Steps to the Research
Dr. James has collaborated with Theodore Speroff, PhD, of the Veterans Affairs Health Services Research Center in Nashville, Tenn., and others on many articles delineating the use of PDSA (plan, do, study, act) methodology—also known as rapid cycle of change methodology—to improve the rigor of quality improvement initiatives.1,2
In a nutshell, says Dr. James, the PDSA model consists of several important steps encompassing a study cycle:
- Establish key clinical processes at your institution that warrant studying, and build an evidence-based best practices guideline. For instance, at Intermountain Healthcare 10% of the system’s processes accounted for 90% of clinicians’ work. Hospitalists pick the most prominent care process (DVT prophylaxis, for example) and build an evidence-based best practice guideline;
- Build best practice guidelines into a workflow format (in the form of standing order sets, data, and decision support) to directly support care at the work flow level;
- Build outcomes data comprising three major sub-categories: medical outcomes, service outcomes, and cost outcomes. Each category is further divided into smaller units. For instance, medical outcomes would include indications for appropriateness, condition-specific complication rates, and achieving therapeutic goals;
- Use electronic medical records to develop a system of decision support that ties together best practices, work flow and outcomes tracking; and
- Build educational materials for patients and for the team of professionals delivering the care.
The beauty of rapid cycle of change methodology, says Dr. James, is that it quickly allows teams to correctly identify worthwhile research projects. The team asks: What is our aim or target? How will we know if the target changes or improves (implying a parallel qualitative or quantitative measurement system)? And finally, what might we change to make things work better? “Rapid cycle” connotes a series of PDSA cycles performed one after another in the context of a measurement system.
Increase the Rigor of Studies
Dr. Schnipper believes that continuous quality improvement methods give researchers a toolkit for conducting successful interventional studies. But to use quality improvement methods (e.g., rapid cycle of change—PDSA—methodology) alone may yield less externally valid study results. For example, he says, using QI methods alone, a researcher might continuously change the intervention (for glucose management, for example), watching the results improve over time. This might be the most effective method for improving glucose control in a specific institution, but this renders results “less generalizable to any other institution. It’s never really a before/after study, much less a concurrent randomized controlled trial,” he says. “Many people believe that if you want to conduct research, you have to ‘hold the intervention still’ for at least a certain amount of time so that it’s describable to other people. You may also decide, in the name of generalizability, not to maximally customize your QI intervention to your institution.”
Dr. Schnipper cites a recent Annals of Internal Medicine study that used a combined methodology. The study, by Fine and colleagues at the University of Pittsburgh in conjunction with the Veterans Affairs Center for Health Equity Research and Promotion, compared three intervention strategies (low, moderate, and high intensity) to improve pneumonia care in emergency departments and assessed the performance in institutions assigned to each strategy.3 The high intensity arm used a continuous quality improvement method, allowing each institution to design an intervention that worked best for it. “It was encouraging to see Annals publish an article of this type,” says Dr. Schnipper. “But the question remains: Is this the best way to publish research, such that it’s most useful for other hospitalists who want to improve care at their institutions? Do you include a 20-page online appendix so other people can see exactly what you did?”