Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Cullum

ORCID ID

Contact details

University of Cambridge
Institute of Public Health
Forvie Site
Robinson Way
Cambridge
CB2 2SR
United Kingdom
+44 (0)1223 330322

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes