Osteoarthritis Musculoskeletal Diseases Arthrosis, unspecified
Conditions
Interventions
Current intervention as of 01/06/2020:
This feasibility trial will be undertaken in a diverse range of general practices in the South of England and will involve approximately 10 GP practices, 20 prim
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/06/2020: PRACTICES: Primary care practices within Wessex CRN. PRACTITIONERS Primary care practitioners (e.g. GP, physiotherapist, or practice nurse) seeing people with OA on a regular basis. While we expect most if not all practitioner participants to be GPs, we want to try to recruit first-contact primary care physiotherapists and practice nurses too because these practitioners (particularly physiotherapists) will be increasingly involved in managing patients with OA in primary care in the future. PATIENTS: All-consulters: Adults. OA sub-sample: Consulting a participating PCP in relation to clinically diagnosed hip and/or knee OA, where OA is the only reason for consulting or one of two main reasons for consulting; minimum 45 years old (as per NICE guidance for OA). Social media recruitment (COVID-19 adaptation) Adults recruited through social media who have had a face-to-face, telephone or video consultation with a GP, Nurse, or Physio based in primary care. _____ Previous inclusion criteria: PRACTICES: Primary care practices within Wessex CRN. PRACTITIONERS Primary care practitioners (e.g. GP, physiotherapist, or practice nurse) seeing people with OA on a regular basis. While we expect most if not all practitioner participants to be GPs, we want to try to recruit first-contact primary care physiotherapists and practice nurses too because these practitioners (particularly physiotherapists) will be increasingly involved in managing patients with OA in primary care in the future. PATIENTS: All-consulters: Adults. OA sub-sample: Consulting a participating PCP in relation to clinically diagnosed hip and/or knee OA, where OA is the only reason for consulting or one of two main reasons for consulting; minimum 45 years old (as per NICE guidance for OA).
Exclusion criteria
Exclusion criteria: PRACTICES Practices who participated in Empathica Development studies 2 or 4 (think aloud studies), as these involve looking at prototypes of the intervention. If they were to be included in this feasibility trial they could contaminate the control arm. PRACTITIONERS: None. PATIENTS Patients who are unable to speak English, unable to consent or complete questionnaires (for example, because of severe mental illness, severe distress, very unwell generally, and difficulty reading or writing. While we would like to include patients who are unable to speak English, the involvement of an interpreter would jeopardize a robust test of our intervention because of empathico’s emphasis on verbal as well as non-verbal communication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Practice and Primary Care Practitioners (PCPs) recruitment will be recorded as number recruited as a function of number invited 2. PCP attrition rates will be recorded as number and reason for withdrawing from the study 3. Patient recruitment will be recorded as number approached and recruited per recruitment session. 4. Patient attrition rates will be recorded as number, proportion and reason for withdrawal (where possible) of consented patients. 5. Cluster randomisation and consent procedures will be assessed for feasibility 6. Practical and ethical procedures of video-recording consultations will be assessed for feasibility | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported clinical outcome measures: 1. Pain symptoms will be assessed though pain intensity, symptom change and symptom bothersomeness pre-consultation and after 2 weeks. 2. OA symptoms will be assessed using the short form of the Hip and Disability Osteoarthritis Score (HOOS-12) and the Knee Injury and Osteoarthritis Score (KOOS-12) pre-consultation and after 2 weeks. 3. Satisfaction with the consultation will be assessed using the Medical Interview Satisfaction Scale (MISS) for UK General practice immediately post consultation 4. Enablement will be measured using the Modified Patient Enablement Instrument (PEI) immediately post consultation and after 2 weeks. 5. Health-related quality of life will be assessed using the SF-12 immediately post consultation and after 2 weeks. 6. Well-being will be measured using the Short Warwick Edinburgh Wellbeing Scale immediately post consultation and after 2 weeks. 7. Pain medication will be assessed using the Bespoke Osteoarthritis Pain Medication Questionnaire after 2 weeks 8. Adverse events will be recorded using a bespoke adverse event form after 2 weeks. Patient-reported process measures: 1. Perceptions of PCP empathy will be measured using the Consultation and Relational Empathy (CARE) questionnaire immediately post-consultation 2. Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS) immediately post-consultation 3. Perceptions of PCP response expectancies will be measured using a bespoke measure immediately post-consultation 4. Response expectancies will be measured using the Expectancy subscale of the CEQ and the Treatment Expectation Questionnaire (TEX-Q) immediately post-consultation 5. Treatment credibility will be assessed using the Credibility subscale of the CEQ immediately post-consultation PCP reported process measures: 1. Self-efficacy for conveying empathy & optimism will be assessed using bespoke self-efficacy scales after completing the intervention. 2. Outcome expectancy | — |
Countries
England, United Kingdom
Contacts
Public ContactSusan Broomfield
Outcome results
None listed