New study suggests CT studies lead to better hospital patient care
All benefit when a few participate
Health care system administrators sometimes believe the investment in clinical trials may not be worth its benefits.
But a new study suggests otherwise. Investigators have found that hospitals that participate in clinical trial research do indeed demonstrate better patient outcomes for all of their patients, including those who are not in clinical trials.1
"A lot of administrators and nurses on the ground worry about trials slowing down the emergency department or not getting X-rays done quickly because a nurse is in there with the patient, getting an informed consent," says Sumit Majumdar, MD, MPH, an associate professor in general internal medicine at the University of Alberta in Edmonton, Alberta, Canada. Majumdar is the first author on the study.
"So there's often a perception from the hospital perspective that trials are a hassle," Majumdar says.
"We wanted to see if it was a good thing for patients and for a hospital to participate in a trial," he adds.
This particular study was designed a little differently than previous ones that have looked at this issue, he notes.
"There are a lot of studies that look at patients who get into a trial, and they compare them to patients who don't get into a trial," Majumdar says. "And those who get into a trial often do as well, if not better."
But the drawback is that patients who are enrolled in a clinical trial often have fewer comorbidities because of strict inclusion/exclusion criteria, he says.
The study's data came from 494 hospitals that treated 174,062 patients with a specific heart condition over a period from 2001 to 2006. All of the hospitals had collected comprehensive data as part of the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association Guidelines). The patients each had non-ST-segment elevation acute coronary syndrome.1
"The hospitals were part of CRUSADE because they were interested in receiving information on how they cared for their patients," says Matthew Roe, MD, an assistant professor of medicine at Duke University Medical Center in Durham, NC. Roe was a co-author of the study.
"These hospitals probably are the cream of the crop because they volunteered to do this," Roe says. "So if you were to look at every hospital in the United States and look at the data, the results probably would be even more dramatic."
An analysis of the CRUSADE data shows that patients at hospitals that participated in clinical trials to a greater degree received better quality of care, evidenced by better use of proven medications, and better procedures like heart catheterization and angioplasty, Roe says.
"One of our major conclusions is that the structure or infrastructure for care at these [research] hospitals may be different," Roe says. "Integrating research into everyday practice has tangible benefits."
The study specifically found that hospitals that participated in trials had significantly lower rates of early mortality when compared with hospitals that did not enroll patients in trials.
The findings could be markers of better protocols, better physician support tools, and better mechanisms of giving feedback to physicians among research hospitals, Roe suggests.
"We can't tell you the exact reasons why, but we think it's a lot of those things put together," Roe says.
The study shows what can be accomplished when hospitals participate in research and have a team of caregivers and an institution that's interested in doing the best they can do for patients, says Stephen L. Kopecky, MD, professor of medicine and cardiovascular diseases, Mayo Clinic, Rochester, MN. Kopecky also is physician reviewer and editorial advisory board member of Clinical Trials Administrator.
Kopecky saw the study as having both good and cautionary news.
One of the study's comparisons is the median composite adherence score related to evidence-based guideline recommendations at the 494 CRUSADE hospitals. Even among the group of hospitals that had the highest enrollment in clinical trials, the median adherence to guidelines was only 81%, Kopecky says.
"This is disconcerting that these hospitals that are the best of the best still are not adhering to guidelines," he says.
The most striking finding in the study was the difference in mortality between the patients treated at hospitals with high trial enrollment and those treated at hospitals with zero trial enrollment, Majumdar says.
"We found that there was an almost 3% absolute difference in mortality rates between the high trial enrollment and the zero trial enrollment hospitals," he says. "And that was adjusted for all sorts of clinical factors and characteristics of the hospitals."
While 3% doesn't sound dramatic, in relative terms it means that the mortality rate among patients treated at hospitals that were high enrollers in trials was about 20% lower than the mortality rate among patients treated at hospitals that did not enroll in trials, Majumdar explains.
Another finding that suggested better treatment for patients at trial-enrolling hospitals involved CRUSADE's nine quality measures.
"CRUSADE had quality measures that looked at every patient to see if they were eligible for those nine measures, and then it creates a score based on the care they received," Majumdar says.
"So if you're eligible for a beta blocker after a heart attack and you receive one, then your score would be 100%," he explains. "We found that the high enrollment hospitals delivered better care on every single measure."
This study makes a business case for a medium-sized or small-sized hospital to consider selecting a common disease or condition and begin enrolling patients in a clinical trial, Majumdar says.
"It doesn't take much participation in research," he adds. "If you have enough infrastructure to enroll 1% of your patients in a trial, then you're actually doing better than if you never bothered to take part in research."
This particular study did not look at individual patients. "We looked at the average patient treatment at the hospital," Majumdar says.
Researchers used cardiology data because they needed a data set in which patients were asked whether they participated in a clinical trial.
"You'd think that would be commonly asked, but CRUSADE was the only dataset I could find that reliably asked the question across all sites," Majumdar says. "And that's why we were able to do this study, because of the simple question asked of every patient."
CRUSADE involved a voluntary registration of hospitals in the United States. All hospitals participating collected information on how they treated patients after a heart attack or with unstable angina.
Of the total number of patients with the condition, 4,590 or 2.6% were enrolled in clinical trials. There were 145 hospitals that enrolled no patients in clinical trials and others that had low to high enrollment in trials.
"If a hospital was in CRUSADE for five years and submits all patients' data for every year, and if over that time not one patient was participating in a trial, then the hospital was considered to be a [research] nonparticipator, Majumdar says.
"Thirty percent of hospitals never participated in a trial over the entire duration of follow-up care," Majumdar says. "We divided the rest into low and high enrollment, defining low enrollment as 1% of patients in a trial, and high enrollment was 5% of patients or greater were in a trial."
There was a median range of 2-4% of patients enrolled in trials, and there were some large hospitals that had 50% of their patients being enrolled in trials, Majumdar notes.
"That gives you an idea of what can be achieved," he says.
But the reality was that the vast majority of patients were never involved in a clinical trial.
"One of our major findings was that over five years in these hospitals across the United States, 97% of patients never got into a trial," he adds.
Since the hospitals in the CRUSADE study all were engaged in quality improvement efforts, the benefits a non-CRUSADE hospital might gain from clinical trial research could be even more dramatic, Majumdar suggests.
"From a hospital's perspective, it's encouraging news," he says.
While clinical trials require extra effort and staff training, the benefits include improved processes and quality, Kopecky says.
"The secret to clinical research is that when taking care of your patients you quickly take that leap from the research arena and apply [the better care, treatment, or technology] to your patient care," Kopecky says.
"On the other hand, you have institutions that don't do research and are still interested in doing the best they can to take care of patients," Kopecky says. "You don't have to be a hospital that's doing clinical research to give good care, but it certainly helps."
Reference
- Majumdar SR, Roe MT, Peterson ED, et al. Better outcomes for patients treated at hospitals that participate in clinical trials. Arch Intern Med 2008;168:657-662.
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