1. QuERY Qu ality Improvement, E vidence Based Practice, R esearch & Y ou Part 2: Research Processes Presented by: Karen Gabel Speroni, BSN, MHSA, PhD, RN -Director, Nursing Research & Chair, Research Council Inova Loudoun Hospital & Inova Fair Oaks Hospital: Virginia -Co-Chair, Inova Health System Nursing Research Council: Virginia -Chair, Shore Health System Nursing Research Council: Maryland 12 November 2011

2. OBJECTIVES Review of day 1: Provide examples of quality improvement (QI) activities, evidence based practice (EBP) projects, research studies and innovations –Day 2 focus: Research and innovation examples focus Review of steps from study idea inception to dissemination of findings Review definitions of QI, EBP and research Karen Gabel Speroni, 11/12/11

3. 33 QI, EBP & Research What is Quality Improvement? –Activity What is Evidence Based Practice? –Project What is Research? –Systematic nursing research

4. Karen Gabel Speroni, 11/12/1144 Quality Improvement Systematic, data guided activities designed to bring about immediate improvement in health care delivery in particular settings –ANCC, 2008. Magnet Recognition Program Application Manual

5. Karen Gabel Speroni, 11/12/115 The QI Report SQUIRE: Standards for QUality Improvement Reporting Excellence Problem or purpose, and aims of the proposed change Methods –Context of the organization or setting –Intervention –Process for change –Measures –Analytic methods Results –How the change evolved and adjustments that were made –Outcomes –Impact of the change on the organization –Challenges Discussion www.squire-statement.org

6. Karen Gabel Speroni, 11/12/1166 Evidence Based Practice The conscientious use/integration of the best research evidence with clinical expertise and patient preferences in nursing practice –Adapted from Sackett et al.,2000 The utilization of clinical expertise, clinical judgment, and best research/practices to improve patient outcomes –Inova Loudoun Hospital, 2010

7. Karen Gabel Speroni, 11/12/1177 Evidence Based Practice Nursing Models Iowa Model Stetler’s Model Rosswurm and Larrabee’s Model John Hopkins Nursing Model ACE Star Model of Knowledge and Transformation (Academic Center for Evidence Based Practice) ARCC Model (Advancing Research & Clinical Practice through Close Collaboration) PARiHS Framework (Promoting Action on Research Implementation in Health Services)

8. Karen Gabel Speroni, 11/12/1188 Research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge –U.S. Department of Health and Human Services, nd., [45 CFR 46,102(d)]

9. Karen Gabel Speroni, 11/12/1199 Nursing Research A systematic search for knowledge about issues of importance to the nursing profession –Polit and Hungler, 1995

10. Karen Gabel Speroni, 11/12/1110 Innovation Innovation in service delivery and organization [is] a novel set of behaviors, routines, and ways of working that are directed at improving health outcomes, administrative efficiency, cost effectiveness, or users’ experiences and that are implemented by planned and coordinated actions –Greenhalgh, 2004

11. Karen Gabel Speroni, 11/12/1111 Nurses are Scientists!!

12. QI, EBP AND RESEARCH How do you integrate the 3 How do we better understand the differences between the 3 Thru the QuERY process: Qu ality Improvement, E vidence Based Practice, R esearch & Y ou Karen Gabel Speroni, 11/11

13. QuERY CONCEPT Developed to help hospital nurses become knowledgeable about each unit’s best –QI activity –EBP project –Research study Provides opportunity for nurses from each hospital unit to showcase their best QI, EBP and research work during the last year –OR, to identify strategic planning needs Through the QUERY work and seminar presentations, hospital nurses are exposed to QI, EBP and research concepts, unit best examples, and unit needs to improve patient outcomes Karen Gabel Speroni, 11/11

14. QuERY CONTEST Annually contest judged by nurses selecting the best QI, EBP and research work that improves –Standard operating procedure –Patient outcomes –Care delivery Electronic contest –List definitions –List each units QI, EBP and research work Award prizes Karen Gabel Speroni, 11/11

15. Speroni, 2011 Publications 2011: ILH Speroni, K.G., Lucas, J., Dugan, L., O’Meara-Lett, M., Putman, M., Daniel, M. & Atherton, M. Comparative Effectiveness of Standard Endotracheal Tubes versus Endotracheal Tubes with Continuous Subglottic Suctioning on Ventilator-Associated Pneumonia Rates (2011) Journal of Nursing Economic$. 29(1): 15-21. Book contribution: McLaughlin, M & Bulla, S. Real Stories of Nursing Research: A Quest for Magnet. 2009. Jones and Bartlett Publishers, Los, Angeles. [Chapter 30, O’Meara-Lett, M. See http://www.jbpub.com/catalog/9780763761660/ http://www.jbpub.com/catalog/9780763761660/ Improvement: Use of the Hi-Lo Evac tube for all intubations throughout the hospital except in the OR

16. Speroni, 2011 Publications 2011: (continued): AHRQ Health Care Innovations Exchange. Innovation Profile/Attempt: [Nurse- Led Weekly Educational Program for Children Focuses on Physical Activity and Food Choices, Leading to Healthier Behaviors, Lower Body Mass Index] ([Karen Gabel Speroni, Inova Loudoun Hospital]). In: AHRQ Health Care Innovations Exchange [Web site]. Rockville (MD): [cited 2009 Apr 13 & updated 2011 July 20]. Available: http://www.innovations.ahrq.gov/content.aspx?id=2406. –Improvement: Implementation of hospital-based Living Fit program for hospital employees and community members Speroni, K.G. (2011) Prospective Evaluation of the Effect of the Nurses Living Fit™ Intervention versus No Intervention on Body Mass Index of Nurses. JOGNN, 40, S86–S87. Speroni, K.G., Earley, C., Seibert, D., Kassem, M., & Williams, D. (2011). Prospective Evaluation of the Effect of the Nurses Living Fit™ Intervention Versus No Intervention on Body Mass Index of Nurses. Journal of Women’s Health, 20(3), 480-481.

17. Speroni, 2011 Publications 2010: ILH Dawson, E., Speroni, K.G., Salisbury, M., & Atherton, M. (2010). Effect of the Workforce Initiatives Safe Handling Minimal Lift Program on Patient Care Provider Injuries, Attributable Costs, and Satisfaction. Journal of the Association of Occupational Health Professionals. XXX(3); 22-26. O’Neil, S., Speroni, K.G., Dugan, L, & Daniel, M. (2010). A Two-tier Study of Direct Care Providers Assessing the Effectiveness of the Red Rule Education Project and Precipitating Factors Surrounding Red Rule Violations. Journal of Quality Management in Health Care, 19:3, 1-6. Harrison, G., Speroni, K.G., Dugan, L., & Daniel, M.G. (2010). A comparison of the quality of blood specimens drawn in the field by Emergency Medical Services verses specimens obtained in the Emergency Department. Journal of Emergency Nursing. 36(1); 16-20. Improvement: Policy change to allow blood drawn by EMS.

18. Speroni, 2011 Publications 2010-2011: IFOH 2011 –Suchicital, L.G., Gujral, H., Speroni, K.G., Eldridge, D. & Atherton, M. (2011). Prospective, Randomized, Pilot Study Evaluating the Effect of Ice Chip Administration versus None on the Bitterness of Crushed Medications in Post Operative Bariatric Patients. Journal of Bariatric Nursing and Surgical Patient Care. 6(1): 15-20. Improvement: Evaluate procedures for provision of ice chips procedure prior to medication administration 2010 –Bergin, C., Kelly, K., Travis, T. & Speroni, K.G. (2010). Interim Analysis of the Pre-Operative Incentive Spirometry Education (POISE) Intervention. Journal of Perianesthesia Nursing, vol 25, No. 3 (June); pp 196-198. Improvement: Documentation in the medical record of pre-operative incentive spirometry levels –Dunn, K.D., Speroni, K.G., & Kassem, M. Stress Reduction Through Yoga. Advance for Nurses. Posted on: January 26, 2010. www.advanceweb.com Retrieved from: http://nursing.advanceweb.com/Student-and-New-Grad- Center/Student-Top-Story/Stress-Reduction-Through-Yoga.aspx?rpid=14www.advanceweb.com

19. Speroni, 2011 Publications 2011: SHS 2011 –Hanlon, L., Punzo, A., Jones, R.A., & Gabel Speroni, K. G. (2011). Cardiopulmonary Complication Rates in Patients Undergoing Total Knee Arthroplasty and Reinfusion of Shed Blood. Journal of Orthopaedic Nursing. 30 (5): 307-311. Improvement: Stopped usage of reinfusion device –Stagg, S., Sheridan, D., Jones, R. A., & Speroni, K. G. Evaluation of a Workplace Bullying Cognitive Rehearsal Program in a Hospital Setting. (2011) The Journal of Continuing Education in Nursing, 42(9), 395-403. In press –Trinkley, D., Bryan, S., Speroni, K.G., Jones, R.A., & Allen, H. Evaluation of Domestic Violence Screening and Positive Screen Rates in Rural Hospital Emergency Departments. In November, 2011, Online Journal of Rural Nursing and Health Care. –Ganter-Ritz, V., Speroni, K.G, & Atherton, M. A Randomized Double Blind Study Comparing Intradermal Anesthetic Tolerability, Efficacy, and Cost-Effectiveness of Lidocaine, Buffered Lidocaine and Bacteriostatic Normal Saline for Peripheral Intravenous Insertion. In Press, March/April 2012, Journal of Infusion Nursing.

20. Speroni, 2011 Selected Publications: 2005-2009 Speroni, K.G., Tea, C., Earley, C., Niehoff, V., & Atherton, M. (2008). Evaluation of a Pilot Hospital-Based Community Program Implementing Fitness and Nutritional Education for Overweight Children. Journal for Specialists in Pediatric Nursing, 13(3), 144-153. –Improvement : Hospital provision of exercise/nutrition classes for children at Inova Fair Oaks Hospital Bowers L., Speroni K.G., Jones L., & Atherton M. (2008). Comparison of Occlusion Rates by Flushing Solutions for Peripherally Inserted Central Catheters with Positive Pressure Luer- Activated Devices. Journal of Infusion Nursing, 31(1), 22-27. Speroni K.G., Earley, C., & Atherton, M. (2007). Evaluating the Effectiveness of the Kids Living Fit™ Program: A Comparative Study. Journal of School Nursing, 23(6), 329-336. –Also see http://www.loudountimes.com/news/2007/dec/22/Speroni-Inova-obesity-nutrition/ for newspaper article covering research: Solinger, S. Learning to eat: Inova researcher says education is key to solving childhood obesity. Loudoun-Times Mirror. December 22, 2007; updated December 28, 2007.http://www.loudountimes.com/news/2007/dec/22/Speroni-Inova-obesity-nutrition/ Speroni, K.G. (2006). A hospital nursing community outreach program on childhood obesity. Nursing Spectrum. Retrieved June 19, 2006, from http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=22247 –Companion article to: Hawke, M. (2006). Taking Research to the Bedside. Nursing Spectrum. Retrieved June 19, 2006, from http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=22054. http://community.nursingspectrum.com/MagazineArticles/article.cfm?AID=22054

21. Speroni, 2011 Selected Publications: 2005-2009 (continued) Leonard Y., Speroni K.G, Atherton M. & Corriher J. (2006) Evaluating use of flash sterilization in the OR with regard to postoperative infections. Journal of the Association of peri-Operating Room Nurses, 83(3), 672-680. Speroni K.G, Dawson E., Atherton, M., & Corriher J. (2005). Influenza vaccination, incidence of symptoms and resulting absenteeism in hospital employees. American Association of Occupational Health Nurses Journal, 53 (11), 477-483. Speroni K.G, Hannah, J., Corriher, J., & Atherton, M. (2005). Evaluation of demographic, behavioral, and procedural factors on pain perception by patients undergoing colonoscopy and moderate sedation. Gastroenterology Nursing Journal, 28(6), 502-508. [Nominated for Best Author award] Dugan L., Leech L., Speroni K.G., & Corriher J. (2005). Factors affecting hemolysis rates in blood samples from newly placed IV sites in the Emergency Department. Journal of Emergency Nursing, 31(4), 338-345. Improvement: Eliminated use of 22G or smaller catheter when drawing blood

22. Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net Speroni’s Steps: From Study Idea Inception to Publishing Research

23. Step 1: Study Idea Discuss your study idea with –Nurse peers –Nurse manager / unit director –Research mentor Present your study idea to Research Council (RC) –Follow Standard Operating Procedure (SOP) for documenting study idea –Complete a contest card Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

24. Step 2: Literature Review Conduct literature review –Email hospital librarian with your study title, study purpose/objective, proposed search terms and request search over last 10 years –Document search terms, databases searched and years searched –Utilize standardized literature review tool to review article Draft a 1-2 page summary for the protocol introduction section –Specify from an evidence based practice perspective how research results could improve standard of care, care delivery and patient outcomes Speroni, 2011 Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

25. Speroni, 2011 Step 2 (continued) Keep electronic copy of all articles referenced in introduction / background section of protocol Determine target journal for dissemination of findings to facilitate writing style of introduction, search terms, and reference formatting in text and the reference listing Present findings to RC to verify if evidence sufficient to answer best practice question or if research should be conducted Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

26. Speroni, 2011 Step 3: Confirm Study Team Study team member types –Principal Investigator –Sub-investigators –Hospital contact –Statisticians –Administrative support –Other multidisciplinary team members needed to complete research Ensure team completes human subjects protection coursework Specify requirements for authorship with study team following Authorship SOP Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

27. Speroni, 2011 Step 4: Draft Research Protocol Draft the research protocol –Follow RC template –Append survey instrument(s) subject completes Surveys patients/subjects touch are appended to the protocol Pilot electronic surveys before submitting to Institutional Review Board (IRB) Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

28. Speroni, 2011 Step 5: Draft Case Report Forms Draft data collection tool –Follow RC template –Case Report Form (CRFs) Patients / subjects do not touch Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

29. Speroni, 2011 Step 6: Draft Study logs Draft study logs –Follow RC template Randomization or observation log Screen Failure Log Protocol Deviation Log Early Termination Log Other logs specific to study Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

30. Speroni, 2011 Step 7: Draft Table Shells Table shells –Follow RC template –Track to each Protocol data collection point CRF item Survey item Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

31. Speroni, 2011 Step 8: Statistician Identify statistician –Work thru RC Provide to statistician draft study documents –Protocol / survey instrument –CRFs –Table shells Ask them to review / write –Sample size calculation –Data analysis methods Confirm database software statistician will use for analysis Design database –Receive statistician approval of database Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

32. Speroni, 2011 Step 9: Evaluate Grant Opportunities Review affiliated associations request for proposals Work with Grants Management Office Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

33. Speroni, 2011 Step 10: Draft IRB Documents Draft IRB documents IRB application Other required IRB documents Informed Consent Form Investigator information Send to research mentor for review –IRB documents –Final Study documents Protocol Case Report Forms Study logs Table shells Follow IRB SOPs in preparation for research Obtain required signatures Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

34. Speroni, 2011 Step 11: Plan Study Initiation Meeting During IRB review create Study Initiation Meeting (SIM) document –Agenda –Protocol Study procedures Chart documentation –Informed Consent IRB approved Informed Consent Form IRB ICF SOPs –Case Report Forms –Study Logs –Table shells –Study requirements RC SOPs Reporting to RC Study files maintenance Database entry –Authorship requirements / team assignment –Study timeline Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

35. Speroni, 2011 Step 11: Plan Study Initiation Meeting (continued) Finalize SIM document with research mentor Schedule SIM based upon date after expected IRB review Include all investigators & study team members participating in daily research Email invite for SIM meeting Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

36. Speroni, 2011 Step 12: Hold SIM Review content of SIM Discuss authorship, follow authorship SOP and targeted journal authorship requirements if specified by journal –Register with www.clinicaltrials.gov if randomized study / journal requireswww.clinicaltrials.gov Document attendance Review database entry procedures Document and address all study process issues identified during SIM Email team when recruitment / study work will begin Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

37. Speroni, 2011 Step 13: Initiate / Conduct Study Submit monthly update to RC Chair Attend each RC meeting Ensure ongoing completion of study documents Track IRB continuing review due dates Ensure research conducted following IRB SOPs Notify IRB of human subjects protection issues, serious adverse events and protocol deviations Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

38. Speroni, 2011 Step 14: Database Entry Ensure ongoing data input Once final data obtained, conduct 100% quality assurance (QA) review of database Document fixes to database, apply fixes and conduct QA of fixes Lock database Provide locked database to research mentor for verification prior to sending to statistician Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

39. Speroni, 2011 Step 15: Data Analysis Using locked database, analyze data per protocol data analysis methods Populate table shells Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

40. Speroni, 2011 Step 16: Report Writing Review authorship SOP and journal authorship requirements if specified Verify target journal Review authorship guidelines Copy FROM PROTOCOL, abstract, introduction, methods and references to manuscript –Update literature search using same search terms and databases for only new years Update introduction if new literature –Update references as needed –Change future tense to past tense in introduction and methods –Draft results Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

41. Speroni, 2011 Step 16: Report Writing (continued) Write discussion –Contrast your findings to literature cited findings –Specify your limitations Write conclusions –Include the ‘so-what’ factor Based upon the results of this research and the evidence in the literature, the hospital standard of care [or SOP or nursing practice] has been modified from xx to xxx Based upon the results of this research and the evidence in the literature, care delivery has been modified from xx to xxx As a result of this research patient outcomes xxx has xxxx Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

42. Speroni, 2011 Step 17: Dissemination of Findings One per study –Manuscript –Poster –Podium presentation Update RC research outcomes table –Dissemination of findings –How research findings impacted standard of care, care delivery and patient outcomes Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

43. Karen Gabel Speroni, November 2011 43 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

44. Speroni, 2011 Last Step: REJOICE IN YOUR ACCOMPLISHMENTS Authors Happy Hour Karen Gabel Speroni, 2011 Contact Kgabelsperoni@smartneighborhood.net to request permission for useKgabelsperoni@smartneighborhood.net

45. Speroni, 2011 SUMMARY Before submitting to the IRB –Write the protocol as if it were the manuscript Include an abstract with headings Write ~ 1 - 1.5 page introduction –From an evidence based practice perspective, results of this research can be used by administration to xxxxxxx Summarize literature search including specifying search terms, years searched and databases searched –Draft the table shells that guide THE END / how you will present your data

46. Speroni, 2011 SUMMARY (continued) After the research has been completed –Copy FROM PROTOCOL, abstract, introduction, methods and references to manuscript Update literature search using same search terms and databases for only new years –Update introduction if new literature Change future tense to past tense in introduction and methods Draft results

47. Speroni, 2011 SUMMARY (continued) Write discussion –Contrast your findings to literature cited findings –Specify your limitations Write conclusions –Include the ‘so-what’ factor Based upon the results of this research and the evidence in the literature, the hospital standard of care [or SOP or nursing practice] has been modified from xx to xxx Based upon the results of this research and the evidence in the literature, care delivery has been modified from xx to xxx As a result of this research patient outcomes xxx has xxxx

48. Speroni, 201148 Speaker Contact Information Karen Gabel Speroni, PhD, RN Director, Nursing Research & Chair, Research Council –Inova Loudoun Hospital –Inova Fair Oaks Hospital Chair, Nursing Research Council, Shore Health System Clinical Scientist, Institutional Review Board –Inova Research Center –George Mason University –Chesapeake Research Review E-mail: kgabelsperoni@ smartneighborhood.ne t kgabelsperoni@ smartneighborhood.ne t

49. Speroni, 2011 Questions & Answers