Preventing Iatrogenic Dependence Linked to Hospitalisation in Elderly Patients Hospitalised in Acute Geriatrics

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• Age ≥ 75 ans

• Unscheduled hospitalisation in one of the participating departments for an acute pathology, excluding post-operative care

Locations
Other Locations
France
Hôpital Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Jacques BODDAERT, Pr
jacques.boddaert@aphp.fr
01 42 16 41 17
Backup
Lorène ZERAH
lorene.zerah@aphp.fr
01 84 82 81 95
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2200
Treatments
Experimental: TAKE CARE
* Use of a dedicated e-health application. In order to promote the implementation of DILH prevention measures, we will use an e-health application developed specifically for the study by PRESAGE in the areas where the intervention will take place. This innovative application will be used on admission for all patients included in the acute geriatric sectors in which the intervention will be deployed. It will first assess the risk of DILH individually for each of the 6 risk factors, and then scale the risk for the patient. Once the risk assessment has been carried out, the system will immediately produce a document setting out the personalized care plan for each patient, and disseminate knowledge through documents aimed at patients and caregivers.~* The use of portable, connected treadmills (Ezygain, CE marked)~* The installation of motion detector lighting in hospital rooms
No_intervention: CURRENT CARE
soins usuels
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov