Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-14
First Post:
2023-04-03
Brief Title:
Geriatric Transitional Care for Older Patients Discharged From the Emergency Department Impact on Early Readmissions
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Geriatric Transitional Care for Older Patients Discharged From the Emergency Department Impact on Early Readmissions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
LASUITE
Brief Summary:
Elderly adults have high rates of emergency department ED visits Specificities of this population challenge organizations of care in the ED and older adults are at risk of pejorative outcomes after an ED stay Numerous interventions have been designed to improve quality of care and outcomes for the older population in these settings with a specific attention to concerning discharge from the ED These interventions are interdisciplinary bridging emergency and geriatric care The wide range and complexity of these interventions make them difficult to assess and compare as highlighted by several reviews in the past ten years Prior analyses helped to categorize different intervention strategies and three main designs inhospital community and transitional interventions started in the ED and pursued in collaboration with community primary care professionals Theses analyses show that the use of multiple strategies and transitional models of care tend to lead to better outcomes and underline that more robust studies are needed to confirm this hypothesis In France a majority of EDs collaborate with Geriatric Mobile Teams GMT to improve quality of care for older patients GMTs are dedicated to patients over 75 years old and interventions in EDs are targeted on patients at risk of worse outcome When ED physicians detect older patients at risk they may call for the GMT for further assessment and management GMTs either work in a inhospital standard approach or with a transitional care management This second strategy less common in France is thought to be be efficient and has never been assessed We have designed a study to compare these methods with the hypothesis that among at-risk older adults hospital-community transition care initiated by GMTs during an ED visit with direct discharge home will be associated with a reduction in the risk of early readmission within 30 days and lower risk of loss of independence at 3 and 6 months It is a french multicentric study with a quasi-experimental design comparing hospitals without transitional care management to hospitals with hospital-community transitional intervention We aim at enrolling 1322 patients aged 75 and more at risk of pejorative outcomes as determined by the Triage Risk Screening Toll TRST The main outcome is a revisit to the ED between day 7 and day 30 secondary outcomes are autonomy mortality use of hospital services and caregiving at home at 6 months
Detailed Description:
The aim of this study is to evaluate the impact of transitional care initiated by Mobile Geriatrics Team MGTs at the time of the ED visit on the incidence of early readmissions on medical journey and autonomy within 6 months after the ED visit for adults aged 75 or older and considered at risk for early readmission This is a multicenter prospective controlled non-randomized quasi-experimental study Inclusion criteria are age 75 years and more returning home after an ED visit with a Triage Risk Screening Tool TRST score 2 Exclusion criteria are living in nursing home being under legal guardianship or incapacity to consent All participants will provide a written consent after receiving oral and written information Participants with language barrier severe cognitive or psychiatric disorders may be included provided that a relative is physically present at the time of the ED visit Otherwise they will not be included The study protocol has been submitted for approval to the ethic committee Five centers two university hospitals three regional hospitals work on an in-hospital strategy and do not perform transitional care After identifying the patient at risk the in-hospital MGT solely provides usual recommendations at the time of the ED visit without offering home-based intervention or coordination with community actors The participants included in these centers will form the control group
Seven centers three university hospitals four regional hospitals work on an transitional care method These centers have an in and out-hospital MGT that carry out geriatric assessment offer home-visits if necessary and have a hospital-community coordination for the management of older patients This coordination is defined by either regular joint clinical meetings joint visits shared professionals or a shared information system After identification of the at-risk patient the first step in management consists in a telephone call by the GMT to the patient or his family and primary care professionals within six days of his return home Depending on the geriatric assessment performed and the coordination organization specific to each center multidisciplinary interventions can then be proposed and deployed The patients included in these centers will form the intervention group
All 12 centers intervention and control meet the following criteria for a standardized in-hospital management during the ED visit including i identification of patients at risk based on clinical characteristics or identification scores with a procedure for reporting to the in-hospital GMT ii a multidisciplinary GMT mobilized in the ED for patients at risk providing a standardized geriatric assessment iii a discharge procedure with at least a medical report and referral to the general practitioner
The principal investigator and the scientific committee will regularly verify that centers continue to meet the conditions of the group it is allocated
After inclusion the participants will benefit from the usual care specific to the inclusion center where they were recruited In the intervention group GMT intervention initiation consists in an early standardized telephone call between D1 and D6 for each participant To respect a pragmatic approach the intervention of the MGT and the out-of-hospital management strategy are deliberately not standardized in order to evaluate the hospital-community coordination fitting each territory
Clinical data will be collected at baseline and during follow-up at three M3 and six M6 months Figure 1 The data collected at baseline during the ED visit D1 by the MGT This evaluation will be based on the patients questioning and the medical record If deemed necessary the GMT may also rely on information transmitted by a relative or the general practitioner in order to cross-check the information as is done routinely The data relative to socio demographic items are age sex autonomy in the week prior to the ED visit using the Activities of Daily Living ADL and Instrumental Activities of Daily Living IADL scales 1819 self-reported difficulty related to housing identification of relatives family and professional caregivers preexisting the ED visit the nutritional risk using the Mini Nutritional Assessment - Short form MNA-SF scale in its alternative version with measurement of calf circumference 20 the screening for cognitive disorders with the Abbreviated Mental Test 4 AMT4 scale 21 and suggestive clinical diagnosis in the mild moderate or severe stage according to the 5th edition of the Diagnostic and Statistical manual of Mental disorders DSM-V criteria the comorbidity level assessed the Charlson index 22 and the number of drugs in the patients usual treatment data on the ED visit that including duration the visit in hours and main diagnosis collected from medical records the history of ED visits or hospitalizations in the previous month and the existence of a regular medical monitoring by the general practitioner twice a year or a geriatric team previously hospitalized in a geriatric wards or appointment with a geriatrician
One independent investigator will perform follow-up telephone interviews in both groups at M3 and M6 to precise the vital status place of living home nursing home ADL and IADL interventions of professional and non-professional caregivers In addition for participants in the intervention group the independent investigator will identify at M6 the MGTs actions after discharge from ED based on the MGTs medical record including the number and duration of telephone calls and home visits the coordination with community professionals medical appointment rehabilitation care request for social worker
The primary endpoint will be the incidence of readmission to an ED between seven D7 to thirty D30 days after discharge from the ED visit leading to inclusion in the study regardless of the reason for admission This data will be collected from the National Health Data System NHDS thus allowing the identification of admissions to an ED on a national level and not exclusively in the centers participating in the research Very early readmissions from D1 to D6 will not be taken into account in the primary endpoint as the time to first intervention in interventional group is a maximum of six days in the framework of the research protocol Moreover these very early readmissions are most often motivated by a rapid deterioration of the initial pathology a diagnostic error or a possible side effect of a therapy 23 Hospital-community transitional care is not intended to avoid this type of very early readmission The ED visits between D1 and D6 and after D30 will be collected in NHDS as secondary endpoints The number of ED visits unplanned hospitalizations and the time duration between inclusion and the first outcome will be also considered
Seven centers three university hospitals four regional hospitals work on an transitional care method These centers have an in and out-hospital MGT that carry out geriatric assessment offer home-visits if necessary and have a hospital-community coordination for the management of older patients This coordination is defined by either regular joint clinical meetings joint visits shared professionals or a shared information system After identification of the at-risk patient the first step in management consists in a telephone call by the GMT to the patient or his family and primary care professionals within six days of his return home Depending on the geriatric assessment performed and the coordination organization specific to each center multidisciplinary interventions can then be proposed and deployed The patients included in these centers will form the intervention group
All 12 centers intervention and control meet the following criteria for a standardized in-hospital management during the ED visit including i identification of patients at risk based on clinical characteristics or identification scores with a procedure for reporting to the in-hospital GMT ii a multidisciplinary GMT mobilized in the ED for patients at risk providing a standardized geriatric assessment iii a discharge procedure with at least a medical report and referral to the general practitioner
The principal investigator and the scientific committee will regularly verify that centers continue to meet the conditions of the group it is allocated
After inclusion the participants will benefit from the usual care specific to the inclusion center where they were recruited In the intervention group GMT intervention initiation consists in an early standardized telephone call between D1 and D6 for each participant To respect a pragmatic approach the intervention of the MGT and the out-of-hospital management strategy are deliberately not standardized in order to evaluate the hospital-community coordination fitting each territory
Clinical data will be collected at baseline and during follow-up at three M3 and six M6 months Figure 1 The data collected at baseline during the ED visit D1 by the MGT This evaluation will be based on the patients questioning and the medical record If deemed necessary the GMT may also rely on information transmitted by a relative or the general practitioner in order to cross-check the information as is done routinely The data relative to socio demographic items are age sex autonomy in the week prior to the ED visit using the Activities of Daily Living ADL and Instrumental Activities of Daily Living IADL scales 1819 self-reported difficulty related to housing identification of relatives family and professional caregivers preexisting the ED visit the nutritional risk using the Mini Nutritional Assessment - Short form MNA-SF scale in its alternative version with measurement of calf circumference 20 the screening for cognitive disorders with the Abbreviated Mental Test 4 AMT4 scale 21 and suggestive clinical diagnosis in the mild moderate or severe stage according to the 5th edition of the Diagnostic and Statistical manual of Mental disorders DSM-V criteria the comorbidity level assessed the Charlson index 22 and the number of drugs in the patients usual treatment data on the ED visit that including duration the visit in hours and main diagnosis collected from medical records the history of ED visits or hospitalizations in the previous month and the existence of a regular medical monitoring by the general practitioner twice a year or a geriatric team previously hospitalized in a geriatric wards or appointment with a geriatrician
One independent investigator will perform follow-up telephone interviews in both groups at M3 and M6 to precise the vital status place of living home nursing home ADL and IADL interventions of professional and non-professional caregivers In addition for participants in the intervention group the independent investigator will identify at M6 the MGTs actions after discharge from ED based on the MGTs medical record including the number and duration of telephone calls and home visits the coordination with community professionals medical appointment rehabilitation care request for social worker
The primary endpoint will be the incidence of readmission to an ED between seven D7 to thirty D30 days after discharge from the ED visit leading to inclusion in the study regardless of the reason for admission This data will be collected from the National Health Data System NHDS thus allowing the identification of admissions to an ED on a national level and not exclusively in the centers participating in the research Very early readmissions from D1 to D6 will not be taken into account in the primary endpoint as the time to first intervention in interventional group is a maximum of six days in the framework of the research protocol Moreover these very early readmissions are most often motivated by a rapid deterioration of the initial pathology a diagnostic error or a possible side effect of a therapy 23 Hospital-community transitional care is not intended to avoid this type of very early readmission The ED visits between D1 and D6 and after D30 will be collected in NHDS as secondary endpoints The number of ED visits unplanned hospitalizations and the time duration between inclusion and the first outcome will be also considered
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A02657-34 | OTHER | ID-RCB | None |