Clinical trial NCT03359408: Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management
Official title: Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management [Verbundprojekt Intersec-CM - sektorenübergreifendes Care Management Zur Unterstützung Kognitiv beeinträchtigter Menschen während Und Nach Einem Krankenhausaufenthalt]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Cognitive Impairment
Neurodegenerative Diseases
Keywords: Health care
Dementia care
Collaborative care
Discharge management
Hospital
Primary care
Lead sponsor: German Center for Neurodegenerative Diseases (DZNE)
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: Evangelisches Klinikum Bethel gGmbH
name: Jena University Hospital
name: German Federal Ministry of Education and Research
First posted: 2017-12-02
Enrollment: 401
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sectorisation of the German health care system causes inefficient treatment, especially in elderly with cognitive impairments. At time of transition from hospitals into primary care it lacks, among others, coordination of post-operative care or timely communication between healthcare providers. This results in deterioration of disease and comorbidities, higher rates of re-admission and institutionalizations. Models of collaborative care have shown their efficacy in primary care. Main goal is to test the effectiveness of Dementia Care Management (DCM) for people with cognitive impairment to improve treatment and care across the in-hospital and primary care sector.

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.

Detailed description: The German health care system is sectorized with health service providers offering a) outpatient treatment and care, b) inpatient treatment and care or c) rehabilitation. While treatment and care within these sectors can be considered to be of high quality, there is a lack of widely available approaches to deliver treatment and care across sectors. Treatment paths for people with chronic diseases or the requirements of elderly people suffering from multimorbidity need frequent transitions between sectors. However, in Germany boundaries of sectors are considered rigid and transitions between sectors are a threat to treatment continuity, which results in inefficient treatment. As this problem has been identified and described by the Advisory Council on the Assessment of Developments in the Health Care System (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen) already in 20121, different approaches have been proposed. This study addresses the lack of integrated cross-sectoral approaches to overcome the challenges caused by the sectorized German health care system.There is sound scientific evidence internationally and nationally that collaborative concepts of care can improve treatment and care of people with dementia in primary care (Thyrian et al. 2017). Those concepts are person-centered in the sense of a) taking into account the individual needs, circumstances and priorities, and b) aiming at outcomes relevant to the individuals life, like everyday functionality, (health related) quality of life and social inclusion.

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?

Eligibility criteria: Inclusion Criteria:

* 70+ years
* minimum hospital stay of 5 days
* living at home
* positive cognitive screening (MMSE)
* written informed consent

Exclusion Criteria:

* stroke

Primary outcomes:
measure: Instrumental and Physical Functionality
timeFrame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Re-Admission to Hospital
timeFrame: Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).
measure: Institutionalisation
timeFrame: Assessed 12 months after the time of hospital discharge (T2).
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
measure: Frailty
timeFrame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Cognitive Status
timeFrame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Resource Utilisation
timeFrame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Use of Medical and Non-Medical Services
timeFrame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Behavioral and Psychological Symptoms of Dementia
timeFrame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Depression
timeFrame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
measure: Caregiver Burden
timeFrame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
state: Mecklenburg-Vorpommern
city: Bielefeld
country: Germany
facility: Evangelisches Klinikum Bethel gGmbH
state: Nordrhein-Westfalen
city: Bochum
country: Germany
facility: Ruhr University Bochum (RUB)
state: North-Rhine-Westfalia
city: Greifswald
country: Germany
facility: German Center for Neurodegenerative Diseases (DZNE)
Study officials:
affiliation: German Center for Neurodegenerative Diseases (DZNE)
name: Jochen René Thyrian, PhD
role: PRINCIPAL_INVESTIGATOR
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