Clinical trial NCT00402311: The Effects and Cost-Effectiveness of an Integrated Multidisciplinary Approach for Psychogeriatric Patients
Official title: A Prospective Randomized Trial on the Effects of a Psychogeriatric Diagnostic Day Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium, Dementia, Amnestic, Cognitive Disorders
Memory Disorders
Keywords: Health Services for the Aged
Geriatric Psychiatry
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2006-11-22
Enrollment: 216
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the effects and cost-effectiveness of a Diagnostic Observation Center for PsychoGeriatric patients (DOC-PG). Our main hypothesis is that DOC-PG has added value compared with usual care regarding Health Related Quality of Life (HRQoL).

Detailed description: An integrated multidisciplinary approach to diagnosing and managing dementia is generally recommended, though rarely investigated. In recent years, multidisciplinary memory clinics (MCs) for patients with dementia have been established in many places over the world. These services have recently also been criticised for being principally hospital-based, for their apparently limited focus that entails only medical diagnostics and pharmacotherapy and for thus diverting resources from community mental health teams(CMHTs) .On the other hand, CMHTs are mainly concerned with the provision and organisation of integrated care, and unlike MCs, CMHTs generally have limited access to hospital-based diagnostics such as brain-imaging.

In April 2002, an outpatient diagnostic facility, the Diagnostic Observation Centre for PsychoGeriatric patients (DOC-PG) was established in Maastricht, the Netherlands. DOC-PG combines the hospital-based approach of the MC with the care-oriented approach of the regional CMHT and aims to provide the general practitioner (GP) with elaborate diagnostic and therapeutic advice for patients with cognitive disorders.

Comparison: DOC-PG is compared with usual care i.e. the GP took care of the diagnosis, or he or she referred the patient to one of the separate regional services, e.g. the Maastricht Memory Clinic (MMC), geriatric medicine, or the department of mental health for the elderly of the mental health community service (CMHT).

Eligibility criteria: Inclusion Criteria:

* Aged 55 years or over
* Suspected of having dementia or combined somatic/psychiatric disorder
* No referral to other local/regional services in the last two years
* Availability of a proxy (visiting the patient at least once a week)

Exclusion Criteria:

* Acute disorders that need a prompt therapeutic intervention
* Living in a nursing home or receiving care that is comparable to that of a nursing home

Primary outcomes:
measure: The Visual Analogue Scale of the EuroQol-5D
Secondary outcomes:
measure: Utility score of the EuroQol-5D
measure: Short Form 36 (SF-36)
measure: Mini Mental State Examination (MMSE)
measure: Global Deterioration Scale (GDS)
measure: NeuroPsychiatric Inventory (NPI)
measure: Instrumental Activities of Daily Living scale (IADL)
measure: Cornell Scale of Depression in Dementia (CSDD)
measure: Perceived Pressure from Informal Care (Dutch translation, EDIZ)
measure: Informal care questionnaire
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Frans R Verhey, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Carmen D. Dirksen, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Johan L Severens, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Alfons Kessels, MD, MSc
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center
name: Claire A Wolfs, MSc
role: STUDY_CHAIR
References:
citation: Wolfs CA, Dirksen CD, Severens JL, Verhey FR. The added value of a multidisciplinary approach in diagnosing dementia: a review. Int J Geriatr Psychiatry. 2006 Mar;21(3):223-32. doi: 10.1002/gps.1454.
citation: Wolfs CAG, Severens JL, Dirksen CD, Kessels A, Jaspers N, Verhey FRJ. 2005. A Randomized Clinical Trial on the Effects of a Diagnostic Observation Centre for PsychoGeriatric patients (DOC-PG). International Psychogeriatrics 17: 370-371
citation: Wolfs CA, Verhey FR, Kessels A, Winkens RA, Severens JL, Dirksen CD. GP concordance with advice for treatment following a multidisciplinary psychogeriatric assessment. Int J Geriatr Psychiatry. 2007 Mar;22(3):233-40. doi: 10.1002/gps.1666.
citation: Wolfs CA, Dirksen CD, Kessels A, Severens JL, Verhey FR. Economic evaluation of an integrated diagnostic approach for psychogeriatric patients: results of a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):313-23. doi: 10.1001/archgenpsychiatry.2008.544.