Improvement of Transition From Hospital to Home for Older Patients in Germany (TIGER)

Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg

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.

Study Overview

• Status: Completed
• Conditions: Geriatric Patients in the Transition From Hospital to Home
• Intervention / Treatment: Behavioral: Pathfinder support

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.

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nürnberg, Germany, 90408
    • Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
  • Bavaria
    • Regensburg, Bavaria, Germany, 93049
      • Hospital of the Order of St.John of God Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pathfinder support; Pathfinder support with development of an individual care plan for the intervention patients and their informal caregivers, with the hospital physicians already inside the hospital setting. This will then be developed and improved further during up to twelve months after hospital release with the primary physician. 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. In the regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.	Behavioral: Pathfinder support; A pathfinder will support the patient with structured activities.
No Intervention: Control without pathfinder support; Control patients will not be supported by pathfinders. In regular assessments they will be tested for functionality and nutritional parameters, quality of life and stress scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality and mobility - 1	Timed up and Go in seconds	up to 12 months
Functionality and mobility - 2	Instrumental activities of daily living (IADL) in scale	up to 12 months
Functionality and mobility - 3	handgrip strength in kilogramms	up to 12 months
Functionality and mobility - 4	pedometer activPAL3 micro	up to 12 months
Functionality and mobility - 5	Short physical performance battery (SPPB) in scale	up to 12 months
Nutritional status	measured bei Mini Nutritional Assessment (MNA)	up to 12 months
Health-related quality of life	Measured by Short-Form-Health Survey (SF-12) questionnaire in scale	up to 12 months
Depression	Measured by Geriatric Depression Scale (GDS) in scale	up to 12 months
Cognitive Status - 1	Measured by Mini-Mental State Examination (MMSE) in scale	up to 12 months
Cognitive Status - 2	Trail Making Test A&B in seconds	up to 12 months
Burden of informal caregivers - 1	Measured by Zarith-questionnaires in scale	up to 12 months
Burden of informal caregivers - 2	Perceived Stress Questionnaire (PSQ)-questionnaires in scale	up to 12 months
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
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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: AOK Bayern; Federal Joint Committee; Friedrich-Alexander-Universität Erlangen-Nürnberg; Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany; Regensburg Physicians Network RAEN; Institute for Nursing Sciences, University of Bielefeld, Germany; Federal Association for Geriatrics, Germany; Institute for Community Medicine, University of Greifswald, Germany
• Investigators: Study Director: Cornel Sieber, Prof. Dr., Institute for Biomedicine of Aging

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; discharge; transitional care, geriatric, readmission,
• Other Study ID Numbers: IBA-2018-TIGER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The final anonymized trial data set will be available to the TIGER consortium. After completion of evaluation and dissemination by the TIGER-consortium, the goal is that an anonymized data set will be made available to interested Researchers upon reasonable request, being deposited in a repository of the University.

During finalization of the study a detailed data sharing plan will be developed and introduced into this trial registry.

• IPD Sharing Time Frame: The repository of the data set is under construction with the University.
• IPD Sharing Access Criteria: Anonymized data set will be available to interested Researchers upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No