Radical Outcome Method
A New Approach to Critical Pathways in Congenital Heart Disease
Background Treatment of congenital heart disease has entered a new era of healthcare delivery and cost containment. Critical pathway method (CPM) has been previously demonstrated by us to produce a significant reduction in average length of stay (ALOS) in hospital of −44%. A new approach, radical outcome method (ROM), has produced comparable results that appear to improve over time. The dynamic nature is examined.
Methods and Results Two hundred consecutive patients with congenital heart disease were treated by a single surgeon at a single health maintenance organization (HMO) facility. ROM was used in all patients. This method uses seven critical moments at which shortening rather than confirmation of the ALOS is possible. This process is completed by the second post-operative day. Overall mortality was 1%. The 200 patients were divided into two consecutive groups of 100 patients to determine the effectiveness of ROM over time. Fifty sets were matched. ALOS hospital decreased by 29 days (mean, 0.6 d/set), P<.003. Thirty sets who underwent cardiopulmonary bypass had a 16% decrease (P<.03), and 20 sets in whom nonbypass procedures were performed had a decrease of 16% (P<.02). ALOS in hospital for the 50 sets decreased from 3.7 to 3.1 days (−16%, P<.003). Outcome data demonstrated no significant difference.
Conclusions ROM, a proactive approach to hospital stay, is a dynamic process that reduces ALOS in hospital. This is achieved by both reducing negative variation in the standard CPM and allowing for positive variation. Outcome data confirm that this approach can reduce ALOS in hospital while providing optimal patient care and family satisfaction, a standard for the new era of healthcare delivery.
Treatment of congenital heart disease has entered a new era of healthcare delivery and cost containment. The pressures of both the marketplace and legislative initiatives demand both a reduction in the cost and utilization of resources, while providing optimal quality care. A number of approaches have been proposed to achieve these ends, including CPM.1 2 3 CPM is the application of an industry technique, total quality management, that teaches that the most effective way to improve quality is to reduce variation in a process of providing a service or product. In the hospital setting, CPM reduces such variation in clinical processes and it has been proposed to improve the quality of care while reducing hospital stay. It is a plan. The success of the technique is predicated on the adherence to that plan. CPM was originally developed as a reactive tool of standard quality assurance to improve clinical outcome by reviewing cases to identify areas where problems may exist. These reviews occur at regular intervals, and the patient course is compared with the proposed plan. It is most effective in a homogeneous population, such as elective coronary bypass graft surgery. However, it has serious limitations because of its reactive nature, which limits variations but restricts performance.4 5 6 7 8 (See “Glossary,” which contains terminology used in the description of the various approaches.) In the very heterogeneous population of patients with congenital heart disease, we have previously used an interactive approach with family involvement to successfully decrease negative variability and reduce ALOS in hospital by 44%.3 This approach, as with all CPM techniques, failed to allow for positive variation, limiting the patient’s progress to the goal of successful completion of the preoperative plan and preventing a patient from “outperforming” that plan. This is a basic problem in CPM and quality assurance techniques that must be recognized. Marked reduction in ALOS in hospital through reduction in variance is possible. However, the power is in the plan, and as such restriction occurs. The significant reduction achieved produces a static, though effective, force, and adherence to the plan becomes the aim and the benchmark of success.
ROM is a proactive approach that uses the basic pathway plan but is revolutionary in that it encourages the patient to outperform the pathway design. A pathway is developed for each patient using a standard CPM grid, based on the lesion and comorbidities, before surgery. In ROM, seven critical moments have been identified at which this plan can change and with it the patient’s pathway grid. In a standard pathway (CPM), the x axis is the time frame and the y axis is the individual pathways followed over time. In ROM, a z axis is introduced. The patient’s response at the critical moments allows for the possibility of movement from the original ROM pathway or level to a lower level, a shortened pathway, that results in a shortened LOS in the hospital. The seven critical moments we have identified are moment 1, the introduction, at which time the family is introduced to our systems, comorbidities are identified, and family involvement in the process is examined. Moment 2, <1 week before surgery, is indoctrination; here, the comorbidities are further identified and empowerment of the family occurs. Moment 3 is surgery, during which there is the potential for shortening and improvement of the plan, both by the nature of the procedure and by the patient’s response. Moment 4 is extubation: if early extubation can occur at the time of surgery or early thereafter, marked acceleration of the patient’s progress can occur. Moment 5 is ambulation; moment 6 is alimentation; and moment 7 is what we call the critical question, “What are we doing special for you in the hospital today that can’t be done at home?” When the answer is “nothing,” the patient is discharged. Clinical experience and documentation in the literature demonstrate that early extubation, ambulation, and the resumption of normal activities, including alimentation, dictate early discharge.3 6 8 At these hinge points on the z axis, positive variation can occur and the patient can outperform the system. Thus, the CPM component reduces negative variation, whereas ROM allows for positive variation, which may accelerate recovery and patient discharge. Our initial experience with ROM demonstrated that it provided the same pathway improvement previously experienced in standard CPM compared with non-CPM patients (decrease in ALOS in hospital, 44%). The current study explores the dynamic nature of the process and whether greater reduction in hospital stay can be documented over time.
Two hundred consecutive patients operated on by a single surgeon at a single health maintenance organization (HMO) facility over the 2-year period from 1992 through 1993 form the study group. Standard CPM was applied to all individual lesions. A grid was constructed, and the plan for individual pathway and ALOS resulted from our prior experience in each lesion subgroup. The LOS for the individual lesions are noted in Table 1⇓, and ROM levels corresponding to lengths of stay of 3, 4, 5, 6, and 7 days were assigned. Comorbidities, including potential family involvement in the process, are included in the determination of the final ROM level and expected LOS. Fig 1⇓ demonstrates the standard ROM grid of the x axis of time, the y axes of the individual pathways, and the z axis of the ROM levels corresponding to hospitalizations of 3, 4, 5, 6 … etc days.
Patient response to the seven critical moments was allowed to drive the system in all 200 patients. The individual patient response to the pathways at the seven critical moments resulted in movement to a higher or lower ROM level. Improvement over the expected course resulted in a decrease in the ROM level and a shortening of the projected hospital stay as demonstrated at moment 4 ambulation and moment 5 alimentation in Fig 2⇓. The 200 consecutive patients were divided into two groups of 100 patients to identify the effectiveness over time. Matching was performed retrospectively by age, operation/lesion, clinical class (New York Heart Association functional class), and diagnosis related groups (DRGs). One hundred patients matched (50 sets); lesions included atrial septal defect (16), ventricular septal defect (10), patent ductus arteriosus (12), coarctation of the aorta (6), pulmonary artery conduit replacement (1), repair of tetralogy of Fallot (1), Fontan procedure (1), aortic valve replacement (1), pulmonary artery band (1), and Blalock-Taussig shunt (1).
Statistical analysis of the entire cohort, as well as the subgroups CPB and non-CPB, was performed using the Wilcoxon signed rank test and nonparametric Spearman’s correlation coefficients to examine the matched pairs and the Mann-Whitney U statistic to examine subsets. Results were expressed as the probability value of both the rank test and the U statistic, the value of the correlation coefficient (r), and probability value of the matched-set comparison. Percent decrease in lesion was assessed.
Additionally, the unmatched patients were examined to determine their ALOS in hospital by lesion and to confirm that the findings in the matched patients were consistent with these patients and that decreased ALOS in hospital was present in the more complex patients who could not be matched.
Finally, outcome data were reviewed, including morbidity, mortality, readmission after <14 days after discharge, unscheduled clinic or emergency visits <14 days after discharge, and negative family assessment survey (HMO family assessment survey).
ROM results in a significant decrease in ALOS in hospital over time. ALOS in hospital was less than plan in 75% of the total group, while it increased in only 5%. In the 50 matched patients, a significant decrease was observed, from 3.7 to 3.1 days (16%, P<.003). When CPB and non-CPB patients were examined, the ALOS in hospital for the 30 sets of CPB patients decreased over time, from 4.0 to 3.4 days (16%, P<.03), and for non-CPB patients the ALOS in hospital for the 20 sets decreased over time, from 3.2 to 2.7 days (16%, P<.02). The data for the individual matched lesions are presented in Table 2⇓. ALOS in hospital decreased by 29 days (mean, 0.6 d/set; P<.003).
The nonmatched patients’ ALOS in hospital data are presented in Table 3⇓ and were consistent with the matched patients in the subgroups observed. Furthermore, although the number of matched patients with more complex lesions was too small to draw conclusions, in the unmatched patients in whom the majority of complex lesions are noted and in whom lesion matching was not possible because of the multiple variables encountered, the findings are consistent with improved results on standard planned LOS for these lesions and much less than prior experience in non-CPM methodology. Outcome data are described in Table 4⇓. No significant differences in morbidity, mortality, readmission, or unscheduled emergency or clinic visits were noted, and no negative family assessments concerning LOS were recorded.
CPM has been used by us for the treatment of patients with congenital cardiac disease.3 This patient subgroup represents a very heterogeneous population, unlike those who have been treated in the past with CPM.4 5 6 7 8 Initially we used an interactive approach to patients with congenital cardiac disease to provide the benefits of pathway methodology while dealing with the heterogeneity of the congenital cardiac surgical population. In our initial experience, we were able to produce a 44% decrease in ALOS in hospital and a 39% decrease in ALOS in intensive care units.3 However, it became clear that, although the congenital cardiac surgical population was heterogeneous, standard pathway methodology (CPM) restricted certain patients in their response to the plans. Although some would venture that in the clinical setting, no one would “hold back” a patient due to an arbitrary or theoretical plan. In fact, pathway methodology (CPM) is so effective in decreasing negative variation and the decrease in ALOS in hospital is so dramatic and predictable that the entire process, as in the industry technique, produces that net effect. However, unlike an industry process, patients within the setting of the pathway design may demonstrate impressive positive variation. ROM allows such patients to drive the system and by their active involvement and that of family and staff to shorten ALOS in hospital. This is the concept of the z axis of ROM. The z axis provides the ability for standard pathways to be constructed, and at specific hinge points all observed from clinical experience, a change from the plan can occur. Thus, although the system uses a CPM formulated for the individual patient as its basic grid, it can change in response to that individual patient’s performance.
Our seven critical moments involve the following: moment 1 is introduction—at this time the family is introduced to our system, comorbidities are identified, and family involvement in the process can be ascertained. At moment 2, <1 week before surgery, indoctrination occurs, there is further identification of comorbidities, and family involvement can be ascertained, but empowerment of the family is the important point at this moment. At surgery, moment 3, there is the potential both for shortening and improvement of the plan, both by the nature of the operation and the patient’s response. Moment 4 is extubation; if early extubation can occur at the time of operation or soon thereafter, a great change in the outcome measures can occur. Pain prevention is a very important part of our methodology; without it, extubation and all subsequent actions cannot occur. It involves not a pro re nata medication schedule but a planned pain prevention/management program. We include per rectum acetaminophen for infants and older patients, transthoracic administration of bupivacaine hydrochloride in patients with thoracotomies, and regular ketorolac tromethamine and aggressive morphine administration followed by ibuprofen and oxycodone and acetaminophen as needed in thoracotomy patients. Early ambulation, moment 5, is initiated when pain prevention is in place on the first postoperative day.6 Alimentation, moment 6, is begun soon after ambulation is successful, and the critical question, “What are we doing special for you in the hospital today that can’t be done at home?,” is presented. When the answer is “nothing,” the patient is discharged, which is moment 7.
As noted previously, clinical experience and documentation in the literature demonstrate that early extubation, ambulation, and a return to normal activities, including alimentation, dictate early discharge.3 6 8 The use of the pain prevention program and empowerment of the families allow us to move patients along the pathway design and accelerate recovery if their response to those critical moments indicates it.9 10 11 12 This reflects the involvement of the entire team as well as the families in the process, and its dynamic nature is demonstrated in the data presented. It is observed both in our matched and unmatched patients, and the positive family assessments confirm that the families’ goal, common to the rest of the team, is early discharge. In reviewing the importance of the individual clinical moments and change in ROM level, extubation and operation most commonly produce the most dramatic changes. Comorbidities such as kyphoscoliosis may negatively impact ambulation, and patients with coarctation repairs may encounter difficulty with alimentation. These are examples of individual and lesion-specific comorbidities. Furthermore, at indoctrination, evaluation of the family situation may affect both negatively or very often positively the ROM level. The ROM levels presented for the individual lesions reflect those present in our prior successful CPM and improvement over nonpathway results. As seen in the present study, greater improvement above these levels is the potential of ROM.
The data of the present study reveal that over time, pathway design using ROM results in a progressive decrease in hospital LOS. The family, the clinical nurse coordinator, the surgeon planner, and the physician and nurse implementers are all involved in this process.2 3 7 Each becomes accustomed to the nature of the plan. Each understands the dynamic nature of the process, and each with acceptance can accelerate the patient response to the plan. However, it is the patient’s involvement through the intercession of these team members that accelerates pathway development in ROM. Since this is achieved by encouraging positive variation of the critical pathway (movement across the z axis), an approach alien to standard industry technique, it is revolutionary in pathway methodology. Here the patient’s response drives the system, and in doing so the patient outperforms the plan. Outcome data confirm that this proactive approach can reduce ALOS in hospital while providing optimal patient care and family satisfaction. Thus, the power of ROM is in the process rather than, as in standard CPM, the plan. The nature of the process is what makes ROM dynamic, allowing for improvement over time, an active element responsive to the patient’s clinical performance.
Selected Abbreviations and Acronyms
|ALOS||=||average length of stay|
|CPM||=||critical pathway method|
|LOS||=||length of stay|
|ROM||=||radical outcome method|
Average length of stay (ALOS): average for a given cohort of patients.
Critical moments: points in pathway design that have been identified as important in patient progress and points at which acceleration of the plan is possible.
Critical pathway method (CPM): clinical application of total quality management technique. Individual pathways are constructed in a grid, and the patient’s progress along each is planned over time.
Dynamic: an active process that changes over time.
Heterogeneous: of a dissimilar or diverse nature.
Homogeneous: of the same or similar nature.
Interactive: works with the pathway plan to decrease variation during the hospitalization to achieve the pathway plan.
Length of stay (LOS): length of hospitalization determined by presence in the hospital at 12:00 midnight of a given day.
Levels: critical pathway plans of a given length of stay—eg, ROM 1, a 3-day hospitalization; ROM 2, a 4-day hospitalization.
Negative variation: variability from the plan that increases length of stay.
Pathway grid: individual pathways on the y axis; time increments of hour, shifts, or days on the x axis.
Positive variation: variability from the plan that decreases length of stay.
Proactive: works to identify and encourage positive variation and improve on the pathway plan.
Radical outcome method (ROM): a process that uses critical pathways to minimize negative variation but encourages positive variation at seven critical moments of clinical importance in patient progress.
Reactive: identifies at regular intervals major and minor variances to the pathway plan and responds to reduce such variation.
Total quality management (TQM): an industry technique that improves quality by decreasing the variation in a process or a service.
Reprint requests to Kevin Turley, MD, Chief, Pediatric Cardiovascular Surgery, California Pacific Medical Center, 2100 Webster St, No. 332, San Francisco, CA 94115.
- Copyright © 1995 by American Heart Association