Physician Group Practices Accrued Large Bonuses Under Medicare's Bundled Payment Model, 2018-20.

The Bundled Payments for Care Improvement Advanced Model (BPCI-A), a voluntary Alternative Payment Model for Medicare, incentivizes hospitals and physician group practices to reduce spending for patient care episodes below preset target prices. The experience of physician groups in BPCI-A is not well understood. We found that physician groups earned $421 million in incentive payments during BPCI-A's first four performance periods (2018-20). Target prices were positively associated with bonuses, with a mean reconciliation payment of $139 per episode in the lowest decile of target prices and $2,775 in the highest decile. In the first year of the COVID-19 pandemic, mean bonuses increased from $815 per episode to $2,736 per episode. These findings suggest that further policy changes, such as improving target price accuracy and refining participation rules, will be important as the Centers for Medicare and Medicaid Services continues to expand BPCI-A and develop other bundled payment models.

The effect of a bundle intervention for ambulatory otorhinolaryngology procedures on same-day case cancellation rate and associated costs.

Cancellations within 24 h of planned elective surgical procedures reduce operating theatre efficiency, add unnecessary costs and negatively affect patient experience. We implemented a bundle intervention that aimed to reduce same-day case cancellations. This consisted of communication tools to improve patient engagement and new screening instruments (automated estimation of ASA physical status and case cancellation risk score plus four screening questions) to identify patients in advance (ideally before case booking) who needed comprehensive pre-operative risk stratification. We studied patients scheduled for ambulatory surgery with the otorhinolaryngology service at a single centre from April 2021 to December 2022. Multivariable logistic regression and interrupted time-series analyses were used to analyse the effects of this intervention on case cancellations within 24 h and costs. We analysed 1548 consecutive scheduled cases. Cancellation within 24 h occurred in 114 of 929 (12.3%) cases pre-intervention and 52 of 619 (8.4%) cases post-intervention. The cancellation rate decreased by 2.7% (95%CI 1.6-3.7%, p < 0.01) during the first month, followed by a monthly decrease of 0.2% (95%CI 0.1-0.4%, p < 0.01). This resulted in an estimated $150,200 (£118,755; €138,370) or 35.3% cost saving (p < 0.01). Median (IQR [range]) number of days between case scheduling and day of surgery decreased from 34 (21-61 [0-288]) pre-intervention to 31 (20-51 [1-250]) post-intervention (p < 0.01). Patient engagement via the electronic health record patient portal or text messaging increased from 75.9% at baseline to 90.8% (p < 0.01) post-intervention. The primary reason for case cancellation was patients' missed appointment on the day of surgery, which decreased from 7.2% pre-intervention to 4.5% post-intervention (p = 0.03). An anaesthetist-driven, clinical informatics-based bundle intervention decreases same-day case cancellation rate and associated costs in patients scheduled for ambulatory otorhinolaryngology surgery.

Reconciliation Payments in the Bundled Payments for Care Improvement Advanced Program and Reductions in Clinical Spending Needed for CMS to Avoid Financial Losses.

This study examines the magnitude of reconciliation payments and clinical spending reductions necessary for the Centers for Medicare & Medicaid Services to break even in the first 4 performance periods of the BPCI-A (Bundled Payments for Care Improvement Advanced) program.

Association of Hospital Participation in Bundled Payments for Care Improvement Advanced With Medicare Spending and Hospital Incentive Payments.

Importance: Bundled Payments for Care Improvement Advanced (BPCI-A) is a Centers for Medicare & Medicaid Services (CMS) initiative that aims to produce financial savings by incentivizing decreases in clinical spending. Incentives consist of financial bonuses from CMS to hospitals or penalties paid by hospitals to CMS. Objective: To investigate the association of hospital participation in BPCI-A with spending, and to characterize hospitals receiving financial bonuses vs penalties. Design, Setting, and Participants: Difference-in-differences and cross-sectional analyses of 4 754 139 patient episodes using 2013-2019 US Medicare claims at 694 participating and 2852 nonparticipating hospitals merged with hospital and market characteristics. Exposures: BPCI-A model years 1 and 2 (October 1, 2018, through December 31, 2019). Main Outcomes and Measures: Hospitals' per-episode spending, CMS gross and net spending, and the incentive allocated to each hospital. Results: The study identified 694 participating hospitals. The analysis observed a -$175 change in mean per-episode spending (95% CI, -$378 to $28) and an aggregate spending change of -$75.1 million (95% CI, -$162.1 million to $12.0 million) across the 428 670 episodes in BPCI-A model years 1 and 2. However, CMS disbursed $354.3 million (95% CI, $212.0 million to $496.0 million) more in bonuses than it received in penalties. Hospital participation in BPCI-A was associated with a net loss to CMS of $279.2 million (95% CI, $135.0 million to $423.0 million). Hospitals in the lowest quartile of Medicaid days received a mean penalty of $0.41 million; (95% CI, $0.09 million to $0.72 million), while those in the highest quartile received a mean bonus of $1.57 million; (95% CI, $1.09 million to $2.08 million). Similar patterns were observed for hospitals across increasing quartiles of Disproportionate Share Hospital percentage and of patients from racial and ethnic minority groups. Conclusions and Relevance: Among US hospitals measured between 2013 and 2019, participation in BPCI-A was significantly associated with an increase in net CMS spending. Bonuses accrued disproportionately to hospitals providing care for marginalized communities.

Patient selection in the Comprehensive Care for Joint Replacement model.

OBJECTIVE: To understand whether the Comprehensive Care for Joint Replacement (CJR) program induces participating hospitals to (1) preferentially select lower risk patients, (2) reduce 90-day episode-of-care costs, (3) improve quality of care, and (4) achieve greater cost reduction during its second year, when downside financial risk was applied. DATA SOURCES: We identified beneficiaries of age 65 years or older undergoing hip or knee joint replacement in the 100% sample of Medicare fee-for-service inpatient (Part A) claims from January 1, 2013 to August 31, 2017. Cases were linked to subsequent outpatient, Part B, home health agency, and skilled nursing facility claims, as well as publicly available participation status for CJR. STUDY DESIGN: We estimated the effect of CJR for hospitals in the 67 metropolitan statistical areas (MSA) selected to participate in CJR (785 hospitals), compared to those in 104 non-CJR MSAs (962 hospitals; maintaining fee-for-service). A difference-in-differences approach was used to detect patient selection, as well as to compare 90-day episode-of-care costs and quality of care between CJR and non-CJR hospitals over the first two performance years. DATA COLLECTION: We excluded 172 hospitals from our analysis due to their preexisting BPCI participation. We focused on elective admissions in the main analysis. PRINCIPAL FINDINGS: While reductions in 90-day episode-of-care costs were greater among CJR hospitals (-$902, 95% CI: -$1305, -$499), largely driven by a 16.8% (p < 0.01) decline in 90-day spending in skilled nursing facilities, CJR hospitals significantly reduced the 90-day readmission rate (-3.9%; p < 0.05) and preferentially avoided patients aged 85 years or older (-5.9%; p < 0.01) and Black (-7.0%; p < 0.01). Cost reduction was greater in 2017 than in 2016, corresponding to the start of downside risk. CONCLUSIONS: Participation in CJR was associated with a modest cost reduction and a reduction in 90-day readmission rates; however, we also observed evidence of preferential avoidance of older patients perceived as being higher risk among CJR hospitals.

Managing the economic challenges in the treatment of heart failure.

BACKGROUND: Treatment of heart failure is complex and inherently challenging. Patients traverse multiple practice settings as inpatients and outpatients, often resulting in fragmented care. The Center for Medicare and Medicaid Services is implementing payment programs that reward delivery of high-quality, cost-effective care, and one of the newer programs, the Bundled Payment for Care Improvement Advanced program, attempts to improve the coordination of care across practices for a hospitalization episode and post-acute care. The quality and cost of care contribute to its value, but value may be defined in different ways by different entities. CONCLUSIONS: The rapidly changing world of digital health may contribute to or detract from the quality and cost of care. Health systems, payers, and patients are all grappling with these issues, which were reviewed at a symposium at the Heart Failure Society of America conference in Philadelphia, Pennsylvania on September 14, 2019. This article constitutes the proceedings from that symposium.

Dissecting the Perioperative Care Bundle.

Enhanced recovery after surgery (ERAS) protocols are comprehensive perioperative care pathways designed to mitigate the physiologic stressors associated with surgery and, in turn, improve clinical outcomes and lead to health care cost savings. Although individual components may differ, ERAS protocols are typically organized as multimodal care "bundles" that, when followed closely and in their entirety, are meant to generate amplified cumulative benefits. This manuscript examines some of the critical components, describes some areas where the science is weak (but dogma may be strong), and provides some of the evidence or lack thereof behind components of a standard ERAS protocol.

Patient Health Outcomes following Dialysis Facility Closures in the United States.

BACKGROUND: Ongoing changes to reimbursement of United States dialysis care may increase the risk of dialysis facility closures. Closures may be particularly detrimental to the health of patients receiving dialysis, who are medically complex and clinically tenuous. METHODS: We used two separate analytic strategies-one using facility-based matching and the other using propensity score matching-to compare health outcomes of patients receiving in-center hemodialysis at United States facilities that closed with outcomes of similar patients who were unaffected. We used negative binomial and Cox regression models to estimate associations of facility closure with hospitalization and mortality in the subsequent 180 days. RESULTS: We identified 8386 patients affected by 521 facility closures from January 2001 through April 2014. In the facility-matched model, closures were associated with 9% higher rates of hospitalization (relative rate ratio [RR], 1.09; 95% confidence interval [95% CI], 1.03 to 1.16), yielding an absolute annual rate difference of 1.69 hospital days per patient-year (95% CI, 0.45 to 2.93). Similarly, in a propensity-matched model, closures were associated with 7% higher rates of hospitalization (RR, 1.07; 95% CI, 1.00 to 1.13; P=0.04), yielding an absolute rate difference of 1.08 hospital days per year (95% CI, 0.04 to 2.12). Closures were associated with nonsignificant increases in mortality (hazard ratio [HR], 1.08; 95% CI, 1.00 to 1.18; P=0.05 for the facility-matched comparison; HR, 1.08; 95% CI, 0.99 to 1.17; P=0.08 for the propensity-matched comparison). CONCLUSIONS: Patients affected by dialysis facility closures experienced increased rates of hospitalization in the subsequent 180 days and may be at increased risk of death. This highlights the need for effective policies that continue to mitigate risk of facility closures.

Savings and outcomes under Medicare's bundled payments initiative for skilled nursing facilities.

BACKGROUND: Model 3 of Medicare's Bundled Payments for Care Improvement (BPCI) was a voluntary alternative payment model that held participating skilled nursing facilities (SNFs) accountable for 90-day costs of care. Its overall impact on Medicare spending and clinical outcomes is unknown. METHODS: Retrospective cohort study using Medicare claims from 2012 to 2017. We used an interrupted time-series design to compare participating vs matched control SNFs on total 90-day Medicare payments and payment components (initial SNF stay, readmissions, and outpatient/clinician), case mix (volume, proportion Medicaid, proportion black, number of comorbidities), and clinical outcomes (90-day readmission, mortality and healthy days at home, and length of initial SNF stay), overall and among key subgroups with frailty or dementia, for 47 of the 48 conditions in the program (excluding major lower extremity joint replacement). RESULTS: Our sample included 1001 participating and 3873 matched control SNFs. At baseline, total Medicare institutional payments were increasing at BPCI SNFs at a rate of $121 per episode per quarter; during the intervention period, payments decreased at a rate of -$398/episode/quarter. Among controls, payments were stable in the baseline period (+$17/episode/quarter) but decreased at -$424/episode/quarter during the intervention period, yielding a nonsignificant difference in slope changes of -$79/episode/quarter (95% confidence interval [CI] -$188, $31, p = 0.16). However, among patients with frailty, spending declined by $620/episode/quarter in the BPCI group, compared with $330/episode/quarter in the non-BPCI group, for a difference in slope changes of -$289 (95% CI -$482, -$96, p = 0.003). There were no differences in the change in slopes in case selection or clinical outcomes overall or in any clinical subgroup. CONCLUSIONS: SNF participation in BPCI was associated with no overall differential change in total Medicare payments per episode, case selection, or clinical outcomes. Exploratory analyses revealed a decrease in Medicare payments in patients with frailty that may warrant further study.

Year 1 of the Bundled Payments for Care Improvement-Advanced Model.

BACKGROUND: The Center for Medicare and Medicaid Innovation launched the Medicare Bundled Payments for Care Improvement-Advanced (BPCI-A) program for hospitals in October 2018. Information is needed about the effects of the program on health care utilization and Medicare payments. METHODS: We conducted a modified segmented regression analysis using Medicare claims and including patients with discharge dates from January 2017 through September 2019 to assess differences between BPCI-A participants and two control groups: hospitals that never joined the BPCI-A program (nonjoining hospitals) and hospitals that joined the BPCI-A program in January 2020, after the conclusion of the intervention period (late-joining hospitals). The primary outcomes were the differences in changes in quarterly trends in 90-day per-episode Medicare payments and the percentage of patients with readmission within 90 days after discharge. Secondary outcomes were mortality, volume, and case mix. RESULTS: A total of 826 BPCI-A participant hospitals were compared with 2016 nonjoining hospitals and 334 late-joining hospitals. Among BPCI-A hospitals, the mean baseline 90-day per-episode Medicare payment was $27,315; the change in the quarterly trends in the intervention period as compared with baseline was -$78 per quarter. Among nonjoining hospitals, the mean baseline 90-day per-episode Medicare payment was $25,994; the change in quarterly trends as compared with baseline was -$26 per quarter (difference between nonjoining hospitals and BPCI-A hospitals, $52 [95% confidence interval {CI}, 34 to 70] per quarter; P<0.001; 0.2% of the baseline payment). Among late-joining hospitals, the mean baseline 90-day per-episode Medicare payment was $26,807; the change in the quarterly trends as compared with baseline was $4 per quarter (difference between late-joining hospitals and BPCI-A hospitals, $82 [95% CI, 41 to 122] per quarter; P<0.001; 0.3% of the baseline payment). There were no meaningful differences in the changes with regard to readmission, mortality, volume, or case mix. CONCLUSIONS: The BPCI-A program was associated with small reductions in Medicare payments among participating hospitals as compared with control hospitals. (Funded by the National Heart, Lung, and Blood Institute.).

Improving target price calculations in Medicare bundled payment programs.

OBJECTIVE: To compare the predictive accuracy of two approaches to target price calculations under Bundled Payments for Care Improvement-Advanced (BPCI-A): the traditional Centers for Medicare and Medicaid Services (CMS) methodology and an empirical Bayes approach designed to mitigate the effects of regression to the mean. DATA SOURCES: Medicare fee-for-service claims for beneficiaries discharged from acute care hospitals between 2010 and 2016. STUDY DESIGN: We used data from a baseline period (discharges between January 1, 2010 and September 30, 2013) to predict spending in a performance period (discharges between October 1, 2015 and June 30, 2016). For 23 clinical episode types in BPCI-A, we compared the average prediction error across hospitals associated with each statistical approach. We also calculated an average across all clinical episode types and explored differences by hospital size. DATA COLLECTION/EXTRACTION METHODS: We used a 20% sample of Medicare claims, excluding hospitals and episode types with small numbers of observations. PRINCIPAL FINDINGS: The empirical Bayes approach resulted in significantly more accurate episode spending predictions for 19 of 23 clinical episode types. Across all episode types, prediction error averaged $8456 for the CMS approach versus $7521 for the empirical Bayes approach. Greater improvements in accuracy were observed with increasing hospital size. CONCLUSIONS: CMS should consider using empirical Bayes methods to calculate target prices for BPCI-A.

Using decision trees to determine participation in bundled payments in sepsis cases.

RATIONALE: The purpose of this research is to determine and develop a valid analytical method that can be easily implemented by providers to evaluate whether they should join the bundled payments for care improvement (BPCI) advanced bundled payment program, and analyze the projected impacts of BPCI advanced payment on their margins. METHODS: We have developed a decision tree model that incorporates the types of sepsis encountered and the resultant typical complications and associated costs. RESULTS: The initial cost of a sepsis episode was $30,386. Since Medicare requires that there is a 3% cost reduction under BPCI, we applied the model with a 3% cost reduction across the board. Since the model considers probabilities of the complications and readmission, there was actually a 3.36% reduction in costs when the 3% reduction was added to the model. We applied 2-way sensitivity analysis to the intensive care unit (ICU) long and short costs. We used the unbundled cost at the high end, and a 10% reduction at the low end. Per patient episode cost varied between $28,117 and $29,658. This is a 5.2% difference between low and high end. Next, we looked at varying the hospital bed (non-ICU) costs. Here the resultant cost varied between $28,708 and $29,099. This is only a 1.34% difference between low and high ends. Finally, we applied a sensitivity analysis varying the attending physician and the intensivist reimbursement fees. The result was a cost that varied between $29,191 and $29,366 which is a difference of only 0.595%. CONCLUSION: This is the precise environment where decision tree analysis modeling is essential. This analysis can guide the hospital in just how to allocate resources in light of the new BPCI advanced payment model.

Medicare bundles for arthroplasty : a journey back to fee for service?

AIMS: There is concern that aggressive target pricing in the new Bundled Payment for Care Improvement Advanced (BPCI-A) penalizes high-performing groups that had achieved low costs through prior experience in bundled payments. We hypothesize that this methodology incorporates unsustainable downward trends on Target Prices and will lead to groups opting out of BPCI Advanced in favour of a traditional fee for service. METHODS: Using the Centers for Medicare and Medicaid Services (CMS) data, we compared the Target Price factors for hospitals and physician groups that participated in both BPCI Classic and BPCI Advanced (legacy groups), with groups that only participated in BPCI Advanced (non-legacy). With rebasing of Target Prices in 2020 and opportunity for participants to drop out, we compared retention rates of hospitals and physician groups enrolled at the onset of BPCI Advanced with current enrolment in 2020. RESULTS: At its peak in July 2015, 342 acute care hospitals and physician groups participated in Lower Extremity Joint Replacement (LEJR) in BPCI Classic. At its peak in March 2019, 534 acute care hospitals and physician groups participated in LEJR in BPCI Advanced. In January 2020, only 14.5% of legacy hospitals and physician groups opted to stay in BPCI Advanced for LEJR. Analysis of Target Price factors by legacy hospitals during both programmes demonstrates that participants in BPCI Classic received larger negative adjustments on the Target Price than non-legacy hospitals. CONCLUSION: BPCI Advanced provides little opportunity for a reduction in cost to offset a reduced Target Price for efficient providers, as made evident by the 85.5% withdrawal rate for BPCI Advanced. Efficient providers in BPCI Advanced are challenged by the programme's application of trend and efficiency factors that presumes their cost reduction can continue to decline at the same rate as non-efficient providers. It remains to be seen if reverting back to Medicare fee for service will support the same level of care and quality achieved in historical bundled payment programmes. Cite this article: Bone Joint J 2021;103-B(6 Supple A):119-125.

Is There An Association Between Bundled Payments and "Cherry Picking" and "Lemon Dropping" in Orthopaedic Surgery? A Systematic Review.

BACKGROUND: The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure that incentivizes improved value for patients. There is concern that such a payment mechanism may lead to patient screening and denying or providing orthopaedic care to patients based on the number and severity of comorbid conditions present associated with complications after surgery. Currently, however, there is no clear consensus about whether such an association exists. QUESTIONS/PURPOSES: In this systematic review, we asked: (1) Is the implementation of a bundled payment model associated with a change in the sociodemographic characteristics of patients undergoing an orthopaedic procedure? (2) Is the implementation of a bundled payment model associated with a change in the comorbidities and/or case-complexity characteristics of patients undergoing an orthopaedic procedure? (3) Is the implementation of a bundled payment model associated with a change in the recent use of healthcare resources characteristics of patients undergoing an orthopaedic procedure? METHODS: This systematic review was registered in PROSPERO before data collection (CRD42020189416). Our systematic review included scientific manuscripts published in MEDLINE, Embase, Web of Science, Econlit, Policyfile, and Google Scholar through March 2020. Of the 30 studies undergoing full-text review, 20 were excluded because they did not evaluate the outcome of interest (patient selection) (n = 8); were editorial, commentary, or review articles (n = 5); did not evaluate the appropriate intervention (introduction of a bundled payment program) (n = 4); or assessed the wrong patient population (not orthopaedic surgery patients) (n = 3). This led to 10 studies included in this systematic review. For each study, patient factors analyzed in the included studies were grouped into the following three categories: sociodemographics, comorbidities and/or case complexity, or recent use of healthcare resources characteristics. Next, each patient factor falling into one of these three categories was examined to evaluate for changes from before to after implementation of a bundled payment initiative. In most cases, studies utilized a difference-in-difference (DID) statistical technique to assess for changes. Determination of whether the bundled payment initiative required mandatory participation or not was also noted. Scientific quality using the Adapted Newcastle-Ottawa Scale had a median (range) score of 8 (7 to 8; highest possible score: 9), and the quality of the total body of evidence for each patient characteristic group was found to be low using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. We could not assess the likelihood of publication using funnel plots because of the variation of patient factors analyzed in each study and the heterogeneity of data precluded a meta-analysis. RESULTS: Of the nine included studies that reported on the sociodemographic characteristics of patients selected for care, seven showed no change with the implementation of bundled payments, and two demonstrated a difference. Most notably, the studies identified a decrease in the percentage of patients undergoing an orthopaedic operative intervention who were dual-eligible (range DID estimate -0.4% [95% CI -0.75% to -0.1%]; p < 0.05 to DID estimate -1.0% [95% CI -1.7% to -0.2%]; p = 0.01), which means they qualified for both Medicare and Medicaid insurance coverage. Of the 10 included studies that reported on comorbidities and case-complexity characteristics, six reported no change in such characteristics with the implementation of bundled payments, and four studies noted differences. Most notably, one study showed a decrease in the number of treated patients with disabilities (DID estimate -0.6% [95% CI -0.97% to -0.18%]; p < 0.05) compared with before bundled payment implementation, while another demonstrated a lower number of Elixhauser comorbidities for those treated as part of a bundled payment program (before: score of 0-1 in 63.6%, 2-3 in 27.9%, > 3 in 8.5% versus after: score of 0-1 in 50.1%, 2-3 in 38.7%, > 3 in 11.2%; p = 0.033). Of the three included studies that reported on the recent use of healthcare resources of patients, one study found no difference in the use of healthcare resources with the implementation of bundled payments, and two studies did find differences. Both studies found a decrease in patients undergoing operative management who recently received care at a skilled nursing facility (range DID estimate -0.50% [95% CI -1.0% to 0.0%]; p = 0.04 to DID estimate: -0.53% [95% CI -0.96% to -0.10%]; p = 0.01), while one of the studies also found a decrease in patients undergoing operative management who recently received care at an acute care hospital (DID estimate -0.8% [95% CI -1.6% to -0.1%]; p = 0.03) or as part of home healthcare (DID estimate -1.3% [95% CI -2.0% to -0.6%]; p < 0.001). CONCLUSION: In six of 10 studies in which differences in patient characteristics were detected among those undergoing operative orthopaedic intervention once a bundled payment program was initiated, the effect was found to be minimal (approximately 1% or less). However, our findings still suggest some level of adverse patient selection, potentially worsening health inequities when considered on a large scale. It is also possible that our findings reflect better care, whereby the financial incentives lead to fewer patients with a high risk of complications undergoing surgical intervention and vice versa for patients with a low risk of complications postoperatively. However, this is a fine line, and it may also be that patients with a high risk of complications postoperatively are not being offered surgery enough, while patients at low risk of complications postoperatively are being offered surgery too frequently. Evaluation of the longer-term effect of these preliminary bundled payment programs on patient selection is warranted to determine whether adverse patient selection changes over time as health systems and orthopaedic surgeons become accustomed to such reimbursement models.

Hospital to Home Transition for Patients With Stroke Under Bundled Payments.

Bundled payments are a promising alternative payment model for reducing costs and improving the coordination of postacute stroke care, yet there is limited evidence supporting the effectiveness of bundled payments for stroke. This may be due to the lack of effective strategies to address the complex needs of stroke survivors. In this article, we describe COMprehensive Post-Acute Stroke Services (COMPASS), a comprehensive transitional care intervention focused on discharge from the acute care setting to home. COMPASS may serve as a potential care redesign strategy under bundled payments for stroke, such as the Centers for Medicare & Medicaid Innovation Bundled Payment for Care Improvement Initiative. The COMPASS care model is aligned with the incentive structures and essential components of bundled payments in terms of care coordination, patient assessment, patient and family involvement, and continuity of care. Ongoing evaluation will inform the design of incorporating COMPASS-like transitional care interventions into a stroke bundle.

Stillbirth rates, service outcomes and costs of implementing NHS England's Saving Babies' Lives care bundle in maternity units in England: A cohort study.

OBJECTIVE: To assess implementation of the Saving Babies Lives (SBL) Care Bundle, a collection of practice recommendations in four key areas, to reduce stillbirth in England. DESIGN: A retrospective cohort study of 463,630 births in 19 NHS Trusts in England using routinely collected electronic data supplemented with case note audit (n = 1,658), and surveys of service users (n = 2,085) and health care professionals (n = 1,064). The primary outcome was stillbirth rate. Outcome rates two years before and after the nominal SBL implementation date were derived as a measure of change over the implementation period. Data were collected on secondary outcomes and process outcomes which reflected implementation of the SBL care bundle. RESULTS: The total stillbirth rate, declined from 4.2 to 3.4 per 1,000 births between the two time points (adjusted Relative Risk (aRR) 0.80, 95% Confidence Interval (95% CI) 0.70 to 0.91, P<0.001). There was a contemporaneous increase in induction of labour (aRR 1.20 (95%CI 1.18-1.21), p<0.001) and emergency Caesarean section (aRR 1.10 (95%CI 1.07-1.12), p<0.001). The number of ultrasound scans performed (aRR 1.25 (95%CI 1.21-1.28), p<0.001) and the proportion of small for gestational age infants detected (aRR 1.59 (95%CI 1.32-1.92), p<0.001) also increased. Organisations reporting higher levels of implementation had improvements in process measures in all elements of the care bundle. An economic analysis estimated the cost of implementing the care bundle at ~£140 per birth. However, neither the costs nor changes in outcomes could be definitively attributed to implementation of the SBL care bundle. CONCLUSIONS: Implementation of the SBL care bundle increased over time in the majority of sites. Implementation was associated with improvements in process outcomes. The reduction in stillbirth rates in participating sites exceeded that reported nationally in the same timeframe. The intervention should be refined to identify women who are most likely to benefit and minimise unwarranted intervention. TRIAL REGISTRATION: The study was registered on (NCT03231007); www.clinicaltrials.gov.