What is the feasibility of testing a vertebral fracture screening tool in a real-world primary care setting?
| ISRCTN | ISRCTN18000119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18000119 |
| ClinicalTrials.gov (NCT) | Nil known |
| Integrated Research Application System (IRAS) | 313632 |
| Protocol serial number | IRAS 313632, NIHR203026 |
| Sponsor | University of Bristol |
| Funder | Research for Patient Benefit Programme |
- Submission date
- 23/02/2022
- Registration date
- 01/03/2022
- Last edited
- 22/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Osteoporosis (weak bones) is one of the most common musculoskeletal conditions in older women. Osteoporotic vertebral fractures (broken bones in the back due to osteoporosis) are particularly important because they identify people at high risk of breaking more bones. However, less than a third of people with vertebral fractures are correctly diagnosed and treated. The main reason for this failure is difficulty understanding who should have spinal x-rays.
The Vfrac tool is a simple questionnaire developed carefully by research involving women with and without osteoporotic vertebral fractures. Vfrac is for healthcare professionals in GP practices to complete for women aged over 65 years with back pain. The output of Vfrac indicates whether or not they should have a spinal x-ray.
Vfrac has never been tested in a real-world situation to find out if it works and is likely to be cost-effective for the NHS. This real-world testing will be a large study involving many GP practices and will look at whether Vfrac improves the treatment of older people with osteoporosis. Before they can design this study, the researchers need information to plan:
1. The size and process of the study, based on information including numbers of women who attend their GP with back pain and the average time it takes for X-ray results to get back to the GP
2. IT requirements, based on what different IT systems GP practices use
3. How Vfrac is used, based on which healthcare professionals see older people with back pain in primary care
4. Whether the tool needs to be changed based on understanding patient and healthcare professionals’ views and experiences of using Vfrac
Who can participate?
Women aged over 65 years at the participating general practices
What does the study involve?
The researchers will:
1. Use a database that collects patient data from GP practices across the UK to calculate the size and design of the large study.
2. Ask six GP practices to be involved in this study, and get half of them to use Vfrac for 12 months. This will help the researchers understand the IT requirements. They will ask patients and healthcare professionals about their views of Vfrac and identify factors that make it easier or more difficult to use.
3. Do a nationwide survey of GP practices to describe which type of healthcare professionals see older people with back pain.
What are the possible benefits and risks of participating?
The main risk relates to the COVID-19 pandemic. Before any face-to-face interview about patients' views and experiences of using Vfrac, a risk assessment will be done to minimse the risk of exposure to COVID-19 by both the patient and researcher. There be no direct benefits of taking part in this study.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
March 2022 to January 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Emma Clark, emma.clark@bristol.ac.uk
Contact information
Public, Scientific, Principal investigator
Musculoskeletal Research Unit, Level 1, L&R Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
 ORCID ID |
0000-0001-8332-9052 |
|---|---|
| Phone | +44 (0)1174147841 |
| emma.clark@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot interventional non-randomized study with nested qualitative evaluation |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Vertebral fracture clinical decision tool for older women with back pain (Vfrac) - a feasibility study |
| Study acronym | Vfrac feasibility |
| Study objectives | Researchers have developed the Vfrac clinical tool using the MRC framework for development and evaluation of complex interventions. The intention of Vfrac is to help healthcare practitioners in primary care decide if an older woman with back pain is at high risk of an osteoporotic vertebral fracture and therefore requires a spinal radiograph to confirm the diagnosis. Vfrac produces a binary output of "Low risk - spinal X-ray is not recommended" or “High risk - spinal X-ray is recommended as may have a vertebral fracture". Statistical modelling suggests it is valid (AUC of 0.802, 95%CI 0.764-0.840), and pre-trial health economic modelling suggests a future trial to reduce uncertainties is justified. Before they plan the future trial the researchers need more information to ensure the trial is adequately powered, that Vfrac is acceptable to patients and healthcare professionals, and that the length of follow-up is appropriate. They also need to understand what usual care is for older people with back pain, as this will be the comparator in any future trial. This feasibility study aims to 1. Optimise the use of the Vfrac decision tool within a real-world clinical situation in primary care by (a) assessing the acceptability of Vfrac, and (b) identifying factors that impact on its implementation, including barriers and facilitators to delivery. Findings will be used to develop a series of recommendations to modify Vfrac and improve delivery in the future randomised controlled trial (RCT). 2. Quantify required trial parameters including (a) final design of the intervention and (b) length of time needed for trial follow up by assessment of UK-wide variability in length of time between initial consultation for back pain and eventual management implementation. 3. Identify processes required to collect accurate and comprehensive data on resource use as a result of Vfrac utilisation through a pilot study. 4. Contribute to the final decision as to whether a future definitive evaluation of Vfrac is warranted. 5. Describe 'usual care' through analysis of control general practices in the pilot study, and through a national survey |
| Ethics approval(s) | Approved 28/06/2022, Yorkshire & The Humber- Bradford Leeds Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)2071048083; bradfordleeds.rec@hra.nhs.uk), ref: 22/YH/0135 |
| Health condition(s) or problem(s) studied | Osteoporotic vertebral fractures |
| Intervention | Work Package 1 (WP1): Pilot Vfrac implementation within primary care Six general practices will be recruited purposively to include large/small practices, practices within different PCNs/clusters and practices that use different IT systems (EMISWeb/SystmOne for example). General practices will be identified and approached by the Bristol Primary Care CRN. Baseline data will be collected from all recruited practices. A clinical update on osteoporosis will be offered to all. Three practices will then be assigned to the implementation arm and three to the control. Those in the implementation arm will be trained in the use of Vfrac and will have it made accessible from their IT systems (through the provision of a URL via pop-ups on typing relevant words such as back pain). Use of the Vfrac tool will be encouraged within their clinical pathways for the management of older women who consult with back pain. The use of the tool in a manner that fits each practice's service delivery model will be facilitated by the research team in discussion with the clinical team. The control practices will use standard clinical processes for older women consulting with back pain. Regular data will then be collected on consultations by older women with back pain from all six general practices every 3 months for 12 months. Work Package 2 (WP2): Nested qualitative assessment of acceptability 16-24 older women who consulted with back pain and had Vfrac used during their clinical consultation within one of the three intervention practices will be recruited to take part in this work package. They will be identified by the unique code generated and embedded within their GP records at the time the result of Vfrac was recorded. They will be approached by the direct clinical care team in their general practice with an information pack about the study. The information pack will contain an introductory letter, a participant information booklet, a consent form and a pre-paid envelope for return to the research team. Those who reply by returning the completed Consent Form will be recruited. In addition, 16-24 healthcare professionals working within the intervention practices will also be recruited. The plan is to undertake approximately four focus group interviews with patients, and four focus groups with healthcare professionals, each focus group with an estimated 4-6 participants. The final sample size will be determined by data saturation. Focus groups will aim to understand and assess the perceived acceptability of Vfrac and identify factors that impact on implementation. To do this the researchers will address two key actions of intervention development: (1) understand and assess the acceptability of Vfrac to healthcare professionals (providers) and patients (recipients), and (2) identify factors that impact on implementation, including barriers and facilitators to delivery. These may include patient-related factors and provider-related factors such as working practices, or service constraints such as time and resources. Work Package 3 (WP3): Additional data collection to inform parameters for the trial through analysis of data from the CPRD (WP3A) and a national survey (WP3B) of CCGs, primary care managers and GPs. Work package 4 (WP4): Decision as to whether a future definitive evaluation is warranted Stop/Go criteria for any future trial are: 1. Accuracy of Vfrac tool – already completed and results are favourable (not part of this study) 2. Modelled cost-effectiveness - already completed and results are favourable (not part of this study) 3. Realistic proportion of older women with back pain identified with vertebral fractures by Vfrac - already completed and results are favourable (not part of this study) 4. Realistic required sample size based feasibility study (WP1) and on analyses of national data (WP3) 5. Realistic required length of follow-up for the future trial based on results of WP1 plus additional analyses of national data (WP3) 6. Evidence that the Vfrac tool is acceptable to healthcare professionals and patients based on results of WP2 |
| Intervention type | Other |
| Primary outcome measure(s) |
WP1: Intervention and control practices |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/01/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 65 Years |
| Sex | Female |
| Target sample size at registration | 32 |
| Key inclusion criteria | WP1: Recruitment of general practices only - no individual patients 1. General practices willing to take part in research within the Bristol area WP2: nested qualitative assessment of acceptability - recruitment of patients and healthcare professionals Inclusion criteria for patients: 1. Female aged >65 years 2. Had Vfrac used during a consultation for back pain 3. Patient is willing and able to give informed consent for participation in this nested evaluation Inclusion criteria for healthcare professionals: 1. Used Vfrac during a consultation for back pain OR were involved in the implementation of Vfrac within IT systems or clinical pathways within one of the three intervention practices 2. Healthcare professional is willing and able to give informed consent for participation in this nested evaluation |
| Key exclusion criteria | WP1: Recruitment of general practices only - no individual patients Does not meet the inclusion criteria WP2: nested qualitative assessment of acceptability - recruitment of patients and healthcare professionals Exclusion criteria for patients: 1. Has not had Vfrac used during a consultation for back pain 2. Patients who do not have the capacity to provide informed consent. Capacity to consent will be assessed by the researcher, in consultation with clinical members of the study team (EC). This is in accordance with the Mental Capacity Act 2005 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/). 3. Participants who are unwilling to provide informed consent Exclusion criteria for healthcare professionals: 1. Participants who are unwilling to provide informed consent |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/05/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Marlborough Street
Bristol
BS1 3NX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | Prof Emma Clark is the data custodian for this study. Direct access will be granted to authorised representatives from the Sponsor and host institution for monitoring and/or audit of the study to ensure compliance with regulations. It is the researchers' intention to share the underpinning research data to maximise reuse. Patients will be asked for permission to share anonymised data beyond the immediate project team. The data will be deposited at the University of Bristol Research Data Repository (as restricted data). A metadata record will be published openly by the repository and this record will clearly state how data can be accessed. The actual data is only made available to authenticated researchers upon application. The criteria the researchers check applicants against is: the applicant has provided a verifiable institutional affiliation; the applicant has provided verifiable institutional contact details; the applicant has nominated an appropriate institutional signatory; the applicant has ethical approval in place (this may not be required, depending on the nature of the requested dataset). The request is referred to the University of Bristol Data Access Committee (DAC) for approval before data can be released. Again, the applicant's host institution must agree to a Data Access Agreement. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/02/2024 | 07/02/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.0 | 25/05/2022 | 17/11/2022 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN18000119_PROTOCOL_V1.0_25May22.pdf
- Protocol file
Editorial Notes
22/01/2025: A contact was removed.
10/07/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2024 to 31/01/2025.
2. The intention to publish date was changed from 01/09/2024 to 31/01/2026.
3. The plain English summary was updated to reflect these changes.
08/03/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/05/2024 to 31/07/2024.
2. The recruitment end date was changed from 31/03/2024 to 31/05/2024.
3. The plain English summary was updated to reflect these changes.
07/02/2024: Publication reference added.
14/08/2023: The recruitment end date was changed from 31/08/2023 to 31/03/2024.
3. The plain English summary was updated to reflect these changes.
11/07/2023: The recruitment end date was changed from 30/06/2023 to 31/08/2023.
17/11/2022: Protocol uploaded (not peer reviewed).
09/09/2022: Contact details updated. Ethics approval details added.
23/02/2022: Trial's existence confirmed by the NIHR.
