Background: Unhealthy alcohol use represents a significant risk for morbidity and mortality among people living with HIV (PLWH), in part through its impact on HIV management. Chronic pain, a common comorbidity, exacerbates suboptimal engagement in the HIV care continuum and has reciprocal detrimental effects on alcohol outcomes. There are no integrated, accessible approaches that address these comorbid conditions among PLWH to date. This paper describes a research study protocol of an integrated telehealth intervention to reduce unhealthy drinking and chronic pain among PLWH (Motivational and Cognitive-Behavioral Management for Alcohol and Pain [INTV]).
Methods: Two-hundred and fifty PLWH with unhealthy drinking and chronic pain will be recruited nationally via online advertisement. Informed consent and baseline assessments occur remotely, followed by 15 days of ecological momentary assessment to assess alcohol use, chronic pain, functioning, and mechanisms of behavior change. Next, participants will be randomized to either the INTV or Control (CTL) condition. Individuals in both conditions will meet with a health counselor through videoconferencing following randomization, and those in the INTV condition will receive 6 additional sessions. At 3- and 6-months post-baseline, participants will complete outcome assessments. It is hypothesized that the INTV condition will result in reduced unhealthy alcohol use and pain ratings compared to the CTL condition.
Conclusion: This protocol paper describes a randomized controlled trial which tests the efficacy of a novel, integrated telehealth approach to reduce unhealthy alcohol use and chronic pain for PLWH, two common comorbid conditions that influence the HIV treatment cascade.
Clinicaltrials:
Gov identifier: NCT05503173.
Background: Opioid related overdose morbidity and mortality continue to significantly impact rural communities. Nationwide, emergency departments (EDs) have seen an increase in opioid use disorder (OUD)-related visits compared to other substance use disorders (SUD). ED-initiated buprenorphine is associated with increased treatment engagement at 30 days. However, few studies assess rural ED-initiated buprenorphine implementation, which has unique implementation barriers. This protocol outlines the rationale and methods of a rural ED-initiated buprenorphine program implementation study.
Methods: This is a two-year longitudinal implementation design with repeated qualitative and quantitative measures of an ED-initiated buprenorphine program in the rural Mountain West. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework outlines intervention assessments. The primary outcome is implementation measured by ED-initiated buprenorphine protocol core components. Reach, adoption, and maintenance are secondary outcomes. External facilitators from an academic institution with addiction medicine and prior program implementation expertise partnered with community hospital internal facilitators to form an implementation team. External facilitators provide ongoing support, recommendations, education, and academic detailing. The implementation team designed and implemented the rural ED-initiated buprenorphine program. The program includes OUD screening, low-threshold buprenorphine initiation, naloxone distribution and administration training, and patient navigator incorporation to provide warm hand off referrals for outpatient OUD management. To address rural based implementation barriers, we organized implementation strategies based on Expert Recommendations for Implementing Change (ERIC). Implementation strategies include ED workflow redesign, local needs assessments, ED staff education, hospital leadership and clinical champion involvement, as well as patient and community resources engagement.
Discussion: Most ED-initiated buprenorphine implementation studies have been conducted in urban settings, with few involving rural areas and none have been done in the rural Mountain West. Rural EDs face unique barriers, but tailored implementation strategies with external facilitation support may help address these. This protocol could help identify effective rural ED-initiated buprenorphine implementation strategies to integrate more accessible OUD treatment within rural communities to prevent further morbidity and mortality.
Trial registration: ClinicalTrials.gov National Clinical Trials, NCT06087991. Registered 11 October 2023 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06087991 .
Background: Unhealthy alcohol use is a common public health problem in HIV care settings in Africa and it affects the HIV continuum of care. In Uganda and other low-income countries, HIV care providers are a key resource in caring for young people (15-24 years) living with HIV (YPLH) with unhealthy alcohol use. Caring for YPLH largely depends on care providers' perceptions of the problem. However, data that explores HIV care providers' perceptions about caring for YPLH with unhealthy drinking are lacking in Uganda. We sought to describe the perceptions of HIV care providers regarding caring for YPLH with unhealthy drinking in the Immune Suppression Syndrome (ISS) Clinic of Mbarara Regional Referral Hospital in southwestern Uganda.
Methods: We used semi-structured in-depth interviews (IDIs) to qualitatively explore HIV care providers' perceptions regarding caring for YPLH with unhealthy alcohol use. The study was conducted at the adolescent immunosuppression (ISS) clinic of Mbarara Regional Referral Hospital. Interviews were tape-recorded and transcribed verbatim. Using thematic content analysis, data from 10 interviews were analyzed.
Results: HIV care providers were concerned and intended to care for YPLH with unhealthy alcohol use. They understood that unhealthy drinking negatively impacts HIV care outcomes and used counseling, peer support, and referrals to routinely intervene. They however, did not apply other known interventions such as health education, medications and follow-up visits because these required family and institutional support which was largely lacking. Additional barriers that HCPs faced in caring for YPLH included; gaps in knowledge and skills required to address alcohol use in young patients, heavy workloads that hindered the provision of psychosocial interventions, late payment of and low remunerations, lack of improvement in some YPLH, and inadequate support from both their families and hospital management.
Conclusion: HIV care providers are important stakeholders in the identification and care of YPLH with unhealthy alcohol use in Southwestern Uganda. There is a need to train and skill HCPs in unhealthy alcohol use care. Such training ought to target the attitudes, subjective norms, and perceived control of the providers.
Background: Diagnosis of alcohol use disorder (AUD) in primary care is critical for increasing access to alcohol treatment. However, AUD is underdiagnosed and may be inequitably diagnosed due to societal structures that determine access to resources (e.g., structural racism that limits opportunities for some groups and influences interpersonal interactions in and beyond health care). This study described patterns of provider-documented AUD in primary care across intersections of race, ethnicity, sex, and community-level socioeconomic status (SES).
Methods: This cross-sectional study used EHR data from a regional healthcare system with 35 primary care clinics that included adult patients who completed alcohol screenings between 3/1/2015 and 9/30/2020. The prevalence of provider-documented AUD in primary care based on International Classification of Diseases-9 (ICD-9) and ICD-10 diagnoses was compared across intersections of race, ethnicity, sex, and community-level SES.
Results: Among 439,375 patients, 6.6% were Latine, 11.0% Asian, 5.4% Black, 1.3% Native Hawaiian/Pacific Islander (NH/PI), 1.5% American Indian/Alaska Native (AI/AN), and 74.2% White, and 58.3% women. The overall prevalence of provider-documented AUD was 1.0% and varied across intersecting identities. Among women, the prevalence was highest for AI/AN women with middle SES, 1.5% (95% CI 1.0-2.3), and lowest for Asian women with middle SES, 0.1% (95% CI 0.1-0.2). Among men, the prevalence was highest for AI/AN men with high and middle SES, 2.0% (95% CI 1.1-3.4) and 2.0% (95% CI 1.2-3.2), respectively, and lowest for Asian men with high SES, 0.5% (95% CI 0.3-0.7). Black and Latine patients tended to have a lower prevalence of AUD than White patients, across all intersections of sex and SES except for Black women with high SES. There were no consistent patterns of the prevalence of AUD diagnosis that emerged across SES.
Conclusion: The prevalence of provider-documented AUD in primary care was highest in AI/AN men and women and lowest in Asian men and women. Findings of lower prevalence of provider-documented AUD in Black and Hispanic than White patients across most intersections of sex and SES differed from prior studies. Findings may suggest that differences in access to resources, which vary in effects across these identity characteristics and lived experiences, influence the diagnosis of AUD in clinical care.
Background: Many people with opioid use disorder who stand to benefit from buprenorphine treatment are unwilling to initiate it due to experience with or fear of both spontaneous and buprenorphine-precipitated opioid withdrawal (BPOW). An effective means of minimizing withdrawal symptoms would reduce patient apprehensiveness, lowering the barrier to buprenorphine initiation. Ketamine, approved by the FDA as a dissociative anesthetic, completely resolved BPOW in case reports when infused at a sub-anesthetic dose range in which dissociative symptoms are common. However, most patients attempt buprenorphine initiation in the outpatient setting where altered mental status is undesirable. We explored the potential of short-term use of ketamine, self-administered sublingually at a lower, sub-dissociative dose to assist ambulatory patients undergoing transition to buprenorphine from fentanyl and methadone.
Methods: Patients prescribed ketamine were either (1) seeking transition to buprenorphine from illicit fentanyl and highly apprehensive of BPOW or (2) undergoing transition to buprenorphine from illicit fentanyl or methadone and experiencing BPOW. We prescribed 4-8 doses of sublingual ketamine 16 mg (each dose bioequivalent to 3-6% of an anesthetic dose), monitored patients daily or near-daily, and adjusted buprenorphine and ketamine dosing based on patient response and prescriber experience.
Results: Over a period of 14 months, 37 patients were prescribed ketamine. Buprenorphine initiation was completed by 16 patients, representing 43% of the 37 patients prescribed ketamine, and 67% of the 24 who reported trying it. Of the last 12 patients who completed buprenorphine initiation, 11 (92%) achieved 30-day retention in treatment. Most of the patients who tried ketamine reported reduction or elimination of spontaneous opioid withdrawal symptoms. Some patients reported avoidance of severe BPOW when used prophylactically or as treatment of established BPOW. We developed a ketamine protocol that allowed four of the last patients to complete buprenorphine initiation over four days reporting only mild withdrawal symptoms. Two patients described cognitive changes from ketamine at a dose that exceeded the effective dose range for the other patients.
Conclusions: Ketamine at a sub-dissociative dose allowed completion of buprenorphine initiation in the outpatient setting in the majority of patients who reported trying it. Further research is warranted to confirm these results and develop reliable protocols for a range of treatment settings.
Background: Although clinical substance use disorder (SUD) care is multidisciplinary there are few opportunities to collaborate for quality improvement or systems change. In Oregon, the Project ECHO (Extension for Community Healthcare Outcomes) model was adapted to create a novel multidisciplinary SUD Leadership ECHO. The objective of this study was to understand the unique effects of the adapted ECHO model, determine if the SUD Leadership ECHO could promote systems change, and identify elements that enabled participant-leaders to make changes.
Methods: Four focus groups were conducted between August and September of 2022 with a purposive sample of participants from the second cohort of the Oregon ECHO Network's SUD Leadership ECHO that ran January to June 2022. Focus group domains addressed the benefits of the adapted ECHO model, whether and why participants were able to make systems change following participation in the ECHO, and recommendations for improvement. Thematic analysis developed emergent themes.
Results: 16 of the 53 ECHO participants participated in the focus groups. We found that the SUD Leadership ECHO built a multi-disciplinary community of practice among leaders and reduced isolation and burnout. Three participants reported making organizational changes following participation in the ECHO. Those who successfully made changes heard best practices and how other organizations approached problems. Barriers to initiating practice and policy changes included lack of formal leadership authority, time constraints, and higher-level systemic issues. Participants desired for future iterations of the ECHO more focused presentations on a singular topic, and asked for a greater focus on solutions, advocacy, and next steps.
Conclusions: The adapted ECHO model was well received by focus group participants, with mixed reports on whether participation equipped them to initiate organizational or policy changes. Our findings suggest that the SUD Leadership ECHO model, with fine-tuning, is a promising avenue to support SUD leaders in promoting systems change and reducing isolation among SUD leaders.
Background: Substance use disorders (SUDs) have been consistently shown to exhibit moderate intergenerational continuity (1-3). While much research has examined genetic and social influences on addiction, less attention has been paid to clients' and lay persons' perceptions of genetic influences on the heritability of SUD (4) and implications for treatment.
Methods: For this qualitative study, twenty-six structured Working Model of the Child Interviews (WMCI) were conducted with mothers receiving inpatient SUD treatment. These interviews were thematically analyzed for themes related to maternal perceptions around intergenerational transmission of substance use behaviours.
Results: Findings show that over half of the mothers in this sample were preoccupied with their children's risk factors for addictions. Among this group, 29% spontaneously expressed concerns about their children's genetic risk for addiction, 54% shared worries about their children's propensity for addiction without mentioning the word gene or genetic. Additionally, 37% had challenges in even discussing their children's future when prompted. These concerns mapped onto internal working models of attachment in unexpected ways, with parents who were coded with balanced working models being more likely to discuss intergenerational risk factors and parents with disengaged working models displaying difficulties in discussing their child's future.
Conclusion: This research suggests that the dominant discourse around the brain-disease model of addictions, in its effort to reduce stigma and self-blame, may have unintended downstream consequences for parents' mental models about their children's risks for future addiction. Parents receiving SUD treatment, and the staff who deliver it, may benefit from psychoeducation about the intergenerational transmission of SUD as part of treatment.
Background: Despite continuing advancements in treatments for opioid use disorder (OUD), continued high rates of relapse indicate the need for more effective approaches, including novel pharmacological interventions. Glucagon-like peptide 1 receptor agonists (GLP-1RA) provide a promising avenue as a non-opioid medication for the treatment of OUD. Whereas GLP-1RAs have shown promise as a treatment for alcohol and nicotine use disorders, to date, no controlled clinical trials have been conducted to determine if a GLP-1RA can reduce craving in individuals with OUD. The purpose of the current protocol was to evaluate the potential for a GLP-1RA, liraglutide, to safely and effectively reduce craving in an OUD population in residential treatment.
Method: This preliminary study was a randomized, double-blinded, placebo-controlled clinical trial designed to test the safety and efficacy of the GLP-1RA, liraglutide, in 40 participants in residential treatment for OUD. Along with taking a range of safety measures, efficacy for cue-induced craving was evaluated prior to (Day 1) and following (Day 19) treatment using a Visual Analogue Scale (VAS) in response to a cue reactivity task during functional near-infrared spectroscopy (fNIRS) and for craving. Efficacy of treatment for ambient craving was assessed using Ecological Momentary Assessment (EMA) prior to (Study Day 1), across (Study Days 2-19), and following (Study Days 20-21) residential treatment.
Discussion: This manuscript describes a protocol to collect clinical data on the safety and efficacy of a GLP-1RA, liraglutide, during residential treatment of persons with OUD, laying the groundwork for further evaluation in a larger, outpatient OUD population. Improved understanding of innovative, non-opioid based treatments for OUD will have the potential to inform community-based interventions and health policy, assist physicians and health care professionals in the treatment of persons with OUD, and to support individuals with OUD in their effort to live a healthy life.
Trial registration: ClinicalTrials.gov: NCT04199728. Registered 16 December 2019, https://clinicaltrials.gov/study/NCT04199728?term=NCT04199728 .
Protocol version: 10 May 2023.
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