QuERY Quality Improvement, Evidence Based Practice, Research

1
QuERY Quality Improvement,
Evidence Based Practice, Research YouPart 2
Research Processes Presented by Karen Gabel
Speroni, BSN, MHSA, PhD, RN -Director, Nursing
Research Chair, Research CouncilInova Loudoun
Hospital Inova Fair Oaks Hospital
Virginia-Co-Chair, Inova Health System Nursing
Research Council Virginia-Chair, Shore Health
System Nursing Research Council Maryland12
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

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QI, EBP Research

• What is Quality Improvement?
• Activity
• What is Evidence Based Practice?
• Project
• What is Research?
• Systematic nursing research

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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

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The QI ReportSQUIRE 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

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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

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Evidence Based Practice Nursing Models

• Iowa Model
• Stetlers Model
• Rosswurm and Larrabees 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)

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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)

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Nursing Research

• A systematic search for knowledge about issues of
  importance to the nursing profession
• Polit and Hungler, 1995

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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

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Nurses are Scientists!!
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QI, EBP AND RESEARCH

• How do you integrate the 3
• How do we better understand the differences
  between the 3
• Thru the QuERY process
• Quality Improvement, Evidence Based Practice,
  Research You

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QuERY CONCEPT

• Developed to help hospital nurses become
  knowledgeable about each units 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

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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

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Publications 2011 ILH

• Speroni, K.G., Lucas, J., Dugan, L.,
  OMeara-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, OMeara-Lett, M. See
  http//www.jbpub.com/catalog/9780763761660/
• Improvement Use of the Hi-Lo Evac tube for all
  intubations throughout the hospital except in the
  OR

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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?id24
  06.
• 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, S86S87.
• 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 Womens Health,
  20(3), 480-481.

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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.
• ONeil, 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, 193, 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.

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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/Stud
  ent-and-New-Grad-Center/Student-Top-Story/Stress-R
  eduction-Through-Yoga.aspx?rpid14

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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.

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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.
• Speroni, K.G. (2006). A hospital nursing
  community outreach program on childhood obesity.
  Nursing Spectrum. Retrieved June 19, 2006, from
  http//community.nursingspectrum.com/MagazineArtic
  les/article.cfm?AID22247
• Companion article to Hawke, M. (2006). Taking
  Research to the Bedside. Nursing Spectrum.
  Retrieved June 19, 2006, from http//community.nur
  singspectrum.com/MagazineArticles/article.cfm?AID
  22054.

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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

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• Speronis Steps
• From Study Idea Inception
• to Publishing Research

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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

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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

Karen Gabel Speroni, 2011 Contact
Kgabelsperoni_at_smartneighborhood.net to request
permission for use
25
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_at_smartneighborhood.net to request
permission for use
26
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_at_smartneighborhood.net to request
permission for use
27
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_at_smartneighborhood.net to request
permission for use
28
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_at_smartneighborhood.net to request
permission for use
29
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_at_smartneighborhood.net to request
permission for use
30
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_at_smartneighborhood.net to request
permission for use
31
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_at_smartneighborhood.net to request
permission for use
32
Step 9 Evaluate Grant Opportunities

• Review affiliated associations request for
  proposals
• Work with Grants Management Office

Karen Gabel Speroni, 2011 Contact
Kgabelsperoni_at_smartneighborhood.net to request
permission for use
33
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_at_smartneighborhood.net to request
permission for use
34
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_at_smartneighborhood.net to request
permission for use
35
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_at_smartneighborhood.net to request
permission for use
36
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 requires
• 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_at_smartneighborhood.net to request
permission for use
37
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_at_smartneighborhood.net to request
permission for use
38
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_at_smartneighborhood.net to request
permission for use
39
Step 15 Data Analysis

• Using locked database, analyze data per protocol
  data analysis methods
• Populate table shells

Karen Gabel Speroni, 2011 Contact
Kgabelsperoni_at_smartneighborhood.net to request
permission for use
40
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_at_smartneighborhood.net to request
permission for use
41
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_at_smartneighborhood.net to request
permission for use
42
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_at_smartneighborhood.net to request
permission for use
43
Contact Kgabelsperoni_at_smartneighborhood.net to
request permission for use
44
Last Step REJOICE IN YOUR ACCOMPLISHMENTS

• Authors Happy Hour

Karen Gabel Speroni, 2011 Contact
Kgabelsperoni_at_smartneighborhood.net to request
permission for use
45
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

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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

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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

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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_at_smartneighborhood.net

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Questions Answers