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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03513159
Other study ID # IBA-2018-TIGER
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2018
Est. completion date February 28, 2021

Study information

Verified date March 2021
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 252
Est. completion date February 28, 2021
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Geriatric Patients in the Transition From Hospital to Home

Intervention

Behavioral:
Pathfinder support
A pathfinder will support the patient with structured activities.

Locations

Country Name City State
Germany Institute for Biomedicine of Aging, University of Erlangen-Nürnberg Nürnberg
Germany Hospital of the Order of St.John of God Regensburg Regensburg Bavaria

Sponsors (9)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School AOK Health Insurance Bavaria, Federal Association for Geriatrics, Germany, Federal Joint Committee, German, Friedrich-Alexander-Universität Erlangen-Nürnberg, Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany, Institute for Community Medicine, University of Greifswald, Germany, Institute for Nursing Sciences, University of Bielefeld, Germany, Regensburg Physicians Network RAEN

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission Rate The number of readmissions of a patient into a hospital within up to 15 months (study period for the patient.plus 3 months prior to enrollment). up to 12 months
Secondary Functionality and mobility - 1 Timed up and Go in seconds up to 12 months
Secondary Functionality and mobility - 2 Instrumental activities of daily living (IADL) in scale up to 12 months
Secondary Functionality and mobility - 3 handgrip strength in kilogramms up to 12 months
Secondary Functionality and mobility - 4 pedometer activPAL3 micro up to 12 months
Secondary Functionality and mobility - 5 Short physical performance battery (SPPB) in scale up to 12 months
Secondary Nutritional status measured bei Mini Nutritional Assessment (MNA) up to 12 months
Secondary Health-related quality of life Measured by Short-Form-Health Survey (SF-12) questionnaire in scale up to 12 months
Secondary Depression Measured by Geriatric Depression Scale (GDS) in scale up to 12 months
Secondary Cognitive Status - 1 Measured by Mini-Mental State Examination (MMSE) in scale up to 12 months
Secondary Cognitive Status - 2 Trail Making Test A&B in seconds up to 12 months
Secondary Burden of informal caregivers - 1 Measured by Zarith-questionnaires in scale up to 12 months
Secondary Burden of informal caregivers - 2 Perceived Stress Questionnaire (PSQ)-questionnaires in scale up to 12 months
Secondary Transfers into nursing homes Comparison between intervention and control group. Data made available by cooperating partner Allgemeine Ortskrankenkasse (AOK) sickness fund in percent Up to 12 months
Secondary Care situation, care supply and quality of care at home Measured by Neues BegutAchtungsinstrument (NBA, Buscher, Wingenfeld & Schaeffer, 2011) as scale up to 12 months