More Highlights of PCORI-Funded Research Results
A growing number of our funded research studies are now producing important results that are being summarized in leading medical journals and presented at major scientific meetings. Here are some of those studies and their findings.
People with a serious mental illness (SMI) may have difficulty with daily activities. In this study, the research team compared two programs to help people with SMI manage their symptoms. In the FOCUS program, people used a smartphone app. In the Wellness Recovery Action Plan, or WRAP, program, people went to group sessions at a clinic. They wanted to see if one program was more effective at helping patients get the care they need.
As published in Psychiatric Services, participants assigned to the smartphone program were more likely than those assigned to the clinic-based program to start treatment—90 percent versus 58 percent—and remain fully engaged in eight weeks of care—56 percent versus 40 percent. Participants in both groups improved significantly and did not differ in clinical outcomes. The increased engagement by the telehealth group suggests that the smartphone-based treatment plan may help increase access to care for patients with SMI.
In this study, the research team found that video house calls were an effective way for people with Parkinson’s disease to get care from specialists. Most patients reported being satisfied or very satisfied with care they received during video house calls. After 12 months, there were no differences between patients who received video house calls and those who didn’t in quality of life, quality of care, or amount of caregiver burden.
Compared with patients who had in-person visits at clinics, patients who used video house calls spent less time traveling to doctor visits. Patients who used video house calls also spent more time talking with specialists during visits.
Now, through a Dissemination and Implementation project, the research team is expanding its telehealth services to include visits with doctors and nurses who specialize in conditions that often accompany Parkinson’s disease, such as dementia and depression.
More than 70 percent of adults with uncomplicated appendicitis were able to safely delay surgery for at least three months by taking a course of intravenous antibiotics, according to early results from The CODA Study published in the New England Journal of Medicine. Researchers issued the results early in response to its relevancy to patients and healthcare providers during the coronavirus pandemic.
The study found that health outcomes associated with antibiotics and appendectomy were similar. The majority of patients on antibiotics also missed less time away from work or school. However, nearly 30 percent who received antibiotics ultimately needed surgery and this group experienced more emergency department and hospital visits than the appendectomy group The study was conducted at 25 sites nationwide and involved a wider range of patients than previous studies, making its results more broadly applicable to typical patients with appendicitis.
An accompanying editorial—noting the timing of the release of the results and the American College of Surgeon’s recent guidance on triage of nonemergency surgical procedures during the pandemic—states that “it will be important to ensure that some people, in particular vulnerable populations, are not offered antibiotic therapy preferentially or without adequate education regarding the longer-term implications.”
View a summary of the early findings from the study. In addition, listen to an episode of “Behind the Knife: The Surgery Podcast,” during which members of the research team discussed the early results of the trial. Listen on Apple Podcasts or Spotify.
Adults with severe obesity who had gastric bypass surgery lost more weight, sustained greater weight loss five years afterward, and had a higher remission rate of type 2 diabetes than those who had either sleeve gastrectomy, a newer, simpler procedure, or adjustable gastric banding, this PCORI-funded study found. It used PCORnet® to analyze data and outcomes of more than 46,000 patients from 41 health systems nationwide, making it the largest study to date to compare these procedures.
People who had bypass maintained an average 26 percent loss of their pre-surgery weight after five years compared to 19 percent with sleeve and just 12 percent with banding. Rates of major problems occurring within 30 days of surgery were small for all three procedures, though highest for bypass. Results appear in the Annals of Internal Medicine, and in two papers in JAMA Surgery. Bypass has been in use longer than the other two procedures. Sleeve has become the most commonly performed approach since its introduction in recent years. Banding is now used in only 10 percent of cases.
A PCORI-funded study in Texas has shown that a decision aid delivered through tobacco quitlines effectively reaches a screening-eligible population and results in informed decisions about lung cancer screening. The researchers devised the patient-centered decision aid to help smokers choose between screening options based on what is most important to them, and then compared its effectiveness versus a traditional brochure that answered common questions about screening.
As the research team reported in JAMA Network Open, compared to the group that received the brochure, patients who used the decision aid were markedly more prepared to make a screening decision. Because the findings suggest that decision aids about lung cancer screening can reach—and significantly help—large numbers of smokers who are eligible for screening through tobacco quitlines, this project has received a PCORI Dissemination and Implementation Award to spread the decision aid to eight state tobacco quitlines.
Two studies in Tennessee and in North Carolina provide men with robust new evidence about the rates of side effects associated with contemporary treatment options for prostate cancer. These options include robot-assisted surgery and newer forms of radiation therapy, as well as active monitoring instead of immediate treatment. The study’s findings can help men better weigh the benefits and risks of their options in consultation with their clinicians.
Two papers (first paper, second paper), one on each study, appeared in a March 2017 issue of JAMA. A related JAMA editorial states, "To date, men with clinically localized prostate cancer have never been better informed about the trade-off they have to make between oncological outcomes and now clearly defined potential adverse effects of available treatments."
Funding from the Agency for Healthcare Research and Quality extended the follow-up period for study participants to expand the evidence base from this project. JAMA published these results in January 2020.
Giving broad-spectrum antibiotics to children with acute respiratory tract infections did not achieve better outcomes than using narrow-spectrum antibiotics, but did increase the rate of harmful effects, a PCORI-funded study found. Earaches, strep throat, and other respiratory tract infections commonly occur in children. Broad-spectrum antibiotics target a wider range of bacteria than narrow-spectrum drugs that target only certain ones, but broad-spectrum carry a somewhat greater risk for creating drug-resistance among bacteria.
The study results published in JAMA support the use of narrow-spectrum antibiotics for most children with these infections. Learn more about this study in a PCORI feature story, and through evidence updates, which are created and disseminated to important stakeholder groups to better present the highlights and context of findings from the study.
Use of antibiotics to treat infections in infants and toddlers was associated with only a small amount of weight gain by age 5—a difference of less than a pound in children of average height and weight who received four or more courses of antibiotics, compared to children who received none, this study found.
This new study is the largest to tackle the issue to date, involving data from more than 360,000 children from 35 health systems nationwide accessed using PCORnet. Because antibiotics are used to promote growth in animals, concerns arose that their use to treat infants’ and toddlers’ infections may be contributing to childhood obesity. Previous studies have had conflicting results. The results appear in Pediatrics.
Although the study alleviates concerns about weight gain as a factor in decision making about antibiotic use in children, other concerns, such as antibiotic resistance, remain important considerations.
Despite ongoing efforts to improve care, medical errors—mistakes that may or may not harm patients—are a leading cause of death nationally. Improving communication in the hospital can help reduce errors. Past research has focused on how staff communicate with each other, but few studies have focused on how staff communicate with patients and families.
To that end, a PCORI-funded research team tested a program called I-PASS that includes parents as active participants in pediatric unit rounds at eight hospitals to see whether it would improve hospital safety. As The BMJ reports, the program reduced harmful medical errors—preventable adverse events—by 38 percent. The research team now plans to expand the program to more hospitals through a second PCORI award. In this video, project Principal Investigator Christopher Landrigan, MD, MPH describes his study.
Blood thinning drugs lower patients’ risk of developing a potentially fatal blood clot during their stays in a hospital. Missing prescribed doses, either because patients decline to take the drugs or a healthcare provider skips doses, is associated with an increased risk of blood clots.
This study looked at data from more than 19,600 patients’ hospital stays. It found that prompting healthcare providers not to skip doses resulted in a significant decrease in missed doses. And giving educational information about the drugs to patients—through a conversation with a provider or a video or printed pamphlet—significantly increased the chances that patients took all doses. The findings have been published in JAMA Network Open.
A randomized trial offered important insights about how to improve advance care planning among people with complex medical situations, especially when language or cultural barriers get in the way.
Researchers developed a culturally tailored, Spanish version of a website, PREPARE, to help Spanish-speaking patients decide what goals are important to them and talk to their providers about those goals.
As the research team reported in JAMA Internal Medicine, their study showed that the website helped Spanish-speaking patients to do advance care planning better than giving them only written forms to state their wishes. The website also enabled them to begin planning on their own without assistance from healthcare staff.
Adults with psoriasis, a chronic skin condition, who used an online program to get care from dermatologists and their primary care providers experienced the same level of improvement as patients who got in-person care in a clinic, this study found. The collaborative online program tested enabled both patients and primary care providers to share and discuss information with the specialists.
In previously studied forms of teledermatology, specialists have not had direct contact with patients. These findings add to evidence about the potential for telehealth to serve as a more widely accessible and convenient addition or alternative to in-person visits with specialty and primary care providers to manage chronic disease. The results appear in JAMA Network Open.
Having a mechanical pump called a left ventricular assist device (LVAD) surgically implanted can prolong the lives of people with end-stage heart failure. But the surgery and the device carry significant risk for harms, such as infections and stroke, making choosing whether to get one very difficult.
Using a shared decision making tool focused on LVAD improved patients’ knowledge about their treatment options’ potential benefits and risks compared to typical educational pamphlets given to patients, this PCORI-funded study found. The decision aid also helped them make initial decisions better aligned with their values. The results were reported in JAMA Internal Medicine.
Chronic pain disproportionately affects people with less education and low incomes. This PCORI-funded study found that such patients were able to more effectively manage chronic pain after receiving simplified versions of either cognitive behavioral therapy (CBT) or pain education compared to those who got usual pain care. CBT and pain education offer nondrug approaches to help manage chronic pain, a condition that is associated with an alarming surge in opioid use disorders.
CBT and pain education also resulted in improved physical function and lower depression. The study also demonstrated that CBT and education can be simplified to serve patients with limited reading skills without losing their effectiveness. Results appear in the Annals of Internal Medicine. A related editorial says this study is important because it heeds the call to resolve disparities in pain treatment. Learn more about how these results can help address disparities in pain care in a PCORI feature article.
The finger pricks that many people with type 2 diabetes do daily to check their blood sugar levels confer little value compared with forgoing this self-monitoring, this study concluded. There has been debate about how much this self-monitoring enhances the health of people with non-insulin-dependent type 2 diabetes, and whether the benefits exceed the inconvenience and discomfort of daily finger pricking, anxiety it can induce, and financial burdens of out-of-pocket costs for the testing equipment. In results that augment findings of previous research, the study found that self-monitoring achieves no significant differences in disease control, hospitalization rates, need to start using insulin, or quality of life.
Although chest pain sends many people to the ER, a significant percentage are not having a heart attack or other serious heart problems. Using a questionnaire called Chest Pain Choice proved effective in helping such individuals decide whether to forgo unnecessary hospital stays and intensive medical tests.
People who used the questionnaire were more knowledgeable about their risk and care options and more involved in their care decisions than people who didn't use it, this study found. There were no differences in rates of heart-related problems in the following weeks between the two groups. Results appear in The BMJ. A Medscape commentary describes the tool as a “win-win-win” for patients, providers, and payers. Learn more about how these results can help patients and clinicians make decisions about chest pain in a PCORI feature article.
Long-term use of opioids, particularly in high doses, for treating chronic pain increases the risks for addiction and overdose. Healthcare providers need guidance about what works to help patients manage their pain and to avoid or minimize the risks associated with opioids. This study in Washington State compared clinics that implemented an initiative focused on more-cautious opioid prescribing to clinics that did not.
Physicians following the initiative prescribed fewer high doses of opioids. The results appear in the Journal of Pain. Learn more about how these results can help advance safer opioid prescribing in a PCORI feature article.
A behavioral health home, a patient-centered way of coordinating care resources, can help people with serious mental illnesses manage their conditions, potentially enabling them to live longer, healthier lives. This PCORI-funded study showed that two ways of providing a behavioral health home to patients with serious mental illnesses, such as bipolar disorder and schizophrenia, are both effective.
The study compared a patient self-directed approach, in which patients used a variety of online resources to manage their health care, to a provider-supported approach, in which patients met with nurses and other clinical staff about managing their care. Both approaches significantly increased patients’ knowledge and confidence to manage their own care, with provider-supported care doing so more quickly. Both approaches also improved patients’ perceived mental health status and increased their engagement in primary and specialty care.
An article published in Health Affairs highlights the study’s results. The research team is exploring ways to implement the behavioral health home model to people who receive care in residential treatment facilities and who attend opioid treatment programs.
As people age, they face an elevated risk of losing their independence through increasing difficulty in getting around. Exercise may help preserve mobility, but programs offered to older adults typically involve exercises that they do while sitting down. This PCORI-funded study compared the effectiveness of a standing exercise program called On the Move with a seated exercise program. It found that On the Move, with its focus on enhancing motor skills and muscle control necessary for walking, was more effective than the seated exercise program at improving older adults’ function and walking ability in the short term. Although the On the Move group reported a few minor injuries and a somewhat greater discontinuation rate, those in it reported feeling equally safe and satisfied with the more challenging program. The results appear in JAMA Internal Medicine.
If clinicians routinely collected data about sexual orientation from patients, it would significantly boost our ability to identify and address health disparities among lesbian, gay, and bisexual populations. However, health systems are not regularly collecting this information. This study determined that while 80 percent of healthcare professionals believe patients would refuse to provide sexual orientation information if asked, only 10 percent of patients say they would refuse. The results appear in JAMA Internal Medicine and LGBT Health. The New York Times also has a feature on the study.
Children taking antibiotics to prevent recurrence of serious infections could remain infection-free, and their families could face fewer costly complications and daily hassles with medical equipment, if the children took the drugs by mouth rather than receiving them through an intravenous line, according to this study. The results appear in JAMA Pediatrics, Pediatrics, and Annals of Surgery. A JAMA Pediatrics commentary says, "the investigators have provided very necessary information about how we can best organize and deliver care to children with a relatively common pediatric diagnosis while improving outcomes, reducing costs and untoward effects, and improving patient satisfaction." Learn more about how these results can inform decisions about treating these infections in a PCORI feature article and a PCORI video.
Using the blood-thinning medicine warfarin enabled stroke survivors, even those over 80, to continue living in their homes longer compared with those who didn’t take the drug, the PROSPER study found. Those taking warfarin stayed in their homes on average 46 more days during the two years after being hospitalized for stroke. Patients advising the researchers said that staying in their homes, rather than being institutionalized in a nursing home or hospital, is the outcome that mattered most. The findings appear in The BMJ. A related editorial calls the study “a solid example of how to refocus research on questions, outcomes, and approaches that could help patients and clinicians to make better healthcare decisions." Learn more about how these results can help stroke survivors gain time at home in a PCORI feature article and a PCORI video.
Using a benefit prediction model, researchers in this study could identify those patients with prediabetes who are most likely to benefit from taking the diabetes drug metformin—and those likely to suffer more harm than good. Although usually safe, metformin causes a potentially serious side effect called lactic acidosis in some people. Knowing which patients won’t benefit from the drug could reduce the number of people who experience this side effect. The paper appears in The BMJ. The incorporation of this benefit prediction model into an electronic health record is now being tested in 50 clinics via this dissemination project. Learn more about how these results can help identify who benefits from medicine in a PCORI feature article.
Two approaches to obesity care helped to reduce body mass index (BMI) scores in children who are overweight or have obesity. Both approaches also improved other key health measures and family satisfaction with the children’s care. This study's two approaches both enhanced the usual primary care for childhood obesity by linking families to community resources and sending supportive text messages. Some of the families also received bimonthly coaching on healthy behaviors, which resulted in slightly but not significantly greater reductions in their children’s BMI scores. Results appear in JAMA Pediatrics. Learn more about this study in a PCORI feature article.