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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?
Scientific title
Health and economic impacts associated with prescribing by expanded scope physiotherapists for patients with musculoskeletal spinal pain: a randomized controlled trial
Secondary ID [1] 293581 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal spinal pain 305824 0
expanded prescribing 309315 0
non medical prescribing 309317 0
Condition category
Condition code
Musculoskeletal 305039 305039 0 0
Osteoarthritis
Musculoskeletal 305040 305040 0 0
Other muscular and skeletal disorders
Public Health 305041 305041 0 0
Health service research
Public Health 305042 305042 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299835 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 304203 0
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.
Timepoint [1] 304203 0
Healthcare resources used within 6 months of baseline (initial assessment).
Secondary outcome [1] 341236 0
Assessment of Quality of Life (AQoL-4D) questionnaire
Timepoint [1] 341236 0
Baseline (initial assessment), at clinical leader discharge from the Back Assessment Clinic/3 months and 6 months
Secondary outcome [2] 341237 0
Patient medication understanding and knowledge measured via a 11 point Global Rating of Change Scale (GROC)
Timepoint [2] 341237 0
3 and 6 months post-initial assessment
Secondary outcome [3] 341238 0
Patient completed diary in accessing healthcare services - time accessing care
Timepoint [3] 341238 0
Patients to record in diary from baseline (initial assessment) up until discharge from BAC or 6 months post-initial assessment
Secondary outcome [4] 341239 0
Patient satisfaction: a patient satisfaction and experience self-completed questionnaire that was designed for this study.
Timepoint [4] 341239 0
3 -6 months post-initial assessment
Secondary outcome [5] 341240 0
Modified Medication Appropriate Index (mMAI) to evaluate the safety and appropriateness of a prescribing physiotherapist determined by experienced prescribers (eg. Medical Officer; Pharmacist).
Timepoint [5] 341240 0
Between 3-6 months post-initial intervention
Secondary outcome [6] 341241 0
Work Productivity and Activity Impairment Questionnaire (WPAIQ)
Timepoint [6] 341241 0
Baseline (initial assessment), at clinical leader discharge from the Back Assessment Clinic/3 months and 6 months
Secondary outcome [7] 350464 0
Two Item Patient Self Efficacy Questionnaire (PSEQ-2) - 2 item questionnaire reflecting impact of pain on lifestyle
Timepoint [7] 350464 0
At baseline (initial assessment), clinical leader discharge from Back Assessment Clinic/3 months and 6 months
Secondary outcome [8] 350466 0
Oswestry Disability Index/Neck Disability Index – region specific questionnaires – the patient will only be requested to complete one region relevant to their symptoms
Timepoint [8] 350466 0
Baseline (initial assessment), discharge from Back Assessment Clinic/3 months and 6 months
Secondary outcome [9] 350467 0
Global Rating of Change scale (pain related) – 11 point scale to determine self reported change from treatment
Timepoint [9] 350467 0
At discharge from Back Assessment Clinic (as per routine practice)
Secondary outcome [10] 350468 0
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?
Timepoint [10] 350468 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [11] 350918 0
Patient completed diary in accessing health care services - out of pocket costs
Timepoint [11] 350918 0
Patients to record in diary from baseline (initial assessment) up until discharge from BAC or 6 months post-initial assessment
Secondary outcome [12] 351173 0
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?
Timepoint [12] 351173 0
2-4 weeks post-inital assessment (intervention group)
Secondary outcome [13] 351174 0
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)
Timepoint [13] 351174 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [14] 351175 0
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)?
Timepoint [14] 351175 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [15] 351176 0
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?
Timepoint [15] 351176 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [16] 351177 0
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)?
Timepoint [16] 351177 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [17] 351178 0
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?
Timepoint [17] 351178 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [18] 351179 0
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?
Timepoint [18] 351179 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [19] 351180 0
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?
Timepoint [19] 351180 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [20] 351181 0
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?
Timepoint [20] 351181 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [21] 351182 0
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?
Timepoint [21] 351182 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [22] 351183 0
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?
Timepoint [22] 351183 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [23] 351184 0
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?
Timepoint [23] 351184 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [24] 351185 0
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?
Timepoint [24] 351185 0
2-4 weeks post-initial assessment (intervention group)
Secondary outcome [25] 351186 0
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?
Timepoint [25] 351186 0
2-4 weeks post-initial assessment (intervention group)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary presenting complaint is non-musculoskeletal in origin;
pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
3/12/2018
Actual
Date of last data collection
Anticipated
3/06/2019
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9526 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 18276 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 298195 0
Government body
Name [1] 298195 0
Allied Health Professions Office of Queensland - Health Practitioner Research Scheme 2018
Country [1] 298195 0
Australia
Funding source category [2] 298202 0
Hospital
Name [2] 298202 0
Princess Alexandra Hospital
Country [2] 298202 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road, Woolloongabba Queensland 4102
Country
Australia
Secondary sponsor category [1] 297300 0
Individual
Name [1] 297300 0
Luen Pearce
Address [1] 297300 0
Back Assessment Clinic,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
Country [1] 297300 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299207 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 299207 0
Ethics committee country [1] 299207 0
Australia
Date submitted for ethics approval [1] 299207 0
18/01/2018
Approval date [1] 299207 0
11/05/2018
Ethics approval number [1] 299207 0
HREC/18/QPAH/101

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

Contacts
Principal investigator
Name 79654 0
Mrs Luen Pearce
Address 79654 0
Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
Country 79654 0
Australia
Phone 79654 0
+61 7 3176 9161
Fax 79654 0
+61 7 3176 9165
Email 79654 0
luen.pearce@health.qld.gov.au
Contact person for public queries
Name 79655 0
Luen Pearce
Address 79655 0
Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
Country 79655 0
Australia
Phone 79655 0
+61 7 3176 9161
Fax 79655 0
+61 7 3176 9165
Email 79655 0
luen.pearce@health.qld.gov.au
Contact person for scientific queries
Name 79656 0
Luen Pearce
Address 79656 0
Back Assessment Clinic,
Princess Alexandra Hospital,
Level 4, PACE Building
20 Cornwall Street
WOOLLOONGABBA QLD 4102
Country 79656 0
Australia
Phone 79656 0
+61 7 3176 9161
Fax 79656 0
+61 7 3176 9165
Email 79656 0
luen.pearce@health.qld.gov.au

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
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Documents added automatically
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