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Trial registered on ANZCTR
Registration number
ACTRN12618001443280
Ethics application status
Approved
Date submitted
16/08/2018
Date registered
28/08/2018
Date last updated
28/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Health and economic impacts associated with prescribing by expanded scope physiotherapists for patients with spinal pain?
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Scientific title
Health and economic impacts associated with prescribing by expanded scope physiotherapists for patients with musculoskeletal spinal pain: a randomized controlled trial
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Secondary ID [1]
293581
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
musculoskeletal spinal pain
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expanded prescribing
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non medical prescribing
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Condition category
Condition code
Musculoskeletal
305039
305039
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0
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Osteoarthritis
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Musculoskeletal
305040
305040
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0
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Other muscular and skeletal disorders
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Public Health
305041
305041
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0
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Health service research
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Public Health
305042
305042
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Expanded scope physiotherapist management of musculoskeletal spinal pain patients with a specific formulary of medicines, which may include prescribing, in an outpatient clinic.
There will be two groups, Control and Intervention. The intervention group is the prescribing group which will include standard physiotherapy screening clinic assessment by expanded scope musculoskeletal physiotherapist in addition to assessment and management of current pain medications including education and/or prescribing/deprescribing from approved formulary (paracetamol, ibuprofen, pregabalin, amitryptilline). The intervention will be delivered by expanded scope musculoskeletal physiotherapists with postgraduate training in pharmacology and quality use of medicines. The intervention will be delivered between 1-3 assessments by the prescribing physiotherapist over a 6 month period.
Participants will be recruited from the Princess Alexandra Hospital Spinal Surgical Services waiting list post-triage by Spinal Consultants to the Back Assessment Clinic (BAC), PACE Building, Princess Alexandra Hospital. There will be a post-initial assessment (2-4 weeks) follow up consult via telephone for the intervention group to monitor adherence, side-effects, medication effect and safety as per the questionnaire developed for this study.
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Intervention code [1]
299835
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Treatment: Drugs
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Comparator / control treatment
The study will not restrict access to any medications for the control or intervention group. The control group will not have any medications prescribed/deprescribed by the expanded scope BAC physiotherapists in this study,
Usual care for the control group will include assessment and management of musculoskeletal spinal pain outpatients by expanded scope physiotherapists in the BAC.
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Control group
Active
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Outcomes
Primary outcome [1]
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Healthcare resource use from the perspective of the health service will be collected using
(a) patient completed diaries and
(b) hospital clinical and administrative records.
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Assessment method [1]
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Timepoint [1]
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Healthcare resources used within 6 months of baseline (initial assessment).
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Secondary outcome [1]
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Assessment of Quality of Life (AQoL-4D) questionnaire
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Assessment method [1]
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Timepoint [1]
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Baseline (initial assessment), at clinical leader discharge from the Back Assessment Clinic/3 months and 6 months
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Secondary outcome [2]
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Patient medication understanding and knowledge measured via a 11 point Global Rating of Change Scale (GROC)
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Assessment method [2]
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Timepoint [2]
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3 and 6 months post-initial assessment
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Secondary outcome [3]
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Patient completed diary in accessing healthcare services - time accessing care
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Assessment method [3]
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Timepoint [3]
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Patients to record in diary from baseline (initial assessment) up until discharge from BAC or 6 months post-initial assessment
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Secondary outcome [4]
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Patient satisfaction: a patient satisfaction and experience self-completed questionnaire that was designed for this study.
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Assessment method [4]
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Timepoint [4]
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3 -6 months post-initial assessment
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Secondary outcome [5]
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Modified Medication Appropriate Index (mMAI) to evaluate the safety and appropriateness of a prescribing physiotherapist determined by experienced prescribers (eg. Medical Officer; Pharmacist).
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Assessment method [5]
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Timepoint [5]
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Between 3-6 months post-initial intervention
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Secondary outcome [6]
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Work Productivity and Activity Impairment Questionnaire (WPAIQ)
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Assessment method [6]
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Timepoint [6]
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Baseline (initial assessment), at clinical leader discharge from the Back Assessment Clinic/3 months and 6 months
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Secondary outcome [7]
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Two Item Patient Self Efficacy Questionnaire (PSEQ-2) - 2 item questionnaire reflecting impact of pain on lifestyle
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Assessment method [7]
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Timepoint [7]
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At baseline (initial assessment), clinical leader discharge from Back Assessment Clinic/3 months and 6 months
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Secondary outcome [8]
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Oswestry Disability Index/Neck Disability Index – region specific questionnaires – the patient will only be requested to complete one region relevant to their symptoms
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Assessment method [8]
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Timepoint [8]
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Baseline (initial assessment), discharge from Back Assessment Clinic/3 months and 6 months
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Secondary outcome [9]
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Global Rating of Change scale (pain related) – 11 point scale to determine self reported change from treatment
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Assessment method [9]
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Timepoint [9]
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At discharge from Back Assessment Clinic (as per routine practice)
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Secondary outcome [10]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor:
Has the Physiotherapist’s prescription been filled or recommended changes made?
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Assessment method [10]
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Timepoint [10]
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [11]
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Patient completed diary in accessing health care services - out of pocket costs
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Assessment method [11]
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Timepoint [11]
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Patients to record in diary from baseline (initial assessment) up until discharge from BAC or 6 months post-initial assessment
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Secondary outcome [12]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have you had any other medication changes since you saw the physiotherapist in BAC?
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Assessment method [12]
351173
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Timepoint [12]
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2-4 weeks post-inital assessment (intervention group)
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Secondary outcome [13]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have your signs and symptoms changed since you saw the Physiotherapist in BAC? (Better, worse, ISQ)
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Assessment method [13]
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Timepoint [13]
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [14]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Are you taking your medications as advised (adherence)?
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Assessment method [14]
351175
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Timepoint [14]
351175
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [15]
351176
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: .What dosage of your medications are you taking?
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Assessment method [15]
351176
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Timepoint [15]
351176
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [16]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: When are you taking your medicines (frequency)?
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Assessment method [16]
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Timepoint [16]
351177
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [17]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have you had any adverse reactions/side effects to your new medication recommended/prescribed by the physiotherapist?
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Assessment method [17]
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Timepoint [17]
351178
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [18]
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have you had any adverse reactions/side effects to your changed medication by the physiotherapist?
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Assessment method [18]
351179
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Timepoint [18]
351179
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [19]
351180
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Do you think you have better understanding of your medicine side effects since seeing the physiotherapist?
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Assessment method [19]
351180
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Timepoint [19]
351180
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [20]
351181
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Has your ability to do normal activities changed since seeing the physiotherapist?
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Assessment method [20]
351181
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Timepoint [20]
351181
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [21]
351182
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor:Do you have a better understanding of your pain medications since seeing the physiotherapist?
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Assessment method [21]
351182
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Timepoint [21]
351182
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [22]
351183
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have you seen the GP since you saw the physiotherapist at BAC?
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Assessment method [22]
351183
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Timepoint [22]
351183
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [23]
351184
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Have you booked a follow up appointment with the GP?
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Assessment method [23]
351184
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Timepoint [23]
351184
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [24]
351185
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Do you have a review appointment with the BAC Physiotherapist?
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Assessment method [24]
351185
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Timepoint [24]
351185
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2-4 weeks post-initial assessment (intervention group)
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Secondary outcome [25]
351186
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Telephone consultation - a telephone call to the patient (intervention group) will be completed by the research assistant to monitor: Are you satisfied with the physiotherapist at BAC prescribing medications?
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Assessment method [25]
351186
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Timepoint [25]
351186
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2-4 weeks post-initial assessment (intervention group)
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Eligibility
Key inclusion criteria
Patients identified through existing triage processes as a suitable patient for musculoskeletal physiotherapy assessment and management in the Back Assessment Clinic at the Princess Alexandra Hospital; aged >18 years; able to communicate in written and spoken English
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Primary presenting complaint is non-musculoskeletal in origin;
pregnant
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be concealed until the time of each participant's allocation using opaque sequentially numbered envelopes stored in a locked cabinet at a remote location. At the time of allocation a research assistant will contact an 'intervention coordinator' where the randomisation sequence is stored who will retrieve and open the next envelope to reveal group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation sequence (1:1 ratio, random permuted block sizes)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Intention-to-treat analyses will be conducted using generalised linear models to examine the potential effect of group allocation (including group by time interactions) with adjustment for baseline differences. Sensitivity analyses will also be conducted: for example, to examine whether the findings are robust against potential contribution of cases of very high resource use or analysis methodology decisions including adjusted vs unadjusted models.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/09/2018
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Actual
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Date of last participant enrolment
Anticipated
3/12/2018
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Actual
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Date of last data collection
Anticipated
3/06/2019
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Actual
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Sample size
Target
106
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
9526
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
18276
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
298195
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Government body
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Name [1]
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Allied Health Professions Office of Queensland - Health Practitioner Research Scheme 2018
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Address [1]
298195
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Level 1, 15 Butterfield, Street, HERSTON, QLD, 4006
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Country [1]
298195
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Australia
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Funding source category [2]
298202
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Hospital
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Name [2]
298202
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Princess Alexandra Hospital
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Address [2]
298202
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199 Ipswich Road, Woolloongabba Queensland 4102
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Country [2]
298202
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Australia
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Primary sponsor type
Hospital
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Name
Princess Alexandra Hospital
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Address
199 Ipswich Road, Woolloongabba Queensland 4102
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
297300
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Luen Pearce
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Address [1]
297300
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Back Assessment Clinic,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
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Country [1]
297300
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299207
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Metro South Health Human Research Ethics Committee
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Ethics committee address [1]
299207
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PAH Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
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Ethics committee country [1]
299207
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Australia
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Date submitted for ethics approval [1]
299207
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18/01/2018
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Approval date [1]
299207
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11/05/2018
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Ethics approval number [1]
299207
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HREC/18/QPAH/101
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Summary
Brief summary
There has been minimal research investigating outpatient clinic physiotherapist prescribing in Australia. The Queensland Health (Allied Health Professions' Office Queensland)/ Queensland University of Technology prescribing course was developed in response to the 2013 Federal, State and Territory Health Ministers endorsed non-medical health prescribing pathway (Health Workforce Australia, 2013). The aim of this study is to examine the potential influence of implementing prescribing by physiotherapists on patient’s healthcare resource usage (including medication use) as well as estimate broader benefits. This trial will also extend the field by describing the safety and appropriateness of extended scope prescribing by physiotherapists for patients with spinal pain. It is anticipated that this information will be valuable for guiding policy and resource allocation decision making regarding future expanded scope prescribing by allied health professions and provide an empirical foundation for further research and clinical service developments in the field.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Luen Pearce
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Address
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Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
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Country
79654
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Australia
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Phone
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+61 7 3176 9161
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Fax
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+61 7 3176 9165
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Email
79654
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[email protected]
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Contact person for public queries
Name
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Mrs Luen Pearce
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Address
79655
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Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
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Country
79655
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Australia
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Phone
79655
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+61 7 3176 9161
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Fax
79655
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+61 7 3176 9165
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Email
79655
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[email protected]
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Contact person for scientific queries
Name
79656
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Mrs Luen Pearce
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Address
79656
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Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
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Country
79656
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Australia
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Phone
79656
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+61 7 3176 9161
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Fax
79656
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+61 7 3176 9165
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Email
79656
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[email protected]
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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.
Download to PDF