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Background: People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.Methods/design: In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.Discussion: This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.Trial Registration: This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013. [ABSTRACT FROM AUTHOR]

Background: Despite numerous options for treating back pain and the increasing healthcare resources devoted to this problem, the prevalence and impact of back pain-related disability has not improved. It is now recognized that psychosocial factors, as well as physical factors, are important predictors of poor outcomes for back pain. A promising new approach that matches treatments to the physical and psychosocial obstacles to recovery, the STarT Back risk stratification approach, improved patients' physical function while reducing costs of care in the United Kingdom (UK). This trial evaluates implementation of this strategy in a United States (US) healthcare setting.Methods: Six large primary care clinics in an integrated healthcare system in Washington State were block-randomized, three to receive an intensive quality improvement intervention for back pain and three to serve as controls for secular trends. The intervention included 6 one-hour training sessions for physicians, 5 days of training for physical therapists, individualized and group coaching of clinicians, and integration of the STarT Back tool into the electronic health record. This prognostic tool uses 9 questions to categorize patients at low, medium or high risk of persistent disabling pain with recommendations about evidence-based treatment options appropriate for each subgroup. Patients at least 18 years of age, receiving primary care for non-specific low back pain, were invited to provide data 1-3 weeks after their primary care visit and follow-up data 2 months and 6 months (primary endpoint) later. The primary outcomes are back-related physical function and pain severity. Using an intention to treat approach, intervention effects on patient outcomes will be estimated by comparing mean changes at the 2 and 6 month follow-up between the pre- and post-implementation periods. The inclusion of control clinics permits adjustment for secular trends. Differences in change scores by intervention group and time period will be estimated using linear mixed models with random effects. Secondary outcomes include healthcare utilization and adherence to clinical guidelines.Discussion: This trial will provide the first randomized trial evidence of the clinical effectiveness of implementing risk stratification with matched treatment options for low back pain in a United States health care delivery system.Trial Registration: NCT02286141. Registered November 5, 2014. [ABSTRACT FROM AUTHOR]

Background Systemic Lupus Erythematosus (lupus) is a chronic autoimmune disease that can impact any organ system and result in life-threatening complications. African-Americans are at increased risk for morbidity and mortality from lupus. Self-management programs have demonstrated significant improvements in health distress, self-reported global health, and activity limitation among people with lupus. Despite benefits, arthritis self-management education has reached only a limited number of people. Self-selection of program could improve such trends. The aim of the current study is to test a novel intervention to improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African-American lupus patients in South Carolina. Methods/design: In a three armed randomized, wait list controlled trial, we will evaluate the effectiveness of a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction from which they can choose as many or few as they wish, compared to a 'set menu' approach and usual care. This unique 'a-la-carte' self-management program will be offered to 50 African-American lupus patients participating in a longitudinal observational web-based SLE Database at the Medical University of South Carolina. Each individualized intervention plan will include 1-4 options, including a mail-delivered arthritis kit, addition and access to an online message board, participation in a support group, and enrollment in a local self-management program. A 'set menu' control group of 50 lupus patients will be offered a standardized chronic disease self-management program only, and a control group of 50 lupus patients will receive usual care. Outcomes will include changes in (a) health behaviors, (b) health status, (c) health care utilization, and (d) biological markers (urinary catecholamines). Discussion: Such a culturally sensitive educational intervention which includes self-selection of program components has the potential to improve disparate trends in quality of life, disease activity, depression, and stress among African-American lupus patients, as better outcomes have been documented when participants are able to choose/dictate the content and/or pace of the respective treatment/intervention program. Since there is currently no "gold standard" self-management program specifically for lupus, this project may have a considerable impact on future research and policy decisions. [ABSTRACT FROM AUTHOR]

Background: Health information technology (HIT) could improve care coordination by providing clinicians remote access to information, improving legibility, and allowing asynchronous communication, among other mechanisms. We sought to determine, from a clinician perspective, how care is coordinated and to what extent HIT is involved when transitioning patients between emergency departments, acute care hospitals, skilled nursing facilities, and home health agencies in settings across the United States.Methods: We performed a qualitative study with clinicians and information technology professionals from six regions of the U.S. which were chosen as national leaders in HIT. We analyzed data through a two person consensus approach, assigning responses to each of nine care coordination activities. We also conducted a literature review of MEDLINE®, CINAHL®, and Embase, analyzing results of studies that examined interventions to improve information transfer during transitions of care.Results: We enrolled 29 respondents from 17 organizations and conducted six focus groups. Respondents reported how HIT is currently used for care coordination activities. HIT is currently used to monitor patients and to align systems-level resources with population needs. However, we identified multiple areas where the lack of interoperability leads to inefficient processes and missing data. Additionally, the literature review identified ten intervention studies that address information transfer, seven of which employed HIT and three of which utilized other communication methods such as telephone calls, faxed records, and nurse case management.Conclusions: Significant care coordination gaps exist due to the lack of interoperability across the United States. We must design, evaluate, and incentivize the use of HIT for care coordination. We should focus on the domains where we found the largest gaps: information transfer, systems to monitor patients, tools to support patients' self-management goals, and tools to link patients and their caregivers with community resources. [ABSTRACT FROM AUTHOR]

Background: Patients seek care from physical therapists for neck pain but it is unclear what the association of the timing of physical therapy (PT) consultation is on 1-year healthcare utilization and costs. The purpose of this study was to compare the 1-year healthcare utilization and costs between three PT timing groups: patients who consulted a physical therapist (PT) for neck pain within 14 days (early PT consultation), between 15 and 90 days (delayed PT consultation) or between 91 and 364 days (late PT consultation).Methods: A retrospective cohort of 308 patients (69.2% female, ages 48.7[±14.5] years) were categorized into PT timing groups. Descriptive statistics were calculated for each group. In adjusted regression models, 1-year healthcare utilization of injections, imaging, opioids and costs were compared between groups.Results: Compared to early PT consultation, the odds of receiving an opioid prescription (aOR = 2.79, 95%CI: 1.35-5.79), spinal injection (aOR = 4.36, 95%CI:2.26-8.45), undergoing an MRI (aOR = 4.68, 95%CI:2.25-9.74), X-ray (aOR = 2.97, 95%CI:1.61-5.47) or CT scan (aOR = 3.36, 95%CI: 1.14-9.97) were increased in patients in the late PT consultation group. Similar increases in risk were found in the delayed group (except CT and Opioids). Compared to the early PT consultation group, mean costs were $2172 ($557, $3786) higher in the late PT contact group and $1063 (95%CI: $ 138 - $1988) higher in the delayed PT consultation group.Discussion: There was an association with the timing of physical therapy consultation on healthcare utilization and costs, where later consultation was associated with increases costs and healthcare utilization. This study examined the association of timing of physical therapy consultation on costs and healthcare utilization, but not the association of increased access to physical therapy consultation. Therefore, the findings warrant further investigation to explore the effects of increased access to physical therapy consultation on healthcare utilization and costs in a prospective study. [ABSTRACT FROM AUTHOR]

Background: Organizational culture and climate are considered key factors in implementation efforts but have not been examined as moderators of implementation strategy comparative effectiveness. We investigated organizational culture and climate as moderators of comparative effectiveness of two sequences of implementation strategies (Immediate vs. Delayed Enhanced Replicating Effective Programs [REP]) combining Standard REP and REP enhanced with facilitation on implementation of an outreach program for Veterans with serious mental illness lost to care at Veterans Health Administration (VA) facilities nationwide.Methods: This study is a secondary analysis of the cluster-randomized Re-Engage implementation trial that assigned 3075 patients at 89 VA facilities to either the Immediate or Delayed Enhanced REP sequences. We hypothesized that sites with stronger entrepreneurial culture, task, or relational climate would benefit more from Enhanced REP than Standard REP. Veteran- and site-level data from the Re-Engage trial were combined with site-aggregated measures of entrepreneurial culture and task and relational climate from the 2012 VA All Employee Survey. Longitudinal mixed-effects logistic models examined whether the comparative effectiveness of the Immediate vs. Delayed Enhanced REP sequences were moderated by culture or climate measures at 6 and 12 months post-randomization. Three Veteran-level outcomes related to the engagement with the VA system were assessed: updated documentation, attempted contact by coordinator, and completed contact.Results: For updated documentation and attempted contact, Veterans at sites with higher entrepreneurial culture and task climate scores benefitted more from Enhanced REP compared to Standard REP than Veterans at sites with lower scores. Few culture or climate moderation effects were detected for the comparative effectiveness of the full sequences of implementation strategies.Conclusions: Implementation strategy effectiveness is highly intertwined with contextual factors, and implementation practitioners may use knowledge of contextual moderation to tailor strategy deployment. We found that facilitation strategies provided with Enhanced REP were more effective at improving uptake of a mental health outreach program at sites with stronger entrepreneurial culture and task climate; Veterans at sites with lower levels of these measures saw more similar improvement under Standard and Enhanced REP. Within resource-constrained systems, practitioners may choose to target more intensive implementation strategies to sites that will most benefit from them.Trial Registration: ISRCTN: ISRCTN21059161 . Date registered: April 11, 2013. [ABSTRACT FROM AUTHOR]

Background: Healthcare organizations increasingly are focused on providing care which is patient-centered rather than disease-focused. Yet little is known about how best to transform the culture of care in these organizations. We sought to understand key organizational factors for implementing patient-centered care cultural transformation through an examination of efforts in the US Department of Veterans Affairs.Methods: We conducted multi-day site visits at four US Department of Veterans Affairs medical centers designated as leaders in providing patient-centered care. We conducted qualitative semi-structured interviews with 108 employees (22 senior leaders, 42 middle managers, 37 front-line providers and 7 staff). Transcripts of audio recordings were analyzed using a priori codes based on the Consolidated Framework for Implementation Research. We used constant comparison analysis to synthesize codes into meaningful domains.Results: Sites described actions taken to foster patient-centered care in seven domains: 1) leadership; 2) patient and family engagement; 3) staff engagement; 4) focus on innovations; 5) alignment of staff roles and priorities; 6) organizational structures and processes; 7) environment of care. Within each domain, we identified multi-faceted strategies for implementing change. These included efforts by all levels of organizational leaders who modeled patient-centered care in their interactions and fostered willingness to try novel approaches to care amongst staff. Alignment and integration of patient centered care within the organization, particularly surrounding roles, priorities and bureaucratic rules, remained major challenges.Conclusions: Transforming healthcare systems to focus on patient-centered care and better serve the "whole" patient is a complex endeavor. Efforts to transform healthcare culture require robust, multi-pronged efforts at all levels of the organization; leadership is only the beginning. Challenges remain for incorporating patient-centered approaches in the context of competing priorities and regulations. Through actions within each of the domains, organizations may begin to truly transform to patient-driven care. [ABSTRACT FROM AUTHOR]