Multistate programme to reduce catheter-associated infections in intensive care units with elevated infection rates.

BACKGROUND: Preventing central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) remains challenging in intensive care units (ICUs). OBJECTIVE: The Agency for Healthcare Research and Quality Safety Program for ICUs aimed to reduce CLABSI and CAUTI in units with elevated rates. METHODS: Invited hospitals had at least one adult ICU with elevated CLABSI or CAUTI rates, defined by a positive cumulative attributable difference metric (CAD >0) in the Centers for Disease Control and Prevention's Targeted Assessment for Prevention strategy. This externally facilitated programme implemented by a national project team and state hospital associations included on-demand video modules and live webinars reviewing a two-tiered approach for implementing key technical and socioadaptive factors to prevent catheter infections, using principles and tools based on the Comprehensive Unit-based Safety Program. CLABSI, CAUTI and catheter use data were collected (preintervention 13 months, intervention 12 months). Multilevel negative binomial models assessed changes in catheter-associated infection rates and catheter use. RESULTS: Of 366 recruited ICUs from 220 hospitals in 16 states and Puerto Rico for two cohorts, 280 ICUs completed the programme including infection outcome reporting; 274 ICUs had complete outcome data for analyses. Statistically significant reductions in adjusted infection rates were not observed (CLABSI incidence rate ratio (IRR)=0.75, 95% CI 0.52 to 1.08, p=0.13; CAUTI IRR=0.79, 95% CI 0.59 to 1.06, p=0.12). Adjusted central line utilisation (IRR=0.97, 95% CI 0.93 to 1.00, p=0.09) and adjusted urinary catheter utilisation were unchanged (IRR=0.98, 95% CI 0.95 to 1.01, p=0.14). CONCLUSION: This multistate programme targeted ICUs with elevated catheter infection rates, but yielded no statistically significant reduction in CLABSI, CAUTI or catheter utilisation in the first two of six planned cohorts. Improvements in the interventions based on lessons learnt from these initial cohorts are being applied to subsequent cohorts.

Qualitative Assessment of a State Partner-Facilitated Health Care-Associated Infection Prevention National Collaborative.

Background: The Centers for Disease Control and Prevention (CDC) funded a 3-year national collaborative focused on facilitating relationships between health care-associated infection (HAI) prevention stakeholders within states and improving HAI prevention activities within hospitals. This program-STRIVE (States Targeting Reduction in Infections via Engagement)-targeted hospitals with elevated rates of common HAIs. Objective: To use qualitative methods to better understand STRIVE's effect on state partner relationships and HAI prevention efforts by hospitals. Design: Qualitative case study, by U.S. state. Setting: 7 of 22 eligible STRIVE state partnerships. Participants: Representatives from state hospital associations, state health departments, and other participating organizations (for example, Quality Innovation Networks-Quality Improvement Organizations), referred to as "state partners." Measurements: Phone interviews (n = 17) with each organization were conducted, recorded, and transcribed. Results: State partners reported that relationships with each other and with participating hospitals improved through STRIVE participation. The partners saw improvements in hospital-level HAI prevention activities, such as improved auditing and feedback practices and inclusion of environmental services in prevention efforts; however, some noted those improvements may not be reflected in HAI rates. Many partners outlined plans to sustain their partner relationships by working on future state-level initiatives, such as opioid abuse prevention and antimicrobial stewardship. Limitation: Only 7 participating states were included; direct feedback from participating hospitals was not available. Conclusion: Although there were no substantial changes in aggregate HAI rates, STRIVE achieved its goal of improving state partner relationships and coordination. This improved collaboration may lead to a more streamlined response to future HAI outbreaks and public health emergencies. Primary Funding Source: Centers for Disease Control and Prevention.

A national collaborative approach to reduce catheter-associated urinary tract infections in nursing homes: A qualitative assessment.

BACKGROUND: Reducing health care-associated infections (HAIs), such as catheter-associated urinary tract infection (CAUTI), is a critical performance improvement target in nursing homes. The Agency for Healthcare Research and Quality Safety Program for Long-term Care: Health Care-Associated Infections/Catheter-Associated Urinary Tract Infection, a national performance improvement program, was designed to promote implementation of a CAUTI prevention program through state-based or regional collaboratives in more than 500 nursing homes across the United States. METHODS: Qualitative interviews were conducted with 8 purposefully selected organizational leads (who led implementation activities for a group of facilities) and 8 facility leads (who led implementation activities at a given facility) to understand implementation successes and challenges and experiences of participants involved in the program. Key themes were identified using a rapid analysis approach. RESULTS: Key themes related to general perceptions, changes due to program participation, and factors influencing program implementation were identified. In general, the program was viewed positively by organizational and facility leads with changes in catheter care practices, staff empowerment, and improvements in knowledge identified as benefits. Implementation challenges included the time required for program start-up as well as issues with staff and physician support, logistic barriers, and staffing turnover. CONCLUSIONS: Despite some challenges, the observed program success and positive views of those participating suggest that collaboratives are an important strategy for providing nursing homes with enhanced expertise and support to prevent HAIs and ensure resident safety.

Series: Pragmatic trials and real world evidence: Paper 6. Outcome measures in the real world.

Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the series (see Box) discusses different types of outcomes and their suitability for pragmatic trials, design choices for measuring these outcomes, and their implications and challenges. Measuring outcomes in pragmatic trials should not interfere with real-world clinical practice to ensure generalizability of trial results, and routinely collected outcomes should be prioritized. Typical outcomes include mortality, morbidity, functional status, well-being, and resource use. Surrogate endpoints are typically avoided as primary outcome. It is important to measure outcomes over a relevant time horizon and obtain valid and precise results. As pragmatic trials are often open label, a less subjective outcome can reduce bias. Methods that decrease bias or enhance precision of the results, such as standardization and blinding of outcome assessment, should be considered when a high risk of bias or high variability is expected. The selection of outcomes in pragmatic trials should be relevant for decision making and feasible in terms of executing the trial in the context of interest. Therefore, this should be discussed with all stakeholders as early as feasible to ensure the relevance of study results for decision making in clinical practice and the ability to perform the study.

Series: Pragmatic trials and real world evidence: Paper 2. Setting, sites, and investigator selection.

This second article in the series on pragmatic trials describes the challenges in selection of sites for pragmatic clinical trials and the impact on validity, precision, and generalizability of the results. The selection of sites is an important factor for the successful execution of a pragmatic trial and impacts the extent to which the results are applicable to future patients in clinical practice. The first step is to define usual care and understand the heterogeneity of sites, patient demographics, disease prevalence and country choice. Next, specific site characteristics are important to consider such as interest in the objectives of the trial, the level of research experience, availability of resources, and the expected number of eligible patients. It can be advisable to support the sites with implementing the trial-related activities and minimize the additional burden that the research imposes on routine clinical practice. Health care providers should be involved in an early phase of protocol development to generate engagement and ensure an appropriate selection of sites with patients who are representative of the future drug users.

Monitoring safety in a phase III real-world effectiveness trial: use of novel methodology in the Salford Lung Study.

BACKGROUND: The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. OBJECTIVE: The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. ACHIEVEMENTS: The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. CONCLUSION: Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Research essentials.

THERE IS an increasing recognition of the importance of involving patients, family members and the public in health research. This involvement is commonly termed patient and public involvement (PPI) and refers to an 'active partnership between the public and researchers'. This is different to children, young people and/or parents being participants in a research project. Effective PPI ensures that research does not just focus on professionally driven priorities, but addresses what actually matters to children, young people and their families.

Research essentials. How to critique quantitative research.

QUANTITATIVE RESEARCH is a systematic approach to investigating numerical data and involves measuring or counting attributes, that is quantities. Through a process of transforming information that is collected or observed, the researcher can often describes a situation or event, answering the 'what' and 'how many' questions about a situation ( Parahoo 2014 ).

Research essentials. Patient-public-engagement involving children and young people.

Central to the modernisation agenda in the UK, patient-public involvement (PPI) emphasises the involvement of service users and carers in all aspects of health care, from commissioning of services and service design to contributing to research agendas. This involvement is grounded in a desire to make health care more responsive to the needs of the patient and enhance the quality of care and treatments.