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| Name | Class |
|---|---|
| KU Leuven | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardio-geriatric co-management | Other | A comprehensive geriatric assessment on admission will stratify patients in groups:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Reach of the intervention using structured observations and process indicators. |
Inclusion Criteria: Patients will be included if they:
Exclusion Criteria: Patients will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30344179 | Derived | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Hospital admission (baseline), and at 30 days, 3 months and 6 months follow-up after hospital discharge. |
| 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. |
| 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. |
| 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. |
| 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). |
| Cognitive status assessed using the Mini-Cog. | Hospital admission (baseline) up to hospital discharge around an average of 12 days. |
| 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. |
| 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. |
| Length of hospital stay. | Hospital admission (baseline) up to hospital discharge around an average of 12 days. |
| 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. |
| Thirty day unplanned readmission rate. | 30 days follow-up after hospital discharge. |
| 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. |
| 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. |
| 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. |
| 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. |
| Unplanned hospital readmissions | Time to the first unplanned hospital readmission | up to 6 months follow-up after hospital discharge |
| 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 |
Reach is defined as the number of eligible patients receiving the intervention. |
| Through study completion, an average of 1 year. |
| 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. |
| 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |