Evaluation of the introduction of a new regional back pain process of care in the North East of England

ISRCTN	ISRCTN65093728
DOI	https://doi.org/10.1186/ISRCTN65093728
Secondary identifying numbers	N/A

Submission date: 29/03/2016
Registration date: 06/04/2016
Last edited: 18/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Low back pain is a major cause of disability and is one of the most costly conditions in the UK. Patient knowledge of the condition is poor which causes unrealistic expectations and demands on the NHS. These demands are met by a variation in back pain management which often results in expensive investigations and unsuccessful care leading to poor results and patients being unsatisfied. A new process (pathway) of managing back pain is being introduced in the north east of England. The main reason for this new pathway is to introduce a structured way of managing low back pain to reduce the current variation in the way low back pain patients are dealt with.

Who can participate?
Patients presenting with back pain in the north east of England.

What does the study involve?
Each participant is first assessed by their GP (or other first contact) using a back pain questionnaire. This determines whether they are sent to see a specialist Triage and Treat Practitioner (TTP) who then manage their treatment. The TTP decides on the next step of the treatment pathway the patient should attend. This may involve, for example, being referred to therapies such as exercises or acupuncture, attending an Intensive Combined Physical and Psychological Programme (a programme that includes intensive exercise, education and help with long-term self-management of the patients back pain), pain management services and possible surgical options. Data is collected through the use of a variety of clinically validated questionnaires and interviews with both patients and staff.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The pathway will be introduced in four Clinical Commissioning Group regional areas, South Tees, Darlington, Hartlepool and Stockton on Tees, and Newcastle/Gateshead.

When is the study starting and how long is it expected to run for?
March 2016 to January 2018

Who is funding the study?
The Health Foundation (UK)

Who is the main contact?
Mr Shaun Wellburn
s.wellburn@tees.ac.uk

Contact information

Mr Shaun Wellburn
Public

Teesside University
Middlesbrough
TS1 3BA
United Kingdom

Phone	01642 738254
Email	s.wellburn@tees.ac.uk

Mr Shaun Wellburn
Scientific

Teesside University
Middlesbrough
TS1 3BA
United Kingdom

Phone	01642 738254
Email	s.wellburn@tees.ac.uk

Study information

Study design	Mixed methods multi-centre interventional evaluation
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Implementation of the North East regional back pain pathway: an evaluation protocol
Study objectives	The key evaluation question is; following the implementation of an integrated pathway of care for people with low back pain and acute radiculopathy, what changes are seen in patient outcomes and experiences, and in the performance of the health service? This overarching question can be broken down into six evaluation objectives: 1. To measure and explain changes in the following clinical and social outcomes for patients: 1.1. Pain 1.2. Function 1.3. Employment status 1.4. Quality of life 1.5. Overall improvement 2. To measure and explain changes in the following health service performance indicators: 2.1. Frequency and nature of patient contacts with health professionals 2.2. Frequency and nature of medical investigations (e.g. X-Rays, MRI) 2.3. Waiting times 2.4. Referral patterns 3. To examine the cost effectiveness of the pathway. 4. To gain an understanding of patient experiences and perceptions of the implementation. 5. To gain an understanding of clinicians’ and strategic leaders’ experiences and perceptions of the implementation 6. To assess the sustainability and the scalability of the back pain pathway
Ethics approval(s)	Teesside University Ethics Committee, 18/09/2015, ref. 115/15 and R179/15
Health condition(s) or problem(s) studied	Back pain
Intervention	A new clinical pathway of care which operationalises NICE guidelines. Key aspects of the pathway are the use of the STarT Back tool to guide pathway route, and case management of patients through Triage and Treat practitioners (specialist allied health professionals and nurses). Individuals attending the GP practice or first contact provider (e.g. physiotherapist) will complete a STarT Back questionnaire. The score of the STarT Back will determine whether the patient is discharged, with advice, to self-management or follows the new back pain pathway. Once referred into the pathway the patient will attend with the Triage and Treat Practitioner (TTP). Triage and Manage Practitioner will then refer, as appropriate, to one of the following options: 1. Core therapies (manual therapy, exercises, acupuncture) 2. Intensive Combined Physical and Psychological Programme (CPPP) 3. Pain services 4. Specialist spinal surgical opinion
Intervention type	Mixed
Primary outcome measure	1. Health status, assessed with the EuroQol (EQ5D) questionnaire, at base 2. Pain, assessed using a Pain Numerical Rating Scale 3. Disability caused by back pain, assessed using the Oswestry Disability Index A qualitative analysis will also be conducted utilising Normalisation Process Theory. Data is collected at baseline, and then again after 5 months and 12 months.
Secondary outcome measures	1. Anxiety, assessed using the General Anxiety Disorder Assessment (GAD7) 2. Patients impression of change in condition, assesed using the Global Subjective Outcome Scale (GSOS) 3. Quality of service, assessed using the Friends and Family Test (FFT) 4. Depression, assessed using The Patient Health Questionnaire (PHQ9) 5. Self-management 6. Work status 7. Work loss 8. Health-care usage 9. Cost-effectiveness analysis Data is collected at baseline, and then again after 5 months and 12 months.
Overall study start date	30/03/2016
Completion date	31/01/2018

Eligibility

Participant type(s)	Mixed
Age group	All
Sex	Both
Target number of participants	For the qualitative aspect approximately 60 participants. For the quantitative component it is difficult to project the total throughput of patients during the time frame of the evaluation. However, it is anticipated that this will be greater than 1000 participants.
Total final enrolment	136
Key inclusion criteria	1. Patients: Individuals who have presented with low back pain in the North East of England 2. Non-patients: Individuals who are involved in the implementation and delivery of the Regional Back Pain Pathway
Key exclusion criteria	There are no specific exclusion criteria
Date of first enrolment	30/03/2016
Date of final enrolment	01/06/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Hartlepool and Stockton on Tees Clinical Commissioning Group

Billingham Health Centre
Queensway
Billingham
TS23 2LA
United Kingdom

Darlington Clinical Commissioning Group

Dr Piper House
King Street
Darlington
DL3 6JL
United Kingdom

Newcastle Gateshead Clinical Commissioning Group

Goldcrest Way
Newburn Riverside (Business Park)
Newcastle Upon Tyne
NE15 8NY
United Kingdom

South Tees Clinical Commissioning Group

14 Trinity Mews
Middlesbrough
TS3 6AL
United Kingdom

Sponsor information

Teesside University
University/education

Borough Road
Middlesbrough
TS1 3BA
England
United Kingdom

Phone	01642 738254
Email	s.wellburn@tees.ac.uk
Website	www.tees.ac.uk
"ROR"	https://ror.org/03z28gk75

Funders

Funder type

Charity

The Health Foundation

No information available

Results and Publications

Intention to publish date	31/07/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	1. To publish one paper on the quantitative findings within six months of completion of the evaluation. 2. To publish two papers on the qualitative findings within six months of completion of the evaluation.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2021	18/11/2021	Yes	No

Editorial Notes

18/11/2021: Publication reference and total final enrolment added.
07/04/2016: Internal review