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Background Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. Methods The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. Discussion Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. Trial Registration : Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

Screening for unhealthy alcohol and drug use is recommended in primary care, and effective implementation requires understanding patients' perspectives. Failure to identify and address potential differences in attitudes toward screening across demographic groups may result in care gaps, but research examining this is limited. We surveyed 977 adult patients in 9 primary care clinics that participated in a screening implementation study. The survey collected demographics and attitudes toward screening/discussion of alcohol/drug use in primary care. We described responses overall and compared across age, gender, race, and ethnicity using Chi-square/Fisher's exact tests. Mean age was 51.1 years, and the sample was 39% male, 61% female, 72% White non-Hispanic, 11% Hispanic, 10% Black non-Hispanic, and 6% other/unknown race non-Hispanic. Most participants across all demographic groups reported supportive attitudes. Comfort reporting drug use was lower among young, male, Black non-Hispanic, and Hispanic patients, and comfort with screening overall was lower among middle-aged, Black non-Hispanic, and Hispanic patients. Results suggest that screening/discussion of alcohol/drug use in primary care is generally highly acceptable to patients across demographic groups. Strategies are needed to increase comfort and alleviate concerns about how medical information will be used, particularly among middle-aged, Black, and Hispanic patients.

Background Stroke is a major cause of death in Ghana. Evidence-based interventions for stroke prevention have been successful in the US; however, in low- and middle-income countries (LMICs), such interventions are scarce. The “Discharge Education Strategies for Reduction of Vascular Events” (DESERVE) intervention led to a 10-mmHg reduction in systolic blood pressure (SBP) among Hispanic survivors of mild/moderate stroke and transient ischemic attack (TIA) at 1-year follow-up. Our objectives were to capture the perceptions of a diverse set of stakeholders in an urban community in Ghana regarding (1) challenges to optimal hypertension management and (2) facilitators and barriers to implementation of an evidence-based, skills-based educational tool for hypertension management in this context. Methods This exploratory study used purposive sampling to enroll diverse stakeholders in Accra ( N = 38). To identify facilitators and barriers, we conducted three focus group discussions: one each with clinical nurses ( n = 5), community health nurses ( n = 20), and hypertensive adults ( n = 10). To further examine structural barriers, we conducted three key informant interviews with medical leadership. All interviews were audio recorded and transcribed. Thematic analysis was carried out via deductive coding based on Proctor’s implementation outcomes taxonomy, which conceptualizes constructs that shape implementation, such as acceptability, adoption, appropriateness, cost, and feasibility. Results Findings highlight facilitators, such as a perceived fit (appropriateness) of the core intervention components across stakeholders. The transferable components of DESERVE include: (1) a focus on risk knowledge, medication adherence, and patient–physician communication, (2) facilitation by lay workers, (3) use of patient testimonials, (4) use of a spirituality framework, and (5) application of a community-based approach. We report potential barriers that suggest adaptations to increase appropriateness and feasibility. These include addressing spiritual etiology of disease, allaying mistrust of biomedical intervention, and tailoring for gender norms. Acceptability may be a challenge among individuals with hypertension, who perceive relative advantage of alternative therapies like herbalism. Key informant interviews highlight structural barriers (high opportunity costs) among physicians, who perceive they have neither time nor capacity to educate patients. Conclusions Findings further support the need for theory-driven, evidence-based interventions among hypertensive adults in urban, multiethnic Ghana. Findings will inform implementation strategies and future research.

During the initial COVID-19 surge, one public hospital in NYC updated their post-discharge outreach approach for patients with substance use disorder, as part of the CATCH (Consult for Addiction Treatment and Care in Hospitals) program. Beginning April 1, 2020, three peers and two addiction counselors attempted telephonic outreach to patients who received a CATCH consultation during hospitalization from program launch (October 7, 2019) through March 31, 2020 ( n  = 329). Outreach calls could include counseling, in-depth peer support, and referrals to substance use services (SUS)—a significant expansion of the services offered via outreach pre-pandemic. CATCH staff successfully reached 29.5% of patients and provided 77.6% of them with supportive counseling and referrals. Thirty percent of unsuccessful calls were due to inactive numbers, and only 8% of patients without housing were reached. Telephonic outreach established a low-barrier connection between patients and SUS that may be valuable during any period, including non-COVID times. Future interventions that address social determinants such as housing and cell phone access concomitantly with substance use should be considered by addiction consultation services to potentially reduce acute care utilization and improve health outcomes.

With acute care utilization and mortality rates increasing among people with opioid use disorder, hospital addiction consult services can provide an important touchpoint for care, potentially leading to improved outcomes. To study the effectiveness of interprofessional hospital addiction consultation services on postdischarge acute care utilization and mortality. In this pragmatic stepped-wedge cluster randomized implementation and effectiveness (hybrid type 1) clinical trial, 6 New York City public hospitals were randomized to an intervention start date, and outcomes were compared during treatment as usual (TAU) and intervention conditions. Participants included adults with hospitalizations identified in Medicaid claims data between October 2017 and January 2021. Eligible patients had an admission or discharge diagnosis of opioid use disorder or opioid poisoning or adverse effects, were hospitalized at least 1 night in a medical or surgical inpatient unit, and were not receiving medication for opioid use disorder before hospitalization. Hospitals implemented the Consult for Addiction Treatment and Care in Hospitals (CATCH) program, an interprofessional inpatient addiction consult service providing specialty care for substance use disorders, with teams consisting of a medical clinician, social worker or addiction counselor, and peer counselor. Acute care utilization (hospitalizations and emergency department [ED] visits) and mortality rates (all-cause deaths, overdose deaths, and opioid-involved overdose deaths) 1 year after hospital discharge. Data for the eligible patients were analyzed July 2023 to September 2024. In total, 1355 eligible admissions were identified (968 [71.4%] men; mean [SD] age, 46.6 [12.4] years). A majority of patients (835 [61.5%]) had at least 1 subsequent hospitalization or ED visit. There were 113 deaths, including 34 overdose deaths (30.1%), of which 28 (82.4%) involved opioids. ED admissions were lower in the intervention period compared with TAU (incidence rate ratio, 0.79 [95% CI, 0.72-0.88]; P < .001). There were no statistically significant differences between CATCH and TAU periods in numbers of hospitalizations (incidence rate ratio, 0.99 [95% CI, 0.87-1.13]) or mortality (eg, hazard ratio for all-cause death, 1.14 [95% CI, 0.98-1.92]). In this prespecified secondary analysis of a cluster randomized clinical trial, postdischarge ED visits decreased with the CATCH program, highlighting the potential of hospital-based addiction consult services to address needs of patients with opioid use. Nonetheless, high rates of acute care utilization and mortality persisted, underscoring the need for comprehensive care strategies that extend beyond the hospital walls, and addressing the complex health and social needs of individuals with opioid use. ClinicalTrials.gov Identifier: NCT03611335.

In this chapter, we discuss the importance of diversity and the inclusion of women and racial/ethnic minority groups in clinical research as a foundation for addressing health disparities. First, we provide a brief background on the scientific and ethical significance of diversity and inclusion in clinical research. Next, we discuss barriers to recruiting representative study populations, including: (i) optimizing the screening pool, (ii) converting eligible participants to enrolled research subjects, and (iii) retaining subjects in a study. We specifically examine patient/community‐, investigator‐, and structural/institutional‐level barriers. Finally, we summarize various best practices for enhancing inclusion of under‐represented groups in clinical research, as well as future directions and research needs.