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Background Care bundles are a set of three to five evidence-informed practices performed collectively and reliably to improve the quality of care. Care bundles are used widely across healthcare settings with the aim of preventing and managing different health conditions. This is the first systematic review designed to determine the effects of care bundles on patient outcomes and the behaviour of healthcare workers in relation to fidelity with care bundles. Methods This systematic review is reported in line with the PRISMA statement for reporting systematic reviews and meta-analyses. A total of 5796 abstracts were retrieved through a systematic search for articles published between January 1, 2001, to February 4, 2017, in the Cochrane Central Register for Controlled Trials, MEDLINE, EMBASE, British Nursing Index, CINAHL, PsychInfo, British Library, Conference Proceeding Citation Index, OpenGrey trials (including cluster-randomised trials) and non-randomised studies (comprising controlled before-after studies, interrupted time series, cohort studies) of care bundles for any health condition and any healthcare settings were considered. Following the removal of duplicated studies, two reviewers independently screen 3134 records. Three authors performed data extraction independently. We compared the care bundles with usual care to evaluate the effects of care bundles on the risk of negative patient outcomes. Random-effect models were used to further explore the effects of subgroups. Results In total, 37 studies (6 randomised trials, 31 controlled before-after studies) were eligible for inclusion. The effect of care bundles on patient outcomes is uncertain. For randomised trial data, the pooled relative risk of negative effects between care bundle and control groups was 0.97 [95% CI 0.71 to 1.34; 2049 participants]. The relative risk of negative patient outcomes from controlled before-after studies favoured the care bundle treated groups (0.66 [95% CI 0.59 to 0.75; 119,178 participants]). However, using GRADE, we assessed the certainty of all of the evidence to be very low (downgraded for risk of bias, inconsistency, indirectness). Conclusions Very low quality evidence from controlled before-after studies suggests that care bundles may reduce the risk of negative outcomes when compared with usual care. By contrast, the better quality evidence from six randomised trials is more uncertain. Trial registration PROSPERO, CRD42016033175

PurposeThe efficacy of the 1-h bundle for emergency department (ED) patients with suspected sepsis, which includes lactate measurement, blood culture, broad-spectrum antibiotics administration, administration of 30 mL/kg crystalloid fluid for hypotension or lactate ≥ 4 mmol/L, remains controversial.MethodsWe carried out a pragmatic stepped-wedge cluster-randomized trial in 23 EDs in France and Spain. Adult patients with Sepsis-3 criteria or a quick sequential organ failure assessment (SOFA) score ≥ 2 or a lactate > 2 mmol/L were eligible. The intervention was the implementation of the 1-h sepsis bundle. The primary outcome was in-hospital mortality truncated at 28 days. Secondary outcomes included volume of fluid resuscitation at 24 h, acute heart failure at 24 h, SOFA score at 72 h, intensive care unit (ICU) length of stay, number of days on mechanical ventilation or renal replacement therapy, vasopressor free days, unnecessary antibiotic administration, and mortality at 28 days. 1148 patients were planned to be analysed; the study period ended after 873 patients were included.Results872 patients (mean age 66, 42% female) were analyzed: 387 (44.4%) in the intervention group and 485 (55.6%) in the control group. Median SOFA score was 3 [1–5]. Median time to antibiotic administration was 40 min in the intervention group vs 113 min in the control group (difference − 73 [95% confidence interval (CI) − 93 to − 53]). There was a significantly higher rate, volume, and shorter time to fluid resuscitation within 3 h in the intervention group. There were 47 (12.1%) in-hospital deaths in the intervention group compared to 61 (12.6%) in the control group (difference in percentage − 0.4 [95% CI − 5.1 to 4.2], adjusted relative risk (aRR) 0.81 [95% CI 0.48 to 1.39]). There were no differences between groups for other secondary endpoints.ConclusionsAmong patients with suspected sepsis in the ED, the implementation of the 1-h sepsis bundle was not associated with significant difference in in-hospital mortality. However, this study may be underpowered to report a statistically significant difference between groups.

Determine the incidence and risk factors for pressure ulcers in a paediatric intensive care unit. Use the information gathered to develop preventive pressure ulcer care bundles. Prospective cohort study using Braden Q Scale for Predicting Pressure Sore Risk and European Pressure Ulcer Advisory Panel Pressure Ulcer Staging tool. General paediatric intensive care unit in a tertiary level hospital between May and October 2017. Seventy-seven children were recruited. Most children were male (n = 42, 54.5%) and all nine children (11.7%) that developed a pressure ulcer were male. The main risk factor for developing a pressure ulcer was lack of physical activity. None of the children assessed as high or severe risk developed a pressure ulcer. Eight (89%) pressure ulcers were assessed as grade one. Seven pressure ulcers (77.8%) were on the facial and scalp area and all seven children were receiving airway support at the time the pressure ulcers developed. Incidence of pressure ulcers was 11.7%, with the facial and scalp area the most common anatomical areas affected. Medical devices appeared to be the prime causative factor. Based on our data we have modified and launched the SSKIN care bundle for the paediatric intensive care unit setting.

BackgroundCentral line-associated bloodstream infections (CLABSIs) are associated with increased mortality, prolonged hospitalisation and increased healthcare costs. Care bundles have reduced CLABSIs in adult intensive care units (ICUs) but replication in paediatric ICUs has had inconsistent outcomes. A systematic review was performed to assess the evidence for the efficacy of care bundles in reducing CLABSIs in the neonatal unit (NNU).MethodsMEDLINE, CINAHL and EMBASE were searched from January 2010 up to January 2017. The Cochrane Library, Web of Science, Zetoc and Ethos were searched for additional studies. Randomised controlled trials (RCTs), quasi-experimental and observational studies were eligible. The primary outcome measure was CLABSI rates per 1000 central line, or patient, days. A meta-analysis was performed using random effects modelling.ResultsTwenty-four studies were eligible for inclusion: six were performed in Europe, 12 were in North America, two in Australia and four were in low/middle-income countries. Five were observational studies and 19 were before and after quality improvement studies. No RCTs were found. Meta-analysis revealed a statistically significant reduction in CLABSIs following the introduction of care bundles (rate ratio=0.40 (CI 0.31 to 0.51), p<0.00001), which equates to a 60% reduction in CLABSI rate.ConclusionThere is a substantial body of quasi-experimental evidence to suggest that care bundles may reduce CLABSI rates in the NNU, though it is not clear which bundle elements are effective in specific settings. Future research should focus on determining what processes promote the effective implementation of infection prevention recommendations, and which elements represent essential components of such care bundles.

Medicare has reinforced its commitment to voluntary bundled payment by building upon the Bundled Payments for Care Improvement (BPCI) initiative via an ongoing successor program, the BPCI Advanced Model. Although lower extremity joint replacement (LEJR) is the highestvolume episode in both BPCI and BPCI Advanced, there is a paucity of independent evidence about its long-term impact on outcomes and about whether improvements vary by timing of participation or arise from patient selection rather than changes in clinical practice. We found that over three years, compared to no participation, participation in BPCI was associated with a 1.6 percent differential decrease in average LEJR episode spending with no differential changes in quality, driven by early participants. Patient selection accounted for 27 percent of episode savings. Our findings have important policy implications in view of BPCI Advanced and its two participation waves.

The incidence of pressure ulcers (PUs) in intensive care units (ICUs) is high and numerous strategies have been implemented to address this issue. One approach is the use of a PU prevention bundle. However, to ensure success care bundle implementation requires monitoring to evaluate the care bundle compliance rate, and to evaluate the effectiveness of implementation strategies in facilitating practice change. The aims of this study were to appraise the implementation of a series of high impact intervention care bundle components directed at preventing the development of PUs, within ICU, and to evaluate the effectiveness of strategies used to enhance the implementation compliance. An observational prospective study design was used. Implementation strategies included regular education, training, audit and feed-back and the presence of a champion in the ICU. Implementation compliance was measured along four time points using a compliance checklist. Of the 60 registered nurses (RNs) working in the critical care setting, 11 participated in this study. Study participants demonstrated a high level of compliance towards the PU prevention bundle implementation (78.1%), with 100% participant acceptance. No significant differences were found between participants’ demographic characteristics and the compliance score. There was a significant effect for time in the implementation compliance (Wilks Lambda=0.29, F (3, 8)=6.35, p<0.016), indicating that RNs needed time to become familiar with the bundle and routinely implement it into their practice. PU incidence was not influenced by the compliance level of participants. The implementation strategies used showed a positive impact on compliance. Assessing and evaluating implementation compliance is critical to achieve a desired outcome (reduction in PU incidence). This study's findings also highlighted that while RNs needed time to familiarise themselves with the care bundle elements, their clinical practice was congruent with the bundle elements.

Admission care bundles have been demonstrated to improve clinical outcomes for patients in several settings. Decompensated cirrhosis care bundles have been developed following previous reports demonstrating poor care for inpatients with alcohol-related liver disease (ARLD). We performed a UK multi-centred retrospective observational study to understand how frequently decompensated cirrhosis admission care bundles were utilised, who they were used for and their impact on outcomes. In this study (1,224 admissions, 104 hospitals), we demonstrated that admission care bundle usage was low across the UK (11.44%). They were more likely to be utilised in patients with ARLD or who were jaundiced, and less likely to be used in patients admitted for gastrointestinal bleeding. The admission care bundle improved the standard of alcohol care and requesting initial investigations. However, there were areas where more than 80% compliance was achieved without the use of a care bundle and areas where less than 50% compliance was achieved with the use of a care bundle. Given the low utilisation of care bundles, we were unable to demonstrate an effect on risk-adjusted mortality. Thus, interdisciplinary work is required to develop tools which are widely used and improve care and outcomes for patients with decompensated cirrhosis.

BackgroundProspective randomized controlled studies have demonstrated that addition of chlorhexidine (CHG) dressings reduces the rate of catheter (central venous and arterial)-associated bloodstream infections (CABSIs). However, studies confirming their impact in a real-world setting are lacking.MethodsWe conducted a real-world data study evaluating the impact of incrementally introducing chlorhexidine dressings (sponge or gel) in addition to an ongoing catheter bundle on the rates of CABSI, expressed as incidence density rates per 1000 catheter-days measured as part of a surveillance program. Poisson regression models were used to compare infection rates over time. Both dressings were used simultaneously during one of the five study periods.ResultsFrom 2006 to 2014, 18,286 patients were admitted (91,292 ICU-days and 155,242 catheter-days). We recorded 111 CABSIs. We observed a progressive but significant decrease of CABSI rates from 1.48 (95% CI 1.09–2.01) without CHG dressings to 0.69 (95% CI 0.43–1.09) and 0.23 (95% CI 0.11–0.48) episodes per 1000 catheter-days when CHG sponge and CHG gel dressings were used (p = 0.0007; p < 0.001). A non-significant lower rate of infections occurred with CHG gel compared with CHG sponge dressings. An identical low rate of allergic skin reactions (0.3/1000 device-days) was observed with both types of CHX dressings. Post-study data until 2018 confirmed a sustained decrease of infection rates over 11 years.ConclusionsThe addition of chlorhexidine dressings to all CVC and arterial lines to an ongoing catheter bundle was associated with a sustained 11-year reduction of all catheter-associated bloodstream infections. This large real-world data study further supports the current recommendations for the systematic use of CHG dressings on all catheters of ICU patients.

Introduction Various approaches have been suggested to identify acute kidney injury (AKI) early and to initiate kidney-protective measures in patients at risk or with AKI. The objective of this study was to evaluate whether care bundles improve kidney outcomes in these patients. Methods We conducted a systematic review of the literature to evaluate the clinical effectiveness of AKI care bundles with or without urinary biomarkers in the recognition and management of AKI. The main outcomes were major adverse kidney events (MAKEs) consisting of moderate-severe AKI, receipt of renal replacement therapy (RRT), and mortality. Results Out of 7434 abstracts screened, 946 published studies were identified. Thirteen studies [five randomized controlled trials (RCTs) and eight non-RCTs] including 16,540 patients were eligible for inclusion in the meta-analysis. Meta-analysis showed a lower incidence of MAKE in the AKI care bundle group [odds ratio (OR) 0.73, 95% confidence interval (CI) 0.66–0.81] with differences in all 3 individual outcomes [moderate–severe AKI (OR 0.65, 95% CI 0.51–0.82), RRT (OR 0.63, 95% CI = 0.46–0.88) and mortality]. Subgroup analysis of the RCTs, all adopted biomarker-based approach, decreased the risk of MAKE (OR 0.55, 95% CI 0.41–0.74). Network meta-analysis could reveal that the incorporation of biomarkers in care bundles carried a significantly lower risk of MAKE when compared to care bundles without biomarkers (OR = 0.693, 95% CI = 0.50–0.96), while the usual care subgroup had a significantly higher risk (OR = 1.29, 95% CI = 1.09–1.52). Conclusion Our meta-analysis demonstrated that care bundles decreased the risk of MAKE, moderate–severe AKI and need for RRT in AKI patients. Moreover, the inclusion of biomarkers in care bundles had a greater impact than care bundles without biomarkers.

In an effort to reduce episode payment variation for joint replacement at US hospitals, the Centers for Medicare and Medicaid Services (CMS) recently implemented the Comprehensive Care for Joint Replacement bundled payment program. Some stakeholders are concerned that the program may unintentionally penalize hospitals because it lacks a mechanism (such as risk adjustment) to sufficiently account for patients' medical complexity. Using Medicare claims for patients in Michigan who underwent lower extremity joint replacement in the period 2011-13, we applied payment methods analogous to those CMS intends to use in determining annual bonuses or penalties (reconciliation payments) to hospitals. We calculated the net difference in reconciliation payments with and without risk adjustment. We found that reconciliation payments were reduced by $827 per episode for each standard-deviation increase in a hospital's patient complexity. Moreover, we found that risk adjustment could increase reconciliation payments to some hospitals by as much as $114,184 annually. Our findings suggest that CMS should include risk adjustment in the Comprehensive Care for Joint Replacement program and in future bundled payment programs.