Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000726954
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
12/07/2011
Date last updated
14/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The implementation and evaluation of Clinical Supervision in mental health settings
Scientific title
A pragmatic randomised controlled trial of clinical supervision: an attempt to establish the evidence base for causal relationships with quality of care and patient outcomes, in mental health settings
Secondary ID [1] 262608 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well being of mental health nurses 268301 0
Quality of care in mental health settings 268306 0
Patient reported outcomes 268307 0
Condition category
Condition code
Mental Health 268433 268433 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 268435 268435 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clinical Supervision [CS] is the provision of time-out and an opportunity within the context of an ongoing professional relationship with an experienced practitioner to engage in guided reflection on current practice, in ways designed to develop and enhance the practice in the future. In practical terms, CS has come to mean small groups of Supervisees (n=~6) or dyads (1:1) attending a pre-arranged meeting with an appropriately trained Clinical Supervisor, for 45-60 minutes per session, at a monthly frequency, for facilitated reflective discussion, in confidence, around matters of professional relevance and importance. In this trial, the outcomes of CS were measured one year after it was introduced into the working arrangements of mental health nurses across Queensland.
Intervention code [1] 266948 0
Other interventions
Comparator / control treatment
No Clinical Supervision was implemented in the Control Arm [usual working practices]
Control group
Active

Outcomes
Primary outcome [1] 269182 0
Reduction in psychological distress in Supervisees, as measured by the General Health Questionnaire 28 item version [GHQ28], the Maslach Burnout Inventory [MBI], the Revised Nurse Work Index Scale [NWI-R], General health [SF-8], the Mental Health Problems Perceptions Questionnaire [MHPPQ] and The Manchester Clinical Supervision Scale [MCSS]
Timepoint [1] 269182 0
One year after randomisation
Primary outcome [2] 269190 0
Improvement in quality of care for patients, as measured by Perception of Unit Quality [PUQ], Service Attachment Questionnaire [SAQ] and the Psychiatric Care Satisfaction Questionnaire [PCSQ]
Timepoint [2] 269190 0
One year after randomisation
Secondary outcome [1] 279082 0
Efficacy of Clinical Supervision [Intervention Arm only], as measured by The Manchester Clinical Supervision Scale [MCSS]
Timepoint [1] 279082 0
One year after randomisation

Eligibility
Key inclusion criteria
Staff inclusion criteria included mental health nurses who had been employed at greater than 0.5 FTE and held contracts for more than a year from the inception of the study. Patient inclusion criteria included those individuals who had been inpatients for more than two weeks, or more than three months on the caseload of a community mental health nurse
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients were excluded if they declined to participate and/or were floridly psychotic and/or had forensic histories

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this trial, a method to generate the sequence in which subjects were randomised was not appropriate. The randomisation process took place at the level of Mental Health Unit, not at the level of subjects. Postcode analysis of the database derived from a previous and separate State-wide Clinical Supervision Staff Survey showed no systematic patterns of CS activity in Queensland, which allowed identification of green-field locations for an RCT. Accordingly, formal invitations were distributed to all Heads of Mental Health Services and other key professional/administrative staff across Queensland for expressions of interest. The Joint Chief Investigators followed-up with personal site visits and detailed correspondence to all who had indicated a preparedness to participate. Eight sites were found to be unsuitable because CS activities were reportedly already in place. Subsequently, Area Nursing Directors and/or Nurse Unit Managers in 17 adult mental health facilities in nine geographical locations across Queensland provided written consent for the study to be conducted. The allocation of facilities to either an Intervention or a Control Arm of the RCT was random, insofar as the Research Team was blind to the characteristics of the facilities that comprised the pool that met the entry criteria [viz; bereft of existing CS arrangements and a willingness to participate in the trial]. The randomisation process by which final choices were made also took cognizance of the relative size of the mental health nursing workforces and of the Accessibility/Remoteness Index of Australia [ARIA]. An appropriate balance was sought to ensure that urban and regional areas were represented in the trial. The eventual design, therefore, was weighted in favour of the intervention arm for pragmatic reasons. All Control groups contributed to the outcome data collection, only.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This was a pragmatic randomised controlled trial*, in which there was randomisation of Mental Health Units [containing clusters of Mental Health Nurses and patients]
*Oxman A, Lombard C, Treweek S, Gagnier J, Maclure M and Zwarenstein M (2009) Why we will remain pragmatists: four problems with the impractical mechanistic framework and a better solution. Journal of Clinical Epidemiology, 62, 485-488
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4233 0
4114
Recruitment postcode(s) [2] 4234 0
4217
Recruitment postcode(s) [3] 4235 0
4305
Recruitment postcode(s) [4] 4236 0
4350
Recruitment postcode(s) [5] 4237 0
4560
Recruitment postcode(s) [6] 4238 0
4570
Recruitment postcode(s) [7] 4239 0
4581
Recruitment postcode(s) [8] 4240 0
4740
Recruitment postcode(s) [9] 4241 0
4870

Funding & Sponsors
Funding source category [1] 267419 0
Charities/Societies/Foundations
Name [1] 267419 0
Golden Casket Foundation
Country [1] 267419 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Golden Casket Foundation
Address
Office of Liquor and Gaming Regulation,
Department of Justice and Attorney-General, Level 6, 33 Charlotte Street, Brisbane Queensland 4000
Country
Australia
Secondary sponsor category [1] 266471 0
None
Name [1] 266471 0
Address [1] 266471 0
Country [1] 266471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269385 0
Cairns Base Hospital Ethics Committee
Ethics committee address [1] 269385 0
PO Box 902, Cairns, Queensland 4870
Ethics committee country [1] 269385 0
Australia
Date submitted for ethics approval [1] 269385 0
Approval date [1] 269385 0
21/06/2007
Ethics approval number [1] 269385 0
EC00157
Ethics committee name [2] 269386 0
Gold Coast Health Service District Human Research Ethics Committee
Ethics committee address [2] 269386 0
108 Nerang Street, Southport, Queensland 4215
Ethics committee country [2] 269386 0
Australia
Date submitted for ethics approval [2] 269386 0
Approval date [2] 269386 0
04/04/2007
Ethics approval number [2] 269386 0
EC00160
Ethics committee name [3] 269387 0
Mackay Health Service District Human Research Ethics Committee
Ethics committee address [3] 269387 0
District Medical Superintendent, Mackay Health Service District, Mackay, Queensland 4740
Ethics committee country [3] 269387 0
Australia
Date submitted for ethics approval [3] 269387 0
Approval date [3] 269387 0
19/06/2007
Ethics approval number [3] 269387 0
EC00407
Ethics committee name [4] 269388 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [4] 269388 0
Level 2, Building 35, PA Hospital, Ipswich Road, Woolloongabba, Queensland 4102
Ethics committee country [4] 269388 0
Australia
Date submitted for ethics approval [4] 269388 0
Approval date [4] 269388 0
31/05/2007
Ethics approval number [4] 269388 0
EC00167
Ethics committee name [5] 269389 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [5] 269389 0
Level 7, Block 7, RBWH, Butterfield St, Herston Queensland 4029
Ethics committee country [5] 269389 0
Australia
Date submitted for ethics approval [5] 269389 0
Approval date [5] 269389 0
14/06/2007
Ethics approval number [5] 269389 0
EC00172
Ethics committee name [6] 269390 0
Toowoomba Health Service District Human Research and Ethics Committee
Ethics committee address [6] 269390 0
PO Box 405, Toowoomba Queensland 4350, Australia
Ethics committee country [6] 269390 0
Australia
Date submitted for ethics approval [6] 269390 0
Approval date [6] 269390 0
29/05/2007
Ethics approval number [6] 269390 0
EC00182
Ethics committee name [7] 269391 0
University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [7] 269391 0
Locked Bag 4, Maroochydore DC, Queensland 4558
Ethics committee country [7] 269391 0
Australia
Date submitted for ethics approval [7] 269391 0
Approval date [7] 269391 0
05/06/2007
Ethics approval number [7] 269391 0
EC00297
Ethics committee name [8] 269392 0
West Moreton Health Service District Human Research Ethics Committee
Ethics committee address [8] 269392 0
The Park Centre for Mental Health, Cnr Ellerton Dve and Wolston Park Road, Wacol, Queensland 4076, Australia
Ethics committee country [8] 269392 0
Australia
Date submitted for ethics approval [8] 269392 0
Approval date [8] 269392 0
24/04/2007
Ethics approval number [8] 269392 0
EC00184

Summary
Brief summary
Clinical supervision [CS], a structured staff support arrangement, has shown promise as a positive contribution to the clinical governance agenda and is now found reflected in health policy themes elsewhere in the world. However, CS is underdeveloped in Australia and the empirical evidence base for the informed implementation of CS, per se, has remained elusive. This large and generously funded pragmatic randomised controlled trial tested the relationships between Clinical Supervision, quality of care and patient outcomes, in mental health settings in Queensland, Australia. Twenty four mental health nurses attended a training course to equip them to provide Clinical Supervision to groups of colleagues in their respective work places across the State. A suite of outcome measures, each with established psychometric properties [including The Manchester Clinical Supervision Scale] measured differences within and between participants in the Intervention and the Control Arms of the trial, over a one year period. Findings confirmed that beneficial and sustainable CS outcomes accrued for Supervisors and Supervisees, and for patients in one private sector mental health facility. However, the effect Clinical Supervision had on nominated outcomes remained difficult to demonstrate across a broad front. Plausible explanations were offered for this and a new framework for future outcomes-related research studies was suggested, in the continuing attempt to strengthen an empirical evidence base for Clinical Supervision.
Trial website
None
Trial related presentations / publications
Publications arising from the current study only:

White E and Winstanley J [2009] Quality of care and patient outcomes: a randomised controlled trial of Clinical Supervision in Queensland, Australia. Final Report. Queensland Treasury/Golden Casket Foundation, Brisbane, Australia [ISBN 978-0-9807398-1-7] Available from Osman Consulting Pty Ltd, Sydney; osmanconsulting@ozemail,com.au]

White E and Winstanley J [2009] Clinical Supervision for nurses working in mental health settings in Queensland, Australia: a randomised controlled trial in progress and emerging challenges. Journal of Research in Nursing, 14:3, pp 263–276 [ISSN 0744 9871]

White E and Winstanley J [2009] Implementation of Clinical Supervision: educational preparation and subsequent diary accounts of the practicalities involved, from an Australian perspective Journal of Psychiatric and Mental Health Nursing, 16, pp 895–903 [ISSN 1351-0126]

White E and Winstanley J [2010] A randomised controlled trial of Clinical Supervision: selected findings from a novel Australian attempt to establish the evidence base for causal relationships with quality of care and patient outcomes, as an informed contribution to mental health nursing practice development. Journal of Research in Nursing, 15:2, pp 151-167 [ISSN 0744 9871]

White E [2010] Clinical Supervision: findings from an Australian research study. Connections, 13:1, pp 37-38. Royal College of Nursing Australia. Canberra

White E [2010] Clinical Supervision: findings from an Australian research study. Online e-news. April. Australian College of Mental Health Nurses. Canberra

White E and Winstanley J [2010] Does clinical supervision lead to better patient outcomes in mental health nursing? NursingTimes,106:16, pp 16-18 [ISSN: 09547762]

White E and Winstanley J [2010] Clinical Supervision: outsider reports of a research-driven implementation program in Queensland, Australia. Journal of Nursing Management, 18, pp689–696 [ISSN 09660429]

White E [2010] Clinical Supervision: findings from an Australian research study. nursing.aust Autumn, 11:1, p19. The College of Nursing. Sydney

White E [2010] Clinical Supervision: latest evidence for clinical practice development and evaluation. Research Briefing Note. Emailed by RCNA directly to all Director of Nursing members [n=320] July. Royal College of Nursing Australia, Canberra

White E [2010] Clinical Supervision: latest evidence for clinical practice development and research. Research Brief. Mental Health Directors of Nursing's Bulletin. Department of Health, London [http://www.mentalhealthforum.org.uk/publications.htm]. Leading Minds, Mental Health and Learning Disability Nurses Directors’ and Leads’ Forum. December [ISSN 1754 0836]

White E [2011] Challenges which may arise when conducting real-life nursing research: an insight into practical issues. Nurse Researcher: the International Journal of Research Methodology in Nursing and Health care. RCN Publishing Company, London [Accepted for publication; ISSN 1351-5578]

White E and Winstanley J [2011] Clinical Supervision for mental health professionals: the evidence base. Social Work and Social Sciences Review. Commissioned for Special Edition; ‘Current Trends in Mental Health Services’ [Accepted for publication; ISSN: 0953-5225]

Winstanley J and White E [2011] The MCSS-26©: revision of The Manchester Clinical Supervision Scale© using the Rasch Measurement Model. Journal of Nursing Measurement [Submitted; Under Review; ISSN 10613749]


Presentations arising from the current study only:

2007 Clinical Supervision: new empirical insights. Royal College of Nursing Australia Annual Conference. Sydney. July

2007 Research: How is it predicting and shaping the future of Clinical Supervision? North Sydney and Central Coast Biannual Clinical Supervision Symposium. Sydney, August

2007 ‘Clinical Supervision represents another cynical managerial device to shift responsibility for risk to individuals’ Facilitator, Hypothetical Debate. North Sydney and Central Coast Biannual Clinical Supervision Symposium. Sydney, August

2007 Quality of care and patient outcomes: a randomised controlled trial of Clinical Supervision in mental health settings in Queensland. 34th ACMHN Annual International Conference. Cairns, Queensland. October

2007 Quality of nursing care and patient outcomes: a randomised controlled trial of a program of nursing supervision in mental health settings in Queensland. University of the Sunshine Coast Annual Research Conference, Queensland. November

2008 Clinical Supervision: new research insights from an Australian perspective. The Royal College of Nursing of the United Kingdom Annual International Nursing Research Conference, Liverpool, England. April

2008 Clinical Supervision: new research insights and implications for Queensland. Mental Health Nurses, Consumers and Carers. 2nd Annual Symposium, Australian College of Mental Health Nurses Inc [Keynote Address], Gold Coast, Queensland. May

2008 Clinical Supervision: the contribution to mental health staff wellbeing. Managing the psychologically injured worker: research, knowledge and practice. 9th International Mental Health Conference [Keynote Address]. Surfers Paradise, Queensland. August

2008 Clinical Supervision in mental health nursing. ABC National Radio. Interview with Charmaine Kane, 19 August

2008 Clinical Supervision: a contribution to health care quality and safety. The 2008 National Forum on Safety and Quality in Health Care, Adelaide Convention Centre, Adelaide, South Australia. October

2008 Clinical Supervision: review of contemporary evidence and immediate challenges. Centre for Education and Workforce Development, Sydney South West Area Health Service, Croydon, New South Wales. November

2009 Clinical supervision: findings from an Australian randomised controlled trial. The Royal College of Nursing of the United Kingdom 50th Annual International Nursing Research Conference, Cardiff, Wales, United Kingdom. March

2009 Clinical Supervision Research. Clinical Supervision Supervisor Training [MHN] Discussion Forum. Queensland Health, Brisbane, Queensland. May

2009 Research into the efficacy of clinical supervision for nurses: an Australian study. Psycho-Social Intervention Symposium. Northern Sydney Central Coast Area Health Service. Macquarie Hospital. New South Wales. August

2009 Measuring Clinical Supervision: an Australian randomized controlled trial. 15th International Network for Psychiatric Nursing Research Conference, St Catherines College, University of Oxford, England. September

2009 A randomised controlled trial of clinical supervision in Queensland mental health services The Australasian Society for Psychiatric Research conference. Australian National University, Canberra. Australian Capital Territory. December

2010 Quality of care and patient outcomes: a randomised trial of Clinical Supervision in mental health settings in Queensland, Australia. 18th European Congress of Psychiatry, European Psychiatric Association. Munich, Germany. March

2010 A randomised trial of Clinical Supervision in mental health nursing settings in Queensland, Australia. Royal College of Nursing UK-wide Mental Health Nursing Conference, Liverpool, England. March

2010 Clinical Supervision: towards an evidence base of clinical practice development for mental health nurses. Invited Keynote. 11th Victorian Psychiatric Nursing Conference, Melbourne. August

2010 Dilemmas and challenges: practical issues which arise when conducting large scale, real-life, mental health nursing research. 16th International Network for Psychiatric Nursing Research Conference, Wadham College, University of Oxford. England. September

2011 Clinical Supervision: towards an evidence base of clinical practice development for mental health nurses. Invited Lead. Clinical Supervision Evaluation Seminar, University of Nottingham/ Rampton High Security Hospital, England. March

2011 The empirical basis of claims for Clinical Supervision outcomes: an Australian pragmatic randomized controlled trial. Royal College of Nursing Australia International Annual Conference [Workforce realities: agenda for action]. Sydney. May
Public notes

Contacts
Principal investigator
Name 32862 0
Address 32862 0
Country 32862 0
Phone 32862 0
Fax 32862 0
Email 32862 0
Contact person for public queries
Name 16109 0
Dr Edward White
Address 16109 0
Osman Consulting Pty Ltd
2/35 Bay Road, Waverton, Sydney
New South Wales 2060
Country 16109 0
Australia
Phone 16109 0
+61 2 9956 6618
Fax 16109 0
Email 16109 0
osmanconsulting@ozemail.com.au
Contact person for scientific queries
Name 7037 0
Dr Edward White
Address 7037 0
Osman Consulting Pty Ltd
2/35 Bay Road, Waverton, Sydney
New South Wales 2060
Country 7037 0
Australia
Phone 7037 0
+61 2 9956 6618
Fax 7037 0
Email 7037 0
osmanconsulting@ozemail.com.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



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