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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02421133
Other study ID # 2014.874
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date November 30, 2016

Study information

Verified date March 2022
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In France, it has be estimated that the hospital readmission rate within 30 days of patients aged 75 or older is 14% (IC95% [12.0-16.7]), nearly a quarter being avoidable. There is evidence that interventions "bridging" the transition from hospital to home involving a dedicated professional (usually nurses) would be most effective in reducing the risk of readmission, but the level of evidence of current studies is low. Our study aims to assess the impact of a program of transitional care from hospital to home for people of 75 years old or more admitted to acute care.


Description:

The study is a stepped wedge randomized cluster study. Intervention: The transition care program, involving a dedicated advanced practice nurse, will include: 1) during the patient's stay in hospital: an individualized needs-based comprehensive discharge plan and a transitional care record ; the notification of the primary care physician about inpatient care and hospital discharge; 2) the day of the discharge: specific explanations about the organization of home care provided by the transition care nurse to the patient; 3) during 4 weeks after discharge: monitoring patients and caregivers regularly through home visits and/or telephone contact,


Recruitment information / eligibility

Status Completed
Enrollment 630
Est. completion date November 30, 2016
Est. primary completion date November 30, 2016
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Patient hospitalized for 48 hours or more in one of the acute geriatric service participating to the study. - Aged 75 or older. - Leaving at home and with home as the planned discharge after the admission. - At risk of hospital readmission emergency visit rates after discharge (if he has two or more of the following criteria (taken from the Triage Risk Screening Tool and from the 2013 French recommendation)). Exclusion Criteria: - Patient leaving in a retirement home. - Patient hospitalized at home. - Patient leaving at home but at 30 km (18 miles) or more from the service of his index admission

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transitional care program.
During the patient's stay in hospital, the transition nurse creates a transitional care file including information about the patient (inpatient medical and nurse care plan, medications), the discharge plan, and the contact information of the relevant primary care providers. She notifies the patient's primary care physician of the date of the discharge to home, of the potential medical problems and of the discharge care plan; a primary care physician visit is planned the month following the discharge. The day of the hospital discharge: meeting with the patient to review the follow-up recommendations. The transition nurse verifies that the medications are prescribed accordingly with the discharge plan, that the patient and his caregiver understand the prescription and are informed with the planned appointments and the biological monitoring. During 4 weeks after the hospital discharge: follow-up by the transition nurse once a week, alternately by telephone and home visit.
standard care program
The patients will be discharged according to the usual care plan of each participating hospital. The medical team does a medical and geriatric assessment of the patients according to the recommendations. The communication of information to the primary care providers (nurse, primary care physician…) is left to the discretion of the medical teams of the discharging hospitals, according to their habits of work.

Locations

Country Name City State
France CH Gériatrique des Monts d'Or Albigny sur Saône
France CH Bourg-en-Bresse Bourg en Bresse
France Centre Hospitalier Alpes Léman Contamine sur Arve
France Hôpital Édouard Herriot Lyon
France Centre Hospitalier Lyon Sud Pierre Benite
France CHG Annecy Pringy
France CH Saint-Chamond Saint Chamond
France Clinique des portes du sud Venissieux
France CH Villefranche Villefranche

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-Day unscheduled hospital readmission or emergency visit rate after the index hospital discharge. Unscheduled hospital readmissions are hospitalizations that are not planned at the moment of the discharge (for example: hospitalization after an emergency visit or upon request of the primary care physician). Within 30 days after hospital discharge.
Secondary Length of stay in the short stay geriatric ward (index hospitalization) Patients will be followed for the duration of hospital stay, an expected average between 2 days and 30 days
Secondary Unscheduled hospital readmissions or emergency room visits Within 30 and 90 days after the index hospital discharge.
Secondary Free-hospitalization survival Within 30 and 90 days after the index hospital discharge.
Secondary Mortality rate Within 30 and 90 days after the index hospital discharge.
Secondary Adverse events (i.e. falls) Within 30 days after the index hospital discharge.
Secondary Quality of life. Measured with the French version of the EUROQOL-5D. Within 30 days after the index hospital discharge.
Secondary Patients' satisfaction care transition programme Measured with the Care Transition Measure® questionnaire. Within 30 days after the index hospital discharge.
Secondary Delay between the index hospital discharge and the implementation of home care. Within 30 days after the index hospital discharge.
Secondary Number of contacts between the transition nurse and the primary care providers or the hospital providers after discharge Within 30 days after the index hospital discharge.
Secondary Costs of unscheduled hospital readmission or emergency visit Hospital and community care costs after discharge 30 days after discharge
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