Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000529943
Ethics application status
Approved
Date submitted
31/03/2011
Date registered
23/05/2011
Date last updated
8/06/2021
Date data sharing statement initially provided
20/11/2019
Date results information initially provided
20/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A multifaceted intervention to facilitate health professional's use of evidence based medicine: an evaluator-blinded randomised controlled trial.
Scientific title
Effectiveness of providing Evidence Based Medicine training with workplace supports for changing the clinical decision making skills of health professional’s who work with people with Cerebral Palsy: An evaluator blinded randomised controlled trial.
Secondary ID [1] 259893 0
Nil
Universal Trial Number (UTN)
U1111-1121-0924
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 265493 0
Condition category
Condition code
Neurological 265644 265644 0 0
Other neurological disorders
Public Health 265896 265896 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multifaceted intervention included a 3 day workshop, and workplace supports intranet resource summarising research evidence and mentoring. The 3-day workshop used the interface of the intranet resource and real clinical examples to educate participants about how to apply research findings to their day to day work. The first 2-days of the workshop were held on consecutive days, with day-3 of the workshop being 8-weeks later. This enabled participants to practice skills that they learned on day-1 and day-2, and to prepare a case study to present in small groups on day-3. The workshop part of the intervention was 8-weeks in duration. The intranet resource synthesized the latest Cerebral Palsy research and presented using a traffic light system corresponding to evidence levels. It also included clinical decision making tools, information about assessment and prognosis related to Cerebral Palsy. The intranet resource was available from the day of the first workshop, and access to it was available to any employee at the Cerebral Palsy Alliance at any time. Managers and clinical seniors provided mentoring to support the use and implementation of the intranet resource and information from the workshops. Managers and clinical seniors attended training and preparation for this via regular meetings for one-year prior to the workshops being conducted. This mentoring was offered to participants from the first day of the workshop. It is ongoing, mandatory and is provided via regular sessions with each health professional.
Intervention code [1] 264318 0
Other interventions
Comparator / control treatment
The control group attended a 3-day workshop about practitioner-patient communication and coaching skills (i.e. a non-EBM educational workshop). The mentoring provided was the same level and conditions provided for the experimental group, however the focus of the mentoring was communication and coaching. The control group were not informed about the intranet resource directly, however as it was available on the employer's intranet service, they did have access to it. For this reason, the intranet resource was not placed on the home page of the intranet. After the 8-week trial period, the intranet resource was moved to a highly accessible place to ensure ease of use.
Control group
Active

Outcomes
Primary outcome [1] 262436 0
Self and peer reported change in evidence-based medicine (EBM) implementation behaviour. A panel of experts familiar with the EBM skills of study participants developed a 25-question evaluation form using the Goal Attainment Scaling (GAS)(Kiresuk & Sherman, 1968). GAS is a psychometrically sound outcome measurement tool, designed to evaluate whether pre-established goals have been attained. Raw goal scores were converted to t-scores, enabling inferential statistical analysis of continuous data.
Timepoint [1] 262436 0
8 weeks after baseline
Secondary outcome [1] 273778 0
Self and peer reported EBM attitudes - measured by Evidence-Based Practice Attitude Scale (subsets 3 and 4) (Aarons 2004).
Timepoint [1] 273778 0
8 weeks after baseline
Secondary outcome [2] 276151 0
EBM knowledge - measured by open-ended questions with pre-defined answers.
Timepoint [2] 276151 0
8 weeks after baseline

Eligibility
Key inclusion criteria
1. Qualified allied health professional
2. Currently employed by the Cerebral Palsy Alliance
3. Role providing direct client services to people with Cerebral Palsy
4. Informed consent
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Health professional without university qualifications
2. Qualified health professional who is not regularly providing direct client services (eg. manager)

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)
All allied health professionals working for The Cerebral Palsy Alliance were invited to participate in the research study. Potential participants for the study received information packages via email. This information package outlined the study design and aims and detailed what participation in the study would involve. Potential participants were encouraged to email any questions that they may have had to the researchers. At the beginning of the first day of continuing education workshops both the experimental and control groups were given the opportunity to ask additional questions about the research study. Those who elected to enroll in the study signed a consent form and placed it in an opaque envelope. From this point, participants assigned themselves a codename and all evaluation forms were place in an opaque envelope and submitted to the investigator. The investigator who decided whether a participant was eligible was blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group randomisation according to geographically distinct worksites was conducted via a random number generator on MS Excel prior to enrollment of participants. Group randomisation and randomising prior to enrolling participants was necessary for pragmatic reasons. Group randomisation also reduced potential contamination if staff members at the same worksite were randomised to different groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/06/2009
Actual
19/06/2009
Date of last participant enrolment
Anticipated
Actual
26/06/2009
Date of last data collection
Anticipated
Actual
25/09/2009
Sample size
Target
130
Accrual to date
Final
135
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 264778 0
Self funded/Unfunded
Name [1] 264778 0
Lanie Campbell
Country [1] 264778 0
Australia
Primary sponsor type
Individual
Name
Lanie Campbell (PhD student)
Address
25 Oxford Street,
Rozelle NSW 2039
Country
Australia
Secondary sponsor category [1] 263895 0
None
Name [1] 263895 0
Address [1] 263895 0
Country [1] 263895 0
Other collaborator category [1] 251922 0
Charities/Societies/Foundations
Name [1] 251922 0
Cerebral Palsy Alliance
Address [1] 251922 0
PO Box 189,
Brookvale NSW 2100
Country [1] 251922 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266758 0
National Health and Medical Research Council Human Research Ethics Committee at The Spastic Centre
Ethics committee address [1] 266758 0
PO Box 189,
Brookvale NSW 2100
Ethics committee country [1] 266758 0
Australia
Date submitted for ethics approval [1] 266758 0
Approval date [1] 266758 0
06/05/2009
Ethics approval number [1] 266758 0
1/05/2009

Summary
Brief summary
The purpose of this study is to find out if an educational package was effective or not. The educational package was a multifaceted approach and included a 3-day workshop, a new intranet site and mentoring. The aim was to improve the way that health professionals apply the latest research in Cerebral Palsy in their day to day work, with the ultimate goal to improve the outcomes for people with Cerebral Palsy.
Trial website
Trial related presentations / publications
Campbell L, Novak I, McIntyre S, Lord S. A KT intervention including the evidence alert system to improve clinician’s evidence-based practice behavior—a cluster randomized controlled trial. Implementation Science. 2013;8(1):132. doi:10.1186/1748-5908-8-132
Public notes

Contacts
Principal investigator
Name 32419 0
Dr Lanie Campbell
Address 32419 0
25 Oxford Street, Rozelle NSW 2039
Country 32419 0
Australia
Phone 32419 0
+612 425201694
Fax 32419 0
Email 32419 0
lani@sowerbycampbell.com
Contact person for public queries
Name 15666 0
Dr Lanie Campbell
Address 15666 0
25 Oxford Street,
Rozelle NSW 2039
Country 15666 0
Australia
Phone 15666 0
+61 (02) 0425201694
Fax 15666 0
Email 15666 0
campbell.lanie@gmail.com
Contact person for scientific queries
Name 6594 0
Dr Lanie Campbell
Address 6594 0
25 Oxford Street,
Rozelle NSW 2039
Country 6594 0
Australia
Phone 6594 0
61 0425201694
Fax 6594 0
Email 6594 0
campbell.lanie@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Campbell L, Novak I, McIntyre S, Lord S. A KT inte... [More Details] 336741-(Uploaded-18-11-2019-13-59-29)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.