Condition category
Not Applicable
Date applied
20/06/2017
Date assigned
28/07/2017
Last edited
21/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

https://www.iwt.be/english/welcome

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

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes