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Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>PROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16\u201390 who visited the randomized primary care clinics from 3\u00a0years before to 2\u00a0years after randomization (anticipated to be\u2009&gt;\u2009170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and\/or health insurance claims (\u201celectronic health records,\u201d [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2\u00a0years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and\/or hospitalizations] over 2\u00a0years post-randomization among patients with documented OUD prior to randomization.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> # NCT03407638 (February 28, 2018); CTN-0074 <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03407638?term=CTN-0074&amp;draw=2&amp;rank=1\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03407638?term=CTN-0074&amp;draw=2&amp;rank=1<\/jats:ext-link><\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13722-021-00218-w","type":"journal-article","created":{"date-parts":[[2021,1,31]],"date-time":"2021-01-31T15:02:16Z","timestamp":1612105336000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment"],"prefix":"10.1186","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct03407638","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1019-5852","authenticated-orcid":false,"given":"Cynthia 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Psychosom Med. 2011;73(4):323\u201335.","journal-title":"Psychosom Med"}],"container-title":["Addiction Science &amp; Clinical Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13722-021-00218-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13722-021-00218-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13722-021-00218-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T17:22:53Z","timestamp":1628616173000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpjournal.biomedcentral.com\/articles\/10.1186\/s13722-021-00218-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,31]]},"references-count":41,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["218"],"URL":"https:\/\/doi.org\/10.1186\/s13722-021-00218-w","relation":{},"ISSN":["1940-0640"],"issn-type":[{"value":"1940-0640","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,31]]},"assertion":[{"value":"10 September 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 January 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 January 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"A single independent, commercial Institutional Review Board (IRB), approved the study including providing waivers of consent and HIPAA authorization, with all sites ceding.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Cynthia I. Campbell is supported by grants and contracts from the National Institute on Drug Abuse (UG1DA040314, R01DA047405), the Food and Drug Administration, and has support managed through her institution from a consortium of pharmaceutical companies to conduct Food and Drug Administration-mandated studies on opioids. Gavin Bart is supported by grants from NIDA and NIDDK. Robert P. Schwartz has provided consultant to Verily Life Sciences, and is the principal investigator of a NIDA-funded study that will be receiving free medication from Alkermes and Indivior. Andrew J. Saxon has royalties as Section Editor, Drug Use Disorders, UpToDate, Inc.; has travel support from Alkermes, Inc.; research support from Medicasafe, Inc.; and consulting fees from Indivior, Inc. Paige D. Wartko, Denise M.\u00a0Boudreau, and Bobbi Jo H.\u00a0Yarborough receive funding from a research contract through their institutions from a consortium of pharmaceutical companies (Allergan, BioDelivery Sciences, Collegium, Daiichi Sankyo, Depomed, Egalet, Endo, Janssen, Mallinckrodt, Pernix, Pfizer, Purdue, and West-Ward) to conduct Food and Drug Administration-mandated studies on opioids.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"9"}}