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Observational Study
. 2022 Dec 29;22(1):1593.
doi: 10.1186/s12913-022-08915-1.

Baseline representativeness of patients in clinics enrolled in the PRimary care Opioid Use Disorders treatment (PROUD) trial: comparison of trial and non-trial clinics in the same health systems

Paige D Wartko  1 , Hongxiang Qiu  2   3   4 , Abisola E Idu  2 , Onchee Yu  2 , Jennifer McCormack  5 , Abigail G Matthews  5 , Jennifer F Bobb  2 , Andrew J Saxon  6 , Cynthia I Campbell  7 , David Liu  8 , Jordan M Braciszewski  9 , Sean M Murphy  10 , Rachael P Burganowski  2 , Mark T Murphy  11 , Viviana E Horigian  12 , Leah K Hamilton  2 , Amy K Lee  2 , Denise M Boudreau  2   13 , Katharine A Bradley  2
Affiliations
Observational Study

Baseline representativeness of patients in clinics enrolled in the PRimary care Opioid Use Disorders treatment (PROUD) trial: comparison of trial and non-trial clinics in the same health systems

Paige D Wartko et al. BMC Health Serv Res. .

Abstract

Background: Pragmatic primary care trials aim to test interventions in "real world" health care settings, but clinics willing and able to participate in trials may not be representative of typical clinics. This analysis compared patients in participating and non-participating clinics from the same health systems at baseline in the PRimary care Opioid Use Disorders treatment (PROUD) trial.

Methods: This observational analysis relied on secondary electronic health record and administrative claims data in 5 of 6 health systems in the PROUD trial. The sample included patients 16-90 years at an eligible primary care visit in the 3 years before randomization. Each system contributed 2 randomized PROUD trial clinics and 4 similarly sized non-trial clinics. We summarized patient characteristics in trial and non-trial clinics in the 2 years before randomization ("baseline"). Using mixed-effect regression models, we compared trial and non-trial clinics on a baseline measure of the primary trial outcome (clinic-level patient-years of opioid use disorder (OUD) treatment, scaled per 10,000 primary care patients seen) and a baseline measure of the secondary trial outcome (patient-level days of acute care utilization among patients with OUD).

Results: Patients were generally similar between the 10 trial clinics (n = 248,436) and 20 non-trial clinics (n = 341,130), although trial clinics' patients were slightly younger, more likely to be Hispanic/Latinx, less likely to be white, more likely to have Medicaid/subsidized insurance, and lived in less wealthy neighborhoods. Baseline outcomes did not differ between trial and non-trial clinics: trial clinics had 1.0 more patient-year of OUD treatment per 10,000 patients (95% CI: - 2.9, 5.0) and a 4% higher rate of days of acute care utilization than non-trial clinics (rate ratio: 1.04; 95% CI: 0.76, 1.42).

Conclusions: trial clinics and non-trial clinics were similar regarding most measured patient characteristics, and no differences were observed in baseline measures of trial primary and secondary outcomes. These findings suggest trial clinics were representative of comparably sized clinics within the same health systems. Although results do not reflect generalizability more broadly, this study illustrates an approach to assess representativeness of clinics in future pragmatic primary care trials.

Keywords: Buprenorphine; Implementation trial; Medication; Nurse care manager; Opioid use disorder; Primary care.

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Conflict of interest statement

Outside the work of this study, Dr. Wartko was funded through a contract awarded to the Harvard Department of Population Medicine from GlaxoSmithKline to assess medication use in pregnancy. Dr. Wartko receives funding from a research contract awarded to Kaiser Permanente Washington Health Research Institute from Syneos Health to conduct Food and Drug Administration-mandated post-marketing research on the risks of opioid analgesic use. Dr. Boudreau receives funding from a consulting contract from Syneos Health to conduct Food and Drug Administration-mandated post-marketing research on the risks of opioid analgesic use. Dr. Boudreau is now an employee of Genentech, Inc. Ms. Yu was awarded a grant by Bayer AG. Dr. Saxon has received consulting fees from Indivior, Inc., travel support from Alkermes, PLC., and royalties from UptoDate, Inc. Dr. Campbell is supported by grants and contracts from the National Institute on Drug Abuse (UG1-DA040314, R01-DA047405) and the Food and Drug Administration. She has received support managed through her institution from the Industry PMR Consortium, a consortium of companies working together to conduct post-marketing studies required by the Food and Drug Administration that assess risks related to opioid analgesic use.

Figures

Fig. 1
Fig. 1
Legend. Study timeline
See this image and copyright information in PMC

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