Geriatric Patients in the Transition From Hospital to HomeTIGERNCT03513159
Improvement of Transition From Hospital to Home for Older Patients in Germany
A study testing Pathfinder support in people with Geriatric Patients in the Transition From Hospital to Home, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Patients in the Transition From Hospital to Home
- What is being tested?
- Pathfinder support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesGermany
- Study dates
- 25 Apr 2018to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- palliative status, planned readmission into hospital within next 4 weeks
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Institute for Biomedicine of Aging, University of Erlangen-Nürnberg
Nuremberg, 90408
Hospital of the Order of St.John of God Regensburg
Regensburg, Bavaria, 93049
About this study
Official title: 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.
Read the 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.
- Being tested
- Pathfinder support
- Keywords
- transitional care, geriatric, readmission,, discharge, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathfinder supportBehavioural
A pathfinder will support the patient with structured activities.
| Study group | Role | What they receive |
|---|---|---|
| Pathfinder support | Experimental | 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. Receives: Behavioral: Pathfinder support |
| Control without pathfinder support | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 12 months
Secondary outcomes (14)
Functionality and mobility - 1
Timed up and Go in seconds
Measured: up to 12 months
Functionality and mobility - 2
Instrumental activities of daily living (IADL) in scale
Measured: up to 12 months
Functionality and mobility - 3
handgrip strength in kilogramms
Measured: up to 12 months
Functionality and mobility - 4
pedometer activPAL3 micro
Measured: up to 12 months
Functionality and mobility - 5
Short physical performance battery (SPPB) in scale
Measured: up to 12 months
Nutritional status
measured bei Mini Nutritional Assessment (MNA)
Measured: up to 12 months
Health-related quality of life
Measured by Short-Form-Health Survey (SF-12) questionnaire in scale
Measured: up to 12 months
Depression
Measured by Geriatric Depression Scale (GDS) in scale
Measured: up to 12 months
Cognitive Status - 1
Measured by Mini-Mental State Examination (MMSE) in scale
Measured: up to 12 months
Cognitive Status - 2
Trail Making Test A\&B in seconds
Measured: up to 12 months
Burden of informal caregivers - 1
Measured by Zarith-questionnaires in scale
Measured: up to 12 months
Burden of informal caregivers - 2
Perceived Stress Questionnaire (PSQ)-questionnaires in scale
Measured: 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
Measured: 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
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start25 Apr 2018
- Primary completion30 Jun 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Geriatric Patients in the Transition From Hospital to HomeStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany, Regensburg Physicians Network RAEN, Friedrich-Alexander-Universität Erlangen-Nürnberg, AOK Bayern, Institute for Nursing Sciences, University of Bielefeld, Germany, Federal Association for Geriatrics, Germany, Federal Joint Committee, Institute for Community Medicine, University of Greifswald, Germany
- Responsible party
- Sponsor
- Investigators
- Cornel Sieber, Prof. Dr., Study director, Institute for Biomedicine of Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513159
- Sponsor's protocol ID
- IBA-2018-TIGER
- Acronym
- TIGER
- Status last verified
- Mar 2021
- First submitted
- 17 Apr 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34488636Rimmele 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.
PubMed 33558344
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg
- ClinicalTrials.gov ID
- NCT03513159
- Acronym / sponsor ID
- TIGER / IBA-2018-TIGER
- Keywords
- transitional care, geriatric, readmission,, discharge, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Hospital of the Order of St.John of God Regensburg, Barmherzige Brueder, Germany, Regensburg Physicians Network RAEN, Friedrich-Alexander-Universität Erlangen-Nürnberg, AOK Bayern, Institute for Nursing Sciences, University of Bielefeld, Germany, Federal Association for Geriatrics, Germany, Federal Joint Committee, Institute for Community Medicine, University of Greifswald, Germany
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pathfinder support | Experimental | Behavioral: Pathfinder supportPathfinder 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. |
| Control without pathfinder support | No intervention | –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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- palliative status, planned readmission into hospital within next 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathfinder supportA pathfinder will support the patient with structured activities. | Behavioural | Pathfinder support |
Primary outcome
Readmission Rate
Time frame: up to 12 months
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).
14 secondary outcomes
Functionality and mobility - 1
Time frame: up to 12 months
Functionality and mobility - 2
Time frame: up to 12 months
Functionality and mobility - 3
Time frame: up to 12 months
Functionality and mobility - 4
Time frame: up to 12 months
Functionality and mobility - 5
Time frame: up to 12 months
Nutritional status
Time frame: up to 12 months
Health-related quality of life
Time frame: up to 12 months
Depression
Time frame: up to 12 months
Cognitive Status - 1
Time frame: up to 12 months
Cognitive Status - 2
Time frame: up to 12 months
Burden of informal caregivers - 1
Time frame: up to 12 months
Burden of informal caregivers - 2
Time frame: up to 12 months
Transfers into nursing homes
Time frame: Up to 12 months
Care situation, care supply and quality of care at home
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 34488636Gehr 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.
- Derived from this study: PubMed 33558344Rimmele 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cornel Sieber, Prof. Dr. study director
Institute for Biomedicine of Aging
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pathfinder support in people with Geriatric Patients in the Transition From Hospital to Home, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission Rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513159, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.