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Ann Thorac Surg 1996;62:386-391
© 1996 The Society of Thoracic Surgeons
California Pacific Medical Center and Kaiser Permanente Medical Center, San Francisco, California
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Abstract |
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 TopFootnotes Abstract IntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Methods. Two hundred fourteen consecutive patients with congenital heart disease were cared for using the cardiovascular radical outcome method. Age ranged from 2 days to 19 years (median age, 3 years). Cardiovascular radical outcome method data were compared with the pathway plan data for each patient.
Results. Survival was 99% (211 patients) with an overall reduction in stay of 156 days (0.74 day/patient) (p < 0.0001). Only 10 patients (5%) exceeded the pathway plan; 201 (95%) reached the planned length of stay (critical pathway method), and 127 patients (60%) had a shorter length of stay than expected by the critical pathway method. One hundred forty-eight patients (70%), including 95 (64%) with more complex conditions, had a length of stay of 3 days and 18% achieved a 2-day length of stay, the maximal response. The process was most effective in the most complex groups, although preoperative comorbidities influenced outcomes. Outcome assessment demonstrated minimal morbidity and excellent family satisfaction.
Conclusions. The radical outcome method is effective in reducing the length of stay of patients with complex congenital heart disease. The power is in the process rather than the plan, and the method provides optimal patient care and family satisfaction.
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Introduction |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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The cardiovascular-radical outcome method (CV ROM) is a process of patient care. It encourages positive variation in patient performance during hospitalization to achieve maximal reduction in length of stay (LOS) and quality in patient care. The origin of this approach can be found in the industry technique called total quality management. This technique is designed to decrease negative variation in the production of a product and in the medical realm, has been termed the critical pathway method (CPM) [1–6].
The CPM is a plan; it develops a framework for care. In the field of congenital heart disease, these plans have been designed around either the lesion or operation involved or the acuity of the patient's condition [1, 5, 6]. In the former, the presenting problem defines the plan, whereas in the latter, it is the severity of the illness. The problem in each is the predetermined fixed time frame. The plans are effective in decreasing negative variation in this predetermined LOS, but in each case, positive variation in patient improvement over the plan is impeded. Although actions that limit a patient's response may appear counterintuitive, so successful have these approaches been that the rigid matrix they create becomes codified.
The ROM, in contrast, is a process rather than a plan [7]. It is a proactive approach to patient care and has been demonstrated to be dynamic, improving results over time in patients matched for age, operation or lesion, clinical class (New York Heart Association functional class), and diagnostic-related groups. The lesions, however, were most often simple, as matching was best accomplished in these subsets [7]. The current study explores the efficacy of the CV ROM in patients with complex congenital heart disease.
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Material and Methods |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Fifteen patients (undergoing 16 operations) were not treated with the method. These included 12 premature infants in whom ligation of a patent ductus arteriosus was performed in the neonatal intensive care unit, 2 patients in whom "come-and-go" operations were performed (removal of a sternal wire in 1 and wound revision in 1), and a 7-year-old patient on a regimen of steroid therapy for systemic lupus erythematosus who underwent emergency pericardiectomy and drainage for tamponade secondary to occult pneumococcal pericarditis 1 month after a pneumococcal pneumonia. This patient was transferred to the medical service on the 4th postoperative day and to the referring institution on the 8th postoperative day for continued antibiotic coverage. Of the 228 patients, this was the only patient who was transferred to another institution for continued therapy rather than discharged home and was the patient in whom wound revision on a come-and-go basis was performed. Thus, the study group comprised 214 consecutive patients in whom the CV-ROM was employed.
The CV-ROM is a proactive approach to the CPM. This approach uses a standard pathway grid, including education and discharge planning, consultation, activity, nutrition, pain prevention/medication, monitoring, extubation/respiratory, diagnostics, and treatments, on the y-axis and a time frame on the x-axis. The time frame is broken down as follows: more than 1 week to admission, our introduction to an elective operation; less than 1 week to admission, empowerment of the family; the operative day; and postoperative days 1, 2, 3, 4, and so on. A z-axis is used in the ROM on which ROM levels, corresponding to hospitalization days (ROM level 1–3-day hospitalization, ROM level 2–4-day hospitalization, and so on) are described. The patient is placed on a specific level, a plan of hospitalization determined by preoperative assessment of both lesion and comorbidities [7].
The lesions or operations in our study group were as follows: no-bypass: patent ductus arteriosus (30 patients), coarctation of the aorta (18), shunt (6), pulmonary artery band (5), coronary artery–camera fistula (1), vascular ring (1), and Glenn procedure (1); bypass: secundum atrial septal defect (40 patients), primum atrial septal defect (1), sinus venosus atrial septal defect (14), right ventricular outflow tract reconstruction (2), ventricular septal defect (VSD) (29), tetralogy of Fallot (17), double-outlet right ventricle (3), subaortic stenosis (4), aortic valve repair or replacement (4), mitral valve repair or replacement (6), atrioventricular canal (6), total anomalous pulmonary venous connection (3), anomalous coronary artery (2), Rastelli procedure (1), redo conduit (6), right hemitruncus and coronary–pulmonary artery fistula (1), aortic root replacement (1), Ross procedure (1), Ross-Konno procedure (1), bidirectional Glenn procedure (5: single ventricle, 4, and right ventricular dysplasia, 1), Fontan operation (4: all, single ventricle), and cardiac tumor (1). The preoperative comorbidities reoperation and major renal, pulmonary, gastrointestinal, neurologic, musculoskeletal, pancreatic, and immunologic or infective disease and psychosocial or family involvement in the process are included in determining the final ROM level and expected LOS (ELOS). (Of note, none of the comorbidities are cardiovascular.)
The process itself involves seven critical moments, which we have previously described: moment 1, introduction; moment 2, empowerment; moment 3, operation; moment 4, extubation; moment 5, ambulation; moment 6, alimentation; and moment 7, what we call the critical question, "What are we doing special for you in the hospital today that cannot be done at home?". These seven moments form hinge points at which positive variation can occur, so that the patient can outperform the system, move to a lower level, and thus have a shorter pathway and a shorter hospitalization. Order sets are changed in response to the patient's performance, and if this occurs, accelerated recovery is possible.
As noted, the initial pathway plan is based on the lesion or operation. Radical outcome method level 1 is a 3-day hospitalization for such lesions as patent ductus arteriosus, coarctation of the aorta, and atrial septal defect; ROM level 2, a 4-day hospitalization for lesions such as VSD; ROM level 3, a 5-day hospitalization for lesions such as tetralogy of Fallot and operations such as valve replacement; ROM level 4, a 6-day hospitalization for lesions such as atrioventricular canal and operation such as conduit replacement; and ROM level 5, a longer hospitalization for the most complex lesions requiring operations such as the Fontan procedure and aortic root replacement.
Figure 1
illustrates the approach. The patient was a 7-year-old girl with aortic insufficiency and increasing left ventricular dysfunction; she had a history of VSD, ventricular septal aneurysm, subaortic membrane, and echocardiographic demonstration of a right sinus of Valsalva aneurysm. This was the primary operation, there was no comorbidity, and the ELOS was 7 days. The CV-ROM level was 5. Introduction (>1 week) showed excellent family involvement, as did empowerment (<1 week). At operation, a Ross-Konno procedure with resection of the subaortic membrane, opening of the VSD, resection of the septal aneurysm, and root replacement with reimplantation of the coronary arteries was done. Closure of the VSD was performed using the pulmonary autograft tissue. Replacement of the pulmonary root was accomplished with a pulmonary allograft. The patient had early extubation and progression to early ambulation on the 1st postoperative day and hence was moved from level 5 to level 2 and ultimately level 1, with discharge on the 3rd postoperative day. The critical moments are hinge points at which movement to a lower level, a shorter pathway design, and a shorter LOS can occur.
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The total group of patients, those having operations without and those having operations with cardiopulmonary bypass, was examined. In the bypass group, subgroups including simple operations with and without VSD closure and complex operations with and without VSD closure were examined. The VSD group, a crossover group, was included in both categories of operations rather than separated as a third group. The effects of comorbidity within the subgroups were also examined.
The variables examined included the following: ALOS; percentage of patients achieving the ELOS, or CPM; percentage with a longer LOS than expected (CPM); percentage with a shorter LOS than expected (CPM); percentage having a 3-day postoperative discharge; percentage with a 2-day postoperative discharge; ± change in the LOS; and ± percent change in the LOS. Cumulative results for all patients in the bypass group and for all patients without comorbidity in the bypass group were examined to determine the relative movement within the CPM or the plan when subjected to CV-ROM. Outcome data included mortality, morbidity (both total and postoperatively during the first 14 days), readmission within 14 days and unscheduled clinic or emergency room visits within 14 days, as these might have been prevented by prolonged hospitalization, and negative assessment concerning LOS on the family satisfaction survey, which was completed by all of the patients' families. Statistical analysis of the data was performed using the nonparametric Mann-Whitney U statistic to examine both the total cohort and the subgroups.
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Results |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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The 211 survivors form the study cohort. Two hundred one patients (95.3%), 60 (97%) in the no-bypass group and 141 (95%) in the bypass group, achieved their planned LOS (CPM), and 10 patients (4.7%), 2 (3%) in the no-bypass group and 8 (5%) in the bypass group, exceeded the ELOS. One hundred twenty-seven patients (60.2%), 40 (65%) in the no-bypass group and 87 (58%) in the bypass group, had a shorter LOS than expected by the CPM. Table 1 demonstrates the CPM ELOS, and the CV-ROM ALOS for all patients, the bypass group, and the no-bypass group. The average change in LOS was -0.74 day per patient.
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), a significant reduction in LOS was noted in all but one subgroup. The percent change increased with the severity of the lesion, with the maximal reduction in LOS achieved in the complex patients without comorbidity when the VSD subgroup was excluded. The comorbidity only subgroup was the sole subgroup in which no significant difference was noted, although the p value was 0.054 with a -3% change in the LOS.
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When the response to the CV-ROM in bypass patients was examined, 100% of the simple patients both with and without VSD achieved their CPM; none exceeded it. Of the patients in this group without a VSD, 29% had a shorter LOS than expected (CPM), and 48% with a VSD had a shorter CPM. Ninety-five percent of the simple patients without a VSD were hospitalized 3 days, as were 86% of the simple patients with a VSD. When the complex patients with and without a VSD with comorbidity were examined, 91% of the patients with a VSD and 88% of the patients without this lesion reached their CPM, 9% with a VSD and 12% without a VSD had a longer CPM. However, 76% of those with a VSD and 79% without a VSD achieved an LOS shorter than their estimated pathway; 44% with a VSD and 35% without a VSD achieved a 3-day hospitalization.
When the effect of comorbidities was examined, complicated patients with a VSD without comorbidity experienced 100% achievement of the ELOS, none had a longer stay, and 82% had a shorter stay, with 61% achieving a 3-day hospitalization. In complicated patients without comorbidity or a VSD, again 100% achieved the ELOS; in none was the LOS longer than planned, and in 92%, it was shorter than planned, including 57% with a 3-day hospitalization. Finally, in the complex comorbidity cohort, despite the fact that only 73% achieved their ELOS and 27% had a longer LOS than predicted, 65% had a shorter LOS than estimated, including 13% with a 3-day hospitalization and 3% with a 2-day hospitalization.
Cumulative results demonstrate the ALOS (CV-ROM) versus the ELOS (CPM) (Fig 2). In the diagonally placed blocks, the denominator is the number of patients expected to achieve that ELOS. The numerator and the other values shown denote the ALOS (CV-ROM) versus that plan. Only 8 patients exceeded the ELOS. All 8 were in the comorbidity group; however, 65% of the patients with comorbidities, in fact, had an LOS shorter than their pathway plan.
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demonstrates the cumulative results for the bypass patients without comorbidity. Here the results in the more complex patients are brought into focus with 21 of 33 patients with an ELOS of 5, 6, or 7 days achieving a 3-day hospitalization, 11 patients achieving a 4-day hospitalization, and 1 patient reaching a 5-day hospitalization. None of these patients required hospitalization for 6 days or longer.
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Of note, four of the six patients requiring readmission or an unscheduled clinic visit had an atrial septal defect or a VSD, and only 2 had more complex lesions, subaortic stenosis and atrioventricular canal. No patient in our most complex subgroups with early discharge required readmission or an unscheduled visit. These data are comparable with and, in fact, less than the incidence per 100 patients in our previously reported ROM series, CPM series, and control patients who, because of matching, were the simplest subgroups [1, 7].
Family satisfaction surveys were completed in all instances. There were no negative responses related to the LOS.
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Comment |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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The CV-ROM takes its origin from an industry technique known as total quality management [2]. This technique attempts to avoid negative variances to produce a uniform outcome in the production of a product. When applied to the medical field, it has been termed the CPM [1, 3]. A pathway grid as described here determines the time course for a patient's hospital course. The pathways define a standard that can be affected by individual variations in the patient's progress. Several approaches have been described in the literature; these include specific diagnosis-directed or procedure-directed approaches, individually tailored as our own, and acuity-based processes [1, 5, 6]. Each defines a critical pathway for the patient involved and, as in total quality management, attempts to decrease negative variability to produce uniformity of outcome. Such techniques have been demonstrated to be so successful that they impair the very unique attribute of human recovery, namely, the ability to outperform the pathway design. This was recognized early in our experience with these methodologies and constitutes the problem addressed in this report.
The CV-ROM involves seven critical moments. The first two, introduction at more than 1 week (the first contact between the clinical nurse coordinator and the family) and empowerment at less than 1 week before admission, set the stage for the entire plan and initiate the process. During this period, the critical pathway plan or grid is established, and the physical and psychosocial comorbidities are defined. The ability to identify these comorbidities preoperatively allows an aggressive attack to modify their impact during the treatment process. Results from the current series demonstrate that in the comorbidity subgroup, 65% had an LOS shorter than the treatment plan despite preoperative prediction of major problems. In our experience, if the patient is presented with a proactive process involving the entire team and designed to encourage positive variation from the pathway design, his or her response to hospitalization can result in not only reduction in negative variation, uniformity of outcome, and reduction in hospital costs because of uniformity of hospital plan, but also improvement in patient care and dramatic acceleration of recovery [7].
This approach or process differs greatly from a fast-track approach where the patient is predetermined to be of a certain risk, and rapid recovery is planned to reduce hospital costs [9]. Likewise, it differs from an acuity-based system such as that of Davis and colleagues [6] in which patients designated as low acuity fit conveniently into a defined pathway, and negative variation is effectively reduced. However, the findings of Davis and associates [10] in regard to economic benefits in patients with congenital heart disease is of great importance. The reduction in variation produces a clear benefit both in patient outcomes and in institutional costs. The CV-ROM is effective in all treatment groups, especially the most complex, and the findings of Davis and co-workers [6, 10] concerning the economic benefit are important in interpreting the results of the current study.
The CV-ROM is not simply a plan of care but a process. It is directed at all patients, both those with simple lesions and those with complex lesions. The current study demonstrates that its effects in patients with simple lesions parallel those of other pathway designs in reducing negative variation, but as the complexity of the lesion increases, LOS is dramatically reduced. In patients with complex lesions, there is a shift toward the pathway design of patients with simple lesions, and in essence, complex patients are moved to a shorter hospital course, and patient care benefits. Patients with comorbidities were identified in the current study and represent special areas of concern that the process defines and aggressively treats. Although all 10 patients with an extended LOS had comorbidities, the aggressive approach to the complex comorbidity cohort resulted in 74% achieving their planned LOS and 65%, a shorter CPM. Figure 3
demonstrates that 64% of the patients without comorbidity in the 5-, 6-, and 7-day categories achieved an LOS of 3 days and that among the patients with comorbidities, 65% produced an LOS shorter than their pathway plan. Thus, the process has been extremely effective both in complex patients and in complex patients with comorbidities.
These results are meaningless if outcome measures fail to demonstrate an improvement in results with early discharge. Patients can have an excellent hospital course, but if because of the method involved, early discharge results in readmissions, emergency room or outpatient visits, or lack of satisfaction from the patients or families, the method is neither cost-effective nor good in terms of patient care. The results of this study demonstrate minimal readmissions or unscheduled clinic or emergency room visits, findings comparable to our results in our non–pathway-treated group [1, 7].
As previously noted, no patient or family expressed negative family satisfaction with the LOS (100% response). One of the problems in patient care of hospitalized children is the failure to include families in the recovery process [9, 11, 12]. The very nature of the ROM integrates patients and families into specific nursing-care activities in the CPM model. It identifies the nursing role to help the family members become part of the health care team, continue the parenting function, and strive to implement the pathway plan [11]. Discharge is the reward of their efforts. When the critical question, What special thing are we doing for you in the hospital that cannot be done at home? receives a negative response, the family, who knows this question (it is noted daily) and is part of the health care team following the child's progress, can clearly appreciate and support the rationale for discharge [1, 9, 12].
The CV-ROM, demonstrated to be a proactive, dynamic approach to hospital stay, greatly reduces the LOS for patients with congenital heart disease, especially those with complex congenital cardiac anomalies. Its power lies in the process rather than just the plan, and it can provide optimal patient care and family satisfaction in this new era of health care delivery.
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Acknowledgments |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Footnotes |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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Address reprint requests to Dr Turley, Pediatric Cardiac Surgery, California Pacific Medical Center, 2100 Webster St, #332, San Francisco, CA 94115.
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References |
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TopFootnotesAbstractIntroductionMaterial and MethodsResultsCommentAcknowledgmentsReferences |
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