Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)

Glass, Joseph E.; Bobb, Jennifer F.; Lee, Amy K.; Richards, Julie; Lapham, Gwen T.; Ludman, Evette; Achtmeyer, Carol E.; Caldeiro, Ryan M.; Parrish, Rebecca; Williams, Emily C.; Lozano, Paula; Bradley, Katharine A.

doi:10.1186/s13012-018-0795-9

Cited by 44 publications

(67 citation statements)

References 79 publications

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“…Thus, our finding that homelessness was positively associated with treatment initiation for AUD is likely not generalizable. Several studies are testing whether integrating AUD treatment into primary care can overcome barriers to AUD treatment . Integrated care has been successfully trialed for patients with mental health and SUDs attending HCV clinics and has been shown to increase rates of HCV treatment .…”

Section: Discussionmentioning

confidence: 99%

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis

et al. 2020

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BaCKgRoUND aND aIMS:Despite the significant medical and economic consequences of coexisting alcohol use disorder (AUD) in patients with cirrhosis, little is known about AUD treatment patterns and their impact on clinical outcomes in this population. We aimed to characterize the use of and outcomes associated with AUD treatment in patients with cirrhosis. appRoaCH aND ReSUltS: This retrospective cohort study included Veterans with cirrhosis who received Veterans Health Administration care and had an index diagnosis of AUD between 2011 and 2015. We assessed the baseline factors associated with AUD treatment (pharmacotherapy or behavioral therapy) and clinical outcomes for 180 days following the first AUD diagnosis code within the study time frame. Among 93,612 Veterans with cirrhosis, we identified 35,682 with AUD, after excluding 2,671 who had prior diagnoses of AUD and recent treatment. Over 180 days following the index diagnosis of AUD, 5,088 (14%) received AUD treatment, including 4,461 (12%) who received behavioral therapy alone, 159 (0.4%) who received pharmacotherapy alone, and 468 (1%) who received both behavioral therapy and pharmacotherapy. In adjusted analyses, behavioral and/or pharmacotherapy-based AUD treatment was associated with a significant reduction in incident hepatic decompensation (6.5% vs. 11.6%, adjusted odds ratio [AOR], 0.63; 95% confidence interval [CI], 0.52, 0.76), a nonsignificant decrease in short-term all-cause mortality (2.6% vs. 3.9%, AOR, 0.79; 95% CI, 0.57, 1.08), and a significant decrease in long-term all-cause mortality (51% vs. 58%, AOR, 0.87; 95% CI, 0.80, 0.96).CoNClUSIoNS: Most Veterans with cirrhosis and coexisting AUD did not receive behavioral therapy or pharmacotherapy treatment for AUD over a 6-month follow-up. The reductions in hepatic decompensation and mortality suggest that future studies should focus on delivering evidence-based AUD treatments to patients with coexisting AUD and cirrhosis.

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Section: Discussionmentioning

confidence: 99%

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis

et al. 2020

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“…While the framework considered in this paper prioritized selecting a population using pre-randomization data for the primary analysis, other studies have taken alternate approaches [17]. One example is a pragmatic, open-cohort, stepped-wedge trial to evaluate a program integrating alcohol-related care into primary care [40]. A main objective of that prior trial was to test whether the intervention increased treatment for alcohol use disorders documented in the EHR as compared to usual primary care.…”

Section: Discussionmentioning

confidence: 99%

“…Avoiding identification bias by restricting the analysis to patients diagnosed before randomization was not appealing because of the nature of the stepped wedge design, whereby patients seen in the clinic before randomization may not have follow-up visits to the clinic during the time period after the clinic crossed over to the intervention group (up to 2-3 years later). Consequently, investigators favored a primary analysis approach that used as its study population all patients who visited the clinic (including patients with a first visit after randomization), because the intervention was not expected to affect this population [40,46,47]. Another example is a cluster-randomized, parallel group trial to test the effectiveness of an intervention to improve colorectal cancer screening rates [41,42].…”

Section: Discussionmentioning

confidence: 99%

Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study

Bobb

Qiu

Matthews

et al. 2020

Trials

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Background: Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after randomization and reliance on electronic health records (EHRs) to identify participants may lead to a form of selection bias referred to as identification bias. This bias can occur when individuals identified as a result of the treatment group assignment are included in analyses. Methods: To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial. PROUD is an ongoing pragmatic, cluster-randomized implementation trial in six health systems to evaluate a program for increasing medication treatment of opioid use disorders (OUDs). A main study objective is to evaluate whether the PROUD intervention decreases acute care utilization among patients with OUD (effectiveness aim). Identification bias is a particular concern, because OUD is underdiagnosed in the EHR at baseline, and because the intervention is expected to increase OUD diagnosis among current patients and attract new patients with OUD to the intervention site. We propose a framework for addressing this source of bias in the statistical design and analysis. Results: The statistical design sought to balance the competing goals of fully capturing intervention effects and mitigating identification bias, while maximizing power. For the primary analysis of the effectiveness aim, identification bias was avoided by defining the study sample using pre-randomization data (pre-trial modeling demonstrated that the optimal approach was to use individuals with a prior OUD diagnosis). To expand generalizability of study findings, secondary analyses were planned that also included patients newly diagnosed post-randomization, with analytic methods to account for identification bias. Conclusion: As more studies seek to leverage existing data sources, such as EHRs, to make clinical trials more affordable and generalizable and to apply novel open-cohort study designs, the potential for identification bias is likely to become increasingly common. This case study highlights how this bias can be addressed in the statistical study design and analysis.

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“…Studies have demonstrated the effectiveness of practice facilitation in primary care settings; a meta-analysis found that odds of providing evidence-based preventive care were 2.76 times higher (95% CI 2.18–3.43) in primary care settings with practice facilitation [ 30 ]. Practice facilitation is increasingly being tested as a means of increasing the provision of substance use-related care in diverse clinical settings [ 34 ], including alcohol-related care in primary care clinics [ 35 ]. However, to our knowledge, the use of practice facilitation to implement alcohol-related care in liver clinic settings has not yet been evaluated.…”

Section: Introductionmentioning

confidence: 99%

Practice facilitation to implement alcohol-related care in Veterans Health Administration liver clinics: a study protocol

Frost

Ioannou

Tsui

et al. 2020

Implement Sci Commun

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Background: Alcohol-related care, including screening, brief intervention, and provision of/referral to medication or behavioral treatments for alcohol use disorder, could be delivered in liver clinics to better reach patients with chronic liver conditions. However, the provision of alcohol-related care in liver clinics is currently suboptimal. Practice facilitation is an evidence-based implementation strategy that may address barriers, harness facilitators, and optimize the implementation of alcohol-related care in liver clinic settings using a clinic-centered approach. We report the protocol of a study to test a practice facilitation intervention to implement alcohol-related care in four Veterans Health Administration liver clinics. Methods: This study will employ a Hybrid Type 3 effectiveness-implementation design, in which implementation outcomes are considered primary and clinical outcomes secondary. Intervention and evaluation design were informed by the Consolidated Framework for Implementation Research. Qualitative data collected from clinical stakeholders and patients were used to tailor the intervention. The intervention involves a 6-month period of external practice facilitation, including regular meetings to identify clinic goals, challenges, and solutions; engagement of clinic champions; provision of training and development of educational materials for clinic staff and patients; and performance monitoring and feedback. Ongoing formative evaluation involves the collection of quantitative facilitator tracking data and qualitative data from meeting notes and patient interviews to describe intervention acceptability, feasibility, and adoption, and adjust implementation as needed. In the summative evaluation, implementation outcomes (clinic rates of screening, brief intervention, and treatment referral/receipt) and clinical outcomes (unhealthy alcohol use, liver health) will be assessed among patients in participating clinics using secondary electronic health record data and interrupted time series analysis.

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Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)

Cited by 44 publications

References 79 publications

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis

Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study

Practice facilitation to implement alcohol-related care in Veterans Health Administration liver clinics: a study protocol

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