Yea Jen Hsu

A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units*

Objectives:To determine the causal effects of an intervention proven effective in pre-post studies in reducing central line-associated bloodstream infections in the intensive care unit. Design:We conducted a multicenter, phased, cluster-randomized controlled trial in which hospitals were randomized into two groups. The intervention group started in March 2007 and the control group started in October 2007; the study period ended September 2008. Baseline data for both groups are from 2006. Setting:Forty-five intensive care units from 35 hospitals in two Adventist healthcare systems. Interventions:A multifaceted intervention involving evidence-based practices to prevent central line-associated bloodstream infections and the Comprehensive Unit–based Safety Program to improve safety, teamwork, and communication. Measurements and Results:We measured central line-associated bloodstream infections per 1,000 central line days and reported quarterly rates. Baseline average central line-associated bloodstream infections per 1,000 central line days was 4.48 and 2.71, for the intervention and control groups (p = .28), respectively. By October to December 2007, the infection rate declined to 1.33 in the intervention group compared to 2.16 in the control group (adjusted incidence rate ratio 0.19; p = .003; 95% confidence interval 0.06–0.57). The intervention group sustained rates <1/1,000 central line days at 19 months (an 81% reduction). The control group also reduced infection rates to <1/1,000 central line days (a 69% reduction) at 12 months. Conclusions:This study demonstrated a causal relationship between the multifaceted intervention and the reduced central line-associated bloodstream infections. Both groups decreased infection rates after implementation and sustained these results over time, replicating the results found in previous, pre-post studies of this multifaceted intervention and providing further evidence that most central line-associated bloodstream infections are preventable.

Physician Satisfaction with Chronic Care Processes: A Cluster-Randomized Trial of Guided Care

PURPOSE Chronically ill older patients with multiple conditions are challenging to care for, and new models of care for this population are needed. This study evaluates the effect of the Guided Care model on primary care physicians’ impressions of processes of care for chronically ill older patients. METHODS In Guided Care a specially educated registered nurse works at the practice with 2 to 5 primary care physicians, performing 8 clinical activities for 50 to 60 chronically ill older patients. The care model was tested in a cluster-randomized controlled trial between 2006 and 2009. All eligible primary care physicians in 14 pods (teams of physicians and their chronically ill older patients) agreed to participate (n = 49). Pods were randomly assigned to provide either Guided Care or usual care. Physicians were surveyed at baseline and 1 year later. We assessed the effects of Guided Care using responses from 38 physicians who completed both survey questionnaires. We measured physicians’ satisfaction with chronic care processes, time spent on chronic care, knowledge of their chronically ill older patients, and care coordination provided by physicians and office staff. RESULTS Compared with the physicians in the control group, those in the Guided Care group rated their satisfaction with patient/family communication and their knowledge of the clinical characteristics of their chronically ill older patients significantly higher (ρ<0.05 in linear regression models). Other differences did not reach statistical significance. CONCLUSIONS Based on physician report, Guided Care provides important benefits to physicians by improving communication with chronically ill older patients and their families and in physicians’ knowledge of their patients’ clinical conditions.

Validity and usefulness of members reports of implementation progress in a quality improvement initiative: findings from the Team Check-up Tool (TCT)

BackgroundTeam-based interventions are effective for improving safety and quality of healthcare. However, contextual factors, such as team functioning, leadership, and organizational support, can vary significantly across teams and affect the level of implementation success. Yet, the science for measuring context is immature. The goal of this study is to validate measures from a short instrument tailored to track dynamic context and progress for a team-based quality improvement (QI) intervention.MethodsDesign: Secondary cross-sectional and longitudinal analysis of data from a clustered randomized controlled trial (RCT) of a team-based quality improvement intervention to reduce central line-associated bloodstream infection (CLABSI) rates in intensive care units (ICUs).Setting: Forty-six ICUs located within 35 faith-based, not-for-profit community hospitals across 12 states in the U.S.Population: Team members participating in an ICU-based QI intervention.Measures: The primary measure is the Team Check-up Tool (TCT), an original instrument that assesses context and progress of a team-based QI intervention. The TCT is administered monthly. Validation measures include CLABSI rate, Team Functioning Survey (TFS) and Practice Environment Scale (PES) from the Nursing Work Index.Analysis: Temporal stability, responsiveness and validity of the TCT.ResultsWe found evidence supporting the temporal stability, construct validity, and responsiveness of TCT measures of intervention activities, perceived group-level behaviors, and barriers to team progress.ConclusionsThe TCT demonstrates good measurement reliability, validity, and responsiveness. By having more validated measures on implementation context, researchers can more readily conduct rigorous studies to identify contextual variables linked to key intervention and patient outcomes and strengthen the evidence base on successful spread of efficacious team-based interventions. QI teams participating in an intervention should also find data from a validated tool useful for identifying opportunities to improve their own implementation.

The team checkup tool: evaluating QI team activities and giving feedback to senior leaders.

This tool can close the gap between hospital executives and frontline QI teams, improve knowledge of team activities, and help teams to identify and remedy barriers to progress.

Influence of the Comprehensive Unit–based Safety Program in ICUs Evidence From the Keystone ICU Project

Using data from the Keystone ICU project, this study examined whether the intensive care units (ICUs) that implemented the Comprehensive Unit-based Safety Program (CUSP) would have greater improvement in safety climate, team progress barriers, and central line–associated bloodstream infections (CLABSIs) than ICUs not implementing CUSP. The study population consisted of 103 ICUs; 60 ICUs (58%) used CUSP, with 6 of them later discontinuing CUSP, and 17 ICUs (16.5%) never used CUSP. The researchers could not determine CUSP use status for the remaining 26 ICUs because of missing data. The use of CUSP was associated with improved safety climate, job satisfaction, and working conditions after a 2-year period, as measured by the Safety Attitudes Questionnaire. Study results on barriers and CLABSIs are inconclusive. This study demonstrated that unit-based, formalized processes targeting cultural improvements in teamwork, communication, self-identification of hazards, and hazard mitigation can improve several aspects of patient safety climate in ICUs.

Impact of self-reported guideline compliance: Bloodstream infection prevention in a national collaborative

BACKGROUND We sought to examine self-reported compliance with 5 evidence-based central line-associated bloodstream infection (CLABSI) prevention practices and link compliance to CLABSI rates in a national patient safety collaborative. METHODS We analyzed data from a national CLABSI prevention program. Adult ICUs participating in the program submitted their CLABSI rates and a Team Checkup Tool (TCT) on a monthly basis. The TCT responses provided self-reported perceptions about how reliably the unit team performed the evidence-based practices in the previous month. Monthly data were aggregated into quarters for the analysis. We analyzed a total of 2775 ICU quarters during the program. RESULTS Chlorhexidine skin preparation and hand hygiene had the highest adherence. Avoidance of the femoral site and removal of unnecessary lines had the lowest compliance. Regression results showed that consistent performance of all practices was significantly associated with lower CLABSI rates. In terms of each practices independent effect, femoral site avoidance for line placement and removal of unnecessary lines were independently associated with lower CLABSI rates after controlling for other factors. CONCLUSION Our findings suggest that uptake of the 2 low-compliance practices, avoidance of the femoral site and removal of unnecessary lines, is important for reducing CLABSI rates in conjunction with other practices.

Use of surrogate outcomes in US FDA drug approvals, 2003–2012: a survey

Objective To evaluate, across a spectrum of diseases, how often surrogate outcomes are used as a basis for drug approvals by the US Food and Drug Administration (FDA), and whether and how the rationale for using treatment effects on surrogates as predictors of treatment effects on patient-centred outcomes is discussed. Study design and setting We used the Drugs@FDA website to identify drug approvals produced from 2003 to 2012 by the FDA. We focused on four diseases (chronic obstructive pulmonary disease (COPD), type 1 or 2 diabetes, glaucoma and osteoporosis) for which surrogates are commonly used in trials. We reviewed the drug labels and medical reviews to provide empirical evidence on how surrogate outcomes are handled by the FDA. Results Of 1043 approvals screened, 58 (6%) were for the four diseases of interest. Most drugs for COPD (7/9, 78%), diabetes (26/26, 100%) and glaucoma (9/9, 100%) were approved based on surrogates while for osteoporosis, most drugs (10/14, 71%) were also approved for patient-centred outcomes (fractures). The rationale for using surrogates was discussed in 11 of the 43 (26%) drug approvals based on surrogates. In these drug approvals, we found drug approvals for diabetes are more likely than the other examined conditions to contain a discussion of trial evidence demonstrating that treatment effects on surrogate outcomes predict treatment effects on patient-centred outcomes. Conclusions Our results suggest that the FDA did not use a consistent approach to address surrogates in assessing the benefits and harms of drugs for COPD, type 1 or 2 diabetes, glaucoma and osteoporosis. For evaluating new drugs, patient-centred outcomes should be chosen whenever possible. If the use of surrogate outcomes is necessary, then a consistent approach is important to review the evidence for surrogacy and consider surrogates usage in the treatment and population under study.

Safety Culture in Cardiac Surgical Teams: Data From Five Programs and National Surgical Comparison

BACKGROUND Little is known about safety culture in the area of cardiac surgery as compared with other types of surgery. The unique features of cardiac surgical teams may result in different perceptions of patient safety and patient safety culture. METHODS We measured and described safety culture in five cardiovascular surgical centers using the Hospital Survey on Patient Safety Culture, and compared the data with the Agency for Healthcare Research and Quality (AHRQ) 2010 comparative database in surgery and anesthesiology (all types). We reported mean scores, standard deviations, and percent positive responses for the two single-item measures and 12 patient safety climate dimensions in the Hospital Survey on Patient Safety Culture. RESULTS In the five cardiac surgical programs, the dimension of teamwork within hospital units had the highest positive score (74% positive responses), and the dimension of nonpunitive response to error had the lowest score (38% positive responses). Surgeons and support staff perceived better safety climate than nurses, perfusionists, and anesthesia practitioners. The cardiac surgery cohort reported more positive safety climate than the AHRQ all-type surgery cohort in four dimensions but lower frequency of reporting mistakes. The cardiac anesthesiology cohort scored lower on two dimensions compared with the AHRQ all-type anesthesiology cohort. CONCLUSIONS This study identifies patient safety areas for improvement in cardiac surgical teams in comparison with all-type surgical teams. We also found that different professional disciplines in cardiac surgical teams perceive patient safety differently.

A bundled quality improvement program to standardize clinical blood pressure measurement in primary care

We evaluated use of a program to improve blood pressure measurement at 6 primary care clinics over a 6‐month period. The program consisted of automated devices, clinical training, and support for systems change. Unannounced audits and electronic medical records provided evaluation data. Clinics used devices in 81.0% of encounters and used them as intended in 71.6% of encounters, but implementation fidelity varied. Intervention site systolic and diastolic blood pressure with terminal digit “0” decreased from 32.1% and 33.7% to 11.1% and 11.3%, respectively. Improvement occurred uniformly, regardless of sites’ adherence to the measurement protocol. Providers rechecked blood pressure measurements less often post‐intervention (from 23.5% to 8.1% of visits overall). Providers at sites with high protocol adherence were less likely to recheck measurements than those at low adherence sites. Comparison sites exhibited no change in terminal digit preference or repeat measurements. This study demonstrates that clinics can apply a pragmatic intervention to improve blood pressure measurement. Additional refinement may improve implementation fidelity.

Maryland multipayor patient-centered medical home program: A 4-year quasiexperimental evaluation of quality, utilization, patient satisfaction, and provider perceptions

Objective: To evaluate impact of the Maryland Multipayor Patient-centered Medical Home Program (MMPP) on: (1) quality, utilization, and costs of care; (2) beneficiaries’ experiences and satisfaction with care; and (3) perceptions of providers. Design: 4-year quasiexperimental design with a difference-in-differences analytic approach to compare changes in outcomes between MMPP practices and propensity score-matched comparisons; pre-post design for patient-reported outcomes among MMPP beneficiaries. Subjects: Beneficiaries (Medicaid-insured and privately insured) and providers in 52 MMPP practices and 104 matched comparisons in Maryland. Intervention: Participating practices received unconditional financial support and coaching to facilitate functioning as medical homes, membership in a learning collaborative to promote education and dissemination of best practices, and performance-based payments. Measures: Sixteen quality, 20 utilization, and 13 cost measures from administrative data; patient-reported outcomes on care delivery, trust in provider, access to care, and chronic illness management; and provider perceptions of team operation, team culture, satisfaction with care provided, and patient-centered medical home transformation. Results: The MMPP had mixed impact on site-level quality and utilization measures. Participation was significantly associated with lower inpatient and outpatient payments in the first year among privately insured beneficiaries, and for the entire duration among Medicaid beneficiaries. There was indication that MMPP practices shifted responsibility for certain administrative tasks from clinicians to medical assistants or care managers. The program had limited effect on measures of patient satisfaction (although response rates were low) and on provider perceptions. Conclusions: The MMPP demonstrated mixed results of its impact and indicated differential program effects for privately insured and Medicaid beneficiaries.