How important is research to your work in quality improvement?
We asked a similar question at a session on research at the IHI/NPSF Patient Safety Congress last May, and 80 percent of attendees said research was important or very important in their patient safety work. This was an informal poll — not a rigorous analysis — but it is encouraging, because it shows that those working in quality improvement (and the subset of patient safety) recognize the importance of using science, data, and evidence to guide their work.
How does someone working in quality improvement make the leap to contributing his or her own research to the field? When does a QI initiative become a research project?
Linking Operations to Research
Most hospitals and health systems have quality improvement teams that work on the operations side to implement new processes or tools. Many also have health services researchers, whose job is to oversee and analyze data related to service lines, costs, outcomes, and other factors. Some institutions also have training grants to teach fellows how to perform health services research, especially research related to health care delivery systems. Recently, the Agency for Healthcare Research and Quality (AHRQ) put out a request for proposals for career development awards that requires applicants to be embedded in health care delivery organizations and study problems related to implementation and dissemination of promising practices.
A first step toward determining if you have a research project masquerading as a QI initiative is to make the link between the QI team and the researchers in your organization. A good health services researcher can be very helpful in grant writing to help fund your project, obtaining Institutional Review Board (IRB) approval, as well as in providing input into design and data collection methodologies. I think you will find that researchers are eager to collaborate with you, because it is an opportunity for them to work within the real world issues of patient care.
An example from my tenure as a Director of Patient Safety was when the QI team worked closely with the health services research team to implement bar code technology in the inpatient pharmacy and, subsequently, on the wards of the hospital. Our research partners helped us figure out what we wanted to measure — in this case, the impact on pharmacy dispensing errors, nursing workflow and satisfaction, and administration errors at the bedside. A steering committee with both operational and research leads oversaw the research side of the project. The involvement of researchers was also critical, because they helped us understand our post-implementation data, and to improve the use of the new tool based on that information.
The Path to Research
Often, there is no clear dividing line between QI initiatives and research. Yet at a time of rapid change in health care, thinking broadly about how improvement projects may be generalized to settings beyond your own is often a worthy endeavor.
Some essential steps to consider:
- Collaborate — If you don’t have easy access to a health services research group, seek out someone in your organization who has a research background. This person can help you think about the implementation of the project and how to measure results. They can also provide guidance on what you need to do methodologically to have publishable results, and they may help guide the structure and content of the final paper.
- Plan — Your QI project team, in consultation with your research collaborator, needs to think through questions such as what will you be measuring and how? What you need in terms of numbers of patients, units, or staff? What will the implementation look like and how will it be communicated to staff? There is a good argument to be made that QI projects should always be rigorous, because if they are not well designed, it may be impossible to learn anything meaningful despite a lot of effort.
- Be patient — Allow time for review and approval of your organization’s IRB, if needed. IRB review is mandatory for any research involving human subjects, including house staff and nursing professionals. Quality improvement projects may be viewed with a different lens than clinical research projects, however, because studies that align with QI goals often pose minimal risk to patients. Some organizations do not require IRB approval, or give a quick review and a waiver, to QI projects that seek to bring care closer to accepted standards, based on the risk posed.
- Document — If you want to publish results you’ll need to document every step, from the goals or hypothesis to the methods used and all of the data points you have chosen to measure through the course of the project. My co-presenter points out that translational researchers who work in the lab have to keep detailed lab notebooks, but quality improvers tend to be less rigorous in keeping records. Follow the example of the bench researcher in recording what happens throughout the project.
- Start at the end — One of the keys to putting together a good research project is to look at your end goal. Imagine getting results that point to “success,” and think carefully about what you need to put in place before you even begin.
Of course, it is important that the leadership of your organization agrees and supports of the project and publication of results. Not all organizations are willing to publicly acknowledge their biggest challenges and improvement opportunities. I’m a big believer in looking at QI through the research lens, however, because it is ultimately a commitment to transparency. Admitting there is room for improvement in your organization, and being open about your efforts to improve, is a powerful message to patients, staff, and the community.
Tejal K. Gandhi, MD, MPH, CPPS, is IHI’s Chief Clinical and Safety Officer.