Systems analysis and improvement approach to improve naloxone distribution within syringe service programs: study protocol of a randomized controlled trial.
Equitable naloxone distribution
Opioid overdose deaths
Randomized controlled trial
Syringe service programs
Systems Analysis and Improvement Approach
Journal
Implementation science : IS
ISSN: 1748-5908
Titre abrégé: Implement Sci
Pays: England
ID NLM: 101258411
Informations de publication
Date de publication:
03 08 2023
03 08 2023
Historique:
received:
05
06
2023
accepted:
24
07
2023
medline:
7
8
2023
pubmed:
4
8
2023
entrez:
3
8
2023
Statut:
epublish
Résumé
More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone's ability to improve naloxone distribution in general and among BIPOC specifically. We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone's ability to improve SSPs' naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness. This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.
Sections du résumé
BACKGROUND
More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone's ability to improve naloxone distribution in general and among BIPOC specifically.
METHODS
We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone's ability to improve SSPs' naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness.
DISCUSSION
This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.
Identifiants
pubmed: 37537665
doi: 10.1186/s13012-023-01288-x
pii: 10.1186/s13012-023-01288-x
pmc: PMC10398915
doi:
Substances chimiques
Naloxone
36B82AMQ7N
Narcotic Antagonists
0
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
33Subventions
Organisme : NIDA NIH HHS
ID : R01 DA055277
Pays : United States
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Int J Drug Policy. 2018 Feb;52:52-55
pubmed: 29232604
BMC Res Notes. 2014 Oct 21;7:743
pubmed: 25335783
Implement Sci. 2015 Mar 30;10:42
pubmed: 25888928
Drug Alcohol Rev. 2011 Jan;30(1):26-32
pubmed: 21219494
J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2:S108-16
pubmed: 27355497
Arch Gen Psychiatry. 2008 Oct;65(10):1214-21
pubmed: 18838638
MMWR Morb Mortal Wkly Rep. 2017 Apr 14;66(14):382-386
pubmed: 28406883
Qual Saf Health Care. 2003 Feb;12(1):40-6
pubmed: 12571344
Biostatistics. 2002 Dec;3(4):459-75
pubmed: 12933592
Addict Behav. 2018 Oct;85:94-99
pubmed: 29883856
Psychiatr Serv. 2019 Dec 1;70(12):1082-1087
pubmed: 31451063
Implement Sci. 2020 Mar 6;15(1):15
pubmed: 32143657
Med Care. 2010 May;48(5):396-401
pubmed: 20393362
Drug Alcohol Depend. 2018 Aug 1;189:37-41
pubmed: 29860058
J Subst Abuse Treat. 2013 Aug;45(2):179-89
pubmed: 23558158
J Consult Clin Psychol. 2015 Feb;83(1):157-68
pubmed: 25181028
Curr HIV/AIDS Rep. 2018 Aug;15(4):293-301
pubmed: 29968173
Int J Drug Policy. 2016 Jan;27:138-45
pubmed: 26394538
Addict Behav. 2018 Nov;86:90-95
pubmed: 29610001
BMC Health Serv Res. 2006 Apr 19;6:52
pubmed: 16623946
Drug Alcohol Depend. 2020 Dec 1;217:108292
pubmed: 32992151
Addiction. 2015 Aug;110(8):1301-10
pubmed: 25917125
Am J Public Health. 2021 Aug;111(8):1382-1384
pubmed: 34464185
Implement Sci Commun. 2022 May 10;3(1):49
pubmed: 35538591
Implement Sci. 2007 Nov 30;2:40
pubmed: 18053122
JAMA Netw Open. 2022 Jan 4;5(1):e2142982
pubmed: 35015062
Implement Sci. 2013 Dec 01;8:139
pubmed: 24289295
Implement Sci. 2014 Apr 17;9:46
pubmed: 24742308
Drug Alcohol Depend. 2018 Jul 1;188:370-376
pubmed: 29776688
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
Addiction. 2021 Jan;116(1):6-17
pubmed: 32533570
Psychol Methods. 2001 Dec;6(4):387-401
pubmed: 11778679
Implement Sci. 2019 Apr 27;14(1):41
pubmed: 31029171
Health Policy Plan. 2021 Feb 16;35(10):1354-1363
pubmed: 33221835
Implement Sci. 2014 Jan 10;9:7
pubmed: 24410955
Health Educ Res. 2009 Apr;24(2):292-305
pubmed: 18469319
J Subst Abuse Treat. 2018 Nov;94:81-90
pubmed: 30243422
Drug Alcohol Depend. 2021 Aug 1;225:108759
pubmed: 34058540
Harm Reduct J. 2023 Jan 13;20(1):5
pubmed: 36639769
Implement Sci. 2014 May 08;9:55
pubmed: 24885976
Int J Drug Policy. 2021 Dec;98:103392
pubmed: 34325184
Am J Emerg Med. 1994 Nov;12(6):650-60
pubmed: 7945608
Drug Alcohol Depend. 2006 Feb 1;81(2):167-78
pubmed: 16043308
J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):e68-76
pubmed: 27082507
Adm Policy Ment Health. 2011 Mar;38(2):65-76
pubmed: 20957426
Drugs (Abingdon Engl). 2015 Feb;22(1):66-76
pubmed: 26045638
J Addict Nurs. 2018 Jul/Sep;29(3):167-171
pubmed: 30180002
Transl Behav Med. 2022 Feb 16;12(2):335-342
pubmed: 34791480
Am J Public Health. 2021 Aug;111(8):e1-e12
pubmed: 34214412
BMC Health Serv Res. 2023 Mar 22;23(1):278
pubmed: 36949494
MMWR Morb Mortal Wkly Rep. 2020 Aug 21;69(33):1117-1121
pubmed: 32817603
Milbank Q. 2013 Jun;91(2):354-94
pubmed: 23758514
J Consult Clin Psychol. 2012 Feb;80(1):29-42
pubmed: 22182262
Health Econ. 2001 Dec;10(8):779-87
pubmed: 11747057
BMJ. 2013 Jan 30;346:f174
pubmed: 23372174
Implement Sci. 2015 Sep 07;10:129
pubmed: 26345357
Am J Addict. 2014 May-Jun;23(3):218-25
pubmed: 24724878
Womens Health Issues. 2018 Sep - Oct;28(5):470-475
pubmed: 30061031
Psychol Methods. 2009 Mar;14(1):43-53
pubmed: 19271847