Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000500550
Ethics application status
Approved
Date submitted
23/11/2006
Date registered
5/12/2006
Date last updated
5/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interactive Educational Workshops and Follow-up Support: A Strategy to Facilitate Allied Health Clinicians' Routine Measurement of Clinical Outcomes
Scientific title
Interactive Educational Workshops and Follow-up Support: A Strategy to Facilitate Allied Health Clinicians' Routine Measurement of Clinical Outcomes
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allied health professionals 1476 0
Condition category
Condition code
Other 1572 1572 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group
1) One-day interactive educational workshop consisting of lectures, small group work and discussion sessions. Content covered included an introduction to outcome measures, setting SMART (Specific, Measurable, Activity based, Review, Time frame) goals, the outcome measurement process, strategies to successfully implement outcome measures, information on nine specific outcome measures relevant to people with cerebral palsy and autism and their carers, matching client limitations and outcome measures, and reporting outcome measure results and clinical decision making.
2) Resource folder containing notes from lectures and small group and discussion activities. A summary and critique of the 9 outcome measures presented including information on developers, access to the measure, cost, copyright, a description of the measure, administration, scoring and interpretation, suitable populations, languages the measure has been published in, International Classification of Functioning, Disability and Health (ICF) level/s targetted by the measure, psychometric properties and references.
3) 3 months of email and telephone follow-up support. All participants in the intervention group receceived 1 group email per week. The purpose of the email was to encourage clinicians to use outcome measures in their daily practise, provide additional information on outcome measures that may be of use to them. The researcher also responded to all individual emails and telephone calls received from participants in the intervention group.
Intervention code [1] 1461 0
Behaviour
Comparator / control treatment
Control group
1) One-day interactive workshop on evidence based practice and critical appraisal. This consisted of lecture content, small group work, and discussion.
2) Printed handouts of lecture notes and critical appraisal guidelines and forms were given to participants.
Control group
Active

Outcomes
Primary outcome [1] 2171 0
An audit of 10% of participants’ de-identified clinical files will be the primary outcome measure for this study. The audit of de-identified clinical files will be used to measure:
1) Change in the frequency of use outcome measures
Timepoint [1] 2171 0
Measured at baseline, then 3 months and 6 months post intervention.
Primary outcome [2] 2172 0
An audit of 10% of participants’ de-identified clinical files will be the primary outcome measure for this study. The audit of de-identified clinical files will be used to measure:
2) Change in the proportion of participants who measure outcomes
Timepoint [2] 2172 0
Measured at baseline, then 3 months and 6 months post intervention.
Primary outcome [3] 2173 0
An audit of 10% of participants’ de-identified clinical files will be the primary outcome measure for this study. The audit of de-identified clinical files will be used to measure:
3) Change in the range of outcome measures used by participants
Timepoint [3] 2173 0
Measured at baseline, then 3 months and 6 months post intervention.
Secondary outcome [1] 3783 0
1) Change in the frequency of use outcome measures
Timepoint [1] 3783 0
Outcomes will be measured at baseline, then 3 months and 6 months post intervention.
Secondary outcome [2] 3784 0
2) Change in the proportion of participants who measure outcomes
Timepoint [2] 3784 0
Outcomes will be measured at baseline, then 3 months and 6 months post intervention.
Secondary outcome [3] 3785 0
3) Change in the range of outcome measures used by participants
Timepoint [3] 3785 0
Outcomes will be measured at baseline, then 3 months and 6 months post intervention.
Secondary outcome [4] 3786 0
4) Change in participants’ knowledge and skills of outcome measurement
Timepoint [4] 3786 0
Outcomes will be measured at baseline, then 3 months and 6 months post intervention.
Secondary outcome [5] 3787 0
5) Participants’ readiness to change their current practice behaviours and measure outcomes will be measured using the Clinician Readiness to Measure Outcomes Scale (developed by the researcher).
Timepoint [5] 3787 0
Outcomes will be measured at baseline, then 3 months and 6 months post intervention.

Eligibility
Key inclusion criteria
1) Be employed by The Spastic Centre New South Wales; 2) Have professional qualifications (diploma, undergraduate degree or postgraduate degree) in the following allied health disciplines: Occupational therapy, physiotherapy, speech pathology, psychology, social work, social welfare or counselling;3) Be of working age
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allied health professionals employed by The Spastic Centre of New South Wales who do not treat clients will be excluded from participating in this study. The reason for this being that participants must be in a position where they actively treat clients in order to be able to measure client progress and effectiveness of interventions using outcome measures.

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)
Central randomisation with opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
External person not involved in the study generated the sequence using Excel software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
1) The educator presenting the one-day workshop (primary researcher - JB) for the intervention group became aware of group allocation on the day of the workshop. The educator required access to the participants' contact details (work email and telephone numbers) for the follow up support program. 2) The participants were aware of their allocation a week prior to the one-day workshop. 3) Audit data collectors (two research assistants) were unaware of group allocation. 4) Audit forms (primary outcome measure) will be returned to the primary researcher (JB) in a sealed archive box to be given to the data entry person (blind to allocation). 5) The surveys (secondary outcome measure) were returned to the primary researcher (JB) identifiable only via allocation number in a sealed reply paid envelope. 6) Surveys (in the sealed envelopes) were then given to a person for data entry who was not aware of group allocation. 7) The primary researcher (JB) will be the data analyst. Participants will be identified on the database by allocation number only.
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
108
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1714 0
University
Name [1] 1714 0
University of Western Sydney
Country [1] 1714 0
Australia
Primary sponsor type
Individual
Name
University of Western Sydney, Dr Catherine Cook, Dr Annie McCluskey & Dr Natasha Lannin
Address
Country
Australia
Secondary sponsor category [1] 1514 0
Charities/Societies/Foundations
Name [1] 1514 0
The Spastic Centre of New South Wales
Address [1] 1514 0
Country [1] 1514 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3172 0
University of Western Sydney
Ethics committee address [1] 3172 0
Ethics committee country [1] 3172 0
Australia
Date submitted for ethics approval [1] 3172 0
Approval date [1] 3172 0
21/10/2005
Ethics approval number [1] 3172 0
HREC 05/181
Ethics committee name [2] 3173 0
The Spastic Centre of New South Wales
Ethics committee address [2] 3173 0
Ethics committee country [2] 3173 0
Australia
Date submitted for ethics approval [2] 3173 0
Approval date [2] 3173 0
22/11/2005
Ethics approval number [2] 3173 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27395 0
Address 27395 0
Country 27395 0
Phone 27395 0
Fax 27395 0
Email 27395 0
Contact person for public queries
Name 10650 0
Julia Bowman
Address 10650 0
University of Western Sydney
Building 24
Campbelltown Campus
Locked Bag 1797
Penrith South DC NSW 1797
Country 10650 0
Australia
Phone 10650 0
+61 2 46203592
Fax 10650 0
+61 2 46203792
Email 10650 0
[email protected]
Contact person for scientific queries
Name 1578 0
Julia Bowman
Address 1578 0
University of Western Sydney
Building 24
Campbelltown Campus
Locked Bag 1797
Penrith South DC NSW 1797
Country 1578 0
Australia
Phone 1578 0
+61 2 46203592
Fax 1578 0
+61 2 46203792
Email 1578 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.