Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).

BACKGROUND: Experts recommend that treatment for substance use disorder (SUD) be integrated into primary care. The Digital Therapeutics for Opioids and Other SUD (DIGITS) Trial tests strategies for implementing reSET® and reSET-O®, which are prescription digital therapeutics for SUD and opioid use disorder, respectively, that include the community reinforcement approach, contingency management, and fluency training to reinforce concept mastery. This purpose of this trial is to test whether two implementation strategies improve implementation success (Aim 1) and achieve better population-level cost effectiveness (Aim 2) over a standard implementation approach. METHODS/DESIGN: The DIGITS Trial is a hybrid type III cluster-randomized trial. It examines outcomes of implementation strategies, rather than studying clinical outcomes of a digital therapeutic. It includes 22 primary care clinics from a healthcare system in Washington State and patients with unhealthy substance use who visit clinics during an active implementation period (up to one year). Primary care clinics implemented reSET and reSET-O using a multifaceted implementation strategy previously used by clinical leaders to roll-out smartphone apps ("standard implementation" including discrete strategies such as clinician training, electronic health record tools). Clinics were randomized as 21 sites in a 2x2 factorial design to receive up to two added implementation strategies: (1) practice facilitation, and/or (2) health coaching. Outcome data are derived from electronic health records and logs of digital therapeutic usage. Aim 1's primary outcomes include reach of the digital therapeutics to patients and fidelity of patients' use of the digital therapeutics to clinical recommendations. Substance use and engagement in SUD care are additional outcomes. In Aim 2, population-level cost effectiveness analysis will inform the economic benefit of the implementation strategies compared to standard implementation. Implementation is monitored using formative evaluation, and sustainment will be studied for up to one year using qualitative and quantitative research methods. DISCUSSION: The DIGITS Trial uses an experimental design to test whether implementation strategies increase and improve the delivery of digital therapeutics for SUDs when embedded in a large healthcare system. It will provide data on the potential benefits and cost-effectiveness of alternative implementation strategies. CLINICALTRIALS: gov Identifier: NCT05160233 (Submitted 12/3/2021). https://clinicaltrials.gov/ct2/show/NCT05160233.

Discrimination and Multimorbidity Among Black Americans: Findings from the National Survey of American Life.

OBJECTIVES: There is a notable lack of research on the risk factors for multimorbidity, which has become more common over recent decades. Black Americans experience discrimination more often than their White counterparts, and also have significantly higher prevalence of multimorbidity. This paper examines the associations between discrimination and multimorbidity among Black Americans. METHODS: We analyzed data from the National Survey of American Life to calculate the prevalence of two types of discrimination (everyday discrimination, major discriminatory events) and multimorbidity (physical, psychiatric, mixed, any). Using multivariable logistic regression, we examined the associations between discrimination and multimorbidity, adjusting for age, sex, years of education, income-to-poverty ratio, and ethnicity. The everyday discrimination scale was discretized into five categories (none, low, medium, high, very high), but was also treated as a continuous variable. The major discriminatory events were analyzed in separate adjusted models, and as a count of events. RESULTS: When compared with those who did not experience any discrimination, people who experienced everyday discrimination were significantly more likely to report all types of multimorbidity in a dose-response fashion at a conventional level of statistical significance. Most major discriminatory events were associated with greater odds of reporting all types of multimorbidity, as were the counts of major discriminatory events, in a dose-response fashion. CONCLUSIONS: We found strong evidence to suggest that discrimination was associated with greater odds of reporting multimorbidity. Future studies can expand on these findings using longitudinal data to capture the relations between discrimination and health over time, or by testing preventive interventions that allay the damaging health effects of discrimination.

Costs of using evidence-based implementation strategies for behavioral health integration in a large primary care system.

OBJECTIVE: To describe the cost of using evidence-based implementation strategies for sustained behavioral health integration (BHI) involving population-based screening, assessment, and identification at 25 primary care sites of Kaiser Permanente Washington (2015-2018). DATA SOURCES/STUDY SETTING: Project records, surveys, Bureau of Labor Statistics compensation data. STUDY DESIGN: Labor and nonlabor costs incurred by three implementation strategies: practice coaching, electronic health records clinical decision support, and performance feedback. DATA COLLECTION/EXTRACTION METHODS: Personnel time spent on these strategies was estimated for five broad roles: (a) project leaders and administrative support, (b) practice coaches, (c) clinical decision support programmers, (d) performance metric programmers, and (e) primary care local implementation team members. PRINCIPAL FINDING: Implementation involved 286 persons, 18 131 person-hours, costing $1 587 139 or $5 per primary care visit with screening or $38 per primary care visit identifying depression, suicidal thoughts and/or alcohol or substance use disorders, in a single year. The majority of person-hours was devoted to project leadership (35%) and practice coaches (34%), and 36% of costs were for the first three sites. CONCLUSIONS: When spread across patients screened in a single year, BHI implementation costs were well within the range for commonly used diagnostic assessments in primary care (eg, laboratory tests). This suggests that implementation costs alone should not be a substantial barrier to population-based BHI.

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.

Alcohol use and receipt of alcohol screening and brief intervention in a representative sample of sexual minority and heterosexual adults receiving health care.

BACKGROUND: Despite evidence of alcohol disparities between sexual minority and heterosexual individuals in the general population, research has not examined whether there are disparities in receipt of alcohol screening and brief intervention - together considered one of the highest prevention priorities for US adults. This study examined differences in alcohol use and receipt of alcohol screening and brief intervention across sexual minority status. METHODS: Behavioral Risk Factor Surveillance System 2014 data from eight US states were used to estimate patterns of alcohol use and receipt of alcohol screening and brief intervention among persons reporting sexual orientation and a checkup in the last two years (N=47,800). Analyses were conducted in 2016-2017. RESULTS: Gay men and bisexual women reported higher rates of alcohol use on some measures compared to heterosexual men and women, respectively. There were some differences in screening and brief intervention by sexual orientation. Lesbian women were more likely to report being asked about heavy episodic drinking than heterosexual women, and among those reporting unhealthy alcohol use, gay men were less likely, and bisexual men were more likely, to report receiving brief intervention compared to heterosexual men. CONCLUSIONS: Overall similarities between sexual minorities and heterosexuals in alcohol use and receipt of screening and brief intervention are encouraging. Nonetheless, research is needed to confirm findings and understand mechanisms underlying disparities in receipt of brief intervention between gay and heterosexual men.

Rethinking alcohol interventions in health care: a thematic meeting of the International Network on Brief Interventions for Alcohol & Other Drugs (INEBRIA).

In 2016, the International Network on Brief Interventions for Alcohol & Other Drugs convened a meeting titled "Rethinking alcohol interventions in health care". The aims of the meeting were to synthesize recent evidence about screening and brief intervention and to set directions for research, practice, and policy in light of this evidence. Screening and brief intervention is efficacious in reducing self-reported alcohol consumption for some with unhealthy alcohol use, but there are gaps in evidence for its effectiveness. Because screening and brief intervention is not known to be efficacious for individuals with more severe unhealthy alcohol use, recent data showing the lack of evidence for referral to treatment as part of screening and brief intervention are alarming. While screening and brief intervention was designed to be a population-based approach, its reach is limited. Implementation in real world care also remains a challenge. This report summarizes practice, research, and policy recommendations and key research developments from our meeting. In order to move the field forward, a research agenda was proposed to (1) address evidence gaps in screening, brief intervention, and referral to treatment, (2) develop innovations to address severe unhealthy alcohol use within primary care, (3) describe the stigma of unhealthy alcohol use, which obstructs progress in prevention and treatment, (4) reconsider existing conceptualizations of unhealthy alcohol use that may influence health care, and (5) identify efforts needed to improve the capacity for addressing unhealthy alcohol consumption in all world regions.

Intersections of poverty, race/ethnicity, and sex: alcohol consumption and adverse outcomes in the United States.

We examine whether intersectionality theory-which formalizes the notion that adverse health outcomes owing to having a marginalized social status, identity, or characteristic, may be magnified for individuals with an additional marginalized social status, identity, or characteristic-can be applied using quantitative methods to describe the differential effects of poverty on alcohol consumption across sex and race/ethnicity. Using the National Epidemiologic Survey on Alcohol and Related Conditions, we analyze longitudinal data from Black, Hispanic, and White drinkers (n = 21,140) to assess multiplicative interactions between poverty, as defined by the US Census Bureau, sex, and race/ethnicity, on adverse alcohol outcomes. Findings indicated that the effect of poverty on the past-year incidence of heavy episodic drinking was stronger among Black men and Black women in comparison to men and women of other racial/ethnic groups. Poverty reduction programs that are culturally informed may help reduce racial/ethnic disparities in the adverse outcomes of alcohol consumption.

Latent class analysis of alcohol treatment utilization patterns and 3-year alcohol related outcomes.

People who obtain treatment for alcohol use problems often utilize multiple sources of help. While prior studies have classified treatment use patterns for alcohol use, an empirical classification of these patterns is lacking. For the current study, we created an empirically derived classification of treatment use and described how these classifications were prospectively associated with alcohol-related outcomes. Our sample included 257 participants of the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC) who first received alcohol treatment in the 3-year period prior to their baseline interview. We used latent class analysis to identify classes of treatment users based on their patterns of treatment use of 13 types of alcohol treatment. Regression models examined how classes of treatment use at baseline were associated with alcohol-related outcomes assessed at a 3-year follow-up interview. Outcomes included a continuous measure of the quantity and frequency of alcohol use and DSM-IV alcohol use disorder status. Four classes of treatment users were identified: (1) multiservice users (8.7%), (2) private professional service users (32.8%), (3) alcoholics anonymous (AA) paired with specialty addiction service users (22.0%), and (4) users of AA alone (36.5%). Those who utilized AA paired with specialty addiction services had better outcomes compared to those who used AA alone. In addition to elucidating the most common treatment utilization patterns executed by people seeking help for their alcohol problems, the results from this study suggest that increased efforts may be needed to refer individuals across sectors of care to improve treatment outcomes.

Alcohol stigma and persistence of alcohol and other psychiatric disorders: a modified labeling theory approach.

BACKGROUND: We sought to apply modified labeling theory in a cross-sectional study of alcohol use disorder (AUD) to investigate the mechanisms through which perceived alcohol stigma (PAS) may lead to the persistence of AUD and risk of psychiatric disorder. METHODS: We conducted structural equation modeling (SEM) including moderated mediation analyses of two waves (W1 and W2) of data from the National Epidemiologic Survey on Alcohol and Related Conditions. We analyzed validated measures of PAS, perceived social support, social network involvement, and psychiatric disorders among (n=3608) adults with two or more DSM-5 AUD symptoms in the first two of the three years between the W1 and W2 survey. Cross-sectional analyses were conducted owing to the assessment of PAS only at W2. RESULTS: Per mediation analyses, lower levels of perceived social support explained the association of PAS with past-year AUD and past-year internalizing psychiatric disorder at W2. The size of the mediated relationship was significantly larger for those classified as labeled (i.e., alcoholic) per their prior alcohol treatment or perceived need (n=938) as compared to unlabeled (n=2634), confirming a hypothesis of moderated mediation. Unexpectedly, mediation was also present for unlabeled individuals. CONCLUSIONS: Lower levels of social support may be an important intermediate outcome of alcohol stigma. Longitudinal data are needed to establish the temporal precedence of PAS and its hypothesized intermediate and distal outcomes. Research is needed to evaluate direct measures of labeling that could replace proxy measures (e.g., prior treatment status) commonly employed in studies of the stigma of psychiatric disorders.