Plain English Summary
Background and study aims
This is an initial study looking at the communication and decision-making that takes place in consultations between physiotherapists and people with back pain. Our goal is to provide some workshops for clinicians to help improve their communication skills and see whether this improves the outcome of treatment and experience of the service from the patientsÂ’ point of view.
Who can participate?
Physiotherapists working in Southern Health NHS Foundation Trust; and people with back pain (aged 18 years or over, able to communicate in English without assistance, with no signs or symptoms suggesting possible serious spinal pathology and no recent spinal surgery).
What does this study involve?
In this initial study, 60 people with back pain will be asked to complete a questionnaire booklet after they have attended their initial consultation. Twelve of these patients will also be asked their permission for a research assistant to watch and audio-record their consultation.
The twelve physiotherapists will be randomly be allocated to one of two groups. One group will attend a workshop about communication skills (the content of which has been developed from earlier work) and the other group will have a workshop about manual therapy skills. The physiotherapists will be asked to evaluate the workshops (via an interview) and two months later, discuss whether the workshops have changed their clinical practice (via focus groups). Both workshops will be delivered by the same facilitator and will be supported by a training manual.
After the workshops, a further 60 people with back pain will be asked to complete the questionnaire booklet as before and once again, twelve of these will be asked if their consultation can be watched and audio-recorded by the research assistant.
What are the possible benefits and risks of participating?
There will be no direct benefit to those taking part before the workshops. The physiotherapists will receive additional teaching and any benefit to people with back pain (after the physiotherapists have attended the workshops) will be measured. Information obtained from this initial study will be used to devise a larger study involving other centres.
By taking part in this study, there are no anticipated risks of physical injury or harm.
Where is the study run from?
This study has been set up by the University of Southampton in collaboration with Southern Health NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
April 2013 to 31st July 2013
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
Dr Lisa Roberts
L.C.Roberts@soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lisa Roberts
ORCID ID
Contact details
Building 45
Faculty of Health Sciences
University of Southampton
Highfield
Southampton
SO17 1BJ
United Kingdom
+44(0) 23 8059 5311
L.C.Roberts@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Feasibility randomised controlled trial: Exploring interaction in back pain consultations
Acronym
Study hypothesis
This feasibility study is testing the efficacy of a theory-based intervention (a communication skills training package for physiotherapists), supported by a training manual.
The key research questions are:
1. Can an educational intervention (a communication skills training package for physiotherapists) increase patients' perceived involvement in decision-making processes and improve: perceptions of empathy; enablement; communication; experience; functional outcome; and cost-effectiveness?
2. Can the educational intervention increase clinician beliefs and behaviours that they are likely to increase patient involvement in decision-making processes?
Ethics approval
Liverpool Central REC, 20/02/2013 Ref: 13/NW/0164
Study design
Randomised controlled feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Back pain
Intervention
Educational workshops (communication skills and manual therapy clinical skills).
Communication skills: 1-day workshop, supported by a training manual, focussing on 3 aspects of communication.
Manual therapy skills: 1-day workshop, supported by a training manual, focussing on specific aspects of delivering manual therapy treatments for people with back pain.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The Consultation And Relational Empathy (CARE) measure.
Primary and secondary measures are recorded at baseline (pre-workshops) and post-workshops (until a quota of 5 new patients have been assessed per participating physiotherapist). The semi-structured interviews to evaluate the workshops will take place within one week of the workshop and the focus group to discuss any impact on practice will be at 2 months.
Secondary outcome measures
1. Intensity of pain (numerical rating scale)
2. The Patient Enablement Instrument (PEI)
3. Brief Illness Perceptions Questionnaire
4. Patient Feedback questionnaire (Chartered Society of Physiotherapy)
5. 7-point enablement scales
6. Roland-Morris Disability Questionnaire
7. EQ5D-5L
8. Satisfaction with the consultation scale
Overall trial start date
22/04/2013
Overall trial end date
31/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Physiotherapists:
1. Registered with the Health and Care Professions Council
2. Band 6 grade working within the musculoskeletal outpatient service at Southern Health NHS Foundation Trust
3. Treating patients with back pain.
Patients:
1. Aged 18 or over, either sex
2. Referred to the outpatient physiotherapy service
3. Reporting back pain
4. With or without referred leg pain
5. Not having received any physical therapy (NHS or private) in the previous three months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 physiotherapists & 120 patients.
Participant exclusion criteria
Physiotherapists:
1. Not fulfilling the inclusion criteria or
2. If they have been involved in either of the first two studies in this research programme, from which the content of the educational workshop was derived.
Patients:
1. If they present with 'red flags' (signs / symptoms suggesting possible serious spinal pathology)
2. If they have received spinal surgery during this care episode
3. If they have another musculoskeletal disorder that is more troublesome than their back pain
4. If they have a serious psychiatric or psychological condition identified by the referring doctor; or
5. If they are unable to communicate in English without assistance
Recruitment start date
22/04/2013
Recruitment end date
31/07/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Building 45
Southampton
SO17 1BJ
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
C/O Dr Martina Prude
Research Governance Office
Legal Services B37
4009
Highfield
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Arthritis Research UK (UK) 17830
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list