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Completed

NCT Number: NCT02890927

Geriatric-CO-mAnagement for Cardiology Patients in the Hospital

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Cardio-geriatric co-management

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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).

  7. Cognitive status assessed using the Mini-Cog.

    Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.

  8. 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.

  9. 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.

  10. Length of hospital stay.

    Time frame: Hospital admission (baseline) up to hospital discharge around an average of 12 days.

  11. 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

  12. Thirty day unplanned readmission rate.

    Time frame: 30 days follow-up after hospital discharge.

  13. 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.

    Time to death

  14. 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.

  15. 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.

  16. 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.

    Functional status will be measured using the Katz Index of Activities of Daily Living.

  17. Unplanned hospital readmissions

    Time frame: up to 6 months follow-up after hospital discharge

    Time to the first unplanned hospital readmission

  18. Hospital costs

    Time frame: Between hospital admission and discharge, an average of 12 days

    Costs registered for to the treatment, care, logistics and stay in the hospital

Other outcomes

  1. Experiences by the intervention participants using focus group discussions and individual interviews.

    Time frame: Through study completion, an average of 1 year.

    The interviews will focus on implementation determinants and the interaction of the intervention with the context in which it was implemented.

  2. Reach of the intervention using structured observations and process indicators.

    Time frame: Through study completion, an average of 1 year.

    Reach is defined as the number of eligible patients receiving the intervention.

  3. Fidelity of the intervention using structured observations and process indicators.

    Time frame: Through study completion, an average of 1 year.

    Fidelity is defined as the extent to which the intervention was implemented as defined in the protocol.

  4. Dose of the intervention using structured observations and process indicators.

    Time frame: Through study completion, an average of 1 year.

    Dose is defined as the number of intervention components delivered as defined in the protocol.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study 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

Acronym: G-COACH

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 7, 2016
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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