Plain English Summary
Background and study aims
One out of three older adults who are discharged from hospital after an episode of emergency department (ED) care end up back in the ED within three months. Several factors can lead to these events such as a new medical condition, unsuccessful treatment of the initial medical condition, poor patient compliance (keeping up with the treatment or medication), inappropriate discharge, and poor out-of-hospital follow-up. To improve the care for older ED patients and especially prevent unplanned ED readmissions, the URGENT care model was developed. The key components of this care model are geriatric (medical care for older people) screening, comprehensive geriatric assessment (CGA) of at-risk patients, interdisciplinary care planning and follow-up. Inpatient follow-up is coordinated by nurses of the inpatient geriatric consultation team. Outpatient follow-up is organized by case managers in home care through telephone calls and home visits if indicated. The care model provides a dedicated geriatric nurse, additionally available on the ED during office hours, to deliver and initiate URGENT procedures. The aim of this study is to examine if the UREGENT care model can prevent unplanned emergency department readmissions as compared the standard level of care model.
Who can participate?
Patients aged 70 and older who are admitted to the ED department
What does the study involve?
Participants are allocated to one or two groups. Those in the first group receive the standard ED care and follow up. Those in the second group receive the URGENT care model which includes examination of risks, full geriatric assessment, care planning and follow up. Participants are followed up to see if there are unplanned readmissions within 90 days after hospitalisation and to see if the URGENT care model improved the ED at being able to detect problems and use referrals to other care such as occupational therapy better.
What are the possible benefits and risks of participating?
There are no direct benefits with participating; however participants receive personalised advice towards their needs of their patients. There are no risks with participating.
Where is the study run from?
University Hospitals Leuven (Belgium)
When is the study starting and how long is it expected to run for?
December 2014 to September 2016
Who is funding the study?
1. Pyxima NV (Belgium)
2. Wit-Gele Kruis Vlaams-Brabant (Belgium)
3. Christelijke Mutualiteit Leuven (Belgium)
Who is the main contact?
Dr Koen Milisen (Scientific)
Miss Els Devriendt (Public)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Koen Milisen
ORCID ID
http://orcid.org/0000-0001-9230-1246
Contact details
Department of Public Health and Primary Care
Academic Centre for Nursing and Midwifery
KU Leuven
Kapucijnenvoer 35/4
Leuven
3000
Belgium
Type
Public
Additional contact
Miss Els Devriendt
ORCID ID
http://orcid.org/0000-0002-1746-7120
Contact details
1 Department of Public Health and Primary Care
Academic Centre for Nursing and Midwifery
KU Leuven
Kapucijnenvoer 35/4
Leuven
3000
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B322201422910
Study information
Scientific title
URGENT - Unplanned Readmission prevention by Geriatric Emergency Network for Transitional care
Acronym
URGENT
Study hypothesis
The URGENT care model prevents unplanned emergency department readmissons within 90 days among older adults in comparison to conventional care.
Ethics approval
The Medical Ethics Committee of the Leuven University Hospitals, 15/07/2015, ref: B322201422910
Study design
This study is designed as a single centre quasi-experimental study (sequential design with two cohorts) where the standard care on the ED in the control cohort is compared with the implementation of the new URGENT care model in the intervention cohort
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Geriatric care models
Intervention
The URGENT study is a single centre quasi-experimental study (sequential design with two cohorts) where the standard care on the emergency department in the control cohort is compared with the implementation of the new URGENT care model in the intervention cohort. Although randomisation could theoretically offer a more powerful design, the complex environment of the emergency department doesn’t allow this method.
Patients in the control cohort receive standard ED care from all healthcare workers involved in their management on the ED. The control cohort is composed from month one to month six.
Participants in the intervention cohort receive the intervention. The intervention cohort will be composed from month 11 to month 18. A dedicated geriatric nurse is available on the emergency department during office hours to deliver a newly developed geriatric care model. This care model comprises four steps:
1. Risk stratification of older emergency department patients
2. Comprehensive geriatric assessment of patients at risk
3. Interdisciplinary care planning
4. Follow-up
This intervention aims at improving problem detection and better use of conventional referrals and interventions (e.g. occupational therapy). The hospital follow-up is done by casemanagers was a newly developed patient approach.
Between these two time-periods there is a gap of four months in which the feasibility of the URGENT care model is tested.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Unplanned remissions is measured using the patient chart review and telephone calls at 30 and 90 days after hospital discharge
Secondary outcome measures
1. Need for hospitalization during index ED visit is measured using chart review at discharge from the ED
2. Length of index emergency department stay is measured using chart review and is calculated as the time between admission to the ED and discharge from the ED
3. Length of inhospital stay measured using chart review and is calculated as the time between discharge from the ED and discharge from the hospital
4. Mortality within 30 and 90 days after hospital discharge is measured using chart review and telephone calls at 30 and 90 days after hospital discharge
5. Functional decline 30 and 90 days after ED discharge is measured using using telephone calls at 30 and 90 days after ED discharge
6. Higher level of care (at the moment of hospital discharge) is measured using chart review and telephone calls at discharge, 30 and 90 days after discharge
Overall trial start date
01/12/2014
Overall trial end date
01/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Dutch-speaking
2. Community-dwelling patients aged 70 years or older
3. Patients admitted to the emergency department were included if their medical condition allowed being interviewed
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
1502
Total final enrolment
1654
Participant exclusion criteria
Patients, transferred from other wards, other hospitals or care facilities.
Recruitment start date
09/12/2014
Recruitment end date
31/05/2016
Locations
Countries of recruitment
Belgium
Trial participating centre
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium
Sponsor information
Organisation
Flanders Innovation and Entrepreneurship
Sponsor details
Ellipsgebouw
Koning Albert II-laan 35
Bus 12
Brussels
1030
Belgium
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals Leuven
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pyxima NV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Wit-Gele Kruis Vlaams-Brabant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Christelijke Mutualiteit Leuven
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from koen.milisen@kuleuven.be
Intention to publish date
31/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30326860
2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31390994 (added 09/08/2019)