Addressing opioid medication misuse at point of service in community pharmacy: A study protocol for an interdisciplinary behavioral health trial.
Community pharmacy
Integrated care
Opioid medication misuse
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
received:
01
12
2021
revised:
06
04
2022
accepted:
06
04
2022
pubmed:
14
4
2022
medline:
25
5
2022
entrez:
13
4
2022
Statut:
ppublish
Résumé
>1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention-Brief Intervention-Medication Therapy Management (BI-MTM)-compared to standard medication counseling (SMC) to address opioid medication misuse. Design. This study is a single-blinded 2-group parallel randomized trial within 13 community pharmacies that will enroll 350 individuals. Participant Recruitment. Pharmacy staff approach patients and ask about interest in completing a brief confidential screening tool, which includes opioid medication misuse assessment. Interested patients who report misuse are asked to provide informed consent. Enrolled patients are assessed for behavioral and physical health at enrollment, 2-months post-enrollment, and 6-months post-enrollment. Following baseline assessment, participants are randomized (1:1 ratio) to: SMC, a medication information/counseling intervention or BI-MTM, an intervention comprised by 4 evidence-based components: medication therapy management, brief intervention, naloxone dispensing, and patient navigation. Primary analyses involve estimating 3-level generalized linear mixed models to relate repeated assessments across time of opioid medication misuse (i.e., the Prescription Opioid Misuse Index) to the intervention. Study results will provide the first critical step towards integrating a highly accessible, low-cost approach to managing risks related to opioid use. Community pharmacies provide an incredibly important setting in which patients can receive high quality care to support health behavior change. Successfully completing this project sets the stage for a large-scale effectiveness study. (NCT#: NCT05141266).
Sections du résumé
BACKGROUND
>1 in 3 of the 9 million individuals engaged in opioid medication misuse obtain legitimate opioid prescriptions and fill these in community pharmacies, which are subsequently misused. This study is testing the efficacy of a pharmacist-led intervention-Brief Intervention-Medication Therapy Management (BI-MTM)-compared to standard medication counseling (SMC) to address opioid medication misuse.
METHODS
Design. This study is a single-blinded 2-group parallel randomized trial within 13 community pharmacies that will enroll 350 individuals. Participant Recruitment. Pharmacy staff approach patients and ask about interest in completing a brief confidential screening tool, which includes opioid medication misuse assessment. Interested patients who report misuse are asked to provide informed consent. Enrolled patients are assessed for behavioral and physical health at enrollment, 2-months post-enrollment, and 6-months post-enrollment.
INTERVENTIONS
Following baseline assessment, participants are randomized (1:1 ratio) to: SMC, a medication information/counseling intervention or BI-MTM, an intervention comprised by 4 evidence-based components: medication therapy management, brief intervention, naloxone dispensing, and patient navigation.
ANALYSES
Primary analyses involve estimating 3-level generalized linear mixed models to relate repeated assessments across time of opioid medication misuse (i.e., the Prescription Opioid Misuse Index) to the intervention.
CONCLUSION
Study results will provide the first critical step towards integrating a highly accessible, low-cost approach to managing risks related to opioid use. Community pharmacies provide an incredibly important setting in which patients can receive high quality care to support health behavior change. Successfully completing this project sets the stage for a large-scale effectiveness study. (NCT#: NCT05141266).
Identifiants
pubmed: 35417771
pii: S1551-7144(22)00085-4
doi: 10.1016/j.cct.2022.106759
pmc: PMC9661693
mid: NIHMS1846916
pii:
doi:
Substances chimiques
Analgesics, Opioid
0
Banques de données
ClinicalTrials.gov
['NCT05141266']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106759Subventions
Organisme : NIDA NIH HHS
ID : R01 DA051546
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
Références
Drug Alcohol Depend. 2008 Apr 1;94(1-3):38-47
pubmed: 18063321
Alcohol Clin Exp Res. 2007 Jul;31(7):1208-17
pubmed: 17451397
Sleep Health. 2019 Feb;5(1):18-22
pubmed: 30670160
J Am Pharm Assoc (2003). 2018 Jul - Aug;58(4):395-403
pubmed: 29691197
Med Care. 2017 Mar;55(3):291-298
pubmed: 27984346
Addiction. 2009 Jan;104(1):109-17
pubmed: 19133895
Epidemiology. 1992 Mar;3(2):143-55
pubmed: 1576220
J Am Pharm Assoc (2003). 2016 May-Jun;56(3):248-256.e6
pubmed: 27053277
Ann Emerg Med. 2019 Nov;74(5):634-646
pubmed: 31229388
J Behav Med. 1997 Dec;20(6):589-605
pubmed: 9429990
Drug Alcohol Depend. 2016 Jan 1;158:132-8
pubmed: 26653341
Pain. 2010 Aug;150(2):332-339
pubmed: 20554392
Biometrics. 2015 Mar;71(1):1-14
pubmed: 25351114
Res Social Adm Pharm. 2016 Mar-Apr;12(2):293-301
pubmed: 26048710
Clin J Pain. 1997 Jun;13(2):116-37
pubmed: 9186019
Drug Alcohol Depend. 2009 Jul 1;103(1-2):16-24
pubmed: 19414225
JAMA. 1999 Nov 10;282(18):1737-44
pubmed: 10568646
J Pediatr. 2015 Sep;167(3):605-12.e1-2
pubmed: 26054942
J Am Pharm Assoc (2003). 2007 Nov-Dec;47(6):762-7
pubmed: 18032141
J Subst Abuse Treat. 2007 Mar;32(2):189-98
pubmed: 17306727
Med Care. 2004 Dec;42(12):1230-41
pubmed: 15550803
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
pubmed: 11124729
J Consult Clin Psychol. 2013 Aug;81(4):722-36
pubmed: 23688145
J Gen Intern Med. 2016 Oct;31(10):1206-11
pubmed: 27170304
Struct Equ Modeling. 2010;17(3):510-534
pubmed: 23935262
N Engl J Med. 2016 Jan 14;374(2):154-63
pubmed: 26760086
J Clin Psychiatry. 2006 Jul;67(7):1062-73
pubmed: 16889449
Drug Alcohol Depend. 2016 Jun 01;163:40-7
pubmed: 27062245
Harv Rev Psychiatry. 2018 Nov/Dec;26(6):352-363
pubmed: 30407234
Drug Alcohol Depend. 2015 Aug 1;153:229-35
pubmed: 26048641
Addict Biol. 2019 Sep;24(5):1034-1043
pubmed: 30088695
Drug Alcohol Depend. 2019 Dec 1;205:107570
pubmed: 31689641
Can J Psychiatry. 2011 Aug;56(8):495-502
pubmed: 21878161
J Pain Symptom Manage. 2008 Sep;36(3):280-8
pubmed: 18619768
Pain Med. 2016 Feb;17(2):295-303
pubmed: 26235471
Epidemiology. 2010 Jul;21(4):540-51
pubmed: 20479643
Am J Epidemiol. 2014 Oct 15;180(8):838-46
pubmed: 25205829
Addict Behav. 2017 Feb;65:224-228
pubmed: 27569698
Res Social Adm Pharm. 2019 Aug;15(8):910-916
pubmed: 29325708
J Subst Abuse Treat. 2008 Dec;35(4):380-6
pubmed: 18657935
J Pain. 2014 Nov;15(11):1092-1101
pubmed: 25092233
Drug Alcohol Depend. 2016 Mar 1;160:127-34
pubmed: 26785634
Lancet Psychiatry. 2017 Sep;4(9):725-732
pubmed: 28396067
J Clin Epidemiol. 2001 Apr;54(4):343-9
pubmed: 11297884
Med Care. 2012 Jun;50(6):494-500
pubmed: 22410408
Int J Behav Nutr Phys Act. 2018 Jan 11;15(1):3
pubmed: 29325557
Implement Sci. 2015 Feb 12;10:21
pubmed: 25889199
J Nerv Ment Dis. 1992 Feb;180(2):101-10
pubmed: 1737971
Biol Psychiatry. 1997 Nov 15;42(10):948-55
pubmed: 9359982
Assessment. 2012 Mar;19(1):89-100
pubmed: 22156717
Am J Manag Care. 2009 Dec;15(12):897-906
pubmed: 20001171
Addict Behav. 2013 Jun;38(6):2230-5
pubmed: 23501140