Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
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 Rebecca Jacob

ORCID ID

Contact details

Department of Liaison Psychiatry
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216167
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544116543

Study information

Scientific title

Decision-making capacity in patients presenting to the Accident and Emergency Services

Acronym

Study hypothesis

To investigate the decision-making capacity in patients presenting to the Accident and Emergency Services, with deliberate self-harm, alcohol intoxication and physical illness.

Hypotheses: Incapacity of patients to consent to treatment will be associated with mental disorders, increased blood alcohol levels and serious physical illness.

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

Treatment

Patient information sheet

Condition

Injury, Occupational Diseases, Poisoning: Self harm

Intervention

The Accident and Emergency Services are an area of medical practice where rapid health care decisions have to be made, often in the context of life threatening illness. Patients may present who are unconscious and are therefore unable to consent to these decisions. Alternatively patients who have the capacity to make an informed choice, may refuse the proposed treatment. The decision-making capacity of patients may be impaired by temporary factors including serious physical or mental illness, substance misuse or permanent conditions such as learning disabilities.

We propose to assess decision-making capacity of patients presenting to the Accident and Emergency Services, with specific emphasis on the categories of deliberate self-harm and alcohol abuse. These categories of patients commonly present to the Accident and Emergency Services and on occasion lack capacity to consent or refuse treatment.

The Law Commission defines incapacity, as 'the inability to understand relevant information, retain this information, or make a decision based on the information given'.

Using this as a framework, patients will be tested for their ability to consent to a health care intervention. In addition to tests of capacity, patients will be breathalysed to assess the relationship between the degree of alcohol intoxication and lack of capacity. For patients presenting with deliberate self-harm, routine rating scales will be used to assess presence and severity of psychopathology. A random, consecutive sample of patients presenting to Casualty will also be included to serve as a control group and comparisons of decision-making capacity will be made between the three study groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/08/2002

Overall trial end date

15/08/2005

Reason abandoned

Eligibility

Participant inclusion criteria

40 subjects 18 years or over.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/08/2002

Recruitment end date

15/08/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Cambridge Consortium - Addenbrooke's

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

Publication citations

Additional files

Editorial Notes