From: Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study
Objectives [To assess:] | Relevant Progression Criteria | Relevant result |
---|---|---|
1. Willingness of both patients and paramedics to participate in the trial. | 1. Recruit at least ten paramedics to conduct the trial | 19 paramedics took part in the trial |
2. At least 60% of recruited participants consent to follow up | 80% of patients consented to follow up | |
2. Compliance with the FICB protocol by paramedics. | 3. At least 50% of intervention participants receive FICB | 55% of intervention participants received FICB |
3. Which outcome measures and costs to use in a full RCT and when they should be collected | 4. Retrieve primary outcomes for at least 70% of consented participants | We checked the mortality status for 100% of participants. 61% of 1 month questionnaires and 71% of 6 month questionnaires were returned |
5. Clinicians are in equipoise about safety and effectiveness of paramedic-administered FICB | ||
The only statistically significant difference between arms was the proportion receiving morphine | ||
4. Acceptability of FICB as a method of providing pain relief in the prehospital care of patients with hip fracture. | 6. Mean participant satisfaction in the experimental arm at least 80% of that in the usual care arm | Mean participant satisfaction in FICB was 97% of that in the usual care arm |
7. Balance of SAEs between arms | SAEs occurred in three experimental participants and four in the usual care arm | |
5. Accuracy of recognition of hip fracture by paramedics. | 8. Paramedics recognise hip fracture with sensitivity of 75% and positive predictive value of 85% | Paramedics recognised hip fracture with sensitivity 77% and positive predictive value of 81% |
6. Sample size required for a fully-powered RCT and period required to recruit these |  | For example, ~ 1900 patients over 24 months. |
7. Whether trial processes and outcomes achieve specified progression criteria for progress to fully-powered trial | We effectively met all progression criteria, with progression criterion four being met for two out of three proposed primary outcomes and progression criterion eight being within reasonable limits. |