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
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 th...
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | BMC Health Services Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12913-022-08915-1 |
| _version_ | 1828083397033984000 |
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| author | Paige D Wartko Hongxiang Qiu Abisola E. Idu Onchee Yu Jennifer McCormack Abigail G. Matthews Jennifer F. Bobb Andrew J. Saxon Cynthia I. Campbell David Liu Jordan M. Braciszewski Sean M. Murphy Rachael P. Burganowski Mark T. Murphy Viviana E. Horigian Leah K. Hamilton Amy K. Lee Denise M. Boudreau Katharine A. Bradley |
| author_facet | Paige D Wartko Hongxiang Qiu Abisola E. Idu Onchee Yu Jennifer McCormack Abigail G. Matthews Jennifer F. Bobb Andrew J. Saxon Cynthia I. Campbell David Liu Jordan M. Braciszewski Sean M. Murphy Rachael P. Burganowski Mark T. Murphy Viviana E. Horigian Leah K. Hamilton Amy K. Lee Denise M. Boudreau Katharine A. Bradley |
| author_sort | Paige D Wartko |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T04:08:24Z |
| format | Article |
| id | doaj.art-51c82585c146449a8ba58eda1fb695e8 |
| institution | Directory Open Access Journal |
| issn | 1472-6963 |
| language | English |
| last_indexed | 2024-04-11T04:08:24Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Health Services Research |
| spelling | doaj.art-51c82585c146449a8ba58eda1fb695e82023-01-01T12:15:51ZengBMCBMC Health Services Research1472-69632022-12-0122111110.1186/s12913-022-08915-1Baseline 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 systemsPaige D Wartko0Hongxiang Qiu1Abisola E. Idu2Onchee Yu3Jennifer McCormack4Abigail G. Matthews5Jennifer F. Bobb6Andrew J. Saxon7Cynthia I. Campbell8David Liu9Jordan M. Braciszewski10Sean M. Murphy11Rachael P. Burganowski12Mark T. Murphy13Viviana E. Horigian14Leah K. Hamilton15Amy K. Lee16Denise M. Boudreau17Katharine A. Bradley18Kaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteThe Emmes CompanyThe Emmes CompanyKaiser Permanente Washington Health Research InstituteCenter of Excellence in Substance Addiction Treatment and Education, VA Puget Sound Health Care SystemKaiser Permanente Northern California Division of ResearchNational Institute on Drug Abuse Center for Clinical Trials NetworkHenry Ford Health, One Ford PlaceDepartment of Population Health Sciences, Weill Cornell Medical CollegeKaiser Permanente Washington Health Research InstituteMultiCare Health SystemDepartment of Public Health Sciences, Miller School of Medicine, University of MiamiKaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteKaiser Permanente Washington Health Research InstituteAbstract 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.https://doi.org/10.1186/s12913-022-08915-1BuprenorphineMedicationNurse care managerOpioid use disorderImplementation trialPrimary care |
| spellingShingle | Paige D Wartko Hongxiang Qiu Abisola E. Idu Onchee Yu Jennifer McCormack Abigail G. Matthews Jennifer F. Bobb Andrew J. Saxon Cynthia I. Campbell David Liu Jordan M. Braciszewski Sean M. Murphy Rachael P. Burganowski Mark T. Murphy Viviana E. Horigian Leah K. Hamilton Amy K. Lee Denise M. Boudreau Katharine A. Bradley 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 BMC Health Services Research Buprenorphine Medication Nurse care manager Opioid use disorder Implementation trial Primary care |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Buprenorphine Medication Nurse care manager Opioid use disorder Implementation trial Primary care |
| url | https://doi.org/10.1186/s12913-022-08915-1 |
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