Clinical trial NCT02890927: Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Assessment
Health Services for the Aged
Cardiovascular Diseases
Activities of Daily Living
Delirium
Frail Elderly
Length of Stay
Keywords: Geriatric Nursing
Geriatric co-management
Geriatric team
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2016-09-07
Enrollment: 454
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Functional decline in activities of daily living assessed using the Katz Index of Activities of Daily Living
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
Secondary outcomes:
measure: Functional decline in activities of daily living assessed using the Barthel Index of Activities of daily. Living.
timeFrame: 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.
measure: Community mobility assessed using the Life-Space assessment.
timeFrame: Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge.
measure: Short Physical Performance Test (SPPB).
timeFrame: Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
measure: Peak handgrip force assessed at the dominant side with the elbow at 90° of flexion, and the forearm and wrist in a neutral position.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Symptomatic infections defined by a clinical diagnosis of pneumonia, urinary tract infection, sepsis and wound infection.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Delirium assessed using the 3D confusion assessment method.
timeFrame: Hospital admission (baseline) and on day 3, 5, 7 and 9 (or every day when a patient is delirious).
measure: Cognitive status assessed using the Mini-Cog.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Falls and fall related injuries.
timeFrame: 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.
measure: Obstipation assessed using nurses recorded observations.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Length of hospital stay.
timeFrame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
measure: Institutionalization.
timeFrame: hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
measure: Thirty day unplanned readmission rate.
timeFrame: 30 days follow-up after hospital discharge.
measure: Survival
timeFrame: Hospital discharge around an average of 12 days, and at 30 days, 3 months and 6 months follow-up after hospital discharge.
measure: Quality of life assessed using the EQ-5D.
timeFrame: 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.
measure: Quality of life index assessed by converting the EQ-5D using standardized index values.
timeFrame: 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.
measure: Functional status on activities of daily living assessed using the Katz Index of Activities of Daily Living.
timeFrame: At 30 days, 3 months and 6 months follow-up after hospital discharge.
measure: Unplanned hospital readmissions
timeFrame: up to 6 months follow-up after hospital discharge
measure: Hospital costs
timeFrame: Between hospital admission and discharge, an average of 12 days
Other outcomes:
measure: Experiences by the intervention participants using focus group discussions and individual interviews.
timeFrame: Through study completion, an average of 1 year.
measure: Reach of the intervention using structured observations and process indicators.
timeFrame: Through study completion, an average of 1 year.
measure: Fidelity of the intervention using structured observations and process indicators.
timeFrame: Through study completion, an average of 1 year.
measure: Dose of the intervention using structured observations and process indicators.
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Johan Flamaing, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leuven
name: Koen Milisen, PhD, MSN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Leuven
name: Mieke Deschodt, PhD, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.