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.

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.

Practical Assessment of Alcohol Use Disorder in Routine Primary Care: Performance of an Alcohol Symptom Checklist.

BACKGROUND: Alcohol use disorder (AUD) is highly prevalent but underrecognized and undertreated in primary care settings. Alcohol Symptom Checklists can engage patients and providers in discussions of AUD-related care. However, the performance of Alcohol Symptom Checklists when they are used in routine care and documented in electronic health records (EHRs) remains unevaluated. OBJECTIVE: To evaluate the psychometric performance of an Alcohol Symptom Checklist in routine primary care. DESIGN: Cross-sectional study using item response theory (IRT) and differential item functioning analyses of measurement consistency across age, sex, race, and ethnicity. PATIENTS: Patients seen in primary care in the Kaiser Permanente Washington Healthcare System who reported high-risk drinking on the Alcohol Use Disorder Identification Test Consumption screening measure (AUDIT-C ≥ 7) and subsequently completed an Alcohol Symptom Checklist between October 2015 and February 2020. MAIN MEASURE: Alcohol Symptom Checklists with 11 items assessing AUD criteria defined in the Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5), completed by patients during routine medical care and documented in EHRs. KEY RESULTS: Among 11,464 patients who screened positive for high-risk drinking and completed an Alcohol Symptom Checklist (mean age 43.6 years, 30.5% female), 54.1% reported ≥ 2 DSM-5 AUD criteria (threshold for AUD diagnosis). IRT analyses demonstrated that checklist items measured a unidimensional continuum of AUD severity. Differential item functioning was observed for some demographic subgroups but had minimal impact on accurate measurement of AUD severity, with differences between demographic subgroups attributable to differential item functioning never exceeding 0.42 points of the total symptom count (of a possible range of 0-11). CONCLUSIONS: Alcohol Symptom Checklists used in routine care discriminated AUD severity consistently with current definitions of AUD and performed equitably across age, sex, race, and ethnicity. Integrating symptom checklists into routine care may help inform clinical decision-making around diagnosing and managing AUD.

Routine Assessment of Symptoms of Substance Use Disorders in Primary Care: Prevalence and Severity of Reported Symptoms.

BACKGROUND: Most patients with substance use disorders (SUDs) never receive treatment and SUDs are under-recognized in primary care (PC) where patients can be treated or linked to treatment. Asking PC patients to directly report SUD symptoms on questionnaires might help identify SUDs but to our knowledge, this approach is previously untested. OBJECTIVE: To describe the prevalence and severity of DSM-5 SUD symptoms reported by PC patients as part of routine care. DESIGN: Cross-sectional study using secondary data. PARTICIPANTS: A total of 241,265 adult patients who visited one of 25 PC sites in an integrated health system in Washington state and had alcohol, cannabis, or other drug use screening documented in their EHRs (March 2015-July 2018) were included in main analyses if they had a positive screen for high-risk substance use defined as AUDIT-C score 7-12 points, or report of past-year daily cannabis use or any other drug use. MAIN MEASURES: The main outcome was number of SUD symptoms based on Diagnostic and Statistical Manual, 5th edition (DSM-5), reported on Symptom Checklists (0-11) for alcohol or other drugs: 2-3 mild; 4-5 moderate; 6-11 severe. RESULTS: Of screened patients, 16,776 (5.7%) reported high-risk use of alcohol (2.4%), cannabis (3.9%), and/or other drugs (1.7%), and 65.0-69.9% of those completed Symptom Checklists. Of those with high-risk alcohol use, 52.5% (95% CI 50.9-54.0%) reported ≥ 2 symptoms consistent with mild-severe alcohol use disorders. Of those reporting daily cannabis use, 29.8% (28.6-30.9%) reported ≥ 2 symptoms consistent with mild-severe SUDs. Of those reporting any other drug use, 37.5% (35.7-39.3%) reported ≥ 2 symptoms consistent with mild-severe SUDs. CONCLUSIONS AND RELEVANCE: Many PC patients who screened positive for high-risk substance use reported symptoms consistent with DSM-5 SUDs on self-report Symptom Checklists. Use of SUD Symptom Checklists could support PC providers in making SUD diagnoses and initiating discussions of substance use.

Integration of screening, assessment, and treatment for cannabis and other drug use disorders in primary care: An evaluation in three pilot sites.

BACKGROUND: This pilot study evaluated whether use of evidence-based implementation strategies to integrate care for cannabis and other drug use into primary care (PC) as part of Behavioral Health Integration (BHI) increased diagnosis and treatment of substance use disorders (SUDs). METHODS: Patients who visited the three pilot PC sites were eligible. Implementation strategies included practice coaching, electronic health record decision support, and performance feedback (3/2015-4/2016). BHI introduced annual screening for past-year cannabis and other drug use, a Symptom Checklist for DSM-5 SUDs, and shared decision-making about treatment options. Main analyses tested whether the proportions of PC patients diagnosed with, and treated for, new cannabis or other drug use disorders (CUDs and DUDs, respectively), differed significantly pre- and post-implementation. RESULTS: Of 39,599 eligible patients, 57% and 59% were screened for cannabis and other drug use, respectively. Among PC patients reporting daily cannabis use (2%) or any drug use (1%), 51% and 37%, respectively, completed an SUD Symptom Checklist. The proportion of PC patients with newly diagnosed CUD increased significantly post-implementation (5 v 17 per 10,000 patients, p < 0.0001), but not other DUDs (10 vs 13 per 10,000, p = 0.24). The proportion treated for newly diagnosed CUDs did not increase post-implementation (1 vs 1 per 10,000, p = 0.80), but did for those treated for newly diagnosed other DUDs (1 vs 3 per 10,000, p = 0.038). CONCLUSIONS: A pilot implementation of BHI to increase routine screening and assessment for SUDs was associated with increased new CUD diagnoses and a small increase in treatment of new other DUDs.

Comparison of DSM-IV and DSM-5 criteria for alcohol use disorders in VA primary care patients with frequent heavy drinking enrolled in a trial.

BACKGROUND: Criteria for alcohol use disorders (AUD) in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) were intended to result in a similar prevalence of AUD as DSM-IV. We evaluated the prevalence of AUD using DSM-5 and DSM-IV criteria, and compared characteristics of patients who met criteria for: neither DSM-5 nor DSM-IV AUD, DSM-5 alone, DSM-IV alone, or both, among Veterans Administration (VA) outpatients in the Considering Healthier drinking Options In primary CarE (CHOICE) trial. METHODS: VA primary care patients who reported frequent heavy drinking and enrolled in the CHOICE trial were interviewed at baseline using the DSM-IV Mini International Neuropsychiatric Interview for AUD, as well as questions about socio-demographics, mental health, alcohol craving, and substance use. We compared characteristics across 4 mutually exclusive groups based on DSM-5 and DSM-IV criteria. RESULTS: Of 304 participants, 13.8% met criteria for neither DSM-5 nor DSM-IV AUD; 12.8% met criteria for DSM-5 alone, and 73.0% met criteria for both DSM-IV and DSM-5. Only 1 patient (0.3%) met criteria for DSM-IV AUD alone. Patients meeting both DSM-5 and DSM-IV criteria had more negative drinking consequences, mental health symptoms and self-reported readiness to change compared with those meeting DSM-5 criteria alone or neither DSM-5 nor DSM-IV criteria. CONCLUSIONS: In this sample of primary care patients with frequent heavy drinking, DSM-5 identified 13% more patients with AUD than DSM-IV. This group had a lower mental health symptom burden and less self-reported readiness to change compared to those meeting criteria for both DSM-IV and DSM-5 AUD. Trial Registration ClinicalTrials.gov NCT01400581. 2011 February 17.