Clinical trial NCT03513159: Improvement of Transition From Hospital to Home for Older Patients in Germany
Official title: Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Patients in the Transition From Hospital to Home
Keywords: transitional care, geriatric, readmission,
discharge
quality of life
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany
name: Regensburg Physicians Network RAEN
name: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: AOK Bayern
name: Institute for Nursing Sciences, University of Bielefeld, Germany
name: Federal Association for Geriatrics, Germany
name: Federal Joint Committee
name: Institute for Community Medicine, University of Greifswald, Germany
First posted: 2018-05-01
Enrollment: 252
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Intervention Group will be supported by the activities of the pathfinder, the Control Group will not. Both Groups will be tested for functional and nutritional Status and for Quality of life and stress scores.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the transsectoral care project TIGER is the reduction of readmission rates of geriatric patients. This aim shall be achieved by improving the hitherto inadequate care process for geriatric patients in the transition from hospital to home. The program offers substantial support of patients and their informal caregivers in the transition process from hospital to home via so called pathfinders, specialized nurses in geriatrics.The pathfinders effectively intertwine stationary and ambulatory care teams caring for a patient, thereby augmenting and complementing effective hospital release management.

Detailed description: Especially for older, chronically ill persons, a hospital stay can promote significant losses in functionality, independence and quality of life, and can increase nutrition deficits and the risk for infections, leading to the occurrence of severe gaps in care after hospital release and to an increased risk for readmission rates.

Even if the German government has recognized the necessity of a multiprofessional integrated care program for older, vulnerable patients and has installed a hospital release management program situated in hospitals in 2012, clarifying entitlements to benefits and setting up ambulatory services contacts, this does not yet meet the complex needs of geriatric patients and their informal caregivers.

Internationally, the Transitional Care Model (TCM) has been developed (M. Naylor et al. 1994) to address the deficits in care of older patients in transition between hospital to home. Via a series of defined activities, a disruption of the care supply chain for older patients in this transition process is being avoided.

The TIGER program will address the needs of geriatric patients and their informal caregivers and will support them via structured continuous activities, on the basis of the TCM, by so called pathfinders, nurses specialized in geriatrics. These pathfinders will develop an individual care plan with the patients, their informal caregivers and the hospital physicians already inside the hospital setting and will then develop and improve this further during up to twelve months after the hospital release of the patient. The pathfinders will coordinate the ambulatory care team services and closely involve the primary physicians. The patients and their informal caregivers will be empowered and educated to achieve a stabilization or improvement in functionality, independence, quality of life, coping with disease, nutritional status and wound healing process of the patients.

The aim of the program is that these activities will lead to a reduction of necessary readmission rates of geriatric patients.

Efficacy, practicability, and limitations of the program will be evaluated scientifically and economically and will be analyzed for a possible saving of costs for the health care system.

Eligibility criteria: Inclusion Criteria:

will go back home after Hospital stay, AOK Patient, MiniMentalStateExamination MMSE score of at least 22, is living within 50 km range of the hospital

Exclusion Criteria:

palliative status, planned readmission into hospital within next 4 weeks

Primary outcomes:
measure: Readmission Rate
timeFrame: up to 12 months
Secondary outcomes:
measure: Functionality and mobility - 1
timeFrame: up to 12 months
measure: Functionality and mobility - 2
timeFrame: up to 12 months
measure: Functionality and mobility - 3
timeFrame: up to 12 months
measure: Functionality and mobility - 4
timeFrame: up to 12 months
measure: Functionality and mobility - 5
timeFrame: up to 12 months
measure: Nutritional status
timeFrame: up to 12 months
measure: Health-related quality of life
timeFrame: up to 12 months
measure: Depression
timeFrame: up to 12 months
measure: Cognitive Status - 1
timeFrame: up to 12 months
measure: Cognitive Status - 2
timeFrame: up to 12 months
measure: Burden of informal caregivers - 1
timeFrame: up to 12 months
measure: Burden of informal caregivers - 2
timeFrame: up to 12 months
measure: Transfers into nursing homes
timeFrame: Up to 12 months
measure: Care situation, care supply and quality of care at home
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Hospital of the Order of St.John of God Regensburg
state: Bavaria
city: Nürnberg
country: Germany
facility: Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
Study officials:
affiliation: Institute for Biomedicine of Aging
name: Cornel Sieber, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Gehr TJ, Freiberger E, Sieber CC, Engel SA. A typology of caregiving spouses of geriatric patients without dementia: caring, worried, desperate. BMC Geriatr. 2021 Sep 6;21(1):483. doi: 10.1186/s12877-021-02425-1.
citation: Rimmele M, Wirth J, Britting S, Gehr T, Hermann M, van den Heuvel D, Kestler A, Koch T, Schoeffski O, Volkert D, Wingenfeld K, Wurm S, Freiberger E, Sieber C; TIGER consortium. Improvement of transitional care from hospital to home for older patients, the TIGER study: protocol of a randomised controlled trial. BMJ Open. 2021 Feb 8;11(2):e037999. doi: 10.1136/bmjopen-2020-037999.