G-COACH: Feasibility of the geriatric co-management for cardiology patients in the hospital programme

ISRCTN ISRCTN22096382
DOI https://doi.org/10.1186/ISRCTN22096382
Secondary identifying numbers REF 22/15/028
Submission date
21/05/2020
Registration date
23/05/2020
Last edited
26/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Older patients admitted to an cardiac care unit often experience functional decline and sustained disability. Geriatric co-management has demonstrated significant improvements on outcomes in older patients with a hip fracture, but has never been evaluated in the cardiac care setting.
This study introduced a new geriatric co-management programme on the cardiac care units of the University Hospitals Leuven. The aim was to evaluate whether this programme was acceptable and feasible to perform.

Who can participate?
Patients aged 75 years or older admitted for acute cadiovascular disease or transcatheter aortic valve implentation to the cardiac care units of the University Hospitals Leuven and healthcare professionals working on the acute cardiac care units of the University Hospitals Leuven.

What does the study involve?
On admission to the hospital, a comprehensive geriatric assessment was performed, care needs were determined, and an interdisciplinary care plan was drafted. A nurse from the geriatrics department provided daily follow-up until hospital discharge.

What are the possible benefits and risks of participating?
The programme was developed to benefit patients, including a better functional status and less complications. There are no direct risks.

Where is the study run from?
University Hospitals Leuven (Belgium)

When is the study starting and how long is it expected to run for?
January 2015 to May 2018

Who is funding the study?
Onderzoeksraad, KU Leuven (Research Council, KU Leuven), Belgium

Who is the main contact?
Dr Mieke Deschodt, mieke.deschodt@kuleuven.be
Prof. Koen Milisen, koen.milisen@kuleuven.be
Prof. Johan Flamaing, johan.flamaing@uzleuven.be

Study website

Contact information

Dr Mieke Deschodt
Scientific

Gerontology and Geriatrics
UZ Herestraat 49 - box 7003 35
Leuven
3000
Belgium

ORCiD logoORCID ID 0000-0003-1560-2277
Phone +32 16 37 76 92
Email mieke.deschodt@kuleuven.be
Prof Koen Milisen
Scientific

Academisch Centrum voor Verpleeg- en Vroedkunde
Kapucijnenvoer 35 blok d - bus 7001
Leuven
3000
Belgium

ORCiD logoORCID ID 0000-0001-9230-1246
Phone +32 16 37 79 79
Email koen.milisen@kuleuven.be
Prof Johan Flamaing
Scientific

Gerontology and Geriatrics
UZ Herestraat 49 - box 7003 35
Leuven
3000
Belgium

Phone +32 16 3 42647
Email johan.flamaing@uzleuven.be

Study information

Study designOne-group experimental single centre feasibility study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleImplementation of the Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH) programme: a feasibility study
Study acronymG-COACH
Study hypothesisIs a geriatric co-management programme implemented on the acute cardiac care units of the University Hospitals Leuven considered acceptable and feasible to perform?
Ethics approval(s)Approved 03/08/2017, The Medical Ethics Committee of the University Hospitals Leuven (Ethische commissie onderzoek UZ Leuven, Herestraat 49, 3000 Leuven, Belgium; +32 16 34 86 00; ec@uzleuven.be), ref: s59543
ConditionOlder patients with geriatric profile admitted to cardiac care units
InterventionNurse-led geriatric co-management programme, including a comprehensive geriatric assessment on hospital admission, risk stratification, daily follow-up by geriatrics team until hospital discharge, implementation of standardised and evidence-based protocols for geriatric syndromes, early rehabilitation, individual exercise programme, and early discharge planning.

Informed consent is obtained within three days of admission to the cardiac care unit (15 minutes). A nurse enrols the patient in the geriatric co-management programme (30 minutes). A researcher performs an interview and asks about the experiences with the programme (15 minutes). A researcher observes daily health status and whether there are any complications (10 minutes) until discharge from the cardiac care unit. The participation ends when discharged from the hospital.
Intervention typeOther
Primary outcome measureExperiences with the programme, including self-perceived acceptability and self-perceived feasibility, measured using structured interviews with questionnaires during hospitalisation.
Secondary outcome measuresMeasured during hospitalisation on the cardiac care unit. This is case dependent (some patients have a long length of stay, others short) and there is no one fixed timepoint:
1. Reach of the programme, measured using registrations in the electronic patient record
2. Fidelity, measured suing registrations in the electronic patient record
3. Dose, measured suing registrations in the electronic patient record
4. Determinants for implementation, measured using a questionnaire and interviews
Overall study start date28/01/2015
Overall study end date31/05/2018

Eligibility

Participant type(s)Mixed
Age groupMixed
SexBoth
Target number of participants3 sequential cohorts of 30 patients with follow-up in the geriatric co-management programme; All healthcare professionals with at least 4 weeks of exposure to the geriatric co-management programme
Total final enrolment199
Participant inclusion criteria1. Patients aged 75 years or older admitted for acute cadiovascular disease or transcatheter aortic valve implentation to the cardiac care units of the University Hospitals Leuven
2. Healthcare professionals working on the acute cardiac care units of the University Hospitals Leuven
Participant exclusion criteria1. Length of stay < 3 days
2. No baseline assessment (included transfers from other units or hospitals)
3. Unable to complete assessment
4. No inform consent
5. Receiving palliative care
Recruitment start date07/11/2017
Recruitment end date02/05/2018

Locations

Countries of recruitment

  • Belgium

Study participating centre

University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium

Sponsor information

KU Leuven
University/education

Oude markt 13
Leuven
3000
Belgium

Phone +32 16 3 24010
Email onderzoek@kuleuven.be
Website https://www.kuleuven.be/english/
ROR logo "ROR" https://ror.org/05f950310

Funders

Funder type

Research council

Onderzoeksraad, KU Leuven
Private sector organisation / Universities (academic only)
Alternative name(s)
Research Council, KU Leuven
Location
Belgium

Results and Publications

Intention to publish date30/06/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPresented at a conference (2019 Wintermeeting, Oostende, Belgium) and submitted for publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Koen Milisen (koen.milisen@kuleuven.be). Each request will be considered on a case basis. Reasonable requests include use of baseline data for epidemiological purposes.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/10/2018 22/05/2020 Yes No
Results article 02/05/2022 26/10/2022 Yes No

Editorial Notes

26/10/2022: Publication reference added.
04/06/2021: The intention to publish date has been changed from 30/06/2021 to 30/06/2022.
04/12/2020: The intention to publish date has been changed from 30/06/2020 to 30/06/2021.
22/05/2020: Trial’s existence confirmed by UZ Leuven.