TY - JOUR
KW - buprenorphine
KW - collaborative care
KW - medication
KW - Nurse care manager
KW - opioid use disorder
KW - Pragmatic trial
KW - primary care
AU - C. I. Campbell
AU - A. J. Saxon
AU - D. M. Boudreau
AU - P. D. Wartko
AU - J. F. Bobb
AU - A. K. Lee
AU - A. G. Matthews
AU - J. McCormack
AU - D. S. Liu
AU - M. Addis
AU - A. Altschuler
AU - J. H. Samet
AU - C. T. LaBelle
AU - J. Arnsten
AU - R. M. Caldeiro
AU - D. T. Borst
AU - A. L. Stotts
AU - J. M. Braciszewski
AU - J. Szapocznik
AU - G. Bart
AU - R. P. Schwartz
AU - J. McNeely
AU - J. M. Liebschutz
AU - J. I. Tsui
AU - J. O. Merrill
AU - J. E. Glass
AU - G. T. Lapham
AU - S. M. Murphy
AU - Z. M. Weinstein
AU - B. J. H. Yarborough
AU - K. A. Bradley
A1 - 
AB - 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.
AD - Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA, 94612, USA. cynthia.i.campbell@kp.org.; Center of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care System, 1660 S Columbian Way, Seattle, WA, 98108, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.; The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.; The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.; National Institute on Drug Abuse Center for Clinical Trials Network, Three White Flint North, 11601 Landsdown Street, North Bethesda, MD, 20852, USA.; Kaiser Permanente Washington Health Research Institute, 1730 Minor Avenue, Seattle, WA, 98101, USA.; Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA, 94612, USA.; 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.; 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.; Albert Einstein College of Medicine, Montefiore Medical Center, 3300 Kossuth Avenue, Bronx, NY, 10467, USA.; Kaiser Permanente Washington, 9800 4th Ave. N.E., Seattle, WA, 98115, USA.; Kootenai Clinic Family Medicine, 1919 Lincoln Way, Suite 315, Coeur d Alene, ID, 83814, USA.; Department of Family & Community Medicine, McGovern Medical School, University of Texas Health Science Center at Houston (TRUNCATED)
BT - Addiction science & clinical practice
C5 - Education & Workforce; Opioids & Substance Use
CP - 1
DO - 10.1186/s13722-021-00218-w
IS - 1
JF - Addiction science & clinical practice
LA - eng
M1 - Journal Article
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.
PY - 2021
SN - 1940-0640; 1940-0632; 1940-0632
SP - 021
EP - w
EP - 9+
T1 - PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment
T2 - Addiction science & clinical practice
TI - PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment
U1 - Education & Workforce; Opioids & Substance Use
U2 - 33517894
U3 - 10.1186/s13722-021-00218-w
VL - 16
VO - 1940-0640; 1940-0632; 1940-0632
Y1 - 2021
Y2 - Jan 31
ER -