Geriatric AssessmentG-COACHNCT02890927
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
A study testing Cardio-geriatric co-management in people with Geriatric Assessment and Health Services for the Aged, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Assessment, Health Services for the Aged, Cardiovascular Diseases
- What is being tested?
- Cardio-geriatric co-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 454 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Are admitted for non-surgical treatment of an acute heart problem (patients may be admitted through the emergency department or the cardiology outpatient services for any heart related acute disease) OR if they are admitted for Transcatheter Aortic Valve Implantation (TAVI);
- Are aged 75 years or older;
- Have an expected length of stay of three days or longer;
- Non-palliative on hospital admission
- Are Dutch speaking and testable;
- Give informed consent or proxy-informed consent;
Who cannot join
- Are admitted from another hospital unit or other hospital;
- Have been admitted to the intensive care unit for three days or longer;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quasi-experimental Before-and-after Study to Compare the Effectiveness of Geriatric Co-management on Preventing Functional Decline as Compared to Standard of Care in Older Cardiology Patients
The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven.
Read the detailed description
This study aims to implement and evaluate a geriatric co-management intervention in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. The study uses a mixed-methods methodology aiming to 1) assess the feasibility and evaluate the effectiveness of geriatric co-management, 2) describe the experiences of intervention participants, and 3) perform a process evaluation. We will first consecutively recruit patients on the cardiology units to measure the standard of care in the control group. The geriatric co-management intervention will then be implemented and piloted on the participating units. Once fully implemented, we will consecutively recruit patients for the intervention group who will receive the geriatric co-management intervention.
- Conditions
- Geriatric Assessment, Health Services for the Aged, Cardiovascular Diseases, Activities of Daily Living, Delirium, Frail Elderly
- Being tested
- Cardio-geriatric co-management
- Keywords
- Geriatric Nursing, Geriatric co-management, Geriatric team
- Medical subject headings
- Cardiovascular Diseases, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardio-geriatric co-managementOther
A comprehensive geriatric assessment on admission will stratify patients in groups:
- Low risk patients are expected to do well and will not receive co-management.
- Medium risk patients are expected to develop complications. A geriatric nurse will visit the cardiology wards daily to co-manage these patients aiming to prevent complications by coordinating interdisciplinary care, implementing protocols, perform assessments and bedside education. The geriatric nurse will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning.
- High risk patients have an acute geriatric syndrome. The geriatric nurse will visit the cardiology wards (see above), and a geriatrician will co-manage the acute geriatric syndrome(s). The geriatrician will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning.
| Study group | Role | What they receive |
|---|---|---|
| Cardio-geriatric co-management | Experimental | A geriatric co-management intervention will be implemented on the cardiology units of the University Hospitals Leuven. Geriatric co-management is defined as a shared responsibility and decision making between the cardiology team and the geriatric team who provides complementary medical care in the prevention and management of geriatric problems. Patients included in the co-management program will undergo a comprehensive geriatric assessment within 24 hours of hospital admission. Receives: Other: Cardio-geriatric co-management |
| Standard of care | No intervention | The control group will receive the standard of care on the cardiology units. This includes multidisciplinary care with a one weekly multidisciplinary team meeting. Team members include a cardiology resident (supervised by a cardiologist), ward nurses, a physical therapist, a social worker and a dietician. A geriatric consultation team is available for consultation services if requested by the cardiology team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
A difference of 1 point on the Katz Index will be considered clinically relevant.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Functional decline in activities of daily living assessed using the Katz Index of Activities of Daily Living
A decline of 1 point between admission and discharge on the Katz Index will be considered clinically relevant.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary outcomes (18)
Functional decline in activities of daily living assessed using the Barthel Index of Activities of daily. Living.
Measured: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Community mobility assessed using the Life-Space assessment.
Measured: Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Short Physical Performance Test (SPPB).
The SPPB consist of gait speed, balance test, and chair stand test.
Measured: Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI).
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Symptomatic infections defined by a clinical diagnosis of pneumonia, urinary tract infection, sepsis and wound infection.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Delirium assessed using the 3D confusion assessment method.
Measured: Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).
Cognitive status assessed using the Mini-Cog.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Falls and fall related injuries.
A fall incident is defined as an unexpected event in which the patient comes to rest on the ground, floor or lower level. Fall related injuries will be divided in two groups: minor and major.
Measured: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Obstipation assessed using nurses recorded observations.
Obstipation is defined as not having passed stool in five days or more.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Length of hospital stay.
Measured: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Institutionalization.
New admission to nursing home or skilled nursing facility
Measured: hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Thirty day unplanned readmission rate.
Measured: 30 days follow-up after hospital discharge.
Survival
Time to death
Measured: Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Quality of life assessed using the EQ-5D.
Measured: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Quality of life index assessed by converting the EQ-5D using standardized index values.
Measured: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
Functional status will be measured using the Katz Index of Activities of Daily Living.
Measured: At 30 days, 3 months and 6 months follow-up after hospital discharge.
Unplanned hospital readmissions
Time to the first unplanned hospital readmission
Measured: up to 6 months follow-up after hospital discharge
Hospital costs
Costs registered for to the treatment, care, logistics and stay in the hospital
Measured: Between hospital admission and discharge, an average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Geriatric AssessmentStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Johan Flamaing, PhD, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenKoen Milisen, PhD, MSN, Principal investigator, University of LeuvenMieke Deschodt, PhD, MSN, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890927
- Sponsor's protocol ID
- 22/15/028
- Acronym
- G-COACH
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deschodt M, Van Grootven B, Jeuris A, Devriendt E, Dierckx de Casterle B, Dubois C, Fagard K, Herregods MC, Hornikx M, Meuris B, Rex S, Tournoy J, Milisen K, Flamaing J. Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study. BMJ Open. 2018 Oct 21;8(10):e023593. doi: 10.1136/bmjopen-2018-023593.
PubMed 30344179
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quasi-experimental Before-and-after Study to Compare the Effectiveness of Geriatric Co-management on Preventing Functional Decline as Compared to Standard of Care in Older Cardiology Patients
- ClinicalTrials.gov ID
- NCT02890927
- Acronym / sponsor ID
- G-COACH / 22/15/028
- Conditions
- Geriatric Assessment, Health Services for the Aged, Cardiovascular Diseases, Activities of Daily Living, Delirium, Frail Elderly
- Keywords
- Geriatric Nursing, Geriatric co-management, Geriatric team
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven.
Detailed description
This study aims to implement and evaluate a geriatric co-management intervention in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. The study uses a mixed-methods methodology aiming to 1) assess the feasibility and evaluate the effectiveness of geriatric co-management, 2) describe the experiences of intervention participants, and 3) perform a process evaluation. We will first consecutively recruit patients on the cardiology units to measure the standard of care in the control group. The geriatric co-management intervention will then be implemented and piloted on the participating units. Once fully implemented, we will consecutively recruit patients for the intervention group who will receive the geriatric co-management intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardio-geriatric co-management | Experimental | Other: Cardio-geriatric co-managementA geriatric co-management intervention will be implemented on the cardiology units of the University Hospitals Leuven. Geriatric co-management is defined as a shared responsibility and decision making between the cardiology team and the geriatric team who provides complementary medical care in the prevention and management of geriatric problems. Patients included in the co-management program will undergo a comprehensive geriatric assessment within 24 hours of hospital admission. |
| Standard of care | No intervention | –The control group will receive the standard of care on the cardiology units. This includes multidisciplinary care with a one weekly multidisciplinary team meeting. Team members include a cardiology resident (supervised by a cardiologist), ward nurses, a physical therapist, a social worker and a dietician. A geriatric consultation team is available for consultation services if requested by the cardiology team. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Are admitted for non-surgical treatment of an acute heart problem (patients may be admitted through the emergency department or the cardiology outpatient services for any heart related acute disease) OR if they are admitted for Transcatheter Aortic Valve Implantation (TAVI);
- Are aged 75 years or older;
- Have an expected length of stay of three days or longer;
- Non-palliative on hospital admission
- Are Dutch speaking and testable;
Key exclusion criteria (2 listed)
- Are admitted from another hospital unit or other hospital;
- Have been admitted to the intensive care unit for three days or longer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardio-geriatric co-managementA comprehensive geriatric assessment on admission will stratify patients in groups: 1. Low risk patients are expected to do well and will not receive co-management. 2. Medium risk patients are expected to develop complications. A geriatric nurse will visit the cardiology wards daily to co-manage these patients aiming to prevent complications by coordinating interdisciplinary care, implementing protocols, perform assessments and bedside education. The geriatric nurse will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning. 3. High risk patients have an acute geriatric syndrome. The geriatric nurse will visit the cardiology wards (see above), and a geriatrician will co-manage the acute geriatric syndrome(s). The geriatrician will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning. | Other | Cardio-geriatric co-management |
Primary outcome
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A difference of 1 point on the Katz Index will be considered clinically relevant.
Functional decline in activities of daily living assessed using the Katz Index of Activities of Daily Living
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
A decline of 1 point between admission and discharge on the Katz Index will be considered clinically relevant.
18 secondary outcomes
Functional decline in activities of daily living assessed using the Barthel Index of Activities of daily. Living.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Community mobility assessed using the Life-Space assessment.
Time frame: Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Short Physical Performance Test (SPPB).
Time frame: Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Symptomatic infections defined by a clinical diagnosis of pneumonia, urinary tract infection, sepsis and wound infection.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Delirium assessed using the 3D confusion assessment method.
Time frame: Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).
Cognitive status assessed using the Mini-Cog.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Falls and fall related injuries.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Obstipation assessed using nurses recorded observations.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Length of hospital stay.
Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Institutionalization.
Time frame: hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Thirty day unplanned readmission rate.
Time frame: 30 days follow-up after hospital discharge.
Survival
Time frame: Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Quality of life assessed using the EQ-5D.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Quality of life index assessed by converting the EQ-5D using standardized index values.
Time frame: Hospital admission (baseline), hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
Time frame: At 30 days, 3 months and 6 months follow-up after hospital discharge.
Unplanned hospital readmissions
Time frame: up to 6 months follow-up after hospital discharge
Hospital costs
Time frame: Between hospital admission and discharge, an average of 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 30344179Deschodt M, Van Grootven B, Jeuris A, Devriendt E, Dierckx de Casterle B, Dubois C, Fagard K, Herregods MC, Hornikx M, Meuris B, Rex S, Tournoy J, Milisen K, Flamaing J. Geriatric CO-mAnagement for Cardiology patients in the Hospital (G-COACH): study protocol of a prospective before-after effectiveness-implementation study. BMJ Open. 2018 Oct 21;8(10):e023593. doi: 10.1136/bmjopen-2018-023593.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Flamaing, PhD, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Koen Milisen, PhD, MSN principal investigator
University of Leuven
Mieke Deschodt, PhD, MSN principal investigator
University of Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-geriatric co-management in people with Geriatric Assessment and Health Services for the Aged, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living. (time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.