A different communication approach in outpatient physiotherapy
| ISRCTN | ISRCTN40708963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40708963 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 249344 |
| Protocol serial number | IRAS 249344 |
| Sponsor | NHS Fife |
| Funder | NHS Fife Research, Development and Innovation Department |
- Submission date
- 21/06/2021
- Registration date
- 21/06/2021
- Last edited
- 15/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Physiotherapy services that treat bone and muscle injuries (musculoskeletal services) have by definition traditionally focused on service users with physical ailments. The healthcare environment is, however, changing rapidly with an aging population, increasing numbers of service users with multiple diseases and increased awareness of the impact of mental health-related conditions. These changes have challenged outpatient physiotherapy services to deliver different and more effective types of care.
The Fife home visit physiotherapy service (ICASS) has been training physiotherapists on using different types of conversations with service users with long-term conditions. The approach called a ‘Personal Outcomes Approach' more readily establishes what matters to service users during their healthcare consultation. Despite the positive feedback from service users and staff, there remains scepticism from some, e.g. staff who focus on the service user’s injured body part, rather than on the person as a whole. Similarly, some managers feel healthcare staff do not need additional communication training as staff are already ‘experts’ in conversations with patients. Whilst the use of a 'Personal Outcomes Approach' appears successful, there is a lack of robust evidence to support its wider adoption.
This project aims to study how the adoption of the 'Personal Outcomes Approach' to healthcare conversations can enhance outcomes for service users and understand more fully how these types of service user-physiotherapist conversations work.
Who can participate?
Patients aged over 16 years referred to the Fife Adult Musculoskeletal Physiotherapy Service with a musculoskeletal-related condition
What does the study involve?
The study involves an analysis of the communication between service users and physiotherapists in their normal consultations to evaluate if adopting a personal outcomes communication approach provides additional benefits for service users and physiotherapists.
What are the possible benefits and risks of participating?
The benefits are that a 'different' communication approach may offer an enhanced experience and outcomes for patients and clinicians. The main ethical issue is that patients will provide voluntary informed consent to have their physiotherapy consultation audibly and digitally recorded. It is deemed that this would be less intrusive than video recording given that some patients may be in a state of partial undress during their consultation depending on their musculoskeletal condition. The recordings would be given a study code and uploaded after each patient consultation to secure NHS servers and be confidential. Verona coding requires the NHS Fife employed research team to access the live recording to code for cues, style and utterances. The recordings will also be accessed by onsite NHS Fife secretarial staff who have experience in typing and transcribing, thus no data will be leaving NHS Fife premises. At this point, the transcriptions will be anonymised to remove any patient-identifiable information.
Where is the study run from?
NHS Fife Victoria Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2019 to December 2024
Who is funding the study?
NHS Fife Research, Development and Innovation Service (UK)
Who is the main contact?
Dr Grant Syme
grant.syme1@nhs.scot
Contact information
Scientific
Department of Physiotherapy
Victoria Hospital
Hayfield Road
Kirkcaldy, Fife
KY2 5AH
United Kingdom
| Phone | +44 (0)1592 648106 |
|---|---|
| Grant.Syme1@nhs.scot |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Realist mixed methods qualitative and quantitative methodologies of current and emerging practice |
| Secondary study design | Realist study |
| Participant information sheet | ISRCTN40708963_PIS_V1.1.pdf |
| Scientific title | The use of a communications-based ‘personal outcomes approach’ in an outpatient musculoskeletal physiotherapy service: a realist evaluation |
| Study acronym | COPE |
| Study objectives | To evaluate the use of a communication 'Personal Outcomes Approach' in musculoskeletal physiotherapy consultations to advance understanding what works, for whom, to what extent and in what circumstances. |
| Ethics approval(s) | Approved 07/01/2020, East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 1048106; NRESCommittee.EastofEngland-CambsandHerts@nhs.net), REC ref: 19/EE/0356 |
| Health condition(s) or problem(s) studied | Musculoskeletal conditions |
| Intervention | The study will use a 'realist methodology' to explore the use of the Personal Outcomes Approach (POA) within the Fife adult musculoskeletal physiotherapy service. Realist studies explore the particular contexts (C) and the potential way it works (mechanisms) (M) that may combine to produce different patient experiences (outcomes) (O) for a patient's physiotherapy experience. The study involves analysis of the communication between service users and physiotherapists in their normal consultations to evaluate if adopting a personal outcomes communication approach provides additional benefits for service users and physiotherapists. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | Communication at the initial physiotherapy consultation evaluated using the Communication Verona Coding Framework at the first consultation |
| Key secondary outcome measure(s) | 1. Communication styles measured using 4 Habits Communication Coding Scheme at the first consultation and after the conclusion of the physiotherapy treatment episode 2. Care empathy measured using Care Measure at the first consultation and after the conclusion of the physiotherapy treatment episode 3. Quality of life measured using Patient Generated Index (PGI) at the first consultation and after the conclusion of the physiotherapy treatment episode 4. Self-efficacy measured using Two Item Short Form Self Efficacy at the first consultation and after the conclusion of the physiotherapy treatment episode 5. Stage of pain change measured using Pain Stages of Change Questionnaire at the first consultation and after the conclusion of the physiotherapy treatment episode |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key inclusion criteria | All adult patients (greater than 16 years) referred to the Fife Adult Musculoskeletal Physiotherapy Service with a musculoskeletal related condition(s) |
| Key exclusion criteria | 1. Patients under 16 years of age 2. Patients unwilling or unable to give informed consent to participate 3. Acute psychiatric conditions 4. Acute mental illness |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 30/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Hayfield Road
Kirkcaldy
KY2 5AH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this is a realist study based predominately on personal qualitative information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version V1.1 | 08/07/2021 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN40708963_PIS_V1.1.pdf
- Uploaded 08/07/2021
Editorial Notes
15/04/2024: The following changes were made:
1. The recruitment suspension was removed and the recruitment end date was changed from 01/03/2022 to 30/08/2024.
2. The overall study end date was changed from 01/03/2024 to 31/12/2024.
11/07/2022: The recruitment is currently suspended.
08/07/2021: The participant information sheet has been uploaded.
21/06/2021: Trial's existence confirmed by the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee.
