title: Paramedic-supplied 'Take Home' Naloxone: protocol for cluster randomised feasibility study.
abstract: BACKGROUND
  'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.
  
  
  METHODS
  Cluster randomised trial with staggered allocation of paramedics (clusters) to groups. We will invite paramedics in an urban area of south Wales, UK to take part. We will randomly allocate those that accept to training sessions during the first 4 months of the trial. Patients attended by paramedics who have been trained and issued THN kits will fall into the intervention group. Patients attended by paramedics following usual practice (until they receive their training and THN kits) will fall into the control group. We will gather data about processes and outcomes of care: numbers of patients eligible for intervention, offered and accepted THN, attended emergency department, suffered further overdose, died within 3 months and about follow-up rates: numbers of patients consented, completed (postal or telephone) questionnaire. We will gather qualitative data about acceptability to patients and paramedics through interviews and focus groups.
  
  
  BACKGROUND
  Ethical approval for this study was granted on 7 December 2011, by South East Wales Research Ethics Committee, Panel C. Results of this study will be reported through peer-reviewed scientific journals, conference presentations and internal organisational report. We will also seek to report our findings through local and national substance misuse networks and publications.
  
  
  BACKGROUND
  ISRCTN98216498.
authors.affiliation: Medical and Clinical Services Directorate, Welsh Ambulance Services NHS Trust, Blackweir Ambulance Station, Cardiff, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Moore
authors.forename: Gregory
authors.initials: G
authors.lastname: Lloyd
authors.forename: Rossana
authors.initials: R
authors.lastname: Oretti
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
authors.forename: Helen
authors.initials: H
authors.lastname: Snooks
mesh_terms: D000293:Adolescent; D000328:Adult; D000488:Allied Health Personnel / Q000193:education; D000701:Analgesics, Opioid / Q000506:poisoning*; D002985:Clinical Protocols; D062787:Drug Overdose / Q000188:drug therapy*; D004632:Emergency Medical Services / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D009270:Naloxone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D018579:Patient Selection; D012107:Research Design; D014852:Wales; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D009270:Naloxone
keywords: Accident & Emergency Medicine; Public Health