RISCS Trial – Risks In Spinal Consenting for Surgery: Establishing the information required to enable informed consent for patients receiving spinal injections

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: The study is a non‐inferiority, randomised, controlled trial. Two different consent forms to consent patients for their spinal injections are used. One form is the standard practice, based on the risks that are recommended to be discussed by the medical profession, in this instance the British Association of Spinal Surgeons based on the complications listed on the British Spinal Register. The intervention consent form is based on the stance of the legal profession with an encyclopaedic level of risks on the consent form based on literature reports. The only difference to routine practice is the change of consent form in the intervention group and the use of STAI questionnaires in both groups. The duration of treatment is as per patients’ current treatment, with follow up to six weeks post operatively; again, this is six weeks post operative follow up is currently routine practice. Participants are randomised between groups when their trial packs are distributed. The packs contain the different consent forms and have being ordered randomly; these are distributed sequentially. CONDITION: Consenting practice for spinal injections ; Musculoskeletal Diseases ; Consenting practice for spinal injections PRIMARY OUTCOME: Number of patients withdrawing consent for injections is measured using the patient records at time of injection. SECONDARY OUTCOME: State of anxiety is measured using state‐trait anxiety inventory (STAI) scores at time of reading consent form and day of surgery. INCLUSION CRITERIA: 1. Spinal injection (facet injection, nerve root or caudal/foraminal injection) 2. Day case, elective patient 3. Able to consent (capacity) 4. Age 18 years or older
Epistemonikos ID: 18f0abb37e908cb873f31458865c951ec4e47b55
First added on: Aug 23, 2024