Hierarchy of Evidence
Quality Improvement vs. Research
The purpose of performing research is to find new knowledge about the effect of a medicine, treatment, or procedure. Health care providers and health care organizations collect data for several different reasons. Data collection is performed to meet the requirements of mandatory reporting by the Centers for Medicare and Medicaid Services. Data are also collected for quality improvement, and data are collected for research purposes. If data are collected for research purposes, different procedures are required. For health care, data collection for quality can be done without acquiring approval or consent, which is required for research studies.
Health care providers use research to provide evidence-based care that promotes quality health outcomes for individuals, families, communities, and health care systems. Health care providers “also use research to shape health policy in direct care, within an organization, and at the local, state, and federal levels” (American Nurses Association, n.d., para. 1). Nursing research can involve new treatments or procedures that may improve care provided to patients. Research is a systematic investigation that evaluates and obtains results to develop or modify medications, procedures, and treatments. Research is intended to answer a question or test a hypothesis. A hypothesis is an educated guess or an assumption that can be validated by testing or experimentation. Once a hypothesis is developed, research can be performed to prove or disprove the hypothesis.
Research contributes to generalizable knowledge, but before a research study is started, it must be approved by an Institutional Review Board (IRB) . An IRB is a committee that applies research ethics to all studies to assure no harm is done to participants. The IRB may approve or disapprove a study, or it can ask for modifications to the study. When research is performed, the participant may have to sign an informed consent form to voluntarily participate in the study.
Quality improvement (QI) is data driven and usually done to improve the quality of care provided to patients. QI may benefit a process, system, and possibly the patient. QI, as defined by the Department of Health and Human Services (2011), consists of “systematic and continuous actions that lead to measurable improvement in health services and the health status of targeted patient groups” (p. 1). When health care providers and nurses carry out a QI project, it may not be the implementation of something new, but an improvement upon something already in place. QI takes a team to produce results. A QI project does not subject the participant to any risk, and the participant may not even be aware of being involved in a QI project. The QI project usually occurs at the facility where the problem was found. Monthly data are collected regarding patient safety at most facilities. Facilities include health care institutions such as hospitals, skilled nursing facilities, long-term facilities, clinics, and doctors’ offices.
There are some circumstances that may occur when a QI project must be submitted to the IRB for evaluation because the possibility exists that the QI project could be considered research. The differences between research and QI can be based on intent. Research contributes to generalizable knowledge, where information from a QI project may only improve upon what is already in place. If the QI project includes a new treatment instead of improving upon what is already in place, then it might be considered research and must be submitted to the IRB for a decision. The IRB will determine whether or not the plan proposed is research or QI. The IRB may rule the study is exempt if done for QI purposes. If there is risk to the participant, then the IRB will require the study to be conducted as research.
Risk to the patient not only means that physical harm may occur, but Health Insurance Portability and Accountability Act (HIPAA) violations can occur as well. If identifiable health information is collected, then the IRB must decide whether to classify the QI project as research or solely QI. Other aspects of a research study that are not part of QI are randomization and informed consent. If these are present, then the project is no longer considered QI. A QI project usually takes place within the organization that is trying to improve upon something that was realized as a result of data collection analysis. Quality indicators are collected monthly, so health care organizations must act if deficiencies are found. If deficiencies are found, action plans must be put in place to correct any problems that are occurring. Figure 4.9 highlights differences between research and QI for approvals and terms.
Research vs. Quality Improvement
|Risk to Research Participant||✓|
Note. *There may be certain circumstances when informed consent and IRB approval are required.
Quality Improvement Project
One of the quality indicators collected monthly in all health care facilities is the number of patient falls. For example, if falls are very high in Organization A, the Quality Department may decide to invest in yellow gowns and yellow socks. Yellow is the color in all hospitals that is associated with patient falls. Data are collected monthly to evaluate the rate of patient falls. If the fall rate decreases by having patients wear a yellow gown and yellow socks, then the QI project was successful. Because of the great results from the QI project, all patients with a high fall risk score will now wear yellow gowns and socks.
If the project was conducted as a research study, changes would be made to the conceptual framework of the study. For example, if a research study using the same group of patients described in the above QI project with the yellow gowns and socks were being conducted, the researcher may compare one group to another. Group A will wear yellow gowns and socks, making Group A the experimental group and Group B the control group. Group A will be all patients in Rooms 1-15 with a high fall risk score and will wear a yellow gown and yellow socks. Group B will be all patients with a high fall risk score in Rooms 16-30 and will wear a regular hospital gown and socks. Data will be collected for Rooms 1-30 for 3 months to evaluate fall rates. The data collected will be compared to the previous 3-month period of fall occurrences (see Table 4.6).
Quality Improvement Strategies
|Research Study: Fall rate will decrease when patients wear yellow gowns and socks over a 3-month period of time (April–June 2018) compared to the fall rate for the previous 3-month period (January–March 2018). Yellow gowns alert health care workers that patient is a high fall risk.|
|YellowGowns||YellowSocks||Number of Falls Over January–March 2018||Number of Falls Over April–June 2018||Did Fall Rate Decrease Over 3 Months|
|Group ARooms 1–15||Yes||Yes||4||1||Yes|
|Group BRooms 16–30||No||No||3||4||No|
|Result—Fall rate decreased when patients wore a yellow gown and yellow socks.|
Quality Improvement Strategies
Various QI strategies are typically used within health care organizations. Several of the current QI strategies will be discussed below, including PDSA cycle, FADE, lean strategy, and Six Sigma. These strategies focus on either improving patient care or improving the processes surrounding patient care. Organizations routinely collect data regarding patient care and performance measures of the departments within the organization. Together they define the quality of patient care provided by a specific organization.
One strategy is “Plan-Do-Study-Act,” or the PDSA cycle . This simple, four-step tool is typically used by an organization for QI (Agency for Healthcare Research and Quality [AHRQ], 2013). Once a problem has been identified, a plan is created to observe the problem and collect data (plan). After the plan has been made, it is tested on a small sample (do), and the data collected is analyzed (study). After the data is studied, changes are made based on what was learned (act).
Hospitals collect data everyday regarding the care of patients. It is every hospital’s goal to provide safe, patient-centered, quality care. The information collected is distributed to hospital committees, and if the hospital performs poorly, the committee must come up with a plan for improvement. Using the PDSA cycle is a quick way to find and implement changes to improve the quality of care provided to patients (see Figure 4.10).
Note. Adapted from “Plan-Do-Study-Act (PDSA) Cycle,” by the Agency for Healthcare Research and Quality, 2013.
FADE , an acronym for focus, analysis, development, and execute and evaluate, is another four-step QI strategy. The focus step is when the problem or process that needs improvement is identified. The analysis involves the collection and analysis of data to define a clear baseline so that any root cause is identified. Performing this step properly is critical to the outcome of this QI strategy. The development step in this strategy is the Development step. In the development step, the action plan is created to support the method of improvement. The last executes the action plan developed and evaluates the results of the plan. Continuous monitoring must also take place to assure the success of change continues (see Figure 4.11).
The Toyota Motor Company developed the lean method for QI to eliminate waste (AHRQ, 2017). If an employee identifies something wasteful, then production is stopped until the wasteful activity can be corrected. Each employee is valued and tasked with finding areas that are wasteful, so corrections can be put into place. In health care, management empowers their employees to identify patient care and process problems in order to minimize inefficiency and focus on providing patients with a safe, patient-centered experience. Employees are also empowered to come up with solutions as well.
The lean strategy is used to advance QI by focusing on the patient experience, regulatory bodies, payers, and all health care providers. If anything is found to cause a problem related to one of these areas, or is found to be a problem, then every employee at every level is made to feel empowered to improve the process or problem. The lean strategy empowers individual employees and multidisciplinary committees to identify and address poor quality standards and procedures. Solutions are found by creating action plans to improve the identified patient problem and process problems as well. The lean method can be summarized using four key points:
1. Everyone is empowered and tasked with identifying patient care and process problems.
2. Management engages employees to identify patient care and process problems.
3. Strategies are created for the reporting of patient care and process problems.
4. Multidisciplinary committees are in place to address patient care and process problems and to create quality action plans for QI.
Lean Six Sigma
Lean Six Sigma is a strategy that focuses on process improvement and, in health care, the elimination of problems that may have led to the death of a patient or to a sentinel event. In lean Six Sigma, there are usually two different aspects of focus. The first emphasis is the removal of waste in the process that contributes to elongated cycle times, such as waiting or extra processing. The second emphasis is on defect elimination. A sentinel event is investigated to ensure that similar events do not occur in the future. It is used to improve patient safety by finding and eliminating life-threatening errors. A process called DMAIC (define, measure, analyze, improve, control) is an approach to improve the process that led to the error, and in health care, this is used as part of the Six Sigma strategy. Six Sigma is similar to PDSA except an additional step is added: control. This fifth step “provides extra emphasis on maintaining high levels of performance and low levels of variability. This typically entails a plan to continuously measure and monitor the process” to assure compliance (Glasgow, 2011, para. 5).
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