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PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment.
Addict Sci Clin Pract. 2021 01 31; 16(1):9.AS

Abstract

BACKGROUND

Most people with opioid use disorder (OUD) never receive treatment. 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.

METHODS

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 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [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 years 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 years post-randomization among patients with documented OUD prior to randomization.

DISCUSSION

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. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1.

Links

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Authors+Show Affiliations

Campbell CI
Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA, 94612, USA. cynthia.i.campbell@kp.org.
Saxon AJ
Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA, 98108, USA.
Boudreau DM
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Wartko PD
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Bobb JF
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Lee AK
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Matthews AG
The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.
McCormack J
The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.
Liu DS
National Institute on Drug Abuse Center for Clinical Trials Network, Three White Flint North, 11601 Landsdown Street, North Bethesda, MD, 20852, USA.
Addis M
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Altschuler A
Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA, 94612, USA.
Samet JH
Boston Medical Center/Boston University School of Medicine: Clinical Addiction Research & Education (CARE) Unit Crosstown Center, 801 Massachusetts Ave., 2nd Floor, Boston, MA, 02118, USA.
LaBelle CT
Boston Medical Center/Boston University School of Medicine: Clinical Addiction Research & Education (CARE) Unit Crosstown Center, 801 Massachusetts Ave., 2nd Floor, Boston, MA, 02118, USA.
Arnsten J
Albert Einstein College of Medicine, Montefiore Medical Center, 3300 Kossuth Avenue, Bronx, NY, 10467, USA.
Caldeiro RM
Kaiser Permanente Washington, 9800 4th Ave. N.E., Seattle, WA, 98115, USA.
Borst DT
Kootenai Clinic Family Medicine, 1919 Lincoln Way, Suite 315, Coeur d Alene, ID, 83814, USA.
Stotts AL
Department of Family & Community Medicine, McGovern Medical School, University of Texas Health Science Center at Houston School, 7000 Fannin Street, Houston, TX, 77030, USA.
Braciszewski JM
Department of Psychiatry, Center for Health Policy and Health Services Research, Henry Ford Health System, 2799 W Grand Blvd, Detroit, MI, 48202, USA.
Szapocznik J
Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, 10th Floor, Miami, FL, 33136, USA.
Bart G
University of Minnesota/Hennepin Healthcare, 701 Park Avenue, Minneapolis, MN, 55415, USA.
Schwartz RP
Friends Research Institute, 1040 Park Avenue, Suite 103, Baltimore, MD, 21201, USA.
McNeely J
NYU Grossman School of Medicine, 180 Madison Ave., New York, NY, 10016, USA.
Liebschutz JM
Division of General Internal Medicine, Center for Research On Health Care, University of Pittsburgh School of Medicine, 200 Lothrop Street, 933West, Pittsburgh, PA, 15213, USA.
Tsui JI
University of Washington/Harborview Medical Center, 325 9th Ave, Seattle, WA, 98104, USA.
Merrill JO
University of Washington/Harborview Medical Center, 325 9th Ave, Seattle, WA, 98104, USA.
Glass JE
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Lapham GT
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.
Murphy SM
Weill Cornell Medical College, 425 East 61st Street, Suite 301, New York, NY, 10065, USA.
Weinstein ZM
Clinical Addiction Research & Education (CARE) Unit, Boston University School of Medicine, Crosstown Center, 801 Massachusetts Ave., 2nd Floor, Boston, MA, 02118, USA.
Yarborough BJH
Kaiser Permanente Northwest, Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227-1098, USA.
Bradley KA
Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.

MeSH

AdolescentAdultAgedAged, 80 and overBuprenorphineFacilities and Services UtilizationFemaleHumansMaleMiddle AgedMulticenter Studies as TopicNurse AdministratorsOpiate Substitution TreatmentOpioid-Related DisordersPragmatic Clinical Trials as TopicPrimary Health CareResearch DesignTreatment Adherence and ComplianceUnited States

Pub Type(s)

Clinical Trial Protocol
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

33517894

Clinical Trial Links

Clinical trial which this article describes

Citation

Campbell, Cynthia I., et al. "PRimary Care Opioid Use Disorders Treatment (PROUD) Trial Protocol: a Pragmatic, Cluster-randomized Implementation Trial in Primary Care for Opioid Use Disorder Treatment." Addiction Science & Clinical Practice, vol. 16, no. 1, 2021, p. 9.
Campbell CI, Saxon AJ, Boudreau DM, et al. PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Addict Sci Clin Pract. 2021;16(1):9.
Campbell, C. I., Saxon, A. J., Boudreau, D. M., Wartko, P. D., Bobb, J. F., Lee, A. K., Matthews, A. G., McCormack, J., Liu, D. S., Addis, M., Altschuler, A., Samet, J. H., LaBelle, C. T., Arnsten, J., Caldeiro, R. M., Borst, D. T., Stotts, A. L., Braciszewski, J. M., Szapocznik, J., ... Bradley, K. A. (2021). PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. Addiction Science & Clinical Practice, 16(1), 9. https://doi.org/10.1186/s13722-021-00218-w
Campbell CI, et al. PRimary Care Opioid Use Disorders Treatment (PROUD) Trial Protocol: a Pragmatic, Cluster-randomized Implementation Trial in Primary Care for Opioid Use Disorder Treatment. Addict Sci Clin Pract. 2021 01 31;16(1):9. PubMed PMID: 33517894.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment. AU - Campbell,Cynthia I, AU - Saxon,Andrew J, AU - Boudreau,Denise M, AU - Wartko,Paige D, AU - Bobb,Jennifer F, AU - Lee,Amy K, AU - Matthews,Abigail G, AU - McCormack,Jennifer, AU - Liu,David S, AU - Addis,Megan, AU - Altschuler,Andrea, AU - Samet,Jeffrey H, AU - LaBelle,Colleen T, AU - Arnsten,Julia, AU - Caldeiro,Ryan M, AU - Borst,Douglas T, AU - Stotts,Angela L, AU - Braciszewski,Jordan M, AU - Szapocznik,José, AU - Bart,Gavin, AU - Schwartz,Robert P, AU - McNeely,Jennifer, AU - Liebschutz,Jane M, AU - Tsui,Judith I, AU - Merrill,Joseph O, AU - Glass,Joseph E, AU - Lapham,Gwen T, AU - Murphy,Sean M, AU - Weinstein,Zoe M, AU - Yarborough,Bobbi Jo H, AU - Bradley,Katharine A, Y1 - 2021/01/31/ PY - 2020/09/10/received PY - 2021/01/15/accepted PY - 2021/2/1/entrez PY - 2021/2/2/pubmed PY - 2021/8/20/medline KW - Buprenorphine KW - Collaborative care KW - Medication KW - Nurse care manager KW - Opioid use disorder KW - Pragmatic trial KW - Primary care SP - 9 EP - 9 JF - Addiction science & clinical practice JO - Addict Sci Clin Pract VL - 16 IS - 1 N2 - BACKGROUND: Most people with opioid use disorder (OUD) never receive treatment. 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. METHODS: 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 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be > 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ("electronic health records," [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 years 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 years post-randomization among patients with documented OUD prior to randomization. DISCUSSION: 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. Trial registration # NCT03407638 (February 28, 2018); CTN-0074 https://clinicaltrials.gov/ct2/show/NCT03407638?term=CTN-0074&draw=2&rank=1. SN - 1940-0640 UR - https://www.unboundmedicine.com/medline/citation/33517894/PRimary_Care_Opioid_Use_Disorders_treatment__PROUD__trial_protocol:_a_pragmatic_cluster_randomized_implementation_trial_in_primary_care_for_opioid_use_disorder_treatment_ DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓13 ↑30]

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