Musculoskeletal pain and other conditions/symptoms Other
Conditions
Interventions
TIP is a cluster-randomized controlled, two parallel groups superiority trial in primary care. General practices (the clusters) will be randomized 1:1 to EMPathicO training versus usual care. Eligible
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Practices: All general practices serving NHS patients in England are eligible. Each hub will work closely with local CRNs to target practices in areas of high deprivation indices and serving patients from diverse ethnic backgrounds. Practices that are part of large multi-practice primary care networks will be eligible but the unit of randomisation will be considered on a case-by-case basis (i.e., randomise as a group or as individual practices). The degree and type of integration and likelihood of contamination between the practices will be considered. Practitioners: All practitioners working within participating general practices and seeing people with MSK pain are eligible and will be encouraged to undertake the EMPathicO training; this may include GPs, physiotherapists, practice nurses, nurse practitioners, physician’s assistants. Patients: MSK group: 1. Adult (aged 18+ years) 2. Verbally consulting a participating practitioner about new, recurrent, or ongoing MSK pain (e.g. back, hip, knee, neck pain - consistent with ICD-11’s diseases of the MSK system) 3. Reporting their average pain in the last week as 4 or more on the numerical rating scale from the Brief Pain Inventory at the index consultation (where 0 = no pain; 10 = pain as bad as you can imagine) 4. Consulting face-to-face in surgery, via the telephone, or via videoconference, even if those consultations were initiated via e-consult/email/initial triage call 5. Has capacity to give informed consent Patients: non-MSK group: 1. Adult (aged 18+ years) 2. Verbally consulting a participating practitioner about something other than MSK pain 3. Has capacity to give informed consent 4. Patients who are consulting for MSK pain and reporting their pain in the last week as less than 4 on the numerical rating scale from the Brief Pain Inventory at the index consultation (where 0 = no pain; 10 = pain as bad as you can imagine)
Exclusion criteria
Exclusion criteria: Practices: The 26 practices (18 from Wessex CRN, 5 from the Keele area) that were involved in the intervention development and feasibility work and have already seen and/or used the intervention Practitioners: Unwilling to undertake the intervention and the trial procedures Patients: MSK pain group and non-MSK group: 1. Consulting solely in written forms, e.g., via e-consult/emails (these patients will not be invited into the study) 2. Has pain known to be caused by malignancy 3. Unable to consent 4. Unable to complete questionnaires (for example, because of severe mental illness or distress, terminal illness) (these patients will be screened out pre-invitation by practice staff) 5. Already enrolled in the trial (e.g., if they consulted a participating practitioner twice within the recruitment window) To support wider access to participation in research and improve sample representatives, people who do not speak or read/write English will not be excluded; instead, an interpreter will be made available to support non-English speakers. If numbers permit, the researchers plan to test for any differences in intervention effectiveness for patients requiring an interpreter during their consultation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain intensity measured using the pain intensity subscale from the Brief Pain Inventory at pre-consultation baseline, post-consultation, 1, 3 and 6 months 2. Patient enablement measured using the modified Patient Enablement Index at post-consultation, 1, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient global impression of symptom severity is measured using the Patient Global Impression of Symptom Severity single item at pre-consultation baseline, post-consultation, 1, 3, and 6 months 2. Patient global impression of symptom change is measured using the Patient Global Impression of Change single item at post-consultation, 1, 3, and 6 months 3. Pain interference is measured using the pain interference subscale from the Brief Pain Inventory at 1 and 6 months 4. Patient satisfaction is measured using the MISS for UK General Practice at post-consultation 5. Patient-reported adverse events are self-reported by patients using standard items at 1, 3, and 6 months Health Economics Outcomes: 1. Health-related quality of life is measured using the EQ-5D-5L and EQ-VAS at pre-consultation baseline, 1 and 6 months 2. Capability wellbeing is measured using the ICECAP-A at pre-consultation baseline, 1 and 6 months 3. Healthcare utilization is measured using the ModRUM core module at post-consultation, 3 and 6 months 4. Prescribed medication utilization is measured using the ModRUM depth questions at 3 and 6 months 5. Personal expenses are measured using bespoke items at 3 and 6 months 6. Productivity is measured using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) at 3 and 6 months | — |
Countries
United Kingdom
Outcome results
None listed