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Impact of a Transitional Care Program on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward (PROUST)

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ClinicalTrials.gov Identifier: NCT02421133
Recruitment Status : Unknown
Verified September 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : April 20, 2015
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment Phase
Geriatrics Other: Transitional care program. Other: standard care program Not Applicable

Detailed 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,

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Transitional Care Program Involving an Advanced Practice Nurse on 30-Day Hospital Readmissions for Elderly Patients Discharged From a Short Stay Geriatric Ward (PROUST Study)
Study Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transitional care program.
The transitional care program from hospital to home will be implemented at three steps: during the patient's stay in hospital, the day of the discharge and during 4 weeks after discharge.
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
No intervention liable to affect the care provided to the patients, the organization of care or the practices of health care professionals will be implemented during the control period (time steps without intervention).
Other: 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.




Primary Outcome Measures :
  1. 30-Day unscheduled hospital readmission or emergency visit rate after the index hospital discharge. [ Time Frame: Within 30 days after 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).


Secondary Outcome Measures :
  1. Length of stay in the short stay geriatric ward (index hospitalization) [ Time Frame: Patients will be followed for the duration of hospital stay, an expected average between 2 days and 30 days ]
  2. Unscheduled hospital readmissions or emergency room visits [ Time Frame: Within 30 and 90 days after the index hospital discharge. ]
  3. Free-hospitalization survival [ Time Frame: Within 30 and 90 days after the index hospital discharge. ]
  4. Mortality rate [ Time Frame: Within 30 and 90 days after the index hospital discharge. ]
  5. Adverse events (i.e. falls) [ Time Frame: Within 30 days after the index hospital discharge. ]
  6. Quality of life. [ Time Frame: Within 30 days after the index hospital discharge. ]
    Measured with the French version of the EUROQOL-5D.

  7. Patients' satisfaction care transition programme [ Time Frame: Within 30 days after the index hospital discharge. ]
    Measured with the Care Transition Measure® questionnaire.

  8. Delay between the index hospital discharge and the implementation of home care. [ Time Frame: Within 30 days after the index hospital discharge. ]
  9. Number of contacts between the transition nurse and the primary care providers or the hospital providers after discharge [ Time Frame: Within 30 days after the index hospital discharge. ]
  10. Costs of unscheduled hospital readmission or emergency visit [ Time Frame: 30 days after discharge ]
    Hospital and community care costs after discharge



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421133


Contacts
Contact: Thomas Gilbert +33478865683 thomas.gilbert@chu-lyon.fr
Contact: Stéphanie Poupon Bourdy +3347472115416 stephanie.poupon-bourdy@chu-lyon.fr

Locations
France
CH Gériatrique des Monts d'Or Recruiting
Albigny sur Saône, France, 69250
Contact: Jean-Stéphane Luiggi    +334 72 08 15 31    js.luiggi@ch-montdor.fr   
CH Bourg-en-Bresse Recruiting
Bourg en Bresse, France, 01012
Contact: Jacquet-Francillon    +334 74 45 40 36    tfrancillon@ch-bourg01.fr   
Centre Hospitalier Alpes Léman Recruiting
Contamine sur Arve, France, 74130
Contact: André DARTIGUEPEYROU         
Hôpital Édouard Herriot Recruiting
Lyon, France, 69437
Contact: Brigitte Comte    +334 72 11 95 60    brigitte.comte@chu-lyon.fr   
Hôpital Édouard Herriot Recruiting
Lyon, France, 69437
Contact: Michel Chuzeville    +334 72 33 34 32    michel.chuzeville@chu-lyon.fr   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Marc Bonnefoy    +334 78 86 15 81    marc.bonnefoy@chu-lyon.fr   
Sub-Investigator: Thomas Gilbert         
CHG Annecy Recruiting
Pringy, France, 74374
Contact: Debray    +334 50 63 66 10    mdebray@ch-annecygenevois.fr   
CH Saint-Chamond Recruiting
Saint Chamond, France, 42400
Contact: Magali Tardy    +334 77 31 19 19    magali.tardy@hopitaldugier.fr   
Clinique des portes du sud Recruiting
Venissieux, France, 69200
Contact: Basile Turkie    +334 27 85 21 16    b.turkie@lesportesdusud.fr   
CH Villefranche Recruiting
Villefranche, France, 69655
Contact: Max Haine, Dr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Marc Bonnefoy Centre Hospitalier Lyon Sud-Hospices Civils de Lyon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02421133     History of Changes
Other Study ID Numbers: 2014.874
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016

Keywords provided by Hospices Civils de Lyon:
Care transition program
Patient readmission
Transition Nurse
Stepped wedge
elderly