Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline.

BACKGROUND: The CHOICE care management intervention did not improve drinking relative to usual care (UC) for patients with frequent heavy drinking at high risk of alcohol use disorders. Patients with alcohol dependence were hypothesized to benefit most. We conducted preplanned secondary analyses to test whether the CHOICE intervention improved drinking relative to UC among patients with and without baseline DSM-IV alcohol dependence. METHODS: A total of 304 patients reporting frequent heavy drinking from 3 VA primary care clinics were randomized (stratified by DSM-IV alcohol dependence, sex, and site) to UC or the patient-centered, nurse-delivered, 12-month CHOICE care management intervention. Primary outcomes included percent heavy drinking days (%HDD) using 28-day timeline follow-back and a "good drinking outcome" (GDO)-abstaining or drinking below recommended limits and no alcohol-related symptoms on the Short Inventory of Problems at 12 months. Generalized estimating equation binomial regression models (clustered on provider) with interaction terms between dependence and intervention group were fit. RESULTS: At baseline, 59% of intervention and UC patients had DSM-IV alcohol dependence. Mean drinking outcomes improved for all subgroups. For participants with dependence, 12-month outcomes did not differ for intervention versus UC patients (%HDD 37% versus 38%, p = 0.76 and GDO 16% versus 16%, p = 0.77). For participants without dependence, %HDD did not differ between intervention (41%) and UC (31%) patients (p = 0.12), but the proportion with GDO was significantly higher among UC participants (26% versus 13%, p = 0.046). Neither outcome was significantly modified by dependence (interaction p values 0.19 for %HDD and 0.10 for GDO). CONCLUSIONS: Among participants with frequent heavy drinking, care management had no benefit relative to UC for patients with dependence, but UC may have had benefits for those without dependence. TRIAL REGISTRATION: ClinicalTrials.gov NCT01400581.

Offering nurse care management for opioid use disorder in primary care: Impact on emergency and hospital utilization in a cluster-randomized implementation trial.

BACKGROUND: Patients with opioid use disorder (OUD) have increased emergency and hospital utilization. The PROUD trial showed that implementation of office-based addiction treatment (OBAT) increased OUD medication treatment compared to usual care, but did not decrease acute care utilization in patients with OUD documented pre-randomization (clinicaltrials.gov/study/NCT03407638). This paper reports secondary emergency and hospital utilization outcomes in patients with documented OUD in the PROUD trial. METHODS: This cluster-randomized implementation trial was conducted in 12 clinics from 6 diverse health systems (March 2015-February 2020). Patients who visited trial clinics and had an OUD diagnosis within 3 years pre-randomization were included in primary analyses; secondary analyses added patients with OUD who were new to the clinic or with newly-documented OUD post-randomization. Outcomes included days of emergency care and hospital utilization over 2 years post-randomization. Explanatory outcomes included measures of OUD treatment. Patient-level analyses used mixed-effect regression with clinic-specific random intercepts. RESULTS: Among 1988 patients with documented OUD seen pre-randomization (mean age 49, 53 % female), days of emergency care or hospitalization did not differ between intervention and usual care; OUD treatment also did not differ. In secondary analyses among 1347 patients with OUD post-randomization, there remained no difference in emergency or hospital utilization despite intervention patients receiving 32.2 (95 % CI 4.7, 59.7) more days of OUD treatment relative to usual care. CONCLUSIONS: Implementation of OBAT did not reduce emergency or hospital utilization among patients with OUD, even in the sample with OUD first documented post-randomization in whom the intervention increased treatment.

Changes in alcohol consumption reported on routine healthcare screenings are associated with changes in depression symptoms.

BACKGROUND: The Alcohol Use Disorders Identification Test-Consumption version (AUDIT-C) has been robustly validated as a point-in-time screen for unhealthy alcohol use, but less is known about the significance of changes in AUDIT-C scores from routine screenings over time. Unhealthy alcohol use and depression commonly co-occur, and changes in drinking often co-occur with changes in depression symptoms. We assess the associations between changes in AUDIT-C scores and changes in depression symptoms reported on brief screens completed in routine care. METHODS: The study sample included 198,335 primary care patients who completed two AUDIT-C screens 11 to 24 months apart and the Patient Health Questionnaire-2 (PHQ-2) depression screen on the same day as each AUDIT-C. Both screening measures were completed as part of routine care within a large health system in Washington state. AUDIT-C scores were categorized to reflect five drinking levels at both time points, resulting in 25 subgroups with different change patterns. For each of the 25 subgroups, within-group changes in the prevalence of positive PHQ-2 depression screens were characterized using risk ratios (RRs) and McNemar's tests. RESULTS: Patient subgroups with increases in AUDIT-C risk categories generally experienced increases in the prevalence of positive depression screens (RRs ranging from 0.95 to 2.00). Patient subgroups with decreases in AUDIT-C risk categories generally experienced decreases in the prevalence of positive depression screens (RRs ranging from 0.52 to 1.01). Patient subgroups that did not have changes in AUDIT-C risk categories experienced little or no change in the prevalence of positive depression screens (RRs ranging from 0.98 to 1.15). CONCLUSIONS: As hypothesized, changes in alcohol consumption reported on AUDIT-C screens completed in routine care were associated with changes in depression screening results. Results support the validity and clinical utility of monitoring changes in AUDIT-C scores over time as a meaningful measure of changes in drinking.

Integrating Alcohol-Related Prevention and Treatment Into Primary Care: A Cluster Randomized Implementation Trial.

Importance: Unhealthy alcohol use is common and affects morbidity and mortality but is often neglected in medical settings, despite guidelines for both prevention and treatment. Objective: To test an implementation intervention to increase (1) population-based alcohol-related prevention with brief interventions and (2) treatment of alcohol use disorder (AUD) in primary care implemented with a broader program of behavioral health integration. Design, Setting, and Participants: The Sustained Patient-Centered Alcohol-Related Care (SPARC) trial was a stepped-wedge cluster randomized implementation trial, including 22 primary care practices in an integrated health system in Washington state. Participants consisted of all adult patients (aged ≥18 years) with primary care visits from January 2015 to July 2018. Data were analyzed from August 2018 to March 2021. Interventions: The implementation intervention included 3 strategies: practice facilitation; electronic health record decision support; and performance feedback. Practices were randomly assigned launch dates, which placed them in 1 of 7 waves and defined the start of the practice's intervention period. Main Outcomes and Measures: Coprimary outcomes for prevention and AUD treatment were (1) the proportion of patients who had unhealthy alcohol use and brief intervention documented in the electronic health record (brief intervention) for prevention and (2) the proportion of patients who had newly diagnosed AUD and engaged in AUD treatment (AUD treatment engagement). Analyses compared monthly rates of primary and intermediate outcomes (eg, screening, diagnosis, treatment initiation) among all patients who visited primary care during usual care and intervention periods using mixed-effects regression. Results: A total of 333 596 patients visited primary care (mean [SD] age, 48 [18] years; 193 583 [58%] female; 234 764 [70%] White individuals). The proportion with brief intervention was higher during SPARC intervention than usual care periods (57 vs 11 per 10 000 patients per month; P < .001). The proportion with AUD treatment engagement did not differ during intervention and usual care (1.4 vs 1.8 per 10 000 patients; P = .30). The intervention increased intermediate outcomes: screening (83.2% vs 20.8%; P < .001), new AUD diagnosis (33.8 vs 28.8 per 10 000; P = .003), and treatment initiation (7.8 vs 6.2 per 10 000; P = .04). Conclusions and Relevance: In this stepped-wedge cluster randomized implementation trial, the SPARC intervention resulted in modest increases in prevention (brief intervention) but not AUD treatment engagement in primary care, despite important increases in screening, new diagnoses, and treatment initiation. Trial Registration: ClinicalTrials.gov Identifier: NCT02675777.

Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Ambient Particle Components and Newborn Blood Pressure in Project Viva.

Background Both elemental metals and particulate air pollution have been reported to influence adult blood pressure (BP). The aim of this study is to examine which elemental components of particle mass with diameter ≤2.5 µm (PM2.5) are responsible for previously reported associations between PM2.5 and neonatal BP. Methods and Results We studied 1131 mother-infant pairs in Project Viva, a Boston-area prebirth cohort. We measured systolic BP (SBP) and diastolic BP (DBP) at a mean age of 30 hours. We calculated average exposures during the 2 to 7 days before birth for the PM2.5 components-aluminum, arsenic, bromine, sulfur, copper, iron, zinc, nickel, vanadium, titanium, magnesium, potassium, silicon, sodium, chlorine, calcium, and lead-measured at the Harvard supersite. Adjusting for covariates and PM2.5, we applied regression models to examine associations between PM2.5 components and median SBP and DBP, and used variable selection methods to select which components were more strongly associated with each BP outcome. We found consistent results with higher nickel associated with significantly higher SBP and DBP, and higher zinc associated with lower SBP and DBP. For an interquartile range increase in the log Z score (1.4) of nickel, we found a 1.78 mm Hg (95% CI, 0.72-2.84) increase in SBP and a 1.30 (95% CI, 0.54-2.06) increase in DBP. Increased zinc (interquartile range log Z score 1.2) was associated with decreased SBP (-1.29 mm Hg; 95% CI, -2.09 to -0.50) and DBP (-0.85 mm Hg; 95% CI: -1.42 to -0.29). Conclusions Our findings suggest that prenatal exposures to particulate matter components, and particularly nickel, may increase newborn BP.

Alcohol-Related Nurse Care Management in Primary Care: A Randomized Clinical Trial.

Importance: Experts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear. Objective: To test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs. Design, Setting, and Participants: This randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (≥4 drinks per day for women and ≥5 drinks per day for men). Interventions: Nurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care. Main Outcomes and Measures: Primary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems. Results: Of 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n = 150) and usual care (n = 154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P = .32-.44). Findings at 3 months were similar. Conclusions and Relevance: The CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care. Trial Registration: clinicaltrials.gov Identifier: NCT01400581.