TY - JOUR
T1 - Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing
T2 - A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial
AU - Stopka, Thomas J
AU - Babineau, Denise C
AU - Gibson, Erin B
AU - Knott, Charles E
AU - Cheng, Debbie M
AU - Villani, Jennifer
AU - Wai, Jonathan M
AU - Blevins, Derek
AU - David, James L
AU - Goddard-Eckrich, Dawn A
AU - Lofwall, Michelle R
AU - Massatti, Richard
AU - DeFiore-Hyrmer, Jolene
AU - Lyons, Michael S
AU - Fanucchi, Laura C
AU - Harris, Daniel R
AU - Talbert, Jeffery
AU - Hammerslag, Lindsey
AU - Oller, Devin
AU - Balise, Raymond R
AU - Feaster, Daniel J
AU - Soares, William
AU - Zarkin, Gary A
AU - Glasgow, LaShawn
AU - Oga, Emmanuel
AU - McCarthy, John
AU - D'Costa, Lauren
AU - Chahine, Rouba
AU - Gomori, Steve
AU - Dalvi, Netrali
AU - Shrestha, Shikhar
AU - Garner, Chad
AU - Shadwick, Aimee
AU - Salsberry, Pamela
AU - Konstan, Michael W
AU - Freisthler, Bridget
AU - Winhusen, John
AU - El-Bassel, Nabila
AU - Samet, Jeffrey H
AU - Walsh, Sharon L
PY - 2024/2/5
Y1 - 2024/2/5
N2 - IMPORTANCE: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined.OBJECTIVE: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing.DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022.INTERVENTION: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity.MAIN OUTCOMES AND MEASURES: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed.RESULTS: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10).CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.
AB - IMPORTANCE: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined.OBJECTIVE: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing.DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022.INTERVENTION: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity.MAIN OUTCOMES AND MEASURES: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed.RESULTS: A total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10).CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04111939.
KW - Adult
KW - Humans
KW - Buprenorphine/therapeutic use
KW - Data Analysis
KW - Educational Status
KW - Intention
KW - Opiate Overdose
KW - Opioid-Related Disorders/drug therapy
KW - Adolescent
KW - Multicenter Studies as Topic
KW - Randomized Controlled Trials as Topic
U2 - 10.1001/jamanetworkopen.2024.0132
DO - 10.1001/jamanetworkopen.2024.0132
M3 - Article
C2 - 38386322
VL - 7
SP - e240132
JO - JAMA network open
JF - JAMA network open
IS - 2
ER -
