Intensive outpatient care is rapidly becoming the primary mode of care for selected patients undergoing high-dose chemotherapy with autologous peripheral blood stem cell (PBSC) transplantation. Although the traditional inpatient model of care may still be necessary for high-risk patients, published data suggest that outpatient care is safe and feasible during or after administration of high-dose chemotherapy and autologous PBSC transplant. Blood and marrow transplant (BMT) centers have developed programs to provide more outpatient care under three basic models: an early discharge model, a delayed admission model, and a comprehensive, or total, outpatient model. This review will describe these models of care and address the elements necessary for the development of an outpatient BMT program, including patient selection, staff development, and patient and caregiver education. Available supportive care strategies to facilitate outpatient care will also be highlighted. Clinical outcome data and pharmacoeconomic analyses evaluating various outpatient BMT programs, as well as limited quality-of-life evaluations, will be reviewed. [ONCOLOGY 14(2):171-185, 2000]
Management of Fluid and Electrolytes—Because of the limited time available to evaluate patients in the clinic, it may be more difficult to monitor fluid volume and status. Approaches that help ensure safe fluid management in outpatient BMT patients include comprehensive fluid intake and output monitoring and recordkeeping by the patient and/or caregiver. Availability of this information for daily review can assist the team in making decisions about the need for intravenous hydration and/or diuresis. Administration of intravenous fluid overnight or continuously by ambulatory infusion pumps is also a safe, commonly used approach to maintaining adequate fluid volume and providing electrolyte replacement.
Nutritional Support—Standards for the administration of parenteral or enteral nutrition in BMT patients undergoing outpatient care also vary among centers. One recent publication describes a clinical pathway for nutritional management of BMT patients under-going outpatient care. Because of the decreased period of neutropenia and lower severity of mucositis with PBSC rescue, many centers are observing a decreased need for supplemental nutrition. A recent trial suggests that parenteral nutrition can be safely administered in the outpatient setting following BMT, but reports no clinical benefit over intravenous hydration in a group of malnourished BMT patients.
Central venous catheter care is another area that warrants special attention when BMT is carried out in the outpatient setting. Recent advances in catheter technology have introduced new multilumen catheters that are sufficient for infusion needs and blood drawing, as well as leukapheresis. New catheters, such as the Neostar catheter, or redesigned Hickman catheters avoid the need for placement of two central venous catheters and allow the use of one catheter for multiple purposes. These catheters remain in place for several weeks to months and require diligent care by the staff, patient, and caregivers to minimize infection, thrombosis, and other catheter-associated complications. Education of the patient and caregiver is essential to ensure appropriate catheter care and recognition of potential complications in the outpatient setting.
Criteria for Hospital Admission
Establishment of admission criteria for hospitalization is also essential to the success of outpatient BMT care. Criteria have been published by various centers and share common principles.[12-14]
For example, the criteria proposed by Meisenberg et al and Geller et al require that patients be readmitted for such complications as uncontrolled nausea, vomiting, or diarrhea; hypotension that is unresponsive to fluid replacement; severe mucositis requiring continuous intravenous narcotics; the absence of a suitable caregiver; or other conditions, at the discretion of the attending physician.[12,14] These two programs do not require automatic admission for first neutropenic fever, but other programs may stipulate such admission, depending on available resources and supportive care strategies.
Other criteria that often warrant readmission include gastrointestinal complications, persistent bleeding, fever associated with signs and symptoms of sepsis, dehydration, symptomatic arrhythmias, or other significant organ dysfunction. Although these medically based admission criteria must be followed to ensure the safe care of the patient, less tangible, but equally important, psychosocial-based admission criteria must also be followed. Psychosocial issues that warrant admission include recognition that the caregiver is unable to meet demands of the outpatient program or that the patient has become noncompliant with outpatient-based instructions.
The impact of outpatient care on the field of BMT has been assessed primarily in historical control–based trials or descriptive reports, which have documented a decrease in BMT-associated costs or resources without compromises in patient safety or the efficacy of the procedure. The Duke program was the first to note a substantial reduction in the duration of hospitalization and charges related to the BMT procedure after implementation of their outpatient care approach. Over a 2-year period, 110 women with primary metastatic breast cancer undergoing high-dose chemotherapy with autologous PBSC or bone marrow transplantation were evaluated. The first 18 women were hospitalized for the entire procedure but were discharged to a local hotel each night. This group served as the pilot group to test the feasibility of the outpatient approach and served as the control group for comparison.
The remaining 92 women were managed under the early discharge and outpatient care approach. Using this approach, 95% of the women were discharged following high-dose chemotherapy administration. In terms of readmissions, approximately 30% of patients required prolonged hospital stays for a median of 11 days and 24% required shorter hospital stays, ranging from 1 to 4 days, usually for evaluation of first neutropenic fever.
Subsequently, Meisenberg et al published the results of a prospective study evaluating the feasibility of a total outpatient care approach for administration of high-dose chemotherapy with autologous PBSC transplantation and post-BMT care. In this study, 113 patients underwent 165 cycles of high-dose chemotherapy with autologous PBSC transplantation for various malignancies.
The first cohort of patients participated in a subtotal outpatient transplantation approach, in which patients were hospitalized for high-dose chemotherapy administration, then discharged for supportive care, and readmitted only for complications that could not be managed in the clinic. After it was determined that subtotal outpatient transplantation was safe, subsequent patients were given the option of a total outpatient transplantation approach, in which all high-dose chemotherapy and supportive care were administered in the outpatient setting.
Of the 165 cycles of high-dose chemotherapy, 85% of the cycles were delivered using one of the outpatient care approaches. With both approaches, approximately 70% of patients never required readmission to the hospital and were successfully and safely managed in the outpatient setting. Among the 30% of patients who required readmission, the median duration of hospitalization was 7 days for those who underwent total outpatient transplantation and 10 days for those who received subtotal outpatient transplantation.
Other investigators have also noted a substantial reduction in overall duration of hospitalization for patients undergoing high-dose chemotherapy with autologous PBSC transplantation in the outpatient setting, as compared with patients requiring the same treatment in the traditional inpatient setting due to medical or psychosocial reasons.[13,14,16,50] Of note, engraftment rates, transfusion requirements, duration of intravenous antibiotic therapy, and rates of documented bacteremia were similar between the inpatient and outpatient transplant groups (Table 6).
Overall Costs and Charges
The reduction in resources achieved with outpatient care of BMT patients can result in substantial decreases in the overall costs and charges associated with high-dose chemotherapy and autologous PSPC rescue. In the Duke program, the average charge for the high-dose chemotherapy procedure decreased from $90,000 to $60,000 for adjuvant treatment of high-risk stage II-III breast cancer and from $115,000 to $90,000 for treatment of metastatic breast cancer. Similarly, Meisenberg et al recently reported a 25% reduction in the overall cost of care in the total outpatient BMT program, as compared with traditional inpatient care.
The University of Nebraska BMT program also realized decreases in transplant associated costs, morbidity, and mortality over a 5-year period. Variables that contributed to these reductions included an increased use of PBSCs and a shift from inpatient to outpatient care during the transplant procedure.[34,52]
It is difficult to compare financial information from different studies, as each reference may vary in the components of transplant included in the financial analysis. Thus, attention should be focused on the percentage reduction in cost or charge associated with outpatient care rather than the exact dollar amounts.
Shifts in Cost Centers
Although outpatient BMT care may decrease the overall cost of transplantation, certain departments, such as the pharmacy department, may experience a shift in cost centers rather than an overall reduction in cost. For example, the pharmacy at the University of Nebraska experienced approximately a 20% reduction in BMT-associated pharmacy costs over a 2-year period; however, the inpatient pharmacy noted a 60% reduction, while the outpatient pharmacy noted a 100% increase in BMT-associated pharmacy costs. This shift was due primarily to the implementation of an early transfer from the inpatient to outpatient approach.
Similarly, Rizzo et al reported that the reduction in inpatient facility charges in patients receiving care in their comprehensive outpatient BMT program ($67,000 reduction per patient) was largely offset by an increase in outpatient facility charges ($54,000 increase per patient).
Even though hospital and overall charges appear to be reduced in an outpatient program, cost-shifting must be acknowledged and addressed when establishing an outpatient BMT program. In the traditional inpatient BMT model, the cost of hospitalization represents the highest percentage of allocated resources. In a financial analysis of resource allocation in our outpatient transplant program, we found that the cost of outpatient staff, injectables, and operating overhead represent most of the direct and indirect costs per patient (Figure 3). Such shifts in cost centers and distribution of resources must be considered for program development and budgeting strategies during the implementation of an outpatient BMT program.
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