes of DILH in the elderly which interact and share common risk factors These causes include immobilization falls undernutrition de novo urinary incontinence confusion and drug side effects DILH is a prevalent issue affecting approximately 40 of elderly patients admitted to the hospital However it is important to note that 80 of these cases can be prevented with appropriate measures
Our primary hypothesis revolves around the idea that by promoting access to knowledge of and implementation of best practice recommendations among healthcare staff both medical and paramedical regarding DILH in the elderly we can effectively reduce the incidence of DILH in the population of patients aged 75 or over who are hospitalized in acute geriatric units excluding post-operative and post-resuscitation cases during unscheduled hospitalizations This will be achieved through the implementation of the TAKE CARE intervention which is a multifaceted organizational intervention designed to facilitate the adoption of all current recommendations for combating DILH in the elderly utilizing innovative equipment such as portable and connected treadmills installation of lighting with motion detectors in hospital room and use of the SYNAPSEMed application
A randomized cluster trial will be conducted across 11 acute geriatric services in France to evaluate the impact of the TAKE CARE intervention compared to usual care in patients The trial will span over a period of 6 months during which a total of 2200 patients will be included Half of the patients n1100 will be admitted to the 11 wings of the geriatric ward in the INTERVENTION arm while the other half n1100 will be assigned to the 11 wings in the control arm Following the inclusion period the patients will be followup for a period of 6 months Demographic and clinical data will be collected from the patients medical records and entered into an electronic CRF CleanWeb by either an investigator or a clinical study technician The URC PSL will manage the CRF through the eTAKE-CARE application as well as the SynapseMed application Data management and statistical analysis will be conducted by the PSL-CFX URC using either the statistical software R version 363 or later R Foundation for Statistical Computing Vienna Austria httpswwwR-projectorg or SAS SAS Institute Inc Cary NC USA
The trial will also include a qualitative component to assess among other things the implementation aspects of this complex intervention individual interviews focus group A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention QALYs quality of life will be assessed using the EQ5D-3L scale which is robust in the geriatric population Two aspects will be taken into account when estimating the cost utility one will be the costs attributable to the purchase and immobilisation of the equipment necessary for the implementation of the intervention and on the other hand the costs associated with operating this equipment in relation to patient care
The effectiveness of the TAKE CARE intervention will be examined through the utilization of a win-ratio method which employs a hierarchical composite criterion This criterion considers the vital status at D7 and the change in ADL score between D15 prior to admission and D7 By comparing the difference in ADL score between D-15 and D7 in the two randomization groups using a mixed linear model with the randomization arm as a fixed effect and a random effect on the cluster A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective
Our primary hypothesis revolves around the idea that by promoting access to knowledge of and implementation of best practice recommendations among healthcare staff both medical and paramedical regarding DILH in the elderly we can effectively reduce the incidence of DILH in the population of patients aged 75 or over who are hospitalized in acute geriatric units excluding post-operative and post-resuscitation cases during unscheduled hospitalizations This will be achieved through the implementation of the TAKE CARE intervention which is a multifaceted organizational intervention designed to facilitate the adoption of all current recommendations for combating DILH in the elderly utilizing innovative equipment such as portable and connected treadmills installation of lighting with motion detectors in hospital room and use of the SYNAPSEMed application
A randomized cluster trial will be conducted across 11 acute geriatric services in France to evaluate the impact of the TAKE CARE intervention compared to usual care in patients The trial will span over a period of 6 months during which a total of 2200 patients will be included Half of the patients n1100 will be admitted to the 11 wings of the geriatric ward in the INTERVENTION arm while the other half n1100 will be assigned to the 11 wings in the control arm Following the inclusion period the patients will be followup for a period of 6 months Demographic and clinical data will be collected from the patients medical records and entered into an electronic CRF CleanWeb by either an investigator or a clinical study technician The URC PSL will manage the CRF through the eTAKE-CARE application as well as the SynapseMed application Data management and statistical analysis will be conducted by the PSL-CFX URC using either the statistical software R version 363 or later R Foundation for Statistical Computing Vienna Austria httpswwwR-projectorg or SAS SAS Institute Inc Cary NC USA
The trial will also include a qualitative component to assess among other things the implementation aspects of this complex intervention individual interviews focus group A medico-economic component with a cost-utility analysis to assess the incremental cost-utility ratio and a hospital microcosting study to assess the costs associated with the TAKE CARE intervention QALYs quality of life will be assessed using the EQ5D-3L scale which is robust in the geriatric population Two aspects will be taken into account when estimating the cost utility one will be the costs attributable to the purchase and immobilisation of the equipment necessary for the implementation of the intervention and on the other hand the costs associated with operating this equipment in relation to patient care
The effectiveness of the TAKE CARE intervention will be examined through the utilization of a win-ratio method which employs a hierarchical composite criterion This criterion considers the vital status at D7 and the change in ADL score between D15 prior to admission and D7 By comparing the difference in ADL score between D-15 and D7 in the two randomization groups using a mixed linear model with the randomization arm as a fixed effect and a random effect on the cluster A win-ratio significantly greater than 1 will allow us to conclude that the TAKE CARE intervention is effective
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