Comparing Dutch Case management care models for people with dementia and their caregivers: The design of the COMPAS study.|
|- candidate number||11039|
|- NTR Number||NTR3268|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jan-2012|
|- Secondary IDs||313080201 ZonMw|
|- Public Title||Comparing Dutch Case management care models for people with dementia and their caregivers: The design of the COMPAS study.|
|- Scientific Title||Comparing Dutch Case management care models for people with dementia and their caregivers: The design of the COMPAS study.|
|- ACRONYM||COMPAS study|
|- hypothesis||Our first hypothesis is that in the two exisiting case management models, the persons with dementia will have less behaviour and mood problems than persons receiving usual care and informal caregivers experience better mental health compared to usual care. Furthermore, we expect a delay in nursing home admission for persons with dementia versus usual care because care needs are better monitored and followed up by services that cooperate within a chain of care. Additionally, an exploratory hypothesis is whether the intensive care/joint agency model is associated with fewer behavioural problems and better follow up care compared to the linkage model, as the services that are part of one organisation may generate more efficiency.|
|- Healt Condition(s) or Problem(s) studied||Dementia|
|- Inclusion criteria||Inclusion criteria for the cohort study are: Community-dwelling individuals with a dementia diagnosis.
|- Exclusion criteria||People who are terminally-ill, for whom admission to a nursing home within 6 months is anticipated, or who do not have an informal caregiver who speaks fluent Dutch are excluded from the study.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2011|
|- planned closingdate||1-mrt-2014|
|- Target number of participants||525|
|- Interventions||Two different case management models compared to usual care. These models are already implemented in Dutch community care. |
|- Primary outcome||1. For informal caregiver: General Health Questionnaire-12;|
2. For persons with Dementia: Neuropsychiatric Inventory.
|- Secondary outcome||Secondary outcome variables for the patient include the following. First, Mortality and institutionalization data will be collected from the informal caregiver or general practitioner. Generic Quality of life will be measured by the SF-12 and the EQ-5D+c (EuroQol). Next to that, disease specific quality of life will be measured using the Qol-AD (Quality of life in Alzheimer’s Disease) and EuroQoL-5d+c all quality of life questionnaires will be completed/administered to the care receiver as well as the primary caregiver proxy. Number of met and unmet needs based on the Camberwell assessment of needs for the elderly (CANE) administered to the care receiver as well as the primary caregiver proxy. Number of crises defined by emergency department visits, unplanned hospitalization and unplanned institutionalization through the cost diary.|
Secondary outcomes variables for the informal caregiver include:
1. Sense of competence to care measured by the Short Sense of Competence Questionnaire (SSCQ)(Cronbach’s á= 0.76);
2. Empowerment measured by the Pearlin Mastery scale;
3. Quality of life measured by the Short Form 12, CarerQol and EuroQoL-5D;
4. Number of experienced crises defined by emergency department visits, unplanned hospitalization and unplanned institutionalization.
Quality of care outcome measures:
Quality of care at the micro level of the care receivers is measured by:
1. 12 indicators on treatment, education, support, and safety (translated and back-translated) from Vickrey asked to the informal caregiver, such as care plan developed, behavioural problems discussed, and non-pharmacological treatments;
2. 10 Indicators from the problems and needs questionnaire, developed by the Dutch Alzheimer Association in conjunction with the Netherlands Institute for Primary Care Research (NIVEL), asked to the informal caregivers.
Cost outcome measures:
Cost diaries are used to collect data on use of care and support and direct and indirect healthcare and non-healthcare costs for patients and caregivers to estimate costs from a societal perspective. Direct healthcare costs include formal care such as general practitioner visits and medication use. Direct non-healthcare costs consist of time spent to care by informal carers. Indirect health care costs include medical costs in life years gained. Indirect non-healthcare costs include days absent from paid work or unable to do daily activities such as housekeeping or voluntary work for caregivers.
Process outcome measures.
For the qualitative process evaluation, the semi-structured interviews with key figures regarding facilitators and barriers of implementation of case management will be based on the theoretical model of adaptive implementation [56, 57]. This model distinguishes different phases of implementation (preparation-, implementation- and continuation phase), and describes factors that can influence implementation at the micro- (care-provider, patient and informal carer), meso- (collaboration between care providers/ organizations) and macro-level (legal and financial framework) for each phase. The interviews are conducted with case managers, project leaders, care coordinators as well as insurers, client organisations and municipalities until a saturation point is reached.
An extensive description of the different case management approaches will be made through data collected by a questionnaire that is based on the Chronic Care model and the essential components of case management as described by Verkade et al.
|- Timepoints||Baseline, six, twelve, eighteen and 24 months.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Hein P.J. Hout, van|
|- CONTACT for SCIENTIFIC QUERIES|| Hein P.J. Hout, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:|
Dementia care in the Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalised care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in the Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered.
Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of the Netherlands with and without case management including a qualitative process evaluation. Inclusion criteria for the cohort study are: community-dwelling individuals with a dementia diagnosis who are not terminally-ill or anticipate admission to a nursing home within 6 months and with an informal caregiver who speaks fluent Dutch. Person with dementia-informal caregiver dyads are followed for two years. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Secondary outcomes include: quality of life and needs assessment in both persons with dementia and caregivers, activity of daily living, competence of care, and number of crises. Costs are measured from a societal perspective using cost diaries. Process indicators measure the quality of care from the participant’s perspective.
The qualitative study uses purposive sampling methods to ensure a wide variation of respondents. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned.
This study provides relevant insights into care processes, description of two case management models along with clinical and economic data from persons with dementia and caregivers to clarify important differences in two case management care models compared to usual care.
|- Main changes (audit trail)|
|- RECORD||27-jan-2012 - 11-feb-2012|
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