Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Cullum HSR/0301
Study information
Scientific title
Acronym
Study hypothesis
Aims of the study:
1. To evaluate the effect of a 'liaison' model of care (screening, plus assessment and co-ordination of management of depressive disorder by a specialist psychiatric nurse) on the health outcomes of elderly medical inpatients.
2. To evaluate the cost-effectiveness of the intervention from the viewpoint of health and social services, and patients and their carers.
Hypotheses: Compared to standard care, after 16 weeks, the 'liaison' model of care will:
1. Increase the number of patients that recover from depression
2. Increase patients' quality of life
3. Increase patients' satisfaction with the service
4. Reduce carer burden
5. Increase the cost-effectiveness ratios for the health benefits (resolution of depression, change in depression rating and quality of life score per cost of resources used).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Depression, anxiety, neuroses
Intervention
1. A visit by a specialist nurse within the first week of admission (intervention arm)
2. Put on a waiting list to see a member of the research team at home (control arm)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Resolution of ICD10 depression and change in depression rating measured by the Montgomery-Asberg Depression Rating Scale (MADRS) at 16 weeks after the initial assessment compared between intervention and comparison groups, adjusted for severity of disability at baseline.
Secondary outcome measures
Change in quality of life score (EuroQOL), difference in patient satisfaction (adapted version of patients' satisfaction with stroke services questionnaire), change in carer burden (Caregiver Strain Index and GHQ-12) at 16 weeks after the initial assessment, compared between intervention and comparison groups. (References for standardised measures given in attached research proposal.) Cost-effectiveness ratios for the health benefits resolution of depression, change in depression and quality of life scores) compared to the resource costs in each arm of the study will be calculated. Resources consumed in secondary care (costs of index admission, subsequent inpatient stay and outpatient contact), primary care (GP consultations, contact with nursing staff including specialist psychiatric nurse), and number of hours care from social services will be calculated from routine data sources including hospital information systems, GP and medical records and social services information systems. The economic impact of the intervention upon patients and their carers will also be evaluated.
Overall trial start date
01/01/2002
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 65 years or over, admitted to general medical wards of a district general hospital (West Suffolk Hospital) with a stay over 5 days, over a period of 15 months (January 2002 to March 2003).
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
138 (added 18/12/09)
Participant exclusion criteria
1. Unable to give informed consent to enter the study due to moderate/severe dementia or other reasons
2. No spoken English
3. Dependent upon alcohol or other psychotropic drugs
4. Due to be transferred or discharged on the day of the initial assessment
5. Too physically ill or too confused to be interviewed
Recruitment start date
01/01/2002
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Cambridge
Cambridge
CB2 2SR
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Eastern (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17537739
Publication citations
-
Results
Cullum S, Tucker S, Todd C, Brayne C, Effectiveness of liaison psychiatric nursing in older medical inpatients with depression: a randomised controlled trial., Age Ageing, 2007, 36, 4, 436-442, doi: 10.1093/ageing/afm058.