Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Percentage of participants that received various forms of Nyxoid training materials during their naloxone training (patient information card, training video, information on leaflet and images in nyxoid pack). |
Percentage (n=3000 (only those receiving nyxoid)) |
Enrolment & Stage 1 interview conducted at 6 months |
|
Other |
Percentage of participants (receiving nyxoid) that appropriately recognised and responded to an overdose. |
Percentage (n=300 (only those receiving nyxoid witnessing O/D) |
Ongoing interviews 6-months post enrolment follow-up |
|
Other |
Percentage of participants (receiving nyxoid) that appropriately responded to an overdose. |
percentage (n=300) |
Ongoing interviews 6-months post enrolment follow-up |
|
Other |
Percentage of participants that had received nyxoid naloxone training prior to enrolling |
Percentage (n=3000) |
Enrolment |
|
Other |
Positive response given (by those receiving nyxoid) stating no improvement after 2-3 minutes OR overdose symptoms come back |
Percentage (n=300) |
Ongoing interviews 6-months post enrolment follow-up |
|
Other |
Percentage of participants (receiving nyxoid) that inappropriately responded to an overdose. |
Percentage (n=300) |
Ongoing interviews 6-months post enrolment follow-up |
|
Other |
Increased understanding of carriage of naloxone products and disposal of used kits |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of how naloxone is administered in an emergency overdose situation, including any problems encountered (e.g. device malfunction or misuse) |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of decision making processes relating to naloxone administration in an emergency opioid overdose situation, including giving/not giving a second dose |
Qualitative interview with those having witnessed an opioid overdose from UK |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of the impact of the social and environmental setting in which the overdose occurs - on naloxone use |
n=60 qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of the links between naloxone carriage and use on willingness to call an ambulance when witnessing an opioid overdose |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of the effectiveness of naloxone administration, including speed of reversal and opioid overdose outcome |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of any negative consequences of naloxone administration (e.g. victim withdrawals, aggression, respiratory depression and death) and their implications for future opioid overdose events witnessed |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of care of the victim both during the opioid overdose and post-naloxone administration |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of knowledge of naloxone, including training and information needs |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Increased understanding of views on the THN training materials |
Qualitative interview with those having witnessed an opioid overdose from UK n=60 |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Accurate diagnosis of Opioid overdose. |
Expert assessment of transcripts of qualitative interviews using non-validated naloxone administration scale. 5-point Likert scale (1 (very low)- 5 (very high) |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Accurate identification of respiratory depression. |
Expert assessment of transcripts of qualitative interviews using non-validated naloxone administration scale. 5-point Likert scale (1 (very low)- 5 (very high). |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Appropriate response to opioid overdose |
Expert assessment of transcripts of qualitative interviews using non-validated naloxone administration scale. 5-point Likert scale (1 (very low)- 5 (very high) |
6-month follow-up (at most recent overdose witnessed) |
|
Other |
Adequate post naloxone aftercare. |
Expert assessment of transcripts of qualitative interviews using non-validated naloxone administration scale. 5-point Likert scale (1 (very low)- 5 (very high) |
6-month follow-up (at most recent overdose witnessed) |
|
Primary |
Frequency of deaths in the 24 hours or later if information is available subsequent to administration of naloxone by lay-persons to reverse an opioid overdose in the real world. |
frequency of deaths among those witnessing opioid overdose (n=600) |
Ongoing - over six months period post enrolment (at most recent overdose witnessed) |
|
Primary |
Administration rate of THN with the intention of reversing an opioid overdose by lay persons provided with THN who witness an opioid overdose. |
Rate of THN administration among those witnessing opioid overdose (n=600) |
Ongoing -over six months period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who indicate carrying THN (on day of interview) |
Percentage (n=6000) |
Ongoing over 6-month period post enrolment |
|
Secondary |
Percentage of participants who witness an opioid overdose over 6-month period. |
Percentage (n=6000) |
Ongoing over 6-month period post enrolment |
|
Secondary |
Confirm death or survival of participants |
percentage (n=600) |
On-going over 6 month period post enrolment |
|
Secondary |
Percentage of participants who witness an opioid overdose who report there was THN present |
Percentage (n=600) |
Ongoing over 6-month period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who are carrying THN when witness an opioid overdose |
Percentage (n=600) |
Ongoing over 6-month period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who witness an opioid overdose, where there was THN present, and administer THN |
Percentage (n=600) |
Ongoing over 6-month period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who witness an overdose and administer THN who report respiratory depression occurred in person they resuscitated within one hour of administering THN |
Percentage (n=600) |
On-going within 6-month period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who witness an overdose, who report a second dose of naloxone administered to a person experiencing an opioid overdose within 1-hour post administration of first dose of THN |
Percentage (n=600) |
6-month follow-up (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants who report withdrawal symptoms (including anger, rage and violence) occurred in person they resuscitated with THN |
Frequency of each symptom witnessed (n=600) (at most recent overdose witnessed) |
On-going over 6-month period post enrolment (at most recent overdose witnessed) |
|
Secondary |
Percentage of participants witnessing an overdose where the person receiving naloxone has survived at 2 hours post administration of naloxone OR at arrival of ambulance/medical assistance if this occurs before 2 hours have passed since opioid overdose |
Percentage (n=600) |
Ongoing over 6-month period post enrolment |
|
Secondary |
Percentage of participants who witness an opioid overdose and report fatal outcomes within 2 hours of identification of opioid overdose or at arrival of ambulance/medical assistance a) of witnessed opioid overdoses b) Of witnessed opioid overdoses |
Percentage (n=600) |
Ongoing over 6-month period post enrolment |
|
Secondary |
Percentage of participants who witness an overdose who correctly diagnosed opioid overdose crisis-through multiple response questions |
Percentage (n=600) |
Ongoing interviews 6-month post enrolment follow-up |
|
Secondary |
Percentage of participants who witness an opioid overdose who correctly diagnose opioid overdose crisis-through multiple response questions |
Percentage (n=600) |
Ongoing interviews 6-month post enrolment follow-up |
|
Secondary |
Percentage of participants who witness an opioid overdose who correctly respond to opioid overdose crisis-through multiple response questions |
Percentage (n=600) |
Ongoing interviews 6-month post enrolment follow-up |
|