Geriatric-CO-mAnagement for Cardiology Patients in the Hospital

NCT02890927 | Completed

• 1 other identifier: 22/15/028
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (18)

• 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.

• 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.

• Short Physical Performance Test (SPPB).

  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.

  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.

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

Other Outcomes (4)

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

  Through study completion, an average of 1 year.

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

  Through study completion, an average of 1 year.

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

  Through study completion, an average of 1 year.

Study Arms (2)

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.

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.

Interventions

Cardio-geriatric co-management OTHER

A 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.

Cardio-geriatric co-management

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Are admitted from another hospital unit or other hospital;
• Have been admitted to the intensive care unit for three days or longer;

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30344179 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johan Flamaing, PhD, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Koen Milisen, PhD, MSN

  University of Leuven

  PRINCIPAL INVESTIGATOR

• Mieke Deschodt, PhD, MSN

  University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

BE (1)