Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management
NCT ID: NCT03359408
Last Updated: 2022-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
401 participants
INTERVENTIONAL
2018-11-01
2022-01-31
Brief Summary
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The study design is a complex, longitudinal, multisite randomized controlled trial. It was designed to treat a hospital-based epidemiological cohort of people above the age of 70 with an adaption of DCM, a treatment proven to be effective in primary care, to the discharge setting. As part of this, specifically trained study staff will develop, implement and monitor a treatment and care plan, based on comprehensive assessments during the hospital stay, recommendations at discharge and unmet needs at home. For the 3 months after discharge study staff will coordinate treatment and care in close cooperation with the discharging hospital, treating physician and other care providers.
Expected results from the study should facilitate the implementation of intersectoral care management systematically on a large scale. Thus, the benefits shown in the trial would be available to a larger population. Results will not be limited to PCI, but rather to any people transitioning between the in-hospital and the primary care sector. Thus, the benefits would be available to elderly people in general.
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Detailed Description
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The trial is a complex, longitudinal, multisite randomized controlled trial (intervention vs. care as usual). Recruitment of the study population will be conducted in two participating hospitals. After meeting the eligibility criteria, participants will be asked for written informed consent. With all participants a basic baseline assessment will be conducted (T0) in the hospital. After that they will be randomized in either the intervention group or control group. The intervention group will then receive the intervention, the control group care as usual. Further data assessments will be conducted at all participants´ home 3 months after discharge (T1) and at the participants´ home 12 months after discharge (T2). A process evaluation will also be applied in this study. Data assessment will be conducted by specifically trained study staff. Places of assessment are chosen for the highest possible convenience for the participants. Data assessments will include a) primary data from the participants being assessed, computer-assisted, face-to face and paper-pencil, b) secondary data from patient records in the hospital and from treating physicians.
The main research question of this protocol addresses the effectiveness of Dementia Care Management (DCM) in the intersectoral setting for people with cognitive impairment (PCI) in treatment and care across the in-hospital and primary care sector. The investigators will test the hypothesis if PCI receiving DCM initiated in hospitals and continued after discharge into ambulatory care do have better health and social outcomes after one year than PCI not receiving DCM. The patient-oriented minor hypotheses of this protocol are: ICM improves (a) health related quality of life sustainable, (b) social functioning and integration and (c) adequate treatment and care for dementia and co-morbidities in the ambulatory setting. It reduces (d) the risk for drug related problems in cognitive impairment and comorbidities and (e) the risk for re-admission to the hospital. The intervention prevents (f) incident delirium - given better awareness in respect to precipitating factors. The healthcare provider-oriented minor hypotheses are: ICM (a) reduces re-admission rates and thus saves costs in the inpatient setting. It increases (b) the chances to delay institutionalization significantly and thus saves costs from perspective of statutory health insurance. It (c) improves communication and exchange between treatment and care provider from different health care sectors sustainable. Furthermore, this protocol evaluates the process of implementing ICM along the main research question: How is ICM evaluated and rated among the different groups affected by it? Specific research questions are: What are the perceived benefits for (a) the providers (in the inpatient setting, (b) providers in the ambulatory setting, (c) the PCI and their caregiver? Is ICM evaluated as (d) improving communication and exchange between treatment and care provider from different health care sectors sustainable? And last not least, (e) what are the enablers and barriers to implement ICM in routine care?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Care as usual
Care as usual, no intervention, just observation of natural change/ trajectories over time
No interventions assigned to this group
Dementia Care Management (DCM)
Subjects in this arm will be provided with "Dementia Care Management" adapted to the intersectoral setting.
Dementia Care Management (DCM)
A specialised discharge management, based on "Dementia Care Management" (DCM; Thyrian et al. 2017, Eichler, Thyrian, Fredrich et al. 2014, Eichler, Thyrian, Dreier et al. 2014, Dreier et al. 2016, ) will be applied to subjects with cognitive impairment. Specifically qualified will conduct comprehensive data assessments during the hospital stay, assess recommendations at discharge and assess unmet needs at home. Supported by a a computerized Intervention Management (IMS) and in close cooperation with the discharging hospital, treating physicians and other care providers, they will develop, implement and monitor a treatment and care plan. Interventional home visits will take place at the participants homes.
Interventions
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Dementia Care Management (DCM)
A specialised discharge management, based on "Dementia Care Management" (DCM; Thyrian et al. 2017, Eichler, Thyrian, Fredrich et al. 2014, Eichler, Thyrian, Dreier et al. 2014, Dreier et al. 2016, ) will be applied to subjects with cognitive impairment. Specifically qualified will conduct comprehensive data assessments during the hospital stay, assess recommendations at discharge and assess unmet needs at home. Supported by a a computerized Intervention Management (IMS) and in close cooperation with the discharging hospital, treating physicians and other care providers, they will develop, implement and monitor a treatment and care plan. Interventional home visits will take place at the participants homes.
Eligibility Criteria
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Inclusion Criteria
* minimum hospital stay of 5 days
* living at home
* positive cognitive screening (MMSE)
* written informed consent
Exclusion Criteria
70 Years
ALL
No
Sponsors
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University Medicine Greifswald
OTHER
Evangelisches Klinikum Bethel gGmbH
UNKNOWN
Jena University Hospital
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
German Center for Neurodegenerative Diseases (DZNE)
OTHER
Responsible Party
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René Thyrian
Working Group leader
Principal Investigators
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Jochen René Thyrian, PhD
Role: PRINCIPAL_INVESTIGATOR
German Center for Neurodegenerative Diseases (DZNE)
Locations
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University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany
Evangelisches Klinikum Bethel gGmbH
Bielefeld, North Rhine-Westphalia, Germany
Ruhr University Bochum (RUB)
Bochum, North-Rhine-Westfalia, Germany
German Center for Neurodegenerative Diseases (DZNE)
Greifswald, , Germany
Countries
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References
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Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
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Cockrell JR, Folstein MF. Mini-Mental State Examination (MMSE). Psychopharmacol Bull. 1988;24(4):689-92. No abstract available.
Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
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Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
Thyrian JR, Hertel J, Wucherer D, Eichler T, Michalowsky B, Dreier-Wolfgramm A, Zwingmann I, Kilimann I, Teipel S, Hoffmann W. Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):996-1004. doi: 10.1001/jamapsychiatry.2017.2124.
Thyrian JR. [People with dementia in primary care : Prevalence, incidence, risk factors and interventions]. Z Gerontol Geriatr. 2017 May;50(Suppl 2):32-38. doi: 10.1007/s00391-017-1223-5. Epub 2017 Apr 6. German.
Dreier A, Thyrian JR, Eichler T, Hoffmann W. Qualifications for nurses for the care of patients with dementia and support to their caregivers: A pilot evaluation of the dementia care management curriculum. Nurse Educ Today. 2016 Jan;36:310-7. doi: 10.1016/j.nedt.2015.07.024. Epub 2015 Jul 31.
Eichler T, Thyrian JR, Fredrich D, Kohler L, Wucherer D, Michalowsky B, Dreier A, Hoffmann W. The benefits of implementing a computerized intervention-management-system (IMS) on delivering integrated dementia care in the primary care setting. Int Psychogeriatr. 2014 Aug;26(8):1377-85. doi: 10.1017/S1041610214000830. Epub 2014 May 9.
Eichler T, Thyrian JR, Dreier A, Wucherer D, Kohler L, Fiss T, Bowing G, Michalowsky B, Hoffmann W. Dementia care management: going new ways in ambulant dementia care within a GP-based randomized controlled intervention trial. Int Psychogeriatr. 2014 Feb;26(2):247-56. doi: 10.1017/S1041610213001786. Epub 2013 Oct 23.
Thyrian JR, Fiss T, Dreier A, Bowing G, Angelow A, Lueke S, Teipel S, Flessa S, Grabe HJ, Freyberger HJ, Hoffmann W. Life- and person-centred help in Mecklenburg-Western Pomerania, Germany (DelpHi): study protocol for a randomised controlled trial. Trials. 2012 May 10;13:56. doi: 10.1186/1745-6215-13-56.
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Ettema TP, Droes RM, de Lange J, Mellenbergh GJ, Ribbe MW. QUALIDEM: development and evaluation of a dementia specific quality of life instrument. Scalability, reliability and internal structure. Int J Geriatr Psychiatry. 2007 Jun;22(6):549-56. doi: 10.1002/gps.1713.
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Boekholt M, Nikelski A, Schumacher-Schoenert F, Kracht F, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Supporting older people with cognitive impairment during and after hospital stays with intersectoral care management (intersec-CM)-results of a randomised clinical trial. Age Ageing. 2025 Feb 2;54(2):afaf011. doi: 10.1093/ageing/afaf011.
Kracht F, Boekholt M, Schumacher-Schonert F, Nikelski A, Chikhradze N, Lucker P, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Describing people with cognitive impairment and their complex treatment needs during routine care in the hospital - cross-sectional results of the intersec-CM study. BMC Geriatr. 2021 Jul 12;21(1):425. doi: 10.1186/s12877-021-02298-4.
Dehl T, Sauerbrey U, Dreier-Wolfgramm A, Nikelski A, Chikhradze N, Keller A, Laufer J, Schumacher-Schoenert F, Kreisel S, Thyrian JR, Hoffmann W, Vollmar HC. Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial. Trials. 2021 Jan 21;22(1):72. doi: 10.1186/s13063-021-05021-1.
Nikelski A, Keller A, Schumacher-Schonert F, Dehl T, Laufer J, Sauerbrey U, Wucherer D, Dreier-Wolfgramm A, Michalowsky B, Zwingmann I, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Supporting elderly people with cognitive impairment during and after hospital stays with intersectoral care management: study protocol for a randomized controlled trial. Trials. 2019 Aug 30;20(1):543. doi: 10.1186/s13063-019-3636-5.
Other Identifiers
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GR007
Identifier Type: -
Identifier Source: org_study_id
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