Geriatric-CO-mAnagement for Cardiology Patients in the Hospital

Cardiovascular Diseases Clinical Trial

— G-COACH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890927
• Other study ID #: 22/15/028
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 2019

Study information

• Verified date: February 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria: Patients will be included if they:

• 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;

Exclusion Criteria: Patients will be excluded if they:

• Are admitted from another hospital unit or other hospital;

• Have been admitted to the intensive care unit for three days or longer;

Related Conditions & MeSH terms

• Activities of Daily Living
• Cardiovascular Diseases
• Delirium
• Frail Elderly
• Geriatric Assessment
• Health Services for the Aged
• Length of Stay

Intervention

Other:
• Cardio-geriatric co-management
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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experiences by the intervention participants using focus group discussions and individual interviews.	The interviews will focus on implementation determinants and the interaction of the intervention with the context in which it was implemented.	Through study completion, an average of 1 year.
Other	Reach of the intervention using structured observations and process indicators.	Reach is defined as the number of eligible patients receiving the intervention.	Through study completion, an average of 1 year.
Other	Fidelity of the intervention using structured observations and process indicators.	Fidelity is defined as the extent to which the intervention was implemented as defined in the protocol.	Through study completion, an average of 1 year.
Other	Dose of the intervention using structured observations and process indicators.	Dose is defined as the number of intervention components delivered as defined in the protocol.	Through study completion, an average of 1 year.
Primary	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.	Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Primary	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.	Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	Functional decline in activities of daily living assessed using the Barthel Index of Activities of daily. Living.		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.
Secondary	Community mobility assessed using the Life-Space assessment.		Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Secondary	Short Physical Performance Test (SPPB).	The SPPB consist of gait speed, balance test, and chair stand test.	Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
Secondary	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).	Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	Symptomatic infections defined by a clinical diagnosis of pneumonia, urinary tract infection, sepsis and wound infection.		Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	Delirium assessed using the 3D confusion assessment method.		Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).
Secondary	Cognitive status assessed using the Mini-Cog.		Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	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.	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.
Secondary	Obstipation assessed using nurses recorded observations.	Obstipation is defined as not having passed stool in five days or more.	Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	Length of hospital stay.		Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary	Institutionalization.	New admission to nursing home or skilled nursing facility	hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Secondary	Thirty day unplanned readmission rate.		30 days follow-up after hospital discharge.
Secondary	Survival	Time to death	Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
Secondary	Quality of life assessed using the EQ-5D.		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.
Secondary	Quality of life index assessed by converting the EQ-5D using standardized index values.		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.
Secondary	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.	At 30 days, 3 months and 6 months follow-up after hospital discharge.
Secondary	Unplanned hospital readmissions	Time to the first unplanned hospital readmission	up to 6 months follow-up after hospital discharge
Secondary	Hospital costs	Costs registered for to the treatment, care, logistics and stay in the hospital	Between hospital admission and discharge, an average of 12 days