Geriatric-CO-mAnagement for Cardiology Patients in the Hospital

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Cardio-geriatric co-management
    • 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.
  • No Intervention: Standard of care
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 on the Katz Index will be considered clinical relevant.

Secondary Measures

  • 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.
  • Decline in 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.
  • Decline in the Short Physical Performance Test (SPPB).
    • Time Frame: Hospital admission (baseline), up to at hospital discharge around an average of 12 days.
    • The SPPB consist of gait speed, balance test, and chair stand test.
  • Decline in 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.
    • Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI).
  • 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 decline 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.
    • 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.
  • Obstipation assessed using nurses recorded observations.
    • Time Frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.
    • Obstipation is defined as not having passed stool in five days or more.
  • 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.
    • New admission to nursing home or skilled nursing facility
  • Thirty day unplanned readmission rate.
    • Time Frame: 30 days follow-up after hospital discharge.
  • Mortality.
    • 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 adjusted life years 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 decline in activities of daily living.
    • Time Frame: At 30 days, 3 months and 6 months follow-up after hospital discharge.
    • Functional decline will be measured using the Katz Index of Activities of Daily Living.

Participating in This Clinical Trial

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;

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Collaborator
    • KU Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Johan Flamaing, PhD, MD, Principal Investigator, Universitaire Ziekenhuizen Leuven
    • Koen Milisen, PhD, MSN, Principal Investigator, University of Leuven
    • Mieke Deschodt, PhD, MSN, Principal Investigator, University of Leuven
  • Overall Contact(s)
    • Bastiaan Van Grootven, MSN, 0032 16 32 05 84, bastiaan.vangrootven@kuleuven.be

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