Quality Improvement

Quality Improvement or Research—Deciding Which Road to Take JULIE M. STAUSMIRE, RN, MSN, ACNS-BC

Critical care nurses are constantly challenged to provide safe, high-quality patient care at a low cost with increasingly scarce resources while implementing the latest evidence-based practices into their own clinical practice. This article is the first in a 4-part series to provide a practical quality improvement guide for critical care nurses interested in implementing system process or performance improvement projects within their own units. Part 1 is designed to answer the question “What method is better for measuring real-world patient outcomes—quality improvement or clinical research?” A broad overview of the differences between quality improvement and clinical research is provided. A newly published checklist to differentiate between attributes of each process is introduced, and readers can test their own knowledge between quality improvement and research with a quick quiz of studies recently published in Critical Care Nurse. (Critical Care Nurse. 2014;34[6]:58-63)

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ritical care nurses are constantly challenged to provide safe, high-quality patient care at a low cost with increasingly scarce resources. Additionally, they are expected to identify and implement the latest evidence-based practices (EBPs) into their own clinical practice. Ideally, advanced practice nurses would be present at every institution to assist department managers and bedside nurses with quality improvement and research projects specific to their department and organizational needs. Unfortunately, out of 4999 registered community hospitals in the United States (January 2014), only 395 (8%) have American Nurses Credentialing Center Magnet status.1 Although not a direct measure of the availability of nursing research resources at every type of institution, the low percentage underscores the important fact that many critical care units are on their own when it comes to implementing a quality improvement or clinical research project. This article is the first in a 4-part series to provide a practical quality improvement guide for critical care nurses interested in implementing projects within their own units. The purpose of this first article is to provide a broad overview of the differences between quality improvement and research, as well as a discussion of the factors that should be considered when deciding which road to take. Future articles will discuss (1) how to identify worthwhile projects; (2) project design, implementation, and documentation; and (3) how to publish quality improvement activities by using the Standards for Quality Improvement Reporting Excellence (SQUIRE) guidelines.2-4 ©2014 American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ccn2014177

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Defining Quality Improvement and Research A quality improvement project can be defined by 3 key factors. First, it is based on existing knowledge that is considered the standard of care with the intent to improve care and system processes, rather than generate new generalizable knowledge. Second, the intent of a quality improvement activity is to identify a clinical performance or system process issue specific to the institution and implement an ongoing flexible system of evidence-based standard of care activities designed to improve outcomes in that setting. Finally, any measurable improvements must be sustained over time, as demonstrated by documentation of ongoing reevaluation and reinforcement of the resources/system practices needed to maintain those outcomes such as the Plan-Do-Study-Act method.5-8 A research study, in contrast to quality improvement, is meant to generate new generalizable knowledge or contribute new knowledge to what is currently known by using experimental methods that may be unproven instead of current standards of care. Research uses a design process with strictly regulated protocols for testing and evaluation of outcomes. Most importantly, human subject protection and obtaining the appropriate type of informed consent are key considerations for research. The degree to which individuals rather than group systems or processes are evaluated or put at risk for potential harm may be the key factor in identifying a project as research requiring approval from the institutional review board (IRB).5 Human subject protection encompasses many areas where any individual subject from the bedside nurse to patients, patients’ families, students, and educators could be exposed to risk as a direct result of the research. It is the responsibility of the IRB to assess the level of risk that the proposed research could incur to human subjects and decide if the research study poses minimal risk, greater than minimal risk with prospect of direct benefit to the subject, or greater than minimal risk with no direct benefit to the subject but could provide generalizable knowledge to benefit society. Possible risks to human subjects that need to be considered include, but are not limited to: • Foreseeable physical risks or discomforts, including death; Author Julie M. Stausmire is an academic research coordinator at Mercy St Vincent Medical Center, Toledo, Ohio. Corresponding author: Julie M. Stausmire, RN, MSN, ACNS-BC, Mercy St Vincent Medical Center, 2213 Cherry St, Toledo, OH 43608 (e-mail: [email protected]). To purchase electronic or print reprints, contact the American Association of Critical-Care Nurses, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 899-1712 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, [email protected].

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• Inappropriate disclosure of protected health information; • Psychological or social risks such as emotional distress, psychological trauma, invasion of privacy, embarrassment, loss of social status or loss of employment; and • Loss of confidentiality.9 Ogrinc et al10 discussed the overlapping of direct patient care, quality improvement, clinical research, and what they called “quality improvement research”—the increasingly gray area where the boundary between quality improvement activities and clinical research is extremely blurred. Other study design names for this gray area include comparative effectiveness research,11 practice-based evidence,12 and EBP.13 The intent of these various research designs is to examine the real-life risks, benefits, and outcomes when evidence from experimental research is translated to the bedside and generalized to Human subject protection is a more diverse popula- key consideration for research. tions with a variety of co-morbid conditions. The goal is to determine what interventions work and what challenges occur when new findings are applied in the clinical setting, especially when interdisciplinary teams are cooperatively engaged in documenting critical evidence for care delivery in specific populations. Comparative effectiveness research studies are excellent ways to apply “best practice” research at the bedside and determine which therapies, in which situations, and with what patient populations truly improve patients’ outcomes compared with the standard of care.14,15 Practice-based evidence research, previously known as clinical practice improvement methodology, is a play on words developed by Horn et al12 from the term evidencebased practice. Whereas EBP emphasizes the transfer of new evidence from randomized controlled trials to the bedside, Horn’s intent for practice-based evidence research is to emphasize new evidence derived from routine clinical practice.12 In academic nursing curricula, EBP projects are frequently required for graduation. Shirey et al13 synthesized the available literature to explore the distinctions between quality improvement, EBP, and research and developed a comprehensive table to compare dimensions such as purpose, types of data collection, limitations, and methods. However, all of these study designs must be individually considered per objective criteria to decide if they fall under the quality improvement or research domain. CriticalCareNurse

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Checklist to Differentiate Between Quality Improvement and Research Ogrinc et al10 published an excellent pilot checklist for differentiating between quality improvement and

research that has been reprinted as a Figure with the permission of the Hastings Center. The tool, developed by an expert panel including several members who also developed the SQUIRE guidelines, is intended for use by

This chart is intended to compare and contrast the general characteristics of quality improvement (QI) and research activities and is for use by institutional review boards (IRBs), administrative reviewers, investigators, and improvers. This chart is intended to guide discussion among these individuals and is not intended to supplant the judgment of IRBs or QI ethics review committees. Please start by considering these overarching questions: 1. Will the activities of this project occur within the standard of care? If NO, then proceed to IRB review. 2. Is there risk? If YES, use chart below to determine whether this project requires QI review or IRB review. 3. Is this project primarily intended to generate generalizable knowledge? If YES to either, proceed to IRB review. 4. Does this project involve vulnerable populations? If YES, use chart below to determine whether this project requires QI review or IRB review.

For each item, choose the column to which the project most closely relates—QI or research. You may choose only 1 answer. Leave the item blank if neither choice applies. Attribute Intent and background

Methods

Intended benefit

Risk

Applicability of results

Quality Improvement

Clinical Research with Human Subjects

__ Describes the nature and severity of a specific local performance gap

__ Identifies a specific deficit in scientific knowledge from the literature

__ Focus is to improve a specific aspect of health or health care delivery that is currently NOT consistently and appropriately being implemented at this site

__ Proposes to address or identify specific hypotheses in order to develop new knowledge or advance existing knowledge

__ Mechanisms of the intervention are expected to change over time (ie, an iterative activity) in response to ongoing feedback

__ Specific protocol defines the intervention, interaction, and use of collected data and tissues, plus project may rely on the randomization of individuals to enhance confidence in differences

__ Plan for intervention and analysis includes an assessment of the system (ie, process flow diagram, fishbone)

__ May use qualitative or quantitative methods to make observations, make comparisons between groups, or generate hypotheses

__ Statistical methods evaluate system-level processes and outcomes over time with statistical process control or other methods

__ Statistical methods primarily compare differences between groups or correlate observed differences with a known health condition

__ Intervention would be considered within the usual clinician-patient therapeutic relationship

__ Intervention, interaction, or use of identifiable private information occurs outside of the usual clinician-patient therapeutic relationship

__ Direct benefit to participants is indicated (eg, decrease __ Direct benefit to each individual participant or for the in risk by receiving a vaccination or by creating a safer institution is not typically the intent or is not certain institutional system) __ Potential local institutional benefit is specified (eg, increased efficiency or decreased cost)

__ Potential societal benefit in developing new or advancing existing generalizable knowledge

__ Primary risk is to privacy or the confidentiality of health information

__ Risks may be minimal, but may include physical, psychological, emotional, social, or financial risks, as well as risk to privacy or the confidentiality of health information from participation in the project

__ Risk may be described as higher for patients by not participating in this activity

__ The informed consent process describes the risks to participants, who individually and voluntarily decide whether to participate or an IRB grants an alteration or waiver of the consent process

__ Implementation is immediate so that review of results occurs throughout the process and may be used for next QI activity

__ Results and analysis may be delayed or periodic throughout the duration of the project, except to protect patient safety. The results will primarily be used to inform further investigations, but may be implemented directly into clinical practice.

__ Extrapolation of results to other settings is possible, but not the main intent of the activity

__ Results are intended to generalize beyond the study population Continued

Figure Instrument to assess the differences between quality improvement (QI) and clinical research with human subjects.

Attribute

Quality Improvement

Clinical Research with Human Subjects

__ System-level outcomes, processes, refinement of the __ It is expected that results will be published or intervention, and the applicability of the intervention in presented to others through a peer-reviewed process Sharing and disseminating specific settings/contexts may be shared through peerreviewed publication and presentation outside the results institution

Interpretation Any checkmarks (even one) in the “Clinical Research” column indicates that there are components of clinical research in the proposed activity. The IRB or QI ethics review agent should initiate a discussion with the improver/investigator to clarify the proposal. If an activity such as public health practice, program evaluation, or quality improvement includes a research component, then IRB review should occur under current federal guidance and the policies of many institutions.

Explanation and Elaboration of Terms 1. Vulnerable population. Any study population that includes students, employees, children, pregnant women, prisoners, active military personnel, individuals who have impaired decision making capacity, or those who are educationally or economically disadvantaged. 2. Intent. The state of the investigator's mind that directs the activity. 3. Quality improvement. The combined and unceasing efforts of everyone—health care professionals, patients and their families, researchers, administrators, payers, planners, educators—to make changes that will lead to better patient outcome, better system performance, and better professional development. 4. Clinical research. A systematic investigation in a clinical setting designed to develop or contribute to generalizable knowledge (The Common Rule definition of research).

References US Dept of Health and Human Services. Protection of Human Subjects: 45CFR 46. 2005; http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. Accessed May 12, 2011. Davidoff F, Batalden P, Stevens D, Ogrinc G, Mooney S. Publication guidelines for quality improvement in health care: evolution of the SQUIRE project. Qual Saf Health Care. 2008;17(suppl 1):i3-i9. www.squire-statement.org.

Figure Continued Reprinted from Ogrinc et al,10 with permission from the Hastings Center.

quality improvement specialists, researchers, and IRB staff to assist in determining if a proposed project is clinical research or quality improvement. The tool examines 6 different project attributes and describes human subject protection criteria for each attribute. The attributes are (1) intent and background of the project, (2) methods to be used, (3) intended benefit, (4) risk, (5) applicability of results, and (6) sharing and disseminating results. The tool’s authors invite others to use the instrument and suggest refinements on the basis of their experiences.

Quick Quiz—Is It Research or Quality Improvement? The studies in the Table have been published in Critical Care Nurse in the past year. Review the key criteria and decide if each study was quality improvement or research.

Should Quality Improvement Projects Have Formal Institutional Oversight? How much oversight should quality improvement projects have in comparison to research studies that

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require IRB oversight? Unlike research, there is no current federal mandate that quality improvement activities be monitored or documented by the institution. Although each institution may have a quality Many of the experts responsible for improvement the SQUIRE guidelines assisted in the department, there development of a checklist to determine is no legal require- if a proposed project is quality ment that each improvement or research unit or group formally present their quality improvement project for review before initiation, document their findings, or report any process deviations or adverse events that may occur. This lack of supervision is problematic on several fronts. First, no impartial external review of a project is available to determine if the project is quality improvement or research. This leads to the second concern: if it is research, there are no protections in place for possible risk to human subjects, including the lack of informed consent. Third, if a quality improvement project were actually a research study conducted without IRB approval, the institution could be subject to federal regulatory CriticalCareNurse

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Table Question No.

Study

Quick quiz: Is it research or quality improvement?

Uses existing knowledge or generating new knowledge

Project interventions

Measurable outcomes

1

From door to recovery: a collaborative approach to the development of a post-cardiac arrest center16

Supported by the 2010 American Heart Association guidelines for postcardiac arrest care

Developed processes, built consensus for protocols, provided support to staff and teams to develop a continuum of patient-focused management after cardiac arrest

Initially only 25% of eligible patients received induced hypothermia, now 98%-100% of all eligible patients for the past 4 years have received induced hypothermia

2

Improving family satisfaction and participation in decision making in an intensive care unit17

Family members are routinely provided a 20-item family satisfaction survey upon patient discharge from surgical intensive care unit (ICU); monthly report generated

Team developed a bundled algorithm for communication interventions at 24, 72, and 96 hours after admission to the ICU A pre-post design compared monthly satisfaction scores before and after implementation of the algorithm

Satisfaction scores for family participation in decision making and how well the health care team worked together improved after implementation of the communication algorithm

3

Voices of family members and significant others in the tele-ICU18

Investigator-developed survey used at 3 health-system networks to assess family members’ perceptions of how well-informed they were about care provided in the tele-ICU

Survey given to 1 significant other associated with a patient who had received care in the tele-ICU for at least 24 hours after obtaining informed consent

Descriptive study outcomes indicated that 66% did not receive information specific to the tele-ICU, and 3 key areas of information were identified that should be provided to family members

4

Inequity of patient assignments: fact or fiction?19

Audited existing daily assignment sheets for total number of shifts, and number of single or double assignments in a pediatric ICU

Developed audit tool in Excel, tracked daily assignments every other month for 6 months Based on results they educated charge nurses and reconfigured rotating charge nurse positions Reaudited 6 months after changes made

First audit showed pattern of inequity in assignments Second audit showed no improvement but distribution pattern had changed Auditing continues every 2 months, summarized and presented to staff

5

Parents’ responses to stress in the neonatal ICU (NICU)20

Used existing validated tools to test for new knowledge regarding the relationship between stress associated with hospitalization of an infant in the NICU and parents’ responses

Parents asked to complete the parental Stressor Scale: NICU and PROMIS short form surveys as well as demographics about themselves and their infant’s birth and health status

Significant correlations found among scores on all of the PROMIS scales for sleep disturbance, depression, anxiety, and fatigue

Answers: 1, quality improvement; 2, quality improvement; 3, research; 4, quality improvement; 5, research.

sanctions. These sanctions could include monetary fines, suspension or withdrawal of the institution’s Federal Assurance status, preventing any further research from being conducted at that institution or making the institution ineligible to receive federal funding.21 If there is any question about a proposed project being quality improvement versus research, the institutional IRB should be consulted.11,13,22 Finally, there is a very real concern that many quality improvement projects are poorly designed and the results

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may not be accurate, interpretation may be limited, and results may not be applicable to the clinical question being studied. The editor of Critical Care Nurse receives many submissions for publication about quality improvement studies that are rejected because of faulty design. Common problems include research conducted as a quality improvement project without IRB approval, studies where the methods invalidated the outcomes, studies where the quality improvement process lacked adequate documentation, or the manuscript did not follow the www.ccnonline.org

SQUIRE reporting guidelines. An institutional oversight committee for quality improvement activities would be one way to overcome these issues.

Which Road to Take? As in many other aspects of health care, there is no clear line dividing quality improvement from research. Each idea must be individually assessed for the scope of the project, identified goals, desired outcomes, and the circumstances surrounding the need to improve specific aspects of care. Any proposed activity arising from a sentinel event should first be discussed with risk management staff. In general, if the purpose of the project is to do rapid cycling of data in a short period of time to determine optimal performance or processes for specific actions or therapies in a specific institution, a quality improvement project is indicated. If the purpose is to generate new knowledge and improve outcomes for a common problem that can be generalized to multiple settings, then an IRB-approved research study is indicated. The use of a standardized checklist for differentiating between quality improvement projects and research allows team members to compare and discuss various aspects of the proposed study, select the most appropriate methods, and design and conduct a study that will ultimately meet professional standards for publication. Nurses should take advantage of all institutional resources when considering a quality improvement project, including consultations with members of the IRB committee, the quality improvement department, and available nursing research mentors. CCN Financial Disclosures None reported.

Now that you’ve read the article, create or contribute to an online discussion about this topic using eLetters. Just visit www.ccnonline.org and select the article you want to comment on. In the full-text or PDF view of the article, click “Responses” in the middle column and then “Submit a response.”

2. Davidoff FI, Batalden P, Stevens D, Ogrinc G, Mooney S; Standards for QUality Improvement Reporting Excellence Development Group. Publication guidelines for quality improvement studies in health care: evolution of the SQUIRE project. Qual Saf Health Care. 2008;17(Suppl 1):i3-i9. 3. Ogrinc GI, Mooney SE, Estrada C, et al. The SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines for quality improvement reporting: explanation and elaboration. Qual Saf Health Care. 2008; 17(Suppl 1): i13-i32. 4. Oermann MH. SQUIRE guidelines for reporting improvement studies in healthcare: implications for nursing publications. J Nurs Care Qual. 2009;24(2):91-95. 5. Lynn J, Baily MA, Bottrell MB, et al. The ethics of using quality improvement methods in health care. Ann Intern Med. 2007;146:666-673. 6. Centers for Disease Control and Prevention Website. Performance Management and Quality Improvement—Definitions. Last updated June 1, 2011. http://www.cdc.gov/stltpublichealth/performance/Definitions .html. Accessed September 25, 2014. 7. Institute for Healthcare Improvement. Plan-Do-Study-Act (PDSA) Worksheet. http://www.ihi.org/resources/Pages/Tools/PlanDoStudyActWorksheet.aspx. Accessed September 25, 2014. 8. Institute for Healthcare Improvement How to Improve. http://www.ihi .org/resources/Pages/HowtoImprove/default.aspx. Accessed September 25, 2014. 9. Office for Human Research Protections. United States Department of Health and Human Services. Protection of Human Subjects. Title 45 Code of Federal Regulations, Part 46. Last updated January 15, 2009. http://www.hhs.gov/ohrp/humansubjects/regbook2013.pdf.pdf. Accessed September 25, 2014. 10. Ogrinc G, Nelson WA, Adams SM, O’Hara AE. An instrument to differentiate between clinical research and quality improvement. IRB. 2013; 35(5):1-8. 11. Kass NE, Pronovost PJ. Quality, safety, and institutional review boards: navigating ethics and oversight in applied health systems research. Am J Med Qual. 2011;26(2):157-159. 12. Horn SD, DeJong G, Deutscher D. Practice-based evidence research in rehabilitation: an alternative to randomized controlled trials and traditional observational studies. Arch Phys Med Rehabil. 2012;93(8 Suppl): S127-S137. 13. Shirey MR, Hauck SL, Embree JL, et al. Showcasing differences between quality improvement, evidence-based practice, and research. J Contin Educ Nurs. 2011;42(2):57-68; quiz 69-70. Epub 2010 Jul 6. 14. Kuehn BM. A push for comparative effectiveness: US initiatives aim to empower patients, physicians. JAMA. 2012;307(15):1570-1571. 15. Kuehn BM. Institute of Medicine outlines priorities for comparative effectiveness research. JAMA. 2009;302(9):936-937. 16. Williams D, Calder S, Coccchi MN, Donnino MW. From door to recovery: a collaborative approach to the development of a post-cardiac arrest center. Crit Care Nurse. 2013;33(5):42-54. 17. Huffines M, Johnson KL, Smitz Naranjo LL, et al. Improving family satisfaction and participation in decision making in an intensive care unit. Crit Care Nurse. 2013;33(5):56-69. 18. Jahrsdoerfer M, Goran S. Voices of family members and significant others in the Tele-Intensive Care Unit. Crit Care Nurse. 2013;33(1):57-67. 19. Marine K, Meehan P, Lyons AC, Curley MA. Inequity of patient assignments: fact or fiction? Crit Care Nurse. 2013;33(2):74-77. 20. Busse MI, Stromgren K, Thorngate L, Thomas KA. Parents’ responses to stress in the neonatal intensive care unit. Crit Care Nurse. 2013;33(4):5259; quiz 60. 21. US Department of Health & Human Services. Compliance Oversight Procedures for Evaluating Institutions. Last revised October 14, 2009. http://www.hhs.gov/ohrp/compliance/evaluation/. Accessed September 25, 2014. 22. Taylor HAI, Pronovost PJ, Faden RR, Kass NE, Sugarman J. The ethical review of health care quality improvement initiatives: findings from the field. Issue Brief (Commonwealth Fund). 2010;95:1-12.

To learn more about quality improvement studies, read “Quality Improvement Program to Reduce the Prevalence of Pressure Ulcers in an Intensive Care Unit” by Elliott et al in the American Journal of Critical Care, July 2008;17:328-334. Available at www.ajcconline.org. References 1. American Nurses Credentialing Center. Find a Magnet Hospital. Last updated February 2014. http://www.nursecredentialing.org/Magnet /FindaMagnetFacility. Accessed September 25, 2014.

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Quality improvement or research--deciding which road to take.

Critical care nurses are constantly challenged to provide safe, high-quality patient care at a low cost with increasingly scarce resources while imple...
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