Condition category
Mental and Behavioural Disorders
Date applied
29/08/2012
Date assigned
29/08/2012
Last edited
17/07/2015
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 Duncan Stewart

ORCID ID

Contact details

King's College London
Health Services and Population Research Department
David Goldberg Centre
Institute of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom
-
duncan.stewart@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11269

Study information

Scientific title

Safewards: a trial of an intervention to reduce conflict and containment in acute inpatient psychiatry

Acronym

Safewards

Study hypothesis

When people are very mentally ill and on an acute psychiatric ward, they can sometimes behave in disturbed and unpredictable ways, doing things that they would not usually do. Some of those behaviours are unsafe or even seriously risky, either to patients or those around them, for example being angry and aggressive to others, or trying to harm themselves. We call all these things together conflict. In attempting to cope with or prevent such events, staff may use containment methods, such as restraint, or extra medication.

Our research team has been investigating the ways staff can act so as to produce an environment which will reduce the frequency of these events, and make wards safer places. We have two ideas about how to do this.

The first is about generating physical wellbeing amongst the staff. A healthy and energetic staff group will be more able to devote time and effort to good patient care. Promoting physical health amongst the staff will enable them to do more effectively what they already know how to do: look after the patients to the best of their ability. Good quality care from the staff will reduce conflict with patients and the need for containment. The second idea is to establish structure, change the words and language staff use, improve mutual regard and build alliances between patients and staff. This trial is about testing these interventions, to see which one works best.

Ethics approval

ref: 11/LO/0798

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe Mental illness

Intervention

Organisational. Optimising structure, thinking carefully about the words and language nurses use, and enhancing mutual regard between staff and patients. Staff wellbeing. Promoting physical health will enable staff to look after patients to the best of their ability.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rates of conflict and containment measured at 6 months

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/12/2011

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Acute psychiatric wards defined as those that primarily serve acutely mentally disordered adults, taking admissions mainly directly from the community.
2. Specifically to include admission wards, assessment wards, triage wards, treatment wards, pre-discharge wards, extra or intensive care; in so far as these wards provide whole or part of the acute care pathway for those temporarily admitted directly from the community.
3. Wards to be included regardless of the gender of patients to which they provide a service, whether male, female or mixed, and regardless of the ward's door locking policy
4. Male & female participants
5. Aged 18 - 65 Years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Wards with other specialist functions (e.g. forensic, long term care, older people, child and adolescent)
2. Wards with major planned changes during the trial (e.g. reconfiguration of catchment areas or patient populations, refurbishment, managerial restructuring)
3. Wards where two or more of the following apply:
3.1. An acting ward manager, no ward manager in post, or cover from ward manager primarily responsible for another ward; unless the local organisational structure is that of one ward manager having responsibility for two wards.
3.2. A locum consultant psychiatrist, where that post is the identified sole consultant responsible for inpatient care.
3.3. Nursing vacancy rates above 30% (9.5% of acute wards in 2005)

Recruitment start date

05/12/2011

Recruitment end date

31/07/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College London
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research [NIHR] ref: RP-PG-0707-10081

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26166187

Publication citations

Additional files

Editorial Notes