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Clinical pathways standardize care for common health conditions. We sought to assess whether institution-wide implementation of multiple standardized pathways was associated with changes in utilization and physical functioning after discharge among pediatric inpatients.
Interrupted time series analysis of admissions to a tertiary care children’s hospital from 12/1/09–3/30/14. Based on diagnosis codes, included admissions were eligible for one of 15 clinical pathways implemented during the study period; admissions from both before and after implementation were included. Post-discharge physical functioning improvement was assessed with the PedsQL™ 4.0 generic core or infant scales. Average hospitalization costs, length of stay (LOS), readmissions, and physical functioning improvement scores were calculated by month relative to pathway implementation. Segmented linear regression was used to evaluate differences in intercept and trend over time before and after pathway implementation.
There were 3808 and 2902 admissions in the pre-pathway and post-pathway groups, respectively. Compared to pre-pathway care, post-pathway care was associated with a significant halt in rising costs (pre-pathway vs. post-pathway slope difference −$155/month [95% CI −$246, −$64]; P=.001) and significantly decreased LOS (pre-pathway vs. post-pathway slope difference −0.03 days per month [95% CI −0.05, −0.02]; P= .02), without negatively impacting patient physical functioning improvement or readmissions.
Implementation of multiple evidence-based, standardized clinical pathways was associated with decreased resource utilization without negatively impacting patient physical functioning improvement. This approach could be widely implemented to improve the value of care provided.
Clinical pathways, which standardize care for common conditions, are increasingly used as hospitals strive to provide higher value care by improving quality while containing costs.1–3 Pathway development aims to accelerate the implementation of evidence into clinical practice, thus decreasing unwarranted variability in care, which is known to lead to worse outcomes and higher costs.4,5
Current evidence supports the effectiveness of some individual pathways to decrease utilization and improve outcomes among specific patient populations.4 However, the impact of studied pathways varies by location and condition, making it difficult to know how much of the effect is due to pathway specifics, and how much is due to standardization and reduced variability itself.2 Additionally, the evidence base for pathway use in pediatric populations is limited.3,6
In 2010, Seattle Children’s Hospital (SCH) undertook a hospital-wide initiative to develop and implement Clinical Standard Work (CSW) pathways for a range of pediatric conditions. The CSW approach applied a standard process to develop and implement evidence-based clinical pathways, aiming to improve outcomes while reducing unnecessary utilization. The objective of this study was to assess whether implementation of the CSW system was associated with hospitalization costs, length of stay (LOS), degree of physical functioning improvement after hospital discharge, and readmissions.
CSW pathway development is guided by three principles: (1) treatment should be evidence-based where possible, and otherwise consensus-based; (2) recommendations should be hardwired into electronic order-sets, to encourage adherence; and (3) outcome measures must be owned and tracked by someone who is responsible for pathway continuous improvement.
Development of each CSW pathway begins with a literature review. Key stakeholders, clinicians and experienced CSW consultants prepare a pathway draft based on the literature, which is then reviewed by other clinical experts. Pathways include an order-set in the electronic medical record, providing suggested orders, embedded decision-support, and references. With launch of each new pathway, relevant clinicians must complete an on-line training module and required quiz. Pathway-related information is posted near clinician computers and materials are integrated into provider and nurse work-flow to simplify pathway use. During implementation, audit-and-feedback and targeted education by clinical champions are used to increase use. Pathway order-set use, selected clinical metrics, and safety events are monitored and reviewed at least quarterly, and revisions are made as needed. Order-set use varies by condition, from 100% order-set activation for eligible patients over time (e.g. neonatal jaundice), to lower levels of use, especially immediately following implementation (e.g., croup, 38% use in the initial 3 months and 68% use in the most recent 3 months; Table 1). The degree to which patients receive pathway-recommended care when the order-set is not activated is unknown, although metrics related to specific recommendations indicate that pathway-recommended care does occur without order-set use. For example, while 21% of patients eligible for the urinary tract infection pathway had order-set activation, 48% received pathway-recommended discharge antibiotics.
Between 2010 and 2014, 15 new pathways related to general pediatric conditions were developed and implemented as part of a larger initiative addressing general pediatric and subspecialty care. Seventeen million dollars were budgeted over 5 years for the initiative (mostly for salary support), including ~1000 person-hours dedicated to developing and implementing each pathway, and 1000 person-hours for pathway maintenance and improvement. Full documentation of each pathway is available at http://www.seattlechildrens.org/healthcare-professionals/gateway/pathways/. Pathways are monitored following implementation, with periodic review and alterations as needed. For example, for the croup pathway, length of stay, order-set usage, and percent of patients receiving dexamethasone are tracked quarterly. This review-and-alteration cycle is a central tenet of continuous performance improvement, and is considered part of the intervention. Given the large number of pathways, we did not study the post-implementation changes separately, but consider them an integral part of the post-pathway intervention period.
This was a retrospective cohort study examining admissions eligible for one of 15 general pediatric pathways between December 1, 2009 and March 30, 2014. We did not include admissions eligible for pathways that pre-dated this time period, as no pre-intervention data would be available, or admissions eligible for pathways for children with complex, uncommon subspecialty conditions, such as inflammatory bowel disease. All included pathways were implemented during the study time period, so the study included pathway-eligible admissions, both before and after implementation, for each of the 15 pathway conditions. Pathway eligibility was based on pathway-specific inclusion and exclusion criteria, including diagnosis, age, and comorbid conditions based on International Classification of Disease 9th Revision - Clinical Modification (ICD-9) codes. To identify the “pathway eligible” cohort during the pre-pathway period, we used the same eligibility criteria that would have qualified for care on the pathway, had the pathway been active. We used the Pediatric Medical Complexity Algorithm (PMCA)7 to classify children as having no chronic conditions, non-complex chronic conditions, or complex chronic conditions, on the basis of retrospective ICD-9 codes, beginning with the date of admission and including up to a 3-year retrospective look-back period. As included pathways were all intended for general pediatric populations, we excluded admissions involving patients with complex chronic conditions. All other pathway-eligible admissions were included in the analysis, regardless of whether the relevant order-set was activated, as pathways were meant to influence clinical care even when the order-set was not utilized. For patients with multiple admissions within the study time frame, only the first admission per 30-day period was eligible.
Patient-level outcome measures included total hospital costs, LOS in days, unplanned 30-day hospital readmissions, and physical functioning improvement following hospitalization.
Total charges per hospital stay, excluding physician professional fees, and LOS data were obtained from hospital administrative data. Charges were converted to costs using hospital-specific cost-to-charge ratios, then inflation-adjusted to 2013 United States dollars using the medical care component of the Consumer Price Index.8,9 The same hospital cost-to-charge ratio was used for both study time-periods. Given the skewed distributions, the highest 1% of costs and LOS were truncated at the 99th percentile.
Improvement in physical functioning after hospital discharge was assessed using the Pediatric Quality of Life Inventory 4.0 Generic Core or Infant Scales (PedsQL™) physical functioning subscale.10–12 We only used the physical functioning subscale, as we hypothesized that changes to clinical care would most likely influence physical (rather than psychosocial) functioning, and previous research has found the physical component to be most responsive to post-hospital recovery.13 At SCH, the PedsQL™ is administered to consenting parents (patients aged 1 month to 18 years) and assenting patients within 72 hours of admission and again 2–8 weeks after discharge. Ineligible families included those who had completed the survey within the past 2 months, had a child who was immunocompromised, or who was admitted for suspected child abuse. In 2011–2013, 65% of eligible families completed the admission survey, and 58% completed the follow-up. For analyses, parent-proxy report was used for all patients < 13 years. For teens, self-report was used when available; otherwise parent proxy-report was used. Scores were converted to a 0–100 scale, and improvement scores were calculated as the difference between follow-up and admission scores. Based on previous research, the minimal clinically important difference (MCID) on the 0–100 scale is 4.5.10
Unplanned 30-day readmissions were assessed from hospital administrative data. Readmissions were classified as unplanned using the methods developed by Berry et al, based on the ICD-9 procedure codes determined likely to represent a readmission related to a planned procedure.14 Readmissions were all-cause and included both inpatient and observation stays.
In order to compare all pathways we considered time on a relative scale, with the month and year of pathway implementation as the 0-point (t0) for each of the 15 included pathways. We then considered all 15 pathways simultaneously, with the time of implementation lined up across pathways, and each pathway contributing a variable number of pre- and post-implementation months based on when it was rolled out within the study period. For example, the pathway for diabetic ketoacidosis was implemented in April 2011, contributing 16 months pre-implementation (months t−16 through t−1) and 35 months post-implementation (months t0 through t34). We truncated groups at 36 months pre- and post-pathway implementation, creating a “≥36 months” category given fewer observations at the tails.
After aligning all pathways around month of implementation, time series data were generated by calculating the mean value for each outcome at each time point (i.e., by month relative to implementation).15,16 Thus, the data point for hospital cost in month +3 reflects average cost of hospitalization for study admissions from all 15 pathways in the third month following pathway implementation. These time series data for each outcome were then used in segmented regression models, which fit a separate regression line to each time period (pre- and post-pathway implementation).17 This method produced separate intercepts and slopes for the pre-and post-pathway periods, each of which was accompanied by a P-value testing whether it was different from 0. We also tested whether the pre- and post-pathway period intercepts and slopes were statistically different from one another, using the lincom command in Stata. This approach allows for detection of differences in both trends over time (i.e., the slope) and intercepts.
To explore the relative contribution of each pathway to the overall findings, we stratified the segmented regression for each outcome by individual pathway. To determine whether changes in patient medical complexity or frequency of observation stays over time influenced our findings, we used segmented regression to evaluate changes in the proportion of study admissions per month with no chronic conditions (versus non-complex chronic conditions), and, in a separate model, with an inpatient stay (versus an observation stay).
This study was approved by the Seattle Children’s institutional review board.
Inclusion criteria were met for 3808 pre-pathway admissions and 2902 post-pathway admissions. Individual pathways contributed 7–44 months of pre-pathway data, and 7–45 months of post-pathway data (Figure 1). Patients with pathway eligible admissions were similar in both time-periods (Table 2).
During the pre-pathway period, hospital costs per admission were steadily rising at a rate of $126 per month (95% confidence interval (CI) $60, $191; Figure 2a). Pathway implementation was associated with a statistically significant halt in the rate of rise in costs (post-pathway slope −$29 per month [95% CI −$100, $34], P-value for slope difference between time periods = .001; R2 = 0.98). Compared to the costs per patient predicted by the pre-pathway slope trajectory, the actual post-pathway costs were $155 lower per month (95% CI −$246, −$64; P=.001).
Using segmented regression, we found that pre-pathway LOS was stable over time, with a mean of 3.3 days and no significant slope to the regression line (Figure 2b). Pathway implementation was associated with a steady decrease in LOS, at a rate of −0.03 days (or 43 minutes) per admission per month (95% CI −0.05, −0.02; P-value for slope difference between time periods = .02; R2 = 0.97), which amounts to 8.6 hours over the course of a year.
There were no significant differences by time period in 30-day readmissions, either in trend over time or intercepts based on segmented regression (Figure 3a).
During the pre-pathway period, there was no significant trend in physical functioning improvement scores (Figure 3b). Following pathway implementation, there was a significant increasing trend over time, at a rate of 0.5 points per month (95% CI 0.1, 0.8), or 6 points per year, which exceeds the MCID of 4.5. However, the difference between the pre- and post-pathway period slopes was not statistically significant (P=.22; model R2= 0.86).
In analyses exploring the relative contribution of each pathway, we found few statistically significant differences from the pre- to post-pathway periods, likely due to smaller samples (eTable 1). The individual results for cost generally mirrored the overall results: 8 pathways had significantly increasing costs pre-pathway, of which 2 demonstrated a statistically significant decrease in slope between pre- and post-pathway period, while 5 showed a decrease that approached significance (P = .05 –.1). Individual results for LOS and physical functioning improvement were more variable, with few significant time trends for either period or the difference between periods. There were no significant readmission findings for any pathway.
We found a small but significant increase in the percent of study patients with no chronic conditions (45.4% pre-pathway, 50.1% post-pathway, P=.01), compared to non-complex chronic conditions, but no significant time trends. In contrast, we found a significantly increasing trend over time in the percent of study patients with an inpatient compared to observation stay (pre-pathway slope −0.7% per month [95% CI −1.1, −0.3], post-pathway slope +0.9% per month [95% CI 0.5, 1.2]; pre- to post-pathway slope difference +1.5% [95% CI 1.0, 2.1], P-value <.001).
In this interrupted time series analysis of general pediatric inpatients, we found that implementation of standardized, pathway-based care was associated with a halt in rising hospital costs, decreased LOS, and stable physical functioning improvement scores over time, without detriment to readmission rates. This study’s primary strength was using a relative time scale for the interrupted time series, so that trends over time could be evaluated while distributing the impact of secular trends within each pathway over various study months. Thus the results are unlikely to be attributable to secular trends.
Implementation of clinical pathways has previously been associated with varying degrees of improvement in clinical complications, physician documentation, LOS and/or hospital costs, depending on study.4,18–20 These previous studies, however, evaluated a single pathway at a time, generating evidence for the impact of a particular pathway within a particular context. 2,4,20–32 The inclusion of patients who received care from a diverse range of pathways was another strength of this study, as it allowed for evaluation of the standardized pathway development and implementation process itself, rather than the elements of a particular condition-specific pathway. By evaluating clinical pathways in aggregate, our findings support an association between evidence-based standardization and the outcomes studied. These findings suggest that a process of pathway development, applied systematically across a broad range of diagnoses, can increase the value of healthcare provided, by improving or maintaining clinical outcomes while decreasing LOS and containing costs. While including a diverse set of pathways in the analysis precluded explicit examination of process measures, previous studies documenting decreased variability in care with standardized pathway use suggest increased adherence to evidence-based care as a potential mechanism to explain our findings.33–35
The current US healthcare climate of high and increasing expenditures with poor health outcomes relative to most other developed nations requires interventions that can address the triple aim of simultaneously improving individual experiences of care, improving the health of populations and reducing per capita healthcare cost.36 To achieve these goals requires understanding the impact of healthcare interventions on patient recovery, from the perspective of patients and families.37 The inclusion of a patient-centered outcome, physical functioning improvement post-discharge, ensured that this study addressed not only costs of care, but important health outcomes, thus allowing us to assess the value of pathway implementation.
In this era of healthcare reform, an intervention such as the one studied here, which was associated with maintained or improved patient-reported outcomes while decreasing or containing healthcare costs and LOS, could be considered by other hospitals and provider networks looking to increase the value of care provided.
While sensitivity analyses demonstrated that the proportion of children with no chronic conditions increased in the post-pathway period, which could have contributed to lower costs and shorter LOS, there was no significant trend in this finding over time. In addition, we found a simultaneous increase in inpatient versus observation hospitalizations, which would be expected to exert the opposite effect on our outcomes (i.e., increased LOS and higher costs). Therefore our results are unlikely to merely reflect a change in study population.
This study has several limitations. We were unable to identify a reasonable parallel control group because the majority of patients with relatively common general pediatric diagnoses were either eligible for one of the 15 study pathways or for a pathway that pre-dated the study period, e.g., asthma. While the relative time scale helped to distribute secular trends within each pathway over both the pre- and post-implementation study periods, there may still be external factors influencing our results. However, there were no changes to pay-for-performance initiatives related to our outcomes during the study time period, or other identifiable factors likely to influence our results. We were unable to determine the degree of pathway adherence, so we likely included patients who did not receive it; however, such cases would bias our results toward the null. While combining diverse pathways together allowed evaluation of standardization in general, it limited our ability to measure the impact on disease-specific clinical outcomes, or track process measures that would indicate whether standardization resulted in decreased variability in care. We were also unable to identify which particular steps within individual pathways had the greatest association with outcomes. However, multifaceted interventions like pathway implementation are more likely to be effective than those with only a single component,38 so isolating the impact of individual steps within pathways may not be useful. In addition, combining pathways together may have obscured effects that are specific to an individual pathway. However, the most prevalent pathway (depressive disorders) contributed less than 15% of admissions to both the pre-and post-implementation periods, making it unlikely to have disproportionately influenced the results. While some of the individual pathways were more impactful than others, the sample sizes within each pathway were generally too small to draw definitive conclusions about how much each pathway contributed to the overall findings.
Implementation of a large-scale system for developing and applying standardized care pathways across several health conditions was associated with decreased LOS and costs of care, while maintaining levels of improvement in patient post-discharge physical functioning. These results suggest an approach that could be implemented broadly. A system of clinical pathways, integrating the best available evidence using a rigorous process, holds promise for meeting the challenges facing our healthcare system today: to enhance the value of care by decreasing costs and resource utilization while maintaining or improving patient-centered outcomes.
Standardized clinical pathways have been shown to improve some aspects of care delivery for particular conditions. It is unknown whether standardized pathway use across multiple conditions can improve the value of care provided.
Implementation of 15 standardized pathways across multiple general pediatric conditions was associated with increased value of care, through decreased length of stay and a halt in rising costs without negatively impacting patient physical functioning improvement or readmissions.
Funding source: This work was funded by the Department of Clinical Effectiveness, through hospital operations at Seattle Children’s Hospital.
The authors would like to thank Kathy Mullin, the entire Clinical Effectiveness team, and the countless individuals who have participated in developing, implementing and monitoring the clinical standard work pathways and guidelines.
Financial disclosures: The authors have no financial relationships relevant to this article to disclose.
Conflict of Interest: The authors have no conflicts of interest to disclose.
Contributor’s StatementsK. Casey Lion: Dr. Lion participated in study conceptualization and design, drafted the initial manuscript, and approved the final manuscript as submitted.
Davene R. Wright: Dr. Wright participated in study conceptualization and design, performed part of the data analysis, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.
Suzanne Spencer: Ms. Spencer was instrumental in data acquisition, performed part of the data analysis, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.
Chuan Zhou: Dr. Zhou participated in study conceptualization and design, performed part of the data analysis, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.
Mark Del Beccaro: Dr. Del Beccaro participated in study conceptualization, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.
Rita Mangione-Smith: Dr. Mangione-Smith oversaw all aspects of the study, participated in study conceptualization and design, critically reviewed and revised the manuscript, and approved the final manuscript as submitted.