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
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
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
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
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
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
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.