Condition category
Mental and Behavioural Disorders
Date applied
03/09/2010
Date assigned
17/03/2011
Last edited
08/09/2014
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

Ms Anna Maratos

ORCID ID

Contact details

CNWL Trust Head of Arts Therapies
Community Mental Health Services
7a Woodfield Road
London
W9 2NW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot randomised controlled trial of enhanced support, openness and supervision for staff working on adult mental health wards

Acronym

SOS

Study hypothesis

Primary hypothesis:
One year after randomisation, staff working on mental health wards that receive interventions aimed at enhancing support, openness and supervision for staff will experience lower levels of burnout than those working on wards that do not.

Secondary hypothesis:
One year after randomisation, levels of staff turnover, staff sickness and use of agency staff will be lower on mental health wards that receive interventions aimed at enhancing support, openness and supervision for staff than on wards that do not.

Tertiary hypothesis:
One year after randomisation, the number of untoward incidents as recorded by incident report forms, will be lower on wards where staff receive enhanced support and supervision compared to wards that do not.

Ethics approval

West London Research Ethics Committee 2, 20/09/2010, ref:10/H0711/62

Study design

Pilot randomised controlled 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 contact m.crawford@imperial.ac.uk to request a patient information sheet

Condition

Mental health

Intervention

A modified cognitive analytic therapy approach to clinical supervision for ward staff in groups. Entitled 'Sharing, Openness and Supervision', this aims to change ward culture so that morale is improved with a positive effect on patient care.

The treatment arm will comprise one group per week of 1.5 hours clinical supervision for the ward team including staff members from all disciplines and from the ward leadership including at least one of ward manager, consultant and modern matron. Registered will be taken to record attendance and fidelity to this model. The clinical supervision groups will be run according to a Cognitive Analytic Therapy approach, adapted to this context.

Please note that there is only one treatment arm; the control arm is not active. The duration of the intervention will be one year and data on job satisfaction will be collected from ward staff at the beginning and end of the year. There will be no follow up after the end of the intervention, but routine ward data on incidents, recruitment and retention and sickness is routinely collected and may be analysed at a future point if appropriate.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Staff-level data:
We will approach all staff who make up the ward establishment, from a list supplied by the ward manager. For these staff we will complete data collection on baseline measures prior to randomisation, using:
1. Maslach Burnout Inventory: a 15-item measure to assess emotional exhaustion, depersonalisation and personal accomplishment
2. Job Content Questionnaire: a 34-item measure to assess job-related stress
3. Basic demographic data: including age, gender and number of hours worked. We will collect this using a proforma specifically designed for the study.

Secondary outcome measures

Ward-level data:
We will also collect the following data from the ward and Trust databases:
1. Untoward incidents:
1.1. Total number of untoward clinical incidents on the ward including medication errors and near-misses in the 6 months prior to randomisation (March - August 2010)
2. Level of severity of clinical untoward incidents rated according to the IR1 form 5-point severity rating scale in the 6 months prior to randomisation
2. Staff costs (6 months prior to randomisation):
2.1. Agency and locum usage
2.2. Turnover of staff
2.3. Sickness rates among ward staff
2.4. Suspensions, disciplinaries

Overall trial start date

01/11/2010

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Staff working on acute open mental health wards in the London Borough of Kensington and Chelsea. These wards are based at two inpatient units: St Charles Hospital and the South Kensington and Chelsea Centre for Mental Health.

Data will not be collected from patients at any point during the course of the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 participants across 6 wards

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/11/2010

Recruitment end date

31/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CNWL Trust Head of Arts Therapies
London
W9 2NW
United Kingdom

Sponsor information

Organisation

Central and North West London NHS Foundation Trust (UK)

Sponsor details

2nd Floor
Greater London House
Hampstead Road
Mornington Crescent
London
NW1 7QN
United Kingdom
feedback.cnwl@nhs.net

Sponsor type

Government

Website

http://www.cnwl.nhs.uk

Funders

Funder type

Government

Funder name

Central and North West London NHS Foundation Trust (UK) - Innovation Fund

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