Can Stem Cell Transplants be performed in Out-patient Setting?

1. Can Stem Cell Transplants be performed in Out-patient Setting? Patrick J. Stiff M.D., M. Parthasarathy M.S. MT,SBB, P. Mumby PhD, A.Toor M.D, T. Rodriguez M.D., S. Wojtowicz R.N.,OCN, S. Zakrzewski R.N., R. Batiste APN, K. Kiley APN, N. Porter APN, K. Potocki APN, M.Volle APN, S.Williams R.N., C. Shipp BSN,HP B. Buturusis M.S. MBA, N. Mohideen M.D., S. Lichtenstein M.S.

2. Opportunity Statement Loyola’s BMT program is growing @ 15% /yr, creating a back log of patients waiting for potentially curative therapy. This delay in starting treatment decreases their chances for cure or may cause the relapse of disease. This delay caused dissatisfaction for patients and their referring physicians and may result in potential patients seeking treatment elsewhere.

3. Desired Outcome • To decrease cost of transplants for the institution and patients • To improve patient satisfaction and quality of life • To decrease the waiting time for transplant • To increase the capacity to perform more allogeneic transplant by moving autotransplants to out patient setting • To make the program more attractive to payors in the competitive Chicago market

4. Most likely causes for Current Opportunity • Lack of space for additional patient rooms in BMT (inpatient) Unit to accommodate growth in referrals • Some patients prefer out-patient over in-patient care • Other National centers have started out-patient BMT programs • We wish to continue our Stature of the #1 BMT program in Illinois.

5. Solutions Implemented To accommodate the growing program and increased demand for beds: • We expanded the transplant program to the out patient setting • Chose Autologous Transplants for this pilot program because the mortality rate is low (1-2%) • Built a uniquely designed 13-bed outpatient transplant unit / Stem Cell Collection facility • Developed the new out-patient Protocol and built the team to perform out-patient Autologous transplants • Established coordination of Homecare at night by providing better education to patients and care givers

6. Solutions Implemented (continued) • Improvements were made in medical supportive care for infection control, pain management and anti-emetic medications. • Psychological assessment and follow up was added to the existing social & spiritual support for the transplant program, including various aspects of quality of life • Patients were provided with options for nearby temporaryhousing by negotiating contracts with local hotels • Efforts are made through social worker to provide economic and housing assistance to needy families

7. Results and Analysis • In 3 yr period 100 TBI based autotransplants were performed in out-patient unit, with a total of 212 auto transplants by the end of 2002 • Results were compared to the 32 TBI based in-patient Auto transplants performed in the same time period • The program was successful with 0% mortality rate and 72% never required a hospital stay despite a week of 0.0 Neutrophil count. • Waiting period for transplant has been decreased by 4 to 6 weeks

8. Results and Analysis • Out-patients are equivalent to inpatients with regard to: • Engraftment • Timely completion of transplant • 30 and 100 day mortality • Quality of life scores in our patients were comparable to published results from inpatient samples • Psychological distress in our sample was slightly better than some reports in BMT literature • Patients were more active and satisfaction improved • Data for CY 2002 alone show an actual cost savings of $550,000 for 35 out-patient transplants ($16,000 savings per transplant)

9. Results and Analysis

10. Results and Analysis

11. Survival 4 yr follow up: Out-Patient vs In-Patient

12. 100 days Survival: Out-Patient vs In-Patient

13. C o n c l u s i o n s • Quality care can be provided at a reduced cost (40%) • We provided care in the out-patient setting that was comparable to the in-patient BMTU, at a substantial savings for the Medical Center • Quality of life analysis demonstrated that participants not only did well but suffered no increased stress associated with out-patient transplant • Future Directions • A new protocol for Allogeneic non-myelo ablative transplants in the out-patient unit has started based on these findings • In addition to psychosocial support for patients, a support group will be offered to the care givers in the out patient setting • More accurate data on Quality of Life for care givers will be collected under an IRB approved protocol for pre and post transplant period