Injuries and accidents, musculoskeletal Musculoskeletal Diseases
Conditions
Interventions
This study is an individual randomised controlled trial with parallel process evaluation and health economic evaluation. An individual patient-level randomised controlled trial was chosen to (a) minim
Sponsors
Keele University
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged >=50 years old eligible for FLS consultation based on having a previous fragility fracture(s) 2. Adult patients able to participate in an FLS appointment (face-to-face or remote consultation) with a participating NHS hospital or associated FLS Process evaluation: 3. As above AND clinicians who deliver iFraP interventions and GPs who consult with an iFraP participant
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to give full informed consent or unable to comply with study procedures 2. Patients with a friend or relative in the study (identified through self-report)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decisional difficulty measured using the Decisional Conflict Scale at 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient level and self-reported: 1. Perceptions of fracture risk assessed using a five-point scale at baseline and 2 weeks 2. Satisfaction with the amount of verbal information and experience assessed using an adapted version of the Satisfaction with Cancer Information Profile at 2 weeks 3. Satisfaction with the amount of written information using an adapted version of the Satisfaction with Cancer Information Profile at 3 months 4. Generic health-related quality of life assessed using the EQ-5D-5L, at baseline, 2 weeks, and 3 months 5. Worry about further falls and fractures assessed using an adapted single item measure at 2 weeks 6. Illness perceptions measured with the Modified Brief Illness Perceptions Questionnaire assessed at baseline, 2 weeks, and 3 months 7. Patient’s perception of patient-centred care measured with the Patient-Professional Interaction Questionnaire (PPIQ) at 2 weeks 8. Weight, smoking and alcohol assessed at baseline and 3 months and change in physical activity assessed at 3 months 9. Healthcare resource use using the Healthcare Resource Use Questionnaire developed for the study at baseline and 3 months If osteoporosis drug treatments were discussed in the consultation: 1. Relative perceived importance of osteoporosis drug treatment benefits and possible side effects and adverse events measured using a bespoke questionnaire at 2 weeks 2. Patient satisfaction with medication information provided using the Satisfaction with Information about Medicines Scale at 2 weeks 3. Medicine perceptions using the Beliefs about Medicines Questionnaire at 2 weeks and 3 months 4. Initiation or intention to initiate (self-report) at 2 weeks and adherence, initiation, persistence, discontinuation, and side effects with osteoporosis drug treatments (self-report) at 3 months 5. Medicine initiation (prescription) and discontinuation from hospital electronic prescribing records at 3 months Process measures: 1. Clinician-reported fidelity of intervention delive | — |
Countries
England, United Kingdom
Contacts
Public ContactJo;Keele Smith;Clinical Trials Unit
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Outcome results
None listed