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What is the feasibility of testing a vertebral fracture screening tool in a real-world primary care setting?

Vertebral fracture clinical decision tool for older women with back pain (Vfrac) - a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18000119
Enrollment
32
Registered
2022-03-01
Start date
2022-06-01
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporotic vertebral fractures Musculoskeletal Diseases Osteoporosis with pathological fracture

Interventions

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

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
WP1: Intervention and control practices 1. Descriptives of each practice, computer system, name of PCN/cluster, other demographic characteristics, number of registered patients, number of women aged =50 and =65 years, as reported by the Practice Manager at baseline 2. The type of healthcare professional carrying out initial consultation for back pain, the number and date of consultations by older women with back pain, resource use after initial consultation for back pain, new diagnoses since initial consultation for back pain, measured using a questionnaire at 3, 6, 9, 12, 15 and 18 months WP1: Intervention practices only (in addition to the above) The proportion of consultations for back pain where Vfrac was used, other consultations where Vfrac was used, results of the Vfrac tool completed in primary care, measured using a questionnaire at 3, 6, 9, 12, 15 and 18 months WP2: nested qualitative assessment of acceptability 1. Understanding of acceptability to healthcare professionals and patients based on Topic Guide using the Theoretical Framework of Acceptability collected during focus groups at baseline 2. Identification of factors that impact on implementation, including barriers and facilitators to delivery based on a Topic Guide using Implementation Science, collected during focus groups at baseline WP3: Additional data collection to inform parameters for the trial, all measured at baseline: WP3A: Data from Clinical Practice Research Datalink (CPRD) will be used to quantify: 1. The range and relative frequencies of healthcare professionals who run the initial consultation for back pain across the UK 2. Levels of and variability in bisphosphonate prescribing and consultation rates for back pain by patient-level characteristics/general practices/regions 3. Variability in the length of time between initial consultation and eventual management implementation 4. Variation in size of general practices WP3B: The researchers will utilise the primary care CRNs, NHS D

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactEmma Clark
emma.clark@bristol.ac.uk+44 (0)1174147841

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026