Purpose. ONS Outcomes Project Prevention of Infection Team. Infection Prevention. Neutropenic Precautions

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1 Nursing Interventions to Prevent Infection: Moving Beyond Nursing Customs to Evidence-Based Nursing Practice Laura Zitella, RN, MS, NP, AOCN Nurse Practitioner Stanford University Hospital and Clinics Assistant Clinical Professor University of California, San Francisco Purpose The purpose of this presentation is to share with you examples of common nursing practices which are based on evidence versus traditionally recommended or intuitive, but not supported by research. ONS Outcomes Project Prevention of Infection Team Infection Prevention Christopher R. Friese, RN, PhD,AOCN Laura Zitella, RN, MS, NP, AOCN Jody Hauser, RN, MS, NP Barbara Holmes Gobel, RN, MS, AOCN Colleen O'Leary, RN, BSN, OCN Myra Woolery- Antill, MN, RN Felicia Andrews, BSN, RN Neutropenic Precautions Mucositis Pharmacologic Interventions Neutropenic Precautions Low microbial diet Protective clothing Protective environment Nursing Custom: Low Microbial Diets Survey completed by 156 institutions 1 78% of the institutions recommended dietary restrictions to their patients Of those, 92% placed neutropenic pts on dietary restrictions during neutropenia and 9% when chemotherapy was initiated However, there are NO studies available that show that dietary restrictions decrease the risk for infection 2. Larson, E. & Nirenberg, A. (2004). Evidence-based nursing practice to prevent infection in hospitalized neutropenic patients with cancer. Oncology Nursing Forum, 31(4), Smith, L.H., & Besser, S.G. (2000). Dietary restrictions for patients with neutropenia: a survey of institutional practices. Oncology Nursing Forum,27(3), Larson, E. & Nirenberg, A. (2004). Evidence-based nursing practice to prevent infection in hospitalized neutropenic patients with cancer. Oncology Nursing Forum, 31(4),

2 Nursing Custom: Protective Clothing & Environments Laminar airflow and HEPA filtration may have some protective effects against infection, but have NOT been found to decrease mortality Cover gowns or other protective clothing have NOT been shown to reduce the risk of infection Handwashing There is strong evidence to support that hand hygiene decreases the risk of person-to-person transmission of infection. Evidence of antiseptic bathing contradictory Larson, E. & Nirenberg, A. (2004). Evidence-based nursing practice to prevent infection in hospitalized neutropenic patients with cancer. Oncology Nursing Forum, 31(4), Mank, A. & van der Lelie, H. (2003). Is there still an indication for nursing patients with prolonged neutropenia in protective isolation?. An evidence-based nursing and medical study of 4 years experience for nursing patients with neutropenia without isolation. European Journal of Oncology Nursing, 7(1), Boyce, J. M., Pittet, D., & Healthcare Infection Control Practices Advisory Committee. Society for Healthcare Epidemiology of America. Association for Professionals in Infection Control. Infectious Diseases Society of America. Hand Hygiene Task, F. (2002). Guideline for Hand Hygiene in Health-Care Settings: recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infection Control & Hospital Epidemiology, 23(12 Suppl). Traditional Nursing Interventions To Prevent Mucositis Mucositis: Evidence Based Practice Salt and Soda oral rinses Chlorhexidine oral rinse (Peridex ) Magic mouthwash The most important factor is consistent oral care There is nothing better than good old saline rinses Clarkson, J.E.,Worthington, H.V., & Eden, O.B. (2003). Interventions for preventing oral mucositis for patients with cancer receiving treatment. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD DOI: / CD Rubenstein, E.B., Peterson, D.E., Schubert, M., Keefe, D., McGuire, D., Epstein, J., et. al.; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. (2004). Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer, 100(9 Suppl), Chlorhexidine will not help your patient..and may hurt! There was NO evidence that chlorhexidine oral rinse was more effective than a placebo or no treatment control in preventing mucositis. The guidelines panel recommends that chlorhexidine NOT be used to treat established oral mucositis. Chlorhexidine-based mouthwashes (i.e. Peridex ) contain alcohol, which can increase the incidence of dry mouth and oral pain. Oral Care Protocols The guidelines panel suggest the use of oral care protocols that include patient education. Based on 3 randomized clinical trials and 3 non-randomized studies A single study demonstrated that tooth brushing reduced the number of oral lesions in patients receiving cancer chemotherapy. Clarkson, J.E.,Worthington, H.V., & Eden, O.B. (2003). Interventions for preventing oral mucositis for patients with cancer receiving treatment. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD DOI: / CD Rubenstein, E.B., Peterson, D.E., Schubert, M., Keefe, D., McGuire, D., Epstein, J., et. al.; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. (2004). Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer, 100(9 Suppl), Rubenstein, E.B., Peterson, D.E., Schubert, M., Keefe, D., McGuire, D., Epstein, J., et. al.; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. (2004). Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer, 100(9 Suppl),

3 Prevention of Oral Candidiasis What works: Drugs absorbed by the GI tract fluconazole, ketoconazole, itraconazole Drugs partially absorbed by the GI tract clotrimazole troches, miconazole What does not work: Nonabsorbable drugs nystatin, oral amphotericin B, nystatin plus chlorhexidine, thymostimulin, amphotericin B plus nystatin, polyenes, natamycin, and norfloxacin plus amphotericin B Pharmacologic Interventions Growth factors (CSF s) Prophylactic antibiotics Worthington, H. V., Eden, O. B., & Clarkson, J. E. (2004). Interventions for preventing oral candidiasis for patients with cancer receiving treatment.[update of Cochrane Database Syst Rev. 2002;(3):CD003807; PMID: ]. Cochrane Database of Systematic Reviews, 4. The Problem: Febrile Neutropenia 25-40% of patients develop febrile neutropenia Administration of CSF s reduce the risk of febrile neutropenia by 50% NCCN Categories of Consensus Category 1: There is uniform NCCN consensus, based on high-level evidence, that the recommendation is appropriate. Category 2A: There is uniform NCCN consensus, based on lower-level evidence including clinical experience, that the recommendation is appropriate. Category 2B: There is nonuniform NCCN consensus (but no major disagreement), based on lower-level evidence including clinical experience, that the recommendation is appropriate. Category 3: There is major NCCN disagreement that the recommendation is appropriate. All recommendations are category 2A unless otherwise noted. National Comprehensive Cancer Network. (2005). Clinical Practice Guidelines in Oncology: Myeloid Growth Factors in Cancer Treatment, Version Retrieved August 20, 2005 from: National Comprehensive Cancer Network. (2004). Clinical Practice Guidelines in Oncology: Fever and Neutropenia, Version Retrieved August 20, 2005 from: NCCN Guidelines for Myeloid Growth Factors Granulopoiesis-stimulating Factors to Prevent Adverse Effects in the Treatment of Malignant Lymphoma The Cochrane Database of Systematic Reviews Recommend CSF for chemotherapy with > 20% risk of febrile neutropenia Consider CSF if 10-20% risk of febrile neutropenia What is the benefit of G-CSF or GM-CSF as prophylaxis in patients with malignant lymphoma? National Comprehensive Cancer Network. (2005). Clinical Practice Guidelines in Oncology: Myeloid Growth Factors in Cancer Treatment, Version Retrieved August 20, 2005 from: Bohlius, J., Reiser, M., Schwarzer, G., & Engert, A. (2004). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD pub3. DOI: / CD pub3.

4 Meta-analysis Design Outcomes 12 randomized controlled trials including 1823 adult patients with malignant lymphoma undergoing chemotherapy Prophylaxis with G-CSF or GM-CSF (CSF s) within 48 hours after chemotherapy versus placebo/no prophylaxis Overall survival Freedom from treatment failure Quality of life Neutropenia Febrile neutropenia Infection Number of patients requiring intravenous antibiotics Infection-related mortality Tumor response Bohlius, J., Reiser, M., Schwarzer, G., & Engert, A. (2004). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD pub3. DOI: / CD pub3. Bohlius, J., Reiser, M., Schwarzer, G., & Engert, A. (2004). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD pub3. DOI: / CD pub3. CSF s Did NOT Reduce: Benefits of CSF s: Overall survival or mortality Freedom from treatment failure Complete tumor response Quality of life. Infection-related mortality Thrombocytopenia or anemia The need for parenteral antibiotics Duration of neutropenia, febrile neutropenia, hospitalization, or parenteral antibiotic treatment Bohlius, J., Reiser, M., Schwarzer, G., & Engert, A. (2004). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD pub3. DOI: / CD pub3. Reduced the risk of neutropenia (ANC< 500) by 33% Reduced the risk of febrile neutropenia (ANC<500) by 41% Reduced the risk of infection by 26% In three studies, patients in the CSF-treated groups received a statistically significant higher dose intensity than the control group. Bohlius, J., Reiser, M., Schwarzer, G., & Engert, A. (2004). Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD pub3. DOI: / CD pub NCCN Guidelines for Fever and Neutropenia Antibacterial prophylaxis (fluoroquinolones) NOT indicated for patients with short-term neutropenia Consider for expected neutropenia ( ANC < 100) for 7 days Antifungal prophylaxis Indicated for allogeneic marrow transplant recipients or patients with GVHD requiring systemic steroids (Category 1) 2004 NCCN Guidelines for Fever and Neutropenia Antiviral prophylaxis Indicated for allogeneic marrow transplant recipients (Category 1) Indicated for patients with acute leukemia undergoing induction or reinduction therapy (Category 1) Indicated for any patient with a HSV infection during neutropenic period that requires therapy Indicated for patients receiving T-cell depleting agents (i.e. fludarabine) National Comprehensive Cancer Network. (2004). Clinical Practice Guidelines in Oncology: Fever and Neutropenia, Version Retrieved August 20, 2005 from: National Comprehensive Cancer Network. (2004). Clinical Practice Guidelines in Oncology: Fever and Neutropenia, Version Retrieved August 20, 2005 from:

5 2004 NCCN Guidelines for Fever and Neutropenia PCP prophylaxis Indicated for patients with acute lymphocytic leukemia throughout antileukemic therapy (Category 1) Consider for recipients of T-cell depleting agents (i.e. fludarabine, 2-CdA) (Category 2B) Consider for patients with malignancy receiving prolonged corticosteroids ( 20 mg/day prednisone) (Category 2B) Consider for autologous peripheral blood stem cell transplant recipients (Category 2B) 2002 Guidelines for the Use of Antimicrobial Agents in Neutropenic Patients Infectious Diseases Society of America Prophylactic antibiotics NOT recommended National Comprehensive Cancer Network. (2004). Clinical Practice Guidelines in Oncology: Fever and Neutropenia, Version Retrieved August 20, 2005 from: Hughes, W.T., Armstrong, D., Bodey, G.P., Bow, E.J., Brown, A.E., Calandra, T., et. al. (2002) guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clinical Infectious Diseases,34, Late-Breaking New Meta-Analysis of Prophylactic Antibiotics In trials comparing antibiotic prophylaxis with placebo or no treatment in neutropenic patients, prophylaxis significantly : Reduced overall mortality by 33% Reduced infection-related mortality by 42% In trials comparing fluoroquinolone prophylaxis with placebo or no treatment in neutropenic patients, prophylaxis significantly : Reduced the overall mortality by 48% Reduced infection-related mortality by 62% The risk for developing resistance or adverse effects was not statistically significant. Let s Look at the Details 95 randomized controlled trials with 9283 patients 64 trials included only patients with hematologic malignancies Only 9 trials consisted of more than 80% of patients with solid tumors 27 studies included patients undergoing bone marrow transplantation Gafter-Gvili, A. Fraser, A., Paul, M. & Leibovici, L. (2005). Meta-analysis: Antibiotic prophylaxis reduces mortality in neutropenic patients. Annals of Internal Medicine, 142, Gafter-Gvili, A. Fraser, A., Paul, M. & Leibovici, L. (2005). Meta-analysis: Antibiotic prophylaxis reduces mortality in neutropenic patients. Annals of Internal Medicine, 142, What Do YOU Think? Is this evidence strong enough to change practice for: Patients with solid tumors? Patients with hematologic malignancies? Patients undergoing bone marrow transplantation? Levofloxacin to Prevent Bacterial Infection in Patients with Cancer and Neutropenia NEJM, September 8, adult patients with cancer in whom chemotherapy-induced neutropenia (ANC<1000) was expected to occur for more than 7 days Levofloxacin 500 mg or placebo from the start of chemotherapy until the resolution of neutropenia

6 Study Design Prospective, multicenter, randomized, placebo-controlled trial 35 centers in Italy Patients examined daily for clinical signs of infection Patient Characteristics 384 assigned to levofloxacin 375 treated 192 had solid tumors or lymphoma 183 had leukemia 339 included in assessment of response 174 had solid tumors or lymphoma 165 had leukemia 760 Patients randomized 376 assigned to placebo 363 treated 184 had solid tumors or lymphoma 179 had leukemia 336 included in assessment of response 171 had solid tumors or lymphoma 165 had leukemia Type of Cancer 49% leukemia 31% non-hodgkin s lymphoma or Hodgkin s disease 13% other hematological cancers 7% solid tumors Outcomes Measured Fever requiring empirical therapy during neutropenia Type and number of documented infections Use of parenteral antimicrobial agents during neutropenia Survival at the resolution of neutropenia Compliance Tolerability Prophylaxis and Neutropenia Median duration of prophylaxis 14 days for patients with solid tumors or lymphoma 25 days for patients with leukemia Median duration of neutropenia(anc<1000) 8 days for patients with solid tumors or lymphoma days for patients with leukemia Results Fever 65% of patients in levofloxacin group 85% of patients in control group (p=0.001) Microbiologically documented infection 22% of patients in levofloxacin group 39% of patients in control group Death due to infection 2.4% of patients in levofloxacin group 3.8% of patients in control group (p=0.36) (Sample size inadequate to determine effect on death rate from infection)

7 Antibacterial Prophylaxis after Chemotherapy for Solid Tumors and Lymphomas NEJM, September 8, adult patients receiving chemotherapy for solid tumors or lymphomas at risk for neutropenia but without planned G- CSF support Levofloxacin 500 mg PO for seven days during anticipated period of neutropenia Treatment began on: Day 8 for 14-day and 21-day cycles Day 5 for regimens associated with early onset of neutropenia (e.g. docetaxel) Day 15 for 28-day cycles Study Design Prospective, multicenter, randomized, placebo-controlled trial 60 centers in the United Kingdom Type of Cancer 35% breast cancer 14% testicular cancer 14% small cell lung cancer 10% non- Hodgkin s lymphoma Other: 8% non-small-cell lung cancer (8%), Hodgkin s disease (3%), ovarian cancer (3%), gastric cancer (2.5%), esophageal cancer (2.5%), bladder cancer (2%), sarcoma (1%), colorectal cancer (1%) Outcomes Measured Fever Incidence of all probable infections Incidence of hospitalization Frequency of severe infection Site of infection Neutrophil count at the onset of infection Causative agent isolated during infection Results Fever 10.8% in patients in levofloxacin group 15.2% in patients in control group (p=0.01) Probable infection 34.2% in patients in levofloxacin group 41.5% in patients in control group (p=0.004) Hospitalization for infection 15.7% in patients in levofloxacin group 21.6% in patients in control group (p=0.004) Neutropenia and Infection Median ANC at onset of infection ANC 300 in patients in levofloxacin group ANC 520 in patients in control group Incidence of mucosal candidiasis 4.7% in patients in levofloxacin group 5.1% in patients in control group 40-45% of fevers and probable infections occurred outside of the expected nadir

8 Summary of Evidence-Based Nursing Interventions DO administer growth factors to patients undergoing chemotherapy with more than 20% risk of neutropenia DO recommend fluoroquinolone prophylaxis for afebrile neutropenic cancer patients DO recommend antifungal medications that are at least partially absorbed from the GI tract to prevent oral candidiasis DO recommend PCP prophylaxis for patients receiving 20 mg/d prednisone DO promote frequent, consistent oral care DO practice good hand hygiene Summary of Evidence-Based Nursing Interventions DO NOT recommend chlorhexidine for oral care DO NOT recommend protective clothing DO NOT routinely place neutropenic patients in protective isolation DO NOT recommend nystatin for the prevention of oral candidiasis There is inadequate evidence to support the use of low microbial diets to prevent infection Case Study Lisa is a 38 year old woman with Stage IIB small cell carcinoma of the ovary S/P cycle #4 of Cisplatin and Etoposide Should Lisa receive a CSF? A. Yes B. No Should Lisa receive prophylactic antibiotics? What oral care would you recommend for Lisa? A. Yes B. No A. Saline rinses B. Chlorhexidine (Peridex ) C. Magic Mouthwash D. Nystatin oral suspension

9 Before you enter Lisa s room, you should: Lisa is admitted with neutropenic fevers. Her ANC is 400. She is hospitalized for antibiotics. You are the nurse admitting her. A. Mask B. Glove C. Wash your hands D. All of the above Which intervention is MOST likely to help prevent infection? A. Neutropenic diets B. Protective isolation (i.e. private room and patient is not permitted to leave room) C. No fresh flowers or plants D. Hand washing Lisa s ANC recovers and she is discharged. She returns to clinic for a follow up appointment. She is concerned about developing another infection and asks you for advice. Which vaccines do you recommend for Lisa? A. Flu vaccine B. Pneumococcal vaccine C. Both A and B D. None What else do you recommend to Lisa? A. Avoid persons who are ill B. Avoid kissing C. Shower with antibacterial soap D. Both A and C

10 Which other medication(s) do you recommend after Lisa s next cycle of chemotherapy (in addition to a CSF)? A. Acyclovir B. Fluconazole C. Levofloxacin D. Bactrim Lisa asks you if she can use FluMist rather than have a flu shot. You aren t sure. Where do you look for the answer? A. B. C. A or B Thank You! Oncology Nursing Society Staff ONS Outcomes Project Prevention of Infection Team Gail Mallory, PhD, RN, CNAA Linda Eaton, MN, RN, AOCN Barbara G. Lubejko, RN, MS Robi Thomas, PhD, RN Mark Vrabel, MLS, AHIP Kelly Egnotovich Christopher R. Friese, RN, PhD,AOCN Laura Zitella, RN, MS, NP, AOCN Jody Hauser, RN, MS, NP Barbara Holmes Gobel, RN, MS, AOCN Colleen O'Leary, RN, BSN, OCN Myra Woolery-Antill, MN, RN Felicia Andrews, BSN, RN