Blood And Marrow Transplant Patients Research Articles

The Impact of Pharmacogenomic CYP3A5 Variants on Calcineurin Inhibitor Metabolism and SLCO1B1 Variants on Methotrexate in Adult Allogeneic BMT Patients

Allogeneic blood and marrow transplant (BMT) is used to transplant a new immune system in patients with hematologic malignancies or immune-mediated disease. BMT patients require initial immune suppression to prevent graft rejection and graft versus host disease (GVHD). Tacrolimus and cyclosporine are calcineurin inhibitors (CNI) and methotrexate is an antimetabolite used to mitigate this immune response. Tacrolimus has data supporting oral dose variation based on pharmacogenomic (PGx) studies for Intermediate Metabolizers (IM) and Poor Metabolizers (PM) on studies done in kidney transplant patients. There are fewer studies on BMT patients in this field, and even less on the variability of IV to oral conversion dosing and first pass metabolism effect based on PGx profiles. Methotrexate has been shown to have PGx mutations affecting its metabolism at higher dosing used for chemotherapy, but its impact on BMT patient dosing is not well-defined. Based on our study, we found statistically significant variability in Tacrolimus concentration based on drug assay levels compared with dosing for Intravenous (IV) and oral formulation based on PGx predicted phenotypes. We further noted a profound effect on first pass metabolism when transitioning between IV and oral dosing of Tacrolimus based on PGx predicted phenotypes. The average oral dose in predicted IM phenotypes divided by the IV dose was 2.68. For the predicted PM phenotype, the average oral dose divided by the IV dose was 1.18. The p-value in a two-tailed nonparametric T-test with equal variance assessing the conversion factor from IV to oral dosing in predicted IM versus PM phenotypes was significant with a p-value of 0.002. Methotrexate metabolism did not seem to be affected by PGx mutations at the doses used for BMT GVHD prevention.

Reducing Central Line Associated Bloodstream Infections in Allogeneic Hematopoietic Stem Cell Transplant Patients

Background: The blood and marrow transplant (BMT) unit at Cleveland Clinic had an increased rate of central line associated bloodstream infections (CLABSIs) in 2020 for allogeneic transplant admissions from an expected average of 1 per month to 4 in August of 2020. We aimed to reduce the number of CLABSIs in allogeneic BMT patients during their transplant admission to an average of 1 per month.Patientsand Methods: We formed a multidisciplinary team with nursing, advanced practice providers (APPs), infection prevention, fellows, residents, BMT staff, and Taussig quality improvement staff. We underwent training through the SolVE (Solutions for Value Enhancement) program, with biweekly meetings for training and coaching sessions to help design and support the quality improvement project.Results: We performed an initial data review of CLABSIs from January 2020 until September 2020 with a total of 13 cases identified. 53% of cases were female, 76% of patients were neutropenic, 53% of patients had mucositis, 61% of patients had diarrhea and 7% of patients had graft versus host disease. Patients had the following underlying diagnoses: myelodysplastic syndrome (4), acute myeloid leukemia (3), acute lymphoblastic leukemia (4) and diffuse large B-cell lymphoma (1). Central line data revealed that all lines were placed at Cleveland Clinic. 76% of lines were removed after identification of infection, 46% of lines had signs of infection or malfunction. Microbiologic data culture revealed that 7 cases were Pseudomonas aeruginosa, 3 Staphylococcus epidermidis, 1 vancomycin-resistant Enterococcus faecalis, 1 Streptococcus mitis and 1 Stenotrophomonas maltophilia.To build our process map we performed a Gemba walk where we observed central line use and access on the BMT unit. We conducted a root cause analysis and identified the following factors as drivers of the rise in CLABSIs: severe immunocompromised state, pre-existing infections, long duration of line present, frequent access, excessive line manipulation, and poor hand hygiene.The changes that were implemented on the unit included: retraining of all nurses on central line care, central line care being added as a topic to the annual competency review, site and tubing checks were to be performed at the time of bedside handoff at shift change, increasing Shine Audits to 40 per week from 10 on average and deep clean of nursing unit by EVS following outbreak of pseudomonas.Following the above interventions, we decided to form a CLABSI review meeting to review each CLABSI in real time and to be able to have a longitudinal comprehensive data collection of factors contributing to each case. These meetings involve nursing, infection prevention, APPs, and physicians directly involved with the patient's care. Data is stored in Redcap and includes patient factors (admission date, conditioning regimen, type of transplant, disease data), line factors (placement date, location, infection date, line removal date), microbiologic data (organism, reason for culture collection), personnel factors, maintenance/environmental factors and space for other comments. Data is presented at regular quality meetings with the section chair to develop further quality improvement projects.Initially the reduction of CLABSI rates did not reach our objective: we had 5 CLABSIs from January to February 2021. However, in the following months (March to June, 2021) we were able to reach our objective of 0-1 CLABSI's per month.ConclusionWe continue to work as a team to reduce the number of infections in the BMT unit. Next steps include continuing CLABSI review meetings, discussions with ICU to better understand indications and process of blood culture collections, discussion with infectious disease for input on other strategies for CLABSI reduction and examining central line processes in other institutions. DisclosuresSobecks: CareDX: Membership on an entity's Board of Directors or advisory committees.

Survival Implications of Opioid Use after Blood and Marrow Transplantation

B ackground Premature death from opioid-related causes imposes an enormous public health burden across the United States. Between 2001 and 2016, the number of opioid-related deaths in the United States increased by 345%, from 9489 to 42 245 deaths (33.3 to 130.7 deaths per million population. Moreover, opioids may have immunosuppressive properties independent of their psychotropic effects; opioid use has been associated with increased invasive pneumococcal disease in a nested case-control study of 1233 Medicaid patients from Tennessee. In liver transplant recipients, opioid use disorder has been associated with increased mortality after transplant. The impact of opioid use disorder on patients receiving blood and marrow transplant (BMT) remains to be defined. Methods We performed a retrospective analysis of all consecutive adult patients who had BMT (autologous and allogeneic) from 1/1/2008 through 1/1/2018 at the James Comprehensive Cancer Center. Overall survival (OS) was measured from the date of transplant to the date of death, censoring at date of last follow up if alive. Progression free survival (PFS) was measured from the date of transplant to the date of disease progression or the date of death, whichever occurred first, censoring at last follow up if no event. OS and PFS were estimated by the Kaplan-Meier method and compared using the log-rank test. Opioid use (OU) was defined as a binary yes/no variable if an opioid was prescribed upon discharge from the hospital after BMT. The impact of OU, along with other patient, disease, and BMT related factors, on PFS/OS, was analyzed using Cox regression method. Results A total of 1585 patients were included in the analysis (Table 1). The median age at BMT was 58 (range=18-79) years; 59% were males; 60% had autologous transplants; and 58% were prescribed opioids upon discharge from the hospital. OU was significantly more in patients who were younger, have had allogeneic transplant, reduced intensity conditioning, had acute myeloid leukemia (AML), or higher BMT comorbidity index (CMI). On univariable analysis, OU was not associated with cumulative incidence of relapse (CIR) or PFS however it was associated with inferior OS; hazard ratio (HR)=1.25, 95% CI: 1.06-1.49; p=0.01 (Figure-1). There were no differences in CIR, PFS, or OS when autologous and allogeneic transplants were analyzed separately. Upon multivariable analysis of OS, OU lost statistical significance after controlling for age, diagnosis, type of transplant, intensity of conditioning regimen, CMI, and disease risk index (DRE). Of interest, OU independently predicted for superior OS at 100 days and 365 days post-BMT; HR=0.29, 95% CI 0.16-0.50 (p=<.0001) and HR=0.47, 95% CI 0.32-0.69 (p<0.001); respectively. Conclusion: Our results suggest that opioid use (OU) may have a long term negative impact on survival in BMT patients. The apparently protective effects of OU early on after BMT is elusive but may be possibly related immunomodulatory effects of opioids. A major limitation of our study is that OU is analyzed at a single time point at hospital discharge after BMT. We plan to undertake a more detailed analysis of ongoing OU after discharge and its impact on survival outcomes after BMT. Disclosures Brammer: Celgene Corporation: Research Funding; Seattle Genetics, Inc.: Speakers Bureau. Efebera:Celgene: Research Funding; Ohio State University: Current Employment; Pharmacyclics: Research Funding; Takeda: Honoraria, Speakers Bureau. Mims:Abbvie: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Other: Data Safety Monitoring Board; Syndax Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Kura Oncology: Membership on an entity's Board of Directors or advisory committees; Leukemia and Lymphoma Society: Other: Senior Medical Director for Beat AML Study; Agios: Consultancy; Novartis: Speakers Bureau. Chaudhry:Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bumma:Sanofi: Speakers Bureau; Amgen: Speakers Bureau. Khan:Amgen: Consultancy; Janssen: Consultancy. Devarakonda:Janssen: Consultancy. Jaglowski:Novartis: Consultancy, Research Funding; CRISPR: Consultancy; Juno: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding. William:Kyowa Kirin: Consultancy, Honoraria; Merck: Research Funding; Seattle Genetics: Research Funding; Incyte: Research Funding; Guidepoint Global: Consultancy; Dova: Research Funding; Celgene: Consultancy, Honoraria.

Impact of Delaying Stem Cell Transplant Related to Dental Work Clearance 1

Purpose The primary purpose of this project was to decrease the percentage of Blood and Marrow Transplant (BMT) delays and/or cancelations due to a lack of dental clearance. A secondary purpose was to identify dental resources and education for patients and nurses. Topic Significance & Study Purpose/Background/Rationale A dental clearance is required for all patients prior to BMT. Poor dentation such as dental caries, periodontitis, and other issues may lead to complications such as: delayed healing of mucositis, need for parenteral nutrition and pain medications, increased length of stay, and increased risk for infection, sepsis, and death. Delays in obtaining dental clearance can place patients at a higher risk for relapse creating the need for additional therapy prior to BMT or cancellation of the BMT. Methods, Intervention, & Analysis After identifying the percentage of BMT patients delayed or canceled related to dental clearance, a review of literature was undertaken in the following areas: dental evaluation prior to BMT, oral status of BMT patients, and effects of delayed BMT. Additionally, current available dental resources, education materials, and nursing knowledge and satisfaction of dental resources were assessed. Based on findings, the following interventions were implemented. BMT nurses worked with social workers to identify dental resources in the community that can provide dental work and clearance for BMT patients that do not have dental insurance or coverage. Patient education materials were developed to include the importance of dental clearance. An education program was developed for both BMT and hematology nursing staff which highlighted the importance of dental clearance as well as the tools and resources available so that patients can be educated early in the BMT process. Findings & Interpretation The percent of patients delayed decreased from 4.6% at baseline to 1.8% and the percent of patients canceled decreased from 2.8% to 0% during the project and has remained below baseline. Nursing staff report less difficulty in obtaining dental clearance from the patients and are far more knowledgeable and satisfied with current dental tools and resources. Discussion & Implications This project supports working with multidisciplinary teams, including the community, to obtain resources for patients to obtain dental clearance. This project was successful in decreasing delays and cancelations in BMT patients related to dental clearance. Regular review of resources is ongoing.

Initiating the Conversation of Oncofertility: The Creation of a Dedicated BMT Oncofertility Nurse Coordinator in the Transplant and Cellular Therapy Patient Population

Topic Significance & Study Purpose/Background/Rationale Patients undergoing hematopoietic stem cell transplantation face a high risk of infertility. Despite existing ASCO, ASRM and NCCN fertility preservation guidelines, as many as 68% of oncology patients report that fertility was not discussed prior to or during therapy. Since infertility in survivorship is known to increase distress and contribute to decreased quality of life, upfront oncofertility discussions must be more embedded into our programmatic education. To increase the prevalence and depth of fertility preservation counseling among Blood and Marrow Transplant (BMT) and cellular therapy patients, the BMT oncofertility coordinator role was developed. Methods, Intervention, & Analysis Two BMT advance practice providers and one transplant coordinator completed the ECHO (Enriching Communication Skills for Health Professionals in Oncofertility) training program through the Moffitt Cancer Center to deepen knowledge of oncofertility in our patient population. Through multidisciplinary working groups with institutional fertility specialists, the BMT team developed an algorithm and standardized workflow. A BMT oncofertility coordinator role was developed to ensure each BMT patient of reproductive age receives individual reproductive counseling, options to preserve, a same day referral to reproductive endocrinology, and support through complex coordination of care and financial support services once a fertility treatment option has been determined. If fertility preservation is not possible, the coordinator provides the information and counseling that increase patients' quality of life before, during and after cancer treatment. Findings & Interpretation Between September 2018 and September 2019, in the first year of this service the oncofertility coordinator has consulted with 102 patients of reproductive age. This role has assisted in addressing critical timeframes ensuring prompt referral to fertility preservation, access to fertility resources, as well as ensuring documentation of fertility preservation discussions in the medical record. Discussion & Implications The role of the BMT oncofertility coordinator has increased access to supportive oncofertility care at the time of cancer diagnosis for both BMT patients and patients across the health system as other clinics have begun consulting the BMT oncofertility coordinator. Increased awareness of the oncofertility services available is needed to ensure all patients of reproductive age are aware of their options for fertility preservation and are given the opportunity to have the family they may desire.

Beating the Benchmark: Adopting a Learning Organization Approach to Clabsi Reduction in BMT

Topic Significance & Study Purpose/Background/Rationale Preventing central line-associated blood stream infections (CLABSIs) is a priority in blood and marrow transplantation (BMT). A central line infection is both costly and potentially a fatal event. Our hybrid unit of 33 inpatient beds and seven outpatient rooms is designed for hematology/oncology patients receiving autologous and allogeneic BMT. According to the National Healthcare Safety Network (2013), our unit is classified as a hematology/oncology unit, with a CLABSI benchmark of 1.4 per 1000 central line days, not a BMT unit with a rate of 2.6 (NHSN, 2013). In 2016, an analysis of our practice identified opportunities for improvement based on a BMT CLABSI rate of 2.5. The goal of this quality improvement initiative was to reduce the CLABSI rate below the benchmark of 1.4, a 44% reduction. Methods, Intervention, & Analysis Our approach included: a collaborative unit-based task force of direct care nurses, nursing assistants, nurse managers, advanced practice providers, infection preventionists and quality specialists; standardizing central line catheters for BMT patients; and clinical surveillance with a focus on line care. Nurse-sensitive practice changes included: education of BMT nurses and assistants, focused risk awareness and practice “musts”; continual review of data at all task force and staff meetings; minimizing intravenous tubing disconnections; product changes for line care; and focused patient education. Findings & Interpretation Subsequent to interventions outlined below, we achieved a remarkable improvement, achieving a rate much less than the national benchmark of 1.4. With the exception of mucosal barrier injury-related CLABSIs, the 2016 CLABSI rate of 2.5 was reduced to zero in 2017, and 0.59 in 2018 (attributed to an increase in allogeneic transplant volume and acuity). The current 2019 rate is zero! Discussion & Implications CLABSI prevention is best accomplished by creating a team environment, where everyone involved is a stakeholder. Reflection and shared decision-making can result in a significant, sustained CLABSI rate reduction in BMT.

Shifting Gears from Transplant to CAR T: Creating a Cell Therapy Nurse Coordinator Role

Topic Significance & Study Purpose/Background/Rationale With the advent of novel cell therapies such as chimeric antigen receptor (CAR)-T, blood and marrow transplant (BMT) programs find themselves in uncharted territory. While CAR-T shares some aspects with BMT, differences in patient care and program needs warrant the creation of a cellular therapy coordinator (CTC) role. This presentation aims to explore the unique development of the CTC role in an intermediate size transplant program providing commercial CAR-T therapy. Methods, Intervention, & Analysis The CTC role resulted from extensive work by a multidisciplinary cell therapy team. The team created CAR-T focused standard operating procedures, and the CTC then translated these policies into direct patient care. While BMT policies have been long established, little precedent exists for CAR-T therapy. The CTC, in collaboration with the cell therapy team, created program-specific patient education publications, set documentation standards, and developed discharge planning tools. The CTC also created an adverse event reporting system as required by the FDA. In a variation from BMT, the CTC assumed responsibility for patient care coordination from the time of consent through the time of program discharge. This allowed for monitoring at all stages, and allowed the CTC to understand the nuances of each patient's CAR-T experience. Findings & Interpretation The program administered CAR-T cells to 17 patients over six months. Retrospective evaluation demonstrated several factors that differentiate the CTC role. Unlike BMT, manufactured CAR-T cells require oversight from pharmaceutical companies, insurance, and the FDA. The CTC maintains a relationship with the pharmaceutical companies through patient registration, event reporting, and facility audits. Since official billing codes do not exist, the CTC has an increased responsibility in the insurance approval process, working closely with financial coordinators and hospital administrators. The CTC also experiences challenges due to an acutely ill patient population. While most BMT patients are in remission, the relapsed/refractory CAR-T patients often require urgent treatment, adding additional time sensitivity to care coordination. Discussion & Implications As new trials and commercial products become available, cancer centers interested in pursuing cellular therapies should consider early implementation of cell therapy nurse coordinators. By understanding the nuances of cell therapy, a designated CTC ensures patient safety and enhance program development.

Integrating Immunotherapy and Bone Marrow Transplant Clinic Operations Policies for FACT Accreditation

Topic Significance & Study Purpose/Background/Rationale Our Blood and Marrow Transplant (BMT) center is part of an NCI-designated cancer center that performs nearly 500 transplants a year. Historically, it was a free-standing hospital/clinic and in 2001 became part of a larger clinical alliance. BMT Physicians manage clinical care and research. Standard Practice guidelines were established with physicians based on the need for standardized care and to educate rotating medical personnel. In the last 25 years BMT care has transferred from hospital to the Ambulatory Clinic. BMT Ambulatory Nurse Management recognized standardization of Operational Policy was essential. This work became the basis for creating the policies required for Foundation for the Accreditation of Cellular Therapy (FACT). Methods, Intervention, & Analysis The BMT clinic managed patient care and staff orientation when chimeric antigen receptor (CAR) T-cell therapy first began at our institution. The Immunotherapy (IMTX) Clinic is now separate from the BMT Clinic but many clinical care guidelines remain similar. It was determined that the IMTX clinic would fall under the BMT FACT accreditation standards, as our needs for accreditation are intertwined. BMT maintains Operations Standards for adult/pediatric inpatient/ambulatory care across three geographic sites of practice. IMTX operations guide adult inpatient/ambulatory care across two institutions in our alliance. Findings & Interpretation BMT and IMTX maintain Operations Standards by review through the Transplant & Immunotherapy Clinic Operations Team (TICOT). TICOT membership includes all departments providing services to BMT and/or IMTX patients and in each institution with patient care involvement. Policies each have designated owners and are distributed a month prior to the meeting when due for revision. At monthly cross-institutional meetings, policies are collaboratively reviewed and approved for the central policy data base. Discussion & Implications Changes in 2015 transferred policy management to the BMT Nursing Supervisor with BMT Medical Director oversight. The IMTX clinical staff is responsible for reviewing policy and addressing the differences to cover IMTX FACT requirements. BMT/IMTX designated CNS reviews policies to assure alignment with FACT standards. Nurse leaders most familiar with clinic operations are critical to the process of policy creation, implementation, revision and maintenance for the best standards of care and practice in BMT/IMTX cellular therapy care delivery.

Nationwide Children's Hospital BMT Smart Forms

Background Integration of patient information across medical institutions remains a major challenge in American healthcare. In particular, meaningful data compilation, extraction and analysis are impeded by separate information technology systems, thereby limiting collaborative efforts addressing translational and patient-centered outcomes research. Furthermore, incorporating predictive models to ensure favorable patient outcomes are critically needed, especially for high-complexity, high-resource utilizing patient populations like blood and marrow transplant (BMT) recipients. To this end, the Nationwide Children's Hospital (NCH) BMT Smart Forms were created with the ultimate goal of developing an analytics-integrated, EMR (electronic medical record)-based smart form for BMT and cell therapy patients, which would have the potential to improve patient outcomes by assimilating clinical data across transplant and cell therapy centers. Smart Form Design and Functionality Originally created in 2013 at Nationwide Children's Hospital, the pre- and post-BMT Smart Forms (SFs) were designed by a collaborative team including members of the BMT Program, Information Services and Technology, Electronic Data Warehouse, and Research Information Solutions and Innovation (RISI). Specifically, the BMT SFs were designed using the Epic® platform to enable clinical and quality reporting and research data capture (Figure 1). In this regard, the SFs contain minimal free text fields to minimize data entry error and standard data elements (SDEs), which facilitate data mapping and routing. Once completed, the SFs can be transformed into clinical documentation for clinical management purposes. By design and through a data visualization platform (QlikView®), the BMT SFs also facilitate internal and external data reporting for transplant- and cell therapy-related agencies including the CIBMTR (Center of International Blood and Marrow Transplant Research), FACT (Federation for Accreditation of Cellular Therapy), and NMDP (National Marrow Donor Program). Clinical data entered into the BMT SFs route into a database with the capability for automated data transfer from within and outside NCH, thereby creating the potential for a combined, multi-institutional database through which data can be easily queried (Figure 2). Lastly, the database enables predictive analytic modeling for common transplant-related metrics (e.g., engraftment) and complications (e.g., infection). Reiterations of the BMT SFs have occurred over time, reflecting new technologies and approaches to transplant care as well as future steps for on-boarding additional transplant centers.

129 - Understanding the Many Facets of a Blood and Marrow Transplant (BMT) Team Registered Nurse Role in an Ambulatory Clinic

Topic Significance & Study Purpose/Background/Rationale: Our Clinic is part of a NCI-designated cancer center performing nearly 500 blood and marrow transplants (BMT) a year. Our standard is to care for BMT patients in the outpatient department; hospitalization occurs with patients, pre-transplant who have multiple co-morbidities, and post-transplant for symptom management. As a result, patient acuity in the outpatient clinic is generally high. We operate 7 days a week with a “Team” concept of Advanced Practice Provider and Team nurse caring for 15-20 patients, and Attending physician with oversight of 2-3 teams. Nurses see patients in twice weekly team visits and multiple independent visits for clinical assessment and teaching. The role of the nurse is currently defined by the scheduled clinic visits, but the responsibilities of care coordination are labor intensive, occur throughout the day and are undefined. Nurses attribute much of their non-patient facing time to responding to phone calls and pages from patients, caregivers, home infusion agencies, research coordinators, lab and pharmacy. Nurses answer daytime phone calls immediately or retrieved from voice mail. Patients with urgent concerns call directly to Reception and are transferred live to the Triage Nurse for immediate response. Data analysis of after-hours BMT Triage calls revealed that most were medication related, but no data existed for daytime calls. Responding to patient needs is crucial to best practice, and a project was undertaken to assess calls to Team nurses. Methods, Intervention, & Analysis: Daytime phone data collection was implemented with Team Nurses. Calls were tracked manually for 7 consecutive days for multiple variables, including length, time, and topic of call. We hypothesized that most calls from patients or home agencies could be recorded and responded to at a later time. The data will be reviewed for deficits in answering live and barriers to prompt response. Issues will be separated into nursing and non-nursing topics for further evaluation. Findings & Interpretation: Data analytics provided the call numbers, length, and time of day for the same 7 days. Calls came at the busiest clinic times and preliminary results indicate most calls can wait for a response. However, there are significant medication questions and symptom management issues that are time-sensitive and need an immediate response. Discussion & Implications: Our preliminary data necessitated an immediate intervention. We revised the Team nurse recorded message to include an automated option that allows callers with urgent needs to connect directly to the Triage Nurse. Further review of the data will allow us to discover if there are non-nursing activities that can be transferred to other personnel to allow the BMT nurse greater capacity to manage care of complicated BMT patients. Continuing to refine nursing responsibilities will allow BMT nurses to function at the top of their license and support best outcomes for all BMT patients.

662 - Keep Calm and Control Pain

Topic Significance & Study Purpose/Background/Rationale: Almost all inpatient blood and marrow transplant (BMT) patients will experience some form of pain while hospitalized related to treatment side effects or disease processes. BMT patient satisfaction scores related to pain control at our center didn't consistently meet benchmarks. Barriers to effective pain management exist and include fear of addiction, side effects of treatment, and combining pain medications with other sedating medications (Kwon, 2014). Nurses may not believe patient reports of pain and feel they are unable to adequately control their pain. Methods, Intervention, & Analysis: BMT patients and nurses were surveyed regarding barriers to pain control. Based on results, pain education was added to the pre-transplant class and a brochure on pain control was developed. Nurses were educated on pain control methods and barriers to adequate pain control. Two visual tools were developed. The Wong-Baker FACES® Pain Rating Scale with a numerical scale for patients to indicate their comfort level, and a tool that identified prescribed pain medication(s) and when the next dose could be administered. Findings & Interpretation: Patient perceptions of barriers to pain control improved in 5 out of 8 categories. Patient satisfaction with pain control increased significantly (Figure 1). Nurse's attitudes and comfort level in managing patient's pain also increased (Figure 2). Nurse's knowledge of pain management remained fairly consistent since the initial knowledge base was already high. These results show that both patients and nurses benefit from pain management education and consistencies with actively managing pain during transplant are beneficial.Figure 2View Large Image Figure ViewerDownload Hi-res image Download (PPT) Discussion & Implications: Providing pain management education can help patients identify barriers and misconceptions, allowing them to set realistic expectations and effectively communicate their pain to nurses during the transplant process. Having visual cues in patient rooms for current pain level and medication administration provides a direct avenue for patient-to-nurse communication in assessing comfort and managing pain.

A Novel Health Informatics Tool to Improve Caregiver Activation: Findings from Pediatric BMT in a Hospital-Based Setting

Background: The rapid adoption of mobile technology by the public and increased emphasis on patient engagement yields an opportune time to leverage health information technology (IT). Yet, a knowledge deficit exists on the use of health IT tools for high-risk populations. Pediatric blood and marrow transplant (BMT) is a medically complex and intense intervention. We have previously shown that BMT patients and caregivers have significant information needs. As such, caregiver activation on behalf of the patient may play an important role in fostering an effective patient-caregiver-provider partnership, which is increasingly recognized as the optimal model for health care delivery. Anxiety over outcomes, compounded by information overload may limit successful activation. Health IT tools offer the potential to overcome constraints in health care delivery limited by provider time and complex health information. We hypothesized that a tablet-based tool displaying personalized health information, including real-time data from the electronic health record, could provide a platform to promote caregiver activation. The implementation and evaluation of our health IT tool (BMT Roadmap) was based on generation of user-centered needs and in collaboration with a trans-disciplinary team, including experts in BMT, health communications, psychology/health behavior, biostatistics, health informatics, and human-computer interaction research. BMT Roadmap included the following domains: 1) laboratory results; 2) medications; 3) clinical trial enrollment; 4) health care provider directory; 5) phases of transplant; and 6) interactive discharge checklist with professionally produced videos on central line care.Methods: Caregivers of pediatric BMT patients were recruited and enrolled on this IRB-approved study. They were instructed to use BMT Roadmap freely throughout the patient's admission. Data collection included mixed methods approaches. System log-use data were recorded, including number of log-ins, domains frequented, and duration of use. Quantitative survey measurements were obtained at baseline (admission), discharge, and day 100 after BMT. These validated surveys measured activation, mood, anxiety, satisfaction, quality of life, and caregiver distress. In depth qualitative interviews were performed at baseline, weekly during admission, at discharge, and at day 100. Both inductive and deductive analysis was used to identify themes for further study.Results: Ten caregivers participated in the study: 80% female, 90% white, median age 36 years (25-54 years). Transplants were 50% autologous and 50% allogeneic. Median time of use was 104.1 minutes (6.4-256.2 minutes) over 29.5 days (21-68 days). Minutes used and days used were strongly inter-correlated (r=.90, p=0.001) and correlated with inpatient days (r=.70, p=0.05; and r=.81, p=0.01 respectively). The most time spent was in the laboratory module, followed by health care provider directory, medication, and phases of care modules (Table 1). Quantitative survey results showed that trait anxiety (STAI-T) was decreased, caregiver quality of life (CQOL) was improved, and caregiver activation (C-PAM) was increased at discharge compared with baseline (Table 2). The highest level of self-rated activation, as assessed by the C-PAM survey increased from 40% (admission) to 50% (discharge), and reached 85.7% (day 100). Total C-PAM score showed a strong trend toward increased activation from admission to day 100 (p=0.08). Caregivers with higher engagement had less trait anxiety at day 100 (r=.82, p=0.02), but engagement was unrelated to minutes of iPad use, days of iPad use, inpatient days, and caregiver quality of life. Caregivers described the iPad as easy to use and all used it for some portion of their stay (Table 3).Conclusions: Our findings indicate that health IT tools adapted to specific clinical conditions have potential to increase caregiver activation. BMT Roadmap was highly useful and easy to use. Validated survey measurements indicated that trait anxiety was decreased, caregiver quality of life was improved, and caregiver activation was increased at discharge compared with baseline. Higher activation was associated with less anxiety at day 100, but unrelated to iPad use (time), inpatient days, caregiver depression, distress or quality of life. We are now expanding BMT Roadmap into the Adult BMT population. [Display omitted] [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

CMV Viremia and African-American Ethnicity Are Risk Factors for Post-Engraftment Blood Stream Infections in Pediatric Allogeneic Blood and Marrow Transplantation

Background: Blood stream infections (BSI) are a major source of morbidity and mortality after allogeneic blood and marrow transplantation (BMT). In studies of risk for BSI various factors have been identified. The impact of cytomegalovirus (CMV) viremia, however, on risk has not been assessed. This is important since both CMV infection and ganciclovir (GCV), the mainstay of pre-emptive therapy, have myelosuppressive and immunosuppressive effects. We conducted a retrospective analysis to test the hypothesis that CMV viremia predisposes allogeneic BMT patients to BSI.Methods: We retrospectively analyzed 278 allogeneic BMTs performed at Children's Healthcare of Atlanta between January 1st 2005 and December 31st 2014 that met eligibility criteria. The primary outcome was the first episode of BSI occurring between day +30 and +100 seen in engrafted patients following allogeneic BMT. We compared clinical characteristics between patients with and without BSI. This analysis was based on a time dependent competing risk model. Risk events including acute GVHD and CMV viremia were counted only when they preceded the BSI. We performed a multivariate analysis to estimate the effect of CMV viremia on risk for BSI in the post-engraftment period (days +30-100).Results: The median age was 9 years (range 0-22 years). 44.6% of the patients were Caucasian, while 38.5% were African-American. 59.7% received an unrelated marrow, unrelated cord or the alternative donor transplant. 60.8% were transplanted for a hematologic malignancy. The cumulative incidence of BSI between day +30 and+100 was 21.9% (95% confidence interval (CI), 17.5-27.3%). The median day of BSI development was 54 (range 30-99). The leading cause of BSI was Staphylococcus epidermidis. Gram-positive cocci were responsible for 71.4% of all BSIs. In the multivariate analysis, three factors were significant: grade III/IV aGVHD (hazard ratio (HR)=3.490, 95% CI 1.530-7.980, P=0.003), CMV viremia (HR=3.410, 95% CI 1.410-8.250, P=0.007), and African-American ethnicity (HR=2.520, 95% CI 1.130-5.600, P=0.024). Form of insurance (Medicaid/no insurance vs. other), employed as a surrogate for income level, had no influence on risk. In the 57 patients with CMV viremia, the frequency of neutropenia (<500/mm3) after the development of CMV viremia until day +100 was 26.3% (15/57), significantly higher than that observed in patients without CMV viremia (5.4% (12/221), P<0.001).Conclusion:Our analysis of risk for post-engraftment BSI in children yielded three factors. One, aGVHD, is well established. The other two, CMV viremia and African-American ethnicity, have not been previously recognized. That CMV viremia would predispose to subsequent BSI is highly plausible. Our results suggest that the risk of CMV viremia may be mediated in part by neutropenia stemming from CMV or its treatment with ganciclovir. That African-American ethnicity has not previously been recognized as a risk factor may simply reflect the ethnic make up of previous studies. Our findings are consistent with those of studies performed in other settings, showing patients of African descent to be at increased risk for bacteremia and sepsis. An increased risk for BSI among patients of African descent could partly explain the concerning excess risk for transplant related mortality previously observed among these patients. DisclosuresNo relevant conflicts of interest to declare.

African American Race Is a Newly Identified Risk Factor for Postengraftment Blood Stream Infections in Pediatric Allogeneic Blood and Marrow Transplantation

Blood stream infections (BSI) are a major source of morbidity and mortality both in allogeneic blood and marrow transplant (BMT) recipients. Various risk factors for BSI in BMT have been identified. The impact of race and cytomegalovirus (CMV) viremia, a common complication after engraftment, however, has not been rigorously assessed. This is important because both CMV infection and ganciclovir, the mainstay of pre-emptive therapy, have myelosuppressive and immunosuppressive effects. We conducted a retrospective analysis to test the hypothesis that race and CMV viremia predispose allogeneic BMT patients to postengraftment BSI. We analyzed 278 allogeneic BMT performed at Children's Healthcare of Atlanta between January 1, 2005 and December 31, 2014 that met eligibility criteria. We performed a multivariate analysis to estimate the effect of CMV viremia on risk for BSI in the postengraftment period (days +30 to 100). Risk for BSI was associated with CMV viremia (hazard ratio [HR], 3.34; 95% confidence interval [CI], 1.51 to 7.36; P = .003); grade III and IV acute graft-versus-host disease (HR, 3.28; 95% CI, 1.55 to 6.92; P = .002), and African American race (HR, 2.22; 95% CI, 1.09 to 4.51; P = .027). The results of our study highlight the importance of a novel risk factor for postengraftment BSI, not previously considered—African American race.

Patient perceptions of a 1-h art-making experience during blood and marrow transplant treatment.

Patients with various forms of cancer receiving blood and marrow transplant (BMT) treatment at an outpatient clinic develop chemotherapy-related symptoms and an increased desire to use complementary and alternative medicine in order to address these symptoms. Art-making offers an inexpensive way to pass time and relieve symptoms during long hours in treatment. Twenty-one BMT patients painted a tile and participated in research. Researchers used semi-structured interviews to understand patients' experiences with art-making. Interviews were recorded, transcribed and coded independently by researchers who met to agree on themes. Ten themes emerged from the data including, meaningful activity (32.2%), expression (18.7%), passing time (13.2%), BMT process (12.1%), social outlet (8.1%), therapy-related symptoms (7.3%), negative aspects of painting (5.9%) and encouragement to paint (2.6%). The results of this study revealed that art-making experience can provide patients a meaningful activity during treatment and an outlet to express their feelings.

Nurses' Role in Decreasing Cardiopulmonary Damage in a Setting of Necessary Cardiopulmonary Toxic Therapy

s / Biol Blood Marrow Transplant 21 (2015) S391eS397 S393 Topic Significance & Study Purpose/Background/ Rationale: The purpose of this study was to determine if adding an instructional video to discharge teaching would standardize and increase efficacy of CVC care discharge teaching conducted by nurses and improve BMT patient and caregiver knowledge and comfort level with CVC care. Central venous catheter (CVC)manipulation and care puts patients at risk of acquiring central-line associated blood stream infections (CLABSIs). Thus it is imperative that caregivers receive standardized education, which takes into account varied learning needs. Research in patient care settings has shown that in addition to traditional patient education methods, videos can provide standardized education and improve both patient knowledge and satisfaction with learning. The current practice at this Academic Medical Facility’s Blood and Marrow Transplant (BMT) program provides patients and caregivers with a written BMT manual describing CVC care, CVC care class, and verbal CVC care teaching prior to discharge. Methods, Intervention, & Analysis: BMT patients and caregivers that received discharge teaching were surveyed to assess their comfort level and knowledge of their CVC care. In addition, nurses who performed CVC care discharge teaching with BMT patients were surveyed regarding their teaching content and procedure. A pilot instructional video demonstrating all aspects of CVC care was developed using current standards. The video was shown to BMT patients and caregivers with preand post-surveys assessing knowledge and comfort level with CVC care. Findings & Interpretation: The nurse surveys as well the patient and caregiver surveys revealed both knowledge and practice discrepancies. The preand post-surveys showed an increase in both CVC care knowledge and comfort level following the viewing of the pilot instructional video. Discussion & Implications: The addition of an instructional video to the current CVC care teaching process will provide standardized CVC care education for patients and caregivers. The video will also ensure that multiple preferred learning methods are being utilized. This is essential in reducing the risk of CVC complications, improving patient knowledge, and increasing patient comfort with CVC care.

Effects of cognitive-behavioral music therapy on fatigue in patients in a blood and marrow transplantation unit: A mixed-method pilot study

Cancer-related fatigue (CRF) is an under-treated condition frequently experienced by cancer patients, which can negatively affect wellbeing during and after hospitalization. The purpose of this mixed-method pilot study was to determine if and how cognitive-behavioral music therapy (CBMT) might reduce fatigue in hospitalized patients in an adult blood and marrow transplant (BMT) unit. The researchers measured the effects of CBMT on five aspects of participant fatigue using a convergent parallel mixed-method design. The participants (N=11) were randomly assigned to experimental or wait-list control conditions and completed the Multidimensional Fatigue Inventory (Smets, Garssen, Bonke, & De Haes, 1995) at pre- and posttest. The experimental participants completed a semi-structured interview prior to hospital discharge. The quantitative results indicated no significant between-group differences regarding fatigue. However, the experimental participants tended to have decreases in the mean fatigue scores from pre- to posttest, whereas the control participants had increases in the mean fatigue scores from pre- to posttest. The qualitative data tended to support the quantitative data and indicated that CBMT: (a) cognitively influenced fatigue by increasing motivation and self-efficacy, (b) affectively influenced fatigue by promoting relaxation and restful states, and (c) represented a meaningful, unique, and holistic service for hospitalized BMT patients. CBMT may be an effective intervention regarding various aspects of fatigue in hospitalized BMT patients. Because of the small sample size, the results should be interpreted with caution. The limitations of the study, implications for clinical practice, and suggestions for future research are provided.

Effects of music therapy on positive and negative affect and pain with hospitalized patients recovering from a blood and marrow transplant: A randomized effectiveness study

Due to the extensive procedures surrounding treatment, cancer patients often experience a variety of physical and psychological symptoms and side effects that negatively impact their quality of life and ability to cope with and manage an illness. Providing a choice of music during a receptive music therapy session may not only distract the patient from negative affective states, but also may provide a sense of autonomy and control over a patient's immediate environment. The purpose of the study was to determine whether receptive music therapy can improve two general dimensions of emotional experience and pain in a single session for hospitalized patients recovering from a blood and marrow transplantation (BMT) procedure. The guiding research question was: Will participants experience improved positive and negative affect and pain immediately following a patient-preferred live music therapy session? Participants (N=32) were randomly assigned to experimental or wait-list control conditions and completed the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988) Short Form version and a Likert-type Pain Scale as a pre- and posttest within a single-session design. In an attempt to provide support, autonomy, and distraction, patient-preferred live music was used in receptive music therapy sessions as previous music therapy researchers indicated patient-selected live music is preferred and can be effective. There were no between-group differences at pretest. Concerning posttest analyses, there were significant between-group differences in positive and negative affect and pain, with experimental participants having more favorable scores than control participants. From the results of this randomized effectiveness study, it seems that a single receptive music therapy session can be an effective intervention concerning positive and negative affect and pain for hospitalized BMT patients. As higher levels of patient engagement may result in stronger treatment effects, future research encouraging hospitalized BMT patients to engage in different types of active music therapy interventions is warranted. Limitations of the study, implications for clinical practice, and suggestions for future research are provided.

Long-term follow-up of imatinib in pediatric Philadelphia chromosome-positive acute lymphoblastic leukemia: Children's Oncology Group Study AALL0031

We previously reported preliminary findings that post induction imatinib mesylate (340 mg/m(2)/day), in combination with intensive chemotherapy, resulted in outcomes similar to blood and marrow transplant (BMT) for pediatric patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). We now report 5-year outcomes of imatinib plus intensive chemotherapy in 91 children (1-21 years) with and without allogeneic BMT (N=91). We explore the impacts of additional chromosomal abnormalities and minimal residual disease (MRD) by flow cytometry on outcomes. The 5-year disease-free survival was similar for Cohort 5 patients, treated with chemotherapy plus imatinib (70%±12%, n=28), sibling donor BMT patients (65%±11%, n=21) and unrelated donor BMT patients (59±15%; P=0.60, n=13). Patients with additional cytogenetic abnormalities had worse outcomes (P=0.05). End induction (pre-imatinib) MRD was not prognostic for Cohort 5 or allogeneic BMT patients, although limited by small numbers. The re-induction rate following relapse was similar to other higher-risk ALL groups. Longer-term follow-up confirms our initial observation of substantially good outcomes for children and adolescents with Ph+ ALL treated with imatinib plus intensive chemotherapy with no advantage for allogeneic BMT.

Chlorhexidine Gluconate Impregnated Waterless Bath System for the Reduction of Blood Stream Infections in the BMT Population

The primary objective was to determine whether blood and marrow transplant (BMT) patients bathed daily with chlorhexidine gluconate (CHG) waterless bath system have lower incidence of skin flora associated (i.e. Staphylococcus epidermis, Staphylococcus aureus) central line associated blood stream infections (CLABSI) and total CLABSIs compared to patients bathed with the standard CHG soap and water method. Patients undergoing BMT are immunocompromised hosts whose leading cause of death during the transplant process is infection. Multiple studies have presented solid evidence that hospital water systems and bath basins are the source of serious waterborne nosocomial infection and exposure comes from showering and bathing. A number of studies in the medical intensive care units have shown a significant reduction in hospital acquired CLABSIs after implementing the use of CHG waterless bath system. This project was an innovative, evidence based intervention to decrease CLABSI rates (5.2/1000 catheter days) through the use of a CHG impregnated waterless bath system for daily hygiene. It included (N=281; 3451 catheter days) historical controls who showered using CHG soap and water bathing during their admission for BMT versus (N=290; 3838 catheter days) patients bathed with CHG waterless bath system. Data for both groups was extracted from a BMT program database. Outcome measures included incidence of total CLABSI and skin flora associated CLABSI. BMT patients bathed with CHG waterless bath intervention had significantly fewer CLABSI associated with skin flora (Staphylococcus epidermis & Staphylococcus aureus) (P < .05). Overall CLABSI rate were reduced from 5.2/1000 catheter days to 4.1/1000 catheter days which did not reach statistical significant but showed an important downward trend. Daily bathing of patients with CHG waterless bath system significantly decreased CLABSI, associated with skin flora. It is an easy, time-efficient, cost-effective intervention to decrease these infections in patients undergoing a BMT.