The STUN (STop UNhealthy) Alcohol Use Now trial: study protocol for an adaptive randomized trial on dissemination and implementation of screening and management of unhealthy alcohol use in primary care
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SUBMITTER: Jonas D
PROVIDER: S-EPMC8593635 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background: The COVID-19 pandemic has brought widespread change to health care practice and research. With heightened stress in the general population, increased unhealthy alcohol use, and added pressures on primary care practices, comes the need to better understand how we can continue practice-based research and address public health priorities amid the ongoing pandemic. The current study considers barriers and facilitators to conducting such research, especially during the COVID-19 pandemic, within the context of recruiting practices for the STop UNhealthy (STUN) Alcohol Use Now trial. The STUN trial uses practice facilitation to implement screening and interventions for unhealthy alcohol use in primary care practices across the state of North Carolina. Methods: Semistructured interviews were conducted with a purposive sample of 15 practice coaches to discuss their recruitment experiences before and after recruitment was paused due to the pandemic. An inductive thematic analysis was used to identify themes and subthemes. Results: Pandemic-related barriers, including challenges in staffing, finances, and new COVID-19-related workflows, were most prominent. Competing priorities, such as quality improvement measures, North Carolina's implementation of Medicaid managed care, and organizational structures hampered recruitment efforts. Coaches also described barriers specific to the project and to the topic of alcohol. Several facilitators were identified, including the rising importance of behavioral health due to the pandemic, as well as existing relationships between practice coaches and practices. Conclusions: Difficulty managing competing priorities and obstacles within existing practice infrastructure inhibit the ability to participate in practice-based research and implementation of evidence-based practices. Lessons learned from this trial may inform strategies to recruit practices into research and to gain buy-in from practices in adopting evidence-based practices more generally.Plain language summaryWhat is known: Unhealthy alcohol use is a significant public health issue, which has been exacerbated during the COVID-19 pandemic. Screening and brief intervention for unhealthy alcohol use is an evidence-based practice shown to help reduce drinking-related behaviors, yet it remains rare in practice. What this study adds: Using a qualitative approach, we identify barriers and facilitators to recruiting primary care practices into a funded trial that uses practice facilitation to address unhealthy alcohol use. We identify general insights as well as those specific to the COVID-19 pandemic. Barriers are primarily related to competing priorities, incentives, and lack of infrastructure. Facilitators are related to framing of the project and the anticipated level and type of resources needed to address unhealthy alcohol use especially as the pandemic wanes. Implications: Our findings provide information on barriers and facilitators to recruiting primary care practices for behavioral health projects and to implementing these activities. Using our findings, we provide a discussion of suggestions for conducting these types of projects in the future which may be of interest to researchers, practice managers, and providers.
| S-EPMC9924268 | biostudies-literature
Project description:Unhealthy alcohol use is the third leading cause of preventable death in the United States. The U.S. Preventive Services Task Force (USPSTF) recommends screening for unhealthy alcohol use but little is known about how best to do so. We used quality improvement techniques to implement a systematic approach to screening and counseling primary care patients for unhealthy alcohol use. Components included use of validated screening and assessment instruments; an evidence-based two-visit counseling intervention using motivational interviewing techniques for those with risky drinking behaviors who did not have an alcohol use disorder (AUD); shared decision making about treatment options for those with an AUD; support materials for providers and patients; and training in motivational interviewing for faculty and residents. Over the course of one year, we screened 52% (N = 5,352) of our clinic's patients and identified 294 with positive screens. Of those 294, appropriate screening-related assessments and interventions were documented for 168 and 72 patients, respectively. Although we successfully implemented a systematic screening program and structured processes of care, ongoing quality improvement efforts are needed to screen the rest of our patients and to improve the consistency with which we provide and document appropriate interventions.
| S-EPMC5213337 | biostudies-literature
Project description:BackgroundUnhealthy alcohol use (UAU) is a leading cause of premature mortality among adults in the USA. Emergency departments (EDs) are key intervention settings for UAU but often have limited time and resources. One low-burden, scalable approach to address UAU is text-messaging interventions. Despite strong research support and promise for scalability, there is little research on how to implement such interventions in healthcare settings. The process of providers making them available to patients in an efficient way within already busy and overburdened ED workflows and patients adopting them remains a new area of research. The purpose of this three-phase study is to develop and test an implementation strategy for UAU text-messaging interventions in EDs.MethodOur first aim is to examine barriers and facilitators to staff offering and patients accepting a text-messaging intervention in the ED using an explanatory, sequential mixed methods approach. We will examine alcohol screening data in the electronic health records of 17 EDs within a large integrated health system in the Northeast and conduct surveys among chairpersons in each. This data will be used to purposively sample 4 EDs for semi-structured interviews among 20 clinical staff, 20 patients, and 4 chairpersons. Our second aim is to conduct a stakeholder-engaged intervention mapping process to develop a multi-component implementation strategy for EDs. Our third aim is to conduct a mixed method 2-arm cluster randomized pilot study in 4 EDs that serve ~11,000 UAU patients per year to assess the feasibility, acceptability, and preliminary effectiveness of the implementation strategy. The Integrated Promoting Action on Research Implementation in Health Services framework will guide study activities.DiscussionLow-burden technology, like text messaging, along with targeted implementation support and strategies driven by identified barriers and facilitators could sustain large-scale ED-based alcohol screening programs and provide much needed support to patients who screen positive while reducing burden on EDs. The proposed study would be the first to develop and test this targeted implementation strategy and will prepare for a larger, fully powered hybrid effectiveness-implementation trial. Findings may also be broadly applicable to implementation of patient-facing mobile health technologies.Trial registrationThis study was registered at ClinicalTrials.gov (NCT05350878) on 4/28/2022.
| S-EPMC9356403 | biostudies-literature
Project description:BackgroundUnhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use.Methods and analysisWe are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation.DiscussionThis study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach.Trial registrationClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.
| S-EPMC7240919 | biostudies-literature
Project description:OBJECTIVES:Concomitant excessive alcohol consumption and benzodiazepine use is associated with adverse health outcomes. We examined associations of unhealthy alcohol use and other patient characteristics with benzodiazepine use. STUDY DESIGN:A cross-sectional analysis of 2,089,525 Kaiser Permanente of Northern California outpatients screened for unhealthy alcohol use in primary care between November 1, 2014, and December 31, 2016. METHODS:We fit multivariable generalized linear models to estimate the associations between unhealthy alcohol use and benzodiazepine dispensation and, among patients who were dispensed a benzodiazepine, mean doses (in mean lorazepam-equivalent daily doses [LEDDs]) and prescription durations. We controlled for patient sex, age, race/ethnicity, estimated household income, Charlson Comorbidity Index (CCI) score, anxiety disorder, alcohol use disorder, insomnia, musculoskeletal pain, and epilepsy. RESULTS:In the 12 months centered around (6 months before and 6 months after) the first alcohol-screening visit, 7.5% of patients used benzodiazepines. The following characteristics were independently associated with higher rates of benzodiazepine use, higher LEDD, and longer prescription duration: older age, white race/ethnicity, lower estimated household income, higher CCI score, and the presence of an anxiety disorder, insomnia, musculoskeletal pain, or epilepsy. Women and patients with an alcohol use disorder or unhealthy alcohol use, compared with men and patients with low-risk drinking or abstinence, were more likely to use a benzodiazepine; however, their LEDDs were lower and their prescription durations were shorter. CONCLUSIONS:Benzodiazepine use in primary care was associated with older age, female sex, white race/ethnicity, lower socioeconomic status, and unhealthy alcohol use. These findings may be applied to develop policies and interventions to promote judicious benzodiazepine use.
| S-EPMC7217068 | biostudies-literature
Project description:BackgroundUnhealthy alcohol use is an unaddressed barrier to achieving and maintaining control of the human immunodeficiency virus (HIV) epidemic. Integrated screening, treatment of common behavioral and mental health comorbidities, and telemedicine can improve alcohol treatment and HIV clinical and quality of life outcomes for rural and underserved populations.ObjectiveIn a randomized controlled clinical trial, we will evaluate the effectiveness and implementation of telephone-delivered Common Elements Treatment Approach (T-CETA), a transdiagnostic cognitive behavioral therapy protocol, on unhealthy alcohol use, HIV, other substance use and mental health outcomes among predominantly rural adults with HIV receiving care at community clinics in Alabama.MethodsAdults with HIV receiving care at four selected community clinics in Alabama will receive a telephone-delivered alcohol brief intervention (BI), and then be assigned at random (stratified by clinic and sex) to no further intervention or T-CETA. Participants will be recruited after screening positively for unhealthy alcohol use or when referred by a provider. The target sample size is 308. The primary outcome will be change in the Alcohol Use Disorder Identification Test (AUDIT) at six- and 12-months post-enrollment. Additional outcomes include HIV (retention in care and viral suppression), patient-reported mental health (anxiety, depression, posttraumatic stress), and quality of life. A range of implementation measures be evaluated including T-CETA provider and client acceptability, feasibility, cost and cost-effectiveness.ConclusionsThis trial will inform alcohol treatment within HIV care programs, including the need to consider comorbidities, and the potential impact of alcohol interventions on HIV and quality of life outcomes.
| S-EPMC10090240 | biostudies-literature
Project description:The US Veterans Health Administration [Veterans Affairs (VA)] used performance measures and electronic clinical reminders to implement brief intervention for unhealthy alcohol use. We evaluated whether documented brief intervention was associated with subsequent changes in drinking during early implementation.Observational, retrospective cohort study using secondary clinical and administrative data.Thirty VA facilities.Outpatients who screened positive for unhealthy alcohol use [Alcohol Use Disorders Identification Test Consumption (AUDIT-C???5)] in the 6 months after the brief intervention performance measure (n?=?22?214) and had follow-up screening 9-15 months later (n?=?6210; 28%).Multi-level logistic regression estimated the adjusted prevalence of resolution of unhealthy alcohol use (follow-up AUDIT-C <5 with ?2 point reduction) for patients with and without documented brief intervention (documented advice to reduce or abstain from drinking).Among 6210 patients with follow-up alcohol screening, 1751 (28%) had brief intervention and 2922 (47%) resolved unhealthy alcohol use at follow-up. Patients with documented brief intervention were older and more likely to have other substance use disorders, mental health conditions, poor health and more severe unhealthy alcohol use than those without (P-values?<?0.05). Adjusted prevalences of resolution were 47% [95% confidence interval (CI)?=?42-52%] and 48% (95% CI?=?42-54%) for patients with and without documented brief intervention, respectively (P?=?0.50).During early implementation of brief intervention in the US Veterans Health Administration, documented brief intervention was not associated with subsequent changes in drinking among outpatients with unhealthy alcohol use and repeat alcohol screening.
| S-EPMC4257468 | biostudies-literature
Project description:BackgroundAdaptive interventions, sometimes referred to as "stepped care", are those interventions in which the type or dosage of treatment offered to patients is tailored to baseline clinical presentation and then adjusted over time in response to patient progress or lack thereof. Currently, no adaptive brief interventions exist specifically for alcohol use disorder (AUD).MethodThis study used a sequential multiple assignment randomized trial design with 160 individuals with AUD recruited both locally and nationally who had a goal to reduce or abstain from drinking. Participants received brief advice (BA) and then the study reassessed them three weeks later; the study randomized those who did not respond to BA, defined as reducing their drinking to low-risk guidelines, to two session of motivational interviewing (MI) or more BA. The study then reassessed participants at week 8. The study re-randomized nonresponders to receive either MI alone or MI plus behavioral self-control therapy (BSCT), also referred to as coping skills therapy, and evaluated participants at week 13.ResultsOverall, participants receiving any BSCT made the greatest reductions in drinking. Participants who received MI at week 4 and BSCT at week 8 outperformed all other groups.ConclusionFindings reveal that prolonged treatment, more sessions, and/or a specific combination of MI and BSCT provided optimal outcomes. Future research should determine whether such an algorithm holds across heterogenous groups of individuals with AUD.
| S-EPMC7900613 | biostudies-literature
Project description:ImportanceUnhealthy alcohol use (UAU) is the fourth most preventable cause of death in the US. The US Preventive Services Task Force recommends that primary care clinicians routinely screen all adults 18 years and older for UAU; however, this preventive service is poorly implemented.ObjectiveTo determine if practice facilitation improved delivery of the recommended care for UAU compared to usual care.Design, setting, and participantsThis practice-level cluster randomized clinical trial was conducted across diverse and representative primary care practices throughout Virginia. A total of 76 primary care practices enrolled between October 2019 and January 2023.InterventionPractices received immediate (intervention) or 6-month delayed (control) practice facilitation, which included tailored educational sessions, workflow management, and tools for addressing UAU.Main outcomes and measuresOutcomes included the increase in recommended screening for UAU, brief interventions, referral for counseling, and medication treatment. Data were collected via medical record review (structured and free text data) and transcripts of practice facilitator sessions and exits interviews.ResultsOf the 76 primary care practices enrolled, 32 were randomized to intervention and 35 to control; 11 789 patients (mean [SD] age, 50.1 [16.3] years; 61.1% women) were randomly selected for analysis, with patient demographics similar to Virginia at large. From baseline to 6 months after intervention, screening with a validated instrument increased from 2.1% (95% CI, 0.5%-8.4%) to 35.5% (95% CI, 11.5%-69.9%) in the intervention group compared to 0.4% (95% CI, 0.1%-1.8%) to 1.4% (95% CI, 0.3%-5.8%) in the control group (P < .001). Brief office-based interventions for the intervention group increased from 26.2% (95% CI, 14.2%-45.8%) to 62.6% (95% CI, 43.6%-78.3%) vs 45.5% (95% CI, 28.0%-64.1%) to 55.1% (95% CI, 36.5%-72.3%) in the control group (P = .008). Identification of UAU, referral for counseling, and medication treatment had similar changes for both groups. Qualitative analyses of transcripts revealed that few clinicians understood the preventive service prior to practice facilitation, but at the end most felt much more competent and confident with screening and brief intervention for UAU.Conclusions and relevanceThis cluster randomized clinical trial demonstrated that practice facilitation can help primary care practices to better implement screening and counseling for UAU into their routine workflow. Effective primary care practice implementation interventions such as this can have a profound effect on the health of communities. Given the number of people that the participating practices care for, this intervention resulted in an additional 114 604 patients being screened annually for UAU who would not have been otherwise.Trial registrationClinicalTrials.gov Identifier: NCT04248023.
| S-EPMC11316228 | biostudies-literature
Project description:BackgroundUnhealthy alcohol use is a leading cause of morbidity and mortality among young people, including university students. Delivering secondary prevention interventions against unhealthy alcohol use is challenging. Information technology has the potential to reach large parts of the general population. The present study is proposed to test a proactive secondary prevention smartphone-based intervention against unhealthy alcohol use.MethodsThis is a parallel-group, randomized controlled trial (1:1 allocation ratio) among 1696 university students with unhealthy alcohol use, identified by screening and followed up at 3, 6, and 12 months. Participants will be randomized to receive access to a smartphone-based intervention or to a no intervention control condition. The primary outcome will be self-reported volume of alcohol drunk over the past 30 days, reported as the mean number of standard drinks per week over the past 30 days, measured at 6 months. Secondary outcomes will be number of heavy drinking days over the past 30 days, at 6 months. Additional outcomes will be maximum number of drinks on any day over the past 30 days, alcohol-related consequences (measured using the Short Inventory of Problems (SIP-2R), and academic performance.DiscussionThe aim of this trial is to close the evidence gap on the efficacy of smartphone-based secondary prevention interventions. If proven effective, smartphone-based interventions have the potential to reach a large portion of the population, completing what is available on the Internet.Trial registrationISRCTN, 10007691. Registered on 2 December 2019. Recruitment will start in April 2020.
| S-EPMC7027100 | biostudies-literature