At the Lifesavers Gala in New York last night, Dr. Greg Simon received the American Foundation for Suicide Prevention (AFSP’s) Research Award for his contributions to suicide prevention. Dr. Simon leads the Suicide Prevention Outreach Trial (SPOT), an NIH Collaboratory Demonstration Project that builds on previous work demonstrating that patients who answer “yes” to thoughts of self-harm on routinely administered PHQ-9 questionnaires at primary care visits are more likely to attempt suicide. For these high-risk patients, SPOT explores different modes of outreach (care management or online skills training versus usual care) to prevent suicide.
“There’s a conspiracy of silence around suicidal thoughts, because it’s awkward to discuss. So we’ve found that we have to incorporate talking about it into our standard care. Our suicide prevention work is a great example of how research and care keep influencing each other to improve our patients’ health. When research springs from clinicians’ and patients’ questions, ‘learning health systems’ can put results into practice much faster than the oft-cited 17-year lag.” — Dr. Greg Simon, from the Kaiser Permanente Washington Health Research Institute Press Release
Dr. Simon and his colleagues are also studying how machine-learning models can be used to predict risk of suicide. The models combine the PHQ-9 mental health questionnaire responses with information from electronic health records, including prior suicide attempts and mental health and substance use diagnoses. In a blog post regarding his research (and recent publication) on machine learning, Dr. Simon compares machine learning to warning lights on cars:
Our paper prompted many questions from clinicians and health system leaders about the practical utility of risk predictions:
“Are machine learning algorithms accurate enough to replace clinicians’ judgment?” our clinical partners asked.
“No,” I answered, “but they are accurate enough to direct clinicians’ attention.”
The AFSP also honored four others, including Anderson Cooper, a CNN and 60-minutes correspondent, and Kate Snow, an NBC news correspondent, for their work raising public awareness of suicide prevention.
Michelle B. Leavy, MPH
Head, Healthcare Research and Policy
Elise Berliner, PhD
Director, Technology Assessment Program
Center for Evidence and Practice Improvement (CEPI)
Agency for Healthcare Research and Quality (AHRQ)
Development of Harmonized Outcome Measures for Use in Research and Clinical Practice
Health outcomes; Patient-centered outcomes; Agency for Healthcare Research and Quality; Patient registries; Clinical data; Patient-reported outcomes; Value-based care; Electronic health records; Learning health system; Conceptual framework
The goal of the Outcome Measures Framework is to create a common conceptual model for classifying the range of outcomes that are relevant to patients and providers across most conditions.
Harmonization of outcome measures is essential to comparing and aggregating results between and among registries, clinical research, and quality reporting, and to facilitating performance and value-based measurement.
A minimum measure set is the minimum set of harmonized measures that can be captured consistently in research and clinical practice.
Developing the framework used a stakeholder-driven process that categorized outcomes as clinical responses, patient-reported, survival, resource utilization, and events of interest for a sample set of 5 clinical areas.
The benefits of developing a core set of measures include reduced clinician burden and improved patient care.
How is this work informing the HL7 work group that is defining standards for registries?
Next steps include implementation of the minimum measure sets in EHRs, registries, and other research efforts; demonstrating the value of a minimum measure set; and encouraging adoption of the measures.
Michael S. Avidan, MBBCh
Dr. Seymour and Rose T. Brown Professor of Anesthesiology
Chief, Division of Clinical and Translational Research
School of Medicine, Department of Anesthesiology
Washington University in St. Louis
The ENGAGES Pragmatic Trial and the Power of Negative Thinking
The ENGAGES pragmatic trial evaluated whether electroencephalogram-guided anesthetic administration decreases postoperative delirium incidence in older patients undergoing major surgery.
Delirium is a disturbance in consciousness or change in cognition for a short period of time as a consequence of a medical illness. 25% to 50% of older adults experience delirium after major surgery, and the number is even higher for ICU patients.
The ENGAGES trial found that, among older adults undergoing major surgery, EEG-guided anesthetic administration, compared with usual care, did not decrease the incidence of postoperative delirium.
Aside from the intensity of patient follow-up and the expertise needed to deliver the EEG-guided protocol, the ENGAGES study fulfilled the criteria for a pragmatic clinical trial as shown in PRECIS-2 ratings.
Clinicians participating in ENGAGES were not researchers but carried out the intervention on the ground. They understood the appeal of it and found it easy to implement.
With respect to study findings, instead of referring to “negative” or “null” findings, why not say, “this is what we found and these are interesting findings.”
The Collaboratory Demonstration Project Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is testing the effectiveness of a novel advance care planning (ACP) video education program in 360 nursing homes within 2 large nursing home healthcare systems. The investigators of PROVEN recently published a study that examines the characteristics of nursing homes associated with implementation of the video. They found that lower quality nursing homes (rated 1 star) had lower offer rates than higher quality nursing homes, suggesting that ongoing support might be necessary in these settings, as well as engagement with a local champion.
ACP is a process by which individuals define their future goals and preferences for medical treatment at the end of life and discuss these goals with their family and healthcare providers. ACP is especially important for nursing home residents, who often receive unnecessary care and experience burdensome transitions at the end of life. The ACP intervention in PROVEN is delivered by an onsite champion at the facility—usually a social worker with structured training in how and when to offer and show the ACP videos to residents and families.
“These results have implications for future pragmatic trials in the NH [nursing home] setting because ongoing engagement between research and NH staff appears crucial for successful integration of interventions into routine clinical practice. Future research is needed to understand how to best engage NHs in implementation and encourage communication between NHs to share pragmatic strategies for improving clinical practice without the support of research staff.”
– Loomer et al. Journal of the American Medical Directors Association
The Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid (CMS) have announced a proposed rule intended to advance interoperability and support the access, exchange, and use of electronic health information. Notably, the rule would require that patients have the ability to electronically access their health information at no cost.
The rule also proposes a United States Core Data for Interoperability (USCDI) standard, which, if adopted, would add data beyond those included in the current common clinical data model to support nationwide interoperability of CMS data. Specifically, clinical notes, data provenance, pediatric vital signs, patient address and phone number (to support data matching) will be added if the measures are adopted.
“Today’s announcement builds on CMS’ efforts to create a more interoperable healthcare system, which improves patient access, seamless data exchange, and enhanced care coordination,” — CMS Administrator Seema Verma, from the NPRM Press Release
James Tulsky, MD
Chair, Department of Psychosocial Oncology and Palliative Care
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School
Chief, Division of Palliative Medicine
Brigham and Women’s Hospital
Angelo Volandes, MD, MPH
Associate Professor of Medicine
Massachusetts General Hospital
Harvard Medical School
Promoting Effective Advance Care Planning Communication in the Elderly: The ACP-PEACE Trial
Pragmatic clinical trial; Advance care planning; ACP PEACE; Dana-Farber Cancer Institute; National Institute on Aging; Palliative care; Video declarations; Goal-concordant care; Patient preferences
Many people with serious illness die without receiving goal-concordant care, and patients over the age of 65 with cancer experience this disproportionately. Helping patients engage in advance care planning (ACP) can empower them to express and record their goals so that their care can be aligned with their preferences.
The ACP PEACE Demonstration Project is a pragmatic, stepped-wedge, randomized trial of a comprehensive ACP program in oncology clinics at 3 health systems. It will involve a combination of 2 evidence-based programs:
VitalTalk teaches clinicians important communication skills in having empathic conversations with seriously ill patients.
ACP Decisions uses videos to promote planning and decision-making by patients and families.
The ACP PEACE study will monitor long-term outcomes to evaluate whether patients received the care they planned for and wanted.
The last element of the ACP PEACE trial is a video declaration (ViDec), recorded by a subset of patients. In recording the ViDec, patients are prompted by questions assessing their confidence with their decision, satisfaction, decisional regret, and patient-provider experience.
The ACP PEACE study team has a scaling strategy in place if the intervention proves effective. Implementing the intervention as standard of care will involve a culture shift from what is currently expected in health systems.
Myles Wolf, MD, MMSc
Charles Johnson, MD, Professor of Medicine
Chief, Duke Nephrology
Duke University School of Medicine
Pragmatic Trials in End-stage Renal Disease (ESRD): HiLo
Pragmatic clinical trial; HiLo; End-stage renal disease; ESRD; Kidney disease; Hypophosphatemia; Serum phosphate; Hemodialysis; A vs B trials; Clinical equipoise; National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK
With high event rates and few proven therapies, patients with end-stage renal disease (ESRD) are in desperate need of clinical innovation.
The NIH Collaboratory’s HiLo Demonstration Project is a pragmatic, multicenter, cluster-randomized, open-label, noninferiority outcomes trial that will compare effects of two different phosphate management strategies in patients with ESRD.
The study hypothesizes that, compared with strict phosphate control, less stringent control will yield noninferior rates of all-cause hospitalization among patients with ESRD undergoing hemodialysis, as well as reduce the risk of all-cause mortality, enhance markers of diet and nutrition, and improve quality of life.
Dialysis clinic dieticians will have a pivotal role in implementing HiLo. They have established a rapport with patients and are among the most motivated caregivers on dialysis teams.
Individual patient-level informed consent for the HiLo trial will be via internet-linked tablets, paper forms, and educational materials including a video. Benefits of obtaining consent include promoting adherence, direct study updates and newsletters to participants, and ability to collect additional data without involving onsite study staff.
HiLo will be the first definitive clinical trial-grade evidence for opinion-based guidelines for phosphate management. Thus, results of HiLo have the potential to rapidly influence ESRD clinical practice.
Real-world data: routinely collected information about a person’s health status in the electronic health record, claims, registries, and other sources, including patient-generated sources.
Real-world evidence: reliable, clinical information derived from real-world data about risks, benefits, and burdens of therapies.
This framework will apply to various pragmatic clinical trials embedded in health care systems and conducted as part of routine care (and will not apply to more traditional clinical trials conducted parallel to care).
Three main considerations are included in the framework:
Will the real-world data be fit for use (do they reliably and adequately represent the concept)?
Will the evidence generated by the trial provide adequate evidence to help answer regulatory questions?
Will the conduct of the study meet FDA regulatory requirements?
A panel funded by the Patient-Centered Outcomes Research Institute (PCORI) recently published recommendations for the oversight of patients who participate in research roles other than as “research subject.” Patients and caregivers participate in many roles, such as co-investigators, study personnel, and advisors in research studies, and this creates novel ethical and regulatory challenges. The panel provides a taxonomy for these roles and recommendations for appropriate oversight. The group also provides recommendations about identifying and engaging a diverse mix of patients and developing mechanisms to protect against possible conflicts of interest. Finally, given the ubiquity of mobile health and other emerging technologies for use by patients, the recommendations provide guidance about the inclusion of these technologies in patient-centered outcomes research, with specific attention to education, best practices, and appropriate privacy protections.
In an accompanying editorial, Dr. Robert Califf expressed his support for the panel’s efforts and their taxonomy for patients in patient-centered outcomes research:
“Given the persistent gap between the slow pace of research and the pressing need for high-quality evidence to guide practice in areas of clinical uncertainty on one hand, and the potential offered by more pragmatic, people-centered research methods on the other, we need positive approaches for making learning through research a routine part of clinical care rather than an exceptional event.”