Safewards

ISRCTN	ISRCTN38001825
DOI	https://doi.org/10.1186/ISRCTN38001825
Protocol serial number	11269
Sponsor	King's College London (UK)
Funder	National Institute for Health Research [NIHR] ref: RP-PG-0707-10081

Submission date: 29/08/2012
Registration date: 29/08/2012
Last edited: 20/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Duncan Stewart
Scientific

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

Email	duncan.stewart@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised interventional process of care trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Safewards: a trial of an intervention to reduce conflict and containment in acute inpatient psychiatry
Study acronym	Safewards
Study objectives	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(s)	ref: 11/LO/0798
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Rates of conflict and containment measured at 6 months
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	300
Key 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 and female participants 5. Aged 18 - 65 years
Key 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)
Date of first enrolment	05/12/2011
Date of final enrolment	31/07/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College London

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Other publications	quality of intervention delivery	17/11/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/11/2017: Publication reference added.