An interventional study of Dementia Care Management (DCM) in Dementia, Cognitive Impairment and Neurodegenerative Diseases, sponsored by German Center for Neurodegenerative Diseases (DZNE). Completed at 4 sites in Germany. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2022-09-07.
Sponsored by German Center for Neurodegenerative Diseases (DZNE) · Not applicable, Interventional, and Treatment
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.
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?
Exclusion Criteria:
Care as usual, no intervention, just observation of natural change/ trajectories over time
Subjects in this arm will be provided with "Dementia Care Management" adapted to the intersectoral setting.
Behavioral: 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.
Instrumental and Physical Functionality
The Bayer Activities of Daily Living Scale (B-ADL; Erzigkeit et al., 2001) will be used. It consists of 25 items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 "never", to 10 "always". All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment.
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Re-Admission to Hospital
Participant will be asked if he/she has been hospitalized within the last 12 months. This is one item in the "the Questionnaire for the Use of Medical and Non-Medical Services in Old Age"; FIMA; (Seidl et al., 2015) which is administered to assess utilisation of health services.
Time frame: Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).
Institutionalisation
Participant will be asked if he/she changed his/her living situation during the last 12 months. The answer will be validated with the question what the participants current living situation is. Both questions are items in the "the Questionnaire for the Use of Medical and Non-Medical Services in Old Age"; FIMA; (Seidl et al., 2015) which is administered to assess utilisation of health services.
Time frame: Assessed 12 months after the time of hospital discharge (T2).
Change in Quality of Life
Quality of life will be assessed using the EQ-5D, a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. As proxy rating the questionnaire QUALIDEM \[Ettema et al., 2007\] will be used to assess the quality of life of people with dementia aged ≥ 65 years.
Time frame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
Frailty
Frailty will be assessed using the Edmonton frailty scale (EFS; Rolfson et al. 2006) will be used. The EFS is reliable tool in geriatric medicine to assess the frailty of older patients on the domains Cognition, General health status, Functional independence, Social support, Medication use, Nutrition, Mood, Continence and Functional performance.
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Cognitive Status
The Mini Mental State Examination (MMSE; Cockrell \& Folstein, 1988) will be used. The MMSE is a 30-point questionnaire to measure cognitive impairment. The questions are grouped into seven categories, each representing a different cognitive domain or function: Orientation to time (5 points); Orientation to place (5 points); Registration of three words (3 points); Attention and Calculation (5 points); Recall of three words (3 points); Language (8 points) and Visual Construction (1 point). Scores of 25-30 out of 30 are considered normal; 21-24 as mild, 10-20 as moderate and \<10 as severe impairment.
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Resource Utilisation
The Resource Utilization in Dementia questionaire (RUD; Wimo et al., 2010) will be used to measure the frequency of utilisation of general physicians and physicians of other specialties, out-patient treatments, in-patient treatments, hospitalisations, institutionalisation and therapeutic appliances.
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Use of Medical and Non-Medical Services
The Questionnaire for the Use of Medical and Non-Medical Services in Old Age \[Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter"; FIMA; Seidl et al., 2015) will be used. The FIMA examines socio-economic variables and other medical factors by determining health-related costs.
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Behavioral and Psychological Symptoms of Dementia
Neuropsychiatric Inventory (NPI; Cummings 1997) will be used. The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores of each domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Depression
The short form of the Geriatric Depression Scale (GDS; Yesavage \& Sheikh,1986) will be used. It consists of 15 questions. One point is conferred for each positively answered question. Scores of 11 - 15 indicate the presence of depression, 5 - 10 a mild depression and 0 - 5 no depression.
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Caregiver Burden
The revised version of the Zarit-Burden Inventory (ZBI; Zarit et al., 1980) will be used.The revised version ZBI is a caregiver self-report measure to examine burden which is associated with functional/behavioural impairments and home care situation. It contains 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total scores range from 0 indicating low burden to 88 indicating high burden.
Time frame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
Plan to share: Undecided — At the current status of the study, this has not been discussed with the funder and the research partners (11/13/17).
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German Center for Neurodegenerative Diseases (DZNE)