Improvement of Transition From Hospital to Home for Older Patients in Germany (TIGER)
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| ClinicalTrials.gov Identifier: NCT03513159 |
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Recruitment Status :
Completed
First Posted : May 1, 2018
Last Update Posted : March 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Geriatric Patients in the Transition From Hospital to Home | Behavioral: Pathfinder support | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 252 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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. |
| Masking: | None (Open Label) |
| Masking Description: | The patients data will be anonymized and entered into an electronic Case Report form. The Outcomes Assessor will only see the anonymized data. |
| Primary Purpose: | Supportive Care |
| Official Title: | Transsectoral Intervention Program for Improvement of Geriatric Care in Regensburg |
| Actual Study Start Date : | April 25, 2018 |
| Actual Primary Completion Date : | June 30, 2020 |
| Actual Study Completion Date : | February 28, 2021 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Pathfinder support
A pathfinder will support the patient with structured activities. |
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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.
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- 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).
- Functionality and mobility - 1 [ Time Frame: up to 12 months ]Timed up and Go in seconds
- Functionality and mobility - 2 [ Time Frame: up to 12 months ]Instrumental activities of daily living (IADL) in scale
- Functionality and mobility - 3 [ Time Frame: up to 12 months ]handgrip strength in kilogramms
- Functionality and mobility - 4 [ Time Frame: up to 12 months ]pedometer activPAL3 micro
- Functionality and mobility - 5 [ Time Frame: up to 12 months ]Short physical performance battery (SPPB) in scale
- Nutritional status [ Time Frame: up to 12 months ]measured bei Mini Nutritional Assessment (MNA)
- Health-related quality of life [ Time Frame: up to 12 months ]Measured by Short-Form-Health Survey (SF-12) questionnaire in scale
- Depression [ Time Frame: up to 12 months ]Measured by Geriatric Depression Scale (GDS) in scale
- Cognitive Status - 1 [ Time Frame: up to 12 months ]Measured by Mini-Mental State Examination (MMSE) in scale
- Cognitive Status - 2 [ Time Frame: up to 12 months ]Trail Making Test A&B in seconds
- Burden of informal caregivers - 1 [ Time Frame: up to 12 months ]Measured by Zarith-questionnaires in scale
- Burden of informal caregivers - 2 [ Time Frame: up to 12 months ]Perceived Stress Questionnaire (PSQ)-questionnaires in scale
- Transfers into nursing homes [ Time Frame: Up to 12 months ]Comparison between intervention and control group. Data made available by cooperating partner Allgemeine Ortskrankenkasse (AOK) sickness fund in percent
- Care situation, care supply and quality of care at home [ Time Frame: up to 12 months ]Measured by Neues BegutAchtungsinstrument (NBA, Buscher, Wingenfeld & Schaeffer, 2011) as scale
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| Ages Eligible for Study: | 75 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513159
| Germany | |
| Hospital of the Order of St.John of God Regensburg | |
| Regensburg, Bavaria, Germany, 93049 | |
| Institute for Biomedicine of Aging, University of Erlangen-Nürnberg | |
| Nürnberg, Germany, 90408 | |
| Study Director: | Cornel Sieber, Prof. Dr. | Institute for Biomedicine of Aging |
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT03513159 |
| Other Study ID Numbers: |
IBA-2018-TIGER |
| First Posted: | May 1, 2018 Key Record Dates |
| Last Update Posted: | March 3, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Clinical Study Report (CSR) |
| Time Frame: | The repository of the data set is under construction with the University. |
| Access Criteria: | Anonymized data set will be available to interested Researchers upon reasonable request |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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transitional care, geriatric, readmission, discharge quality of life |