The Patient-Centered Outcomes Research Institute (PCORI) board of governors has approved $57 million to fund 14 new comparative clinical effectiveness research (CER) studies. The funds will support studies of a range of conditions and problems that impose high burdens on patients, caregivers and the healthcare system.
That total includes $32 million to fund three large-scale pragmatic clinical studies. Such studies represent an effort to produce results that are broadly applicable to a greater variety of patients and care situations and can be more quickly taken up in routine clinical practice than traditional clinical research results. The newly approved awards are:
• $13.6 million for a study based at UCLA that will compare whether a health-system-based strategy or a community-based strategy to support caregivers and individuals with dementia is more effective at keeping people in their homes and reducing caregiver stress and depression.
• $11.9 million for a University of Florida project comparing two forms of radiation therapy for prostate cancer — traditional X-ray therapy, called intensity-modulated radiation therapy (IMRT), and a newer treatment called proton therapy, which uses less radiation but costs more.
• $6.5 million for a study led by the UCLA Fielding School of Public Health to compare strategies for increasing the use of the human papillomavirus (HPV) vaccine among Latino populations, which have a lower rate of HPV vaccination than the general population. This project will compare three interventions: a clinic-based approach that includes training staff on discussing the vaccine with patients and their parents; a parent-based approach that involves strategies to notify and encourage parents outside the clinic, such as text reminders and letters; and a combined clinic-based and parent-based based approach.
“Like all of our pragmatic clinical studies, these new awards will help answer significant questions regarding treatment and delivery of care that are important to patients and those who care for them,” said PCORI Executive Director Joe Selby, MD, MPH. “These large studies feature the engagement of stakeholder groups on the research team and have been judged as having a high potential to change practice and improve patients’ outcomes.”
The board also approved $25 million for 11 additional studies, including:
• $4.9 million for a University of Washington project that addresses how best to deliver collaborative, patient-centered care for trauma survivors. The study will determine which of two approaches to the care of injured patients results in improving post-injury function and concerns, PTSD symptoms, and emergency department utilization. One approach uses a collaborative-care Intervention that includes frontline trauma staff and peer support, while the other involves trauma staff teamed with mental health consultation.
• $2.8 million to the Georgetown University Medical Center for a randomized controlled study of treatments for anxiety disorders to compare the effectiveness of mindfulness treatment to escitalopram, a standard medication for people with anxiety disorders. Many individuals are reluctant to take psychiatric medications.
• $2.1 million for a Fenway Community Health Center project to improve the health of sexual- and gender-minority patients by comparing patients’ outcomes and satisfaction with care before and after clinicians participate in a training program about providing culturally competent care and collecting data on sexual orientation and gender identity.
• $1.9 million for RTI International to determine whether health systems can improve rates of retention of patients in substance abuse treatment and patient outcomes by applying a systematic approach to matching patients with addiction treatment developed by the American Society of Addiction Medicine, as opposed to traditional methods. This study will compare outcomes of health systems that implement the matching approach with those that opt not to.
With these latest awards, PCORI has invested $2 billion to fund more than 400 patient-centered CER studies and other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.
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