November 16, 2018: Primary Palliative Care for Emergency Medicine (PRIM-ER) (Corita Grudzen, MD, MSHS)

Speakers

Corita R. Grudzen, MD, MSHS, FACEP
Vice Chair for Research
Associate Professor of Emergency Medicine and Population Health
Ronald O. Perelman Department of Emergency Medicine
NYU School of Medicine

Topic

Primary Palliative Care for Emergency Medicine (PRIM-ER)

Keywords

PRIM-ER; Emergency department; Palliative care; Demonstration project; Pragmatic trial; Stepped-wedge study design; Clinical decision support; Best practice alerts; Advance care planning

Key Point

  • The PRIM-ER trial is a pragmatic, cluster-randomized, stepped wedge Demonstration Project that will implement primary palliative care in emergency medicine across a diverse group of 35 emergency departments (EDs).
  • PRIM-ER’s clinical decision support intervention is tailored to each ED site. The study aims to enable system, organizational, and provider change in the emergency department workflow.
  • The study team is identifying and preparing site champions by conducting communication skills training in serious illness for emergency physicians and staff using the EM Talk program.

Discussion Themes

It is important to consider sustainability of the intervention during the planning phase of the trial. Plan for staff turnover and how new staff will be educated and oriented to the intervention.

The volume and sophistication of best practice alerts (BPAs) received by physicians varies across U.S. emergency departments. Alert “fatigue” can be a concern.

For more information on the PRIM-ER Demonstration Project, visit the PRIM-ER website on the Living Textbook.

Tags

@Collaboratory1, #pctGR, #EmergencyMedicine

September 4, 2018: Spotlight on a New Demonstration Project: PRIM-ER

In the United States, half of persons 65 years and older have an emergency department visit in the last month of life, and three-quarters have an emergency department visit in the last 6 months of life. Admissions to intensive care units by emergency clinicians are on the rise, especially for older patients. Meanwhile, three-quarters of older adults with serious illness have thought about end-of-life care, and only 12% want life-prolonging care.

The Primary Palliative Care for Emergency Medicine (PRIM-ER) pragmatic clinical trial will address this gap in the delivery of goal-directed emergency care of older adults. PRIM-ER will implement primary palliative care in a diverse group of 35 emergency departments. The trial will test the hypothesis that older patients with serious, life-limiting illness who receive care from clinicians with primary palliative care skills are less likely to be admitted to inpatient settings, are more likely to be discharged home or to palliative care service, and will have higher home health and hospice use, fewer inpatient days and intensive care unit admissions at 6 months, and longer survival than patients receiving care before implementation of the intervention.

“Giving emergency nurses, physician assistants, doctors the knowledge and skills they need to better care for patients with serious illness will ease symptom burden, improve quality of life, and get patients to the places where they want to be at the end of life.”

As a new addition to the NIH Collaboratory’s family of innovative Demonstration Projects, the PRIM-ER trial will feature evidence-based, multidisciplinary primary palliative care education; simulation-based workshops on communication in serious illness; clinical decision support, and provider audit and feedback.

PRIM-ER is led by principal investigator Dr. Corita Grudzen of New York University with support from the National Institute on Aging and the National Center for Complementary and Integrative Health. Watch a video interview with Dr. Grudzen, and read more about PRIM-ER.

August 23, 2018: PROVEN Team Uses PRECIS-2 to Evaluate Ongoing Trial Implementation

A tool used to rate how the design of a pragmatic clinical trial will influence the real-world applicability of its results can also be used in real time to assess the impact of changes in trial implementation, a recent study published in Trials found.

When designing a pragmatic trial to test the effectiveness of an intervention under “real-world” conditions, researchers use the Pragmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) to assess how a variety of design features may affect the applicability of trial results for the intended users. A pragmatic trial differs from a traditional “explanatory” trial, which tests the efficacy of an intervention under ideal conditions. PRECIS-2 rates design features on a scale from “explanatory” to “pragmatic” within several domains. The end users of trial results, such as health care systems, may need the results to be more or less “pragmatic” on the explanatory–pragmatic spectrum in order to implement the intervention in their own care delivery settings.

In a novel effort, researchers with the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) used PRECIS-2 during the conduct of the trial to assess the effects of midtrial changes in implementation. PROVEN, an ongoing NIH Collaboratory Demonstration Project, is a pragmatic, cluster randomized trial evaluating the effectiveness of video-assisted decision support tools for advance care planning in nursing homes.

In the initial design of PROVEN, design features in the implementation-focused domains of PRECIS-2 were relatively pragmatic, especially in the domain measuring flexibility in the delivery of the intervention. As the trial progressed, adaptations in implementation that were necessary to address challenges in monitoring and protocol adherence led to more explanatory approaches. The investigators concluded that some pragmatic trials, such as those conducted in complex health care systems like nursing homes, “may benefit from a more dynamic approach to implementation which allows for fluidity between pragmatic and explanatory features.” PRECIS-2 can be useful in evaluating the impact of midtrial adaptations with these dynamic approaches to trial implementation.

PROVEN is one of the first large-scale pragmatic trials to be conducted in nursing homes. Learn more about PRECIS-2 in the Living Textbook.

August 14, 2018: Interview With NIH Collaboratory Leadership Highlights New Demonstration Projects

In a recent video interview, NIH Collaboratory leaders Dr. Lesley Curtis, Dr. Adrian Hernandez, and Dr. Catherine Meyers share their enthusiasm for the Collaboratory’s 6 new Demonstration Projects. The projects include new areas of expertise, such as pediatrics, new digital technologies, and the Collaboratory’s first A vs B trial.

“The new demonstration projects coming into the Collaboratory provide the opportunity to generate more knowledge and new knowledge about what works best in these settings. That’s really exciting.”—Lesley Curtis, PhD

August 10, 2018: STOP CRC Trial Finds Higher Rates of Colorectal Cancer Screening in Community Clinics Using an EHR-Based Outreach Tool

The primary results of the Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC) trial, an NIH Collaboratory Demonstration Project, were published online this week in JAMA Internal Medicine. The analysis found that colorectal cancer screening rates were higher in community clinics that implemented a mailed fecal immunochemical test (FIT) outreach program than in clinics that practiced usual care. The improved screening rates occurred despite low and highly variable rates of implementation of the program among participating clinics.

Almost half of eligible adults in the United States are not up to date with recommended screening for colorectal cancer, the second leading cause of cancer-related deaths. Screening rates are especially low among racial/ethnic minority and low-income populations, including those served at federal qualified health center clinics.

The STOP CRC trial tested a program to improve colorectal cancer screening rates in 26 clinics within 8 federal qualified health centers. The intervention involved embedding a tool in the electronic health record to identify patients who were overdue for colorectal cancer screening, mailing a FIT kit and reminder letter to eligible patients, and implementing a practice improvement process at participating clinics. Of the 26 clinics in the study, 13 received the intervention and 13 practiced usual care.

Compared with clinics that practiced usual care, intervention clinics had a significantly higher proportion of participants who completed a FIT (3.4 percentage points) and any colorectal cancer screening (3.8 percentage points). The higher screening rates occurred despite another important finding of the study, that low rates of implementation of the intervention were common. Higher rates of implementation were correlated with higher rates of FIT completion.

The STOP CRC experience offers lessons on how to use electronic health records to improve guideline-based screening. In a recent NIH Collaboratory Grand Rounds, investigators Dr. Gloria Coronado and Dr. Beverly Green presented findings from the trial and lessons from the implementation of the intervention. Download a study snapshot about the STOP CRC trial.

Additional reading:

Read the press release from the Kaiser Permanente Center for Health Research: Community Health Centers Can Help Boost Rates of Colorectal Cancer Screening, Kaiser Permanente Study Shows

Read Dr. Beverly Green’s blog post on the Kaiser Permanente Washington Health Research Institute’s Healthy Findings blog: Community Health Centers Can Boost Colon Cancer Screening

May 5, 2018: New Article Explores Opportunities for Funding the Training of Future Health Services Researchers

In a new article, Dr. Vincent Mor, an NIH Collaboratory investigator, and Dr. Paul Wallace describe the history, current status, and opportunities for funding training in health services research (HSR). While the number of organizations seeking to solve problems with health services research has been expanding, direct government support for HSR is declining. The authors project 5 key challenges for the field and its professional development:

  • Formulating and prioritizing research topics
  • Whether to use team- or individual-based approaches
  • How new data sources, analytic methods, and the need for faster results affect supply and demand for HSR
  • Shifts from public to institutional funding and the associated effects on generalizability
  • Balancing proprietary concerns regarding data, predictive models, and study results with the need to improve public health and rapidly disseminate information

According to the authors, sustainable solution will involve active collaboration between those who use HSR as a part of decision-making (and will likely pay for it) and those who produce it.

“We believe that the key change needed to productively address the above challenges will be a closer collaboration between HSR users, especially health systems, and academic HSR training programs to work towards producing timely, internally relevant, and externally generalizable knowledge (Mor and Wallace 2018).”

Dr. Mor is a principal investigator for the Pragmatic Trial of Video Education in Nursing Homes (PROVEN) trial, one of the NIH Collaboratory Demonstration Projects.

Mor V, Wallace P. 2018.  Funding the Training of Future Health Services Researchers. Health Services Research. doi:10.1111/1475-6773.12844.

April 9, 2018: PPACT Study Design Paper Published

Congratulations to Dr. Lynn DeBar and the investigators of the Collaborative Care for Chronic Pain in Primary Care pragmatic trial for recently publishing their study design paper. One of the NIH Collaboratory Demonstration Projects, the trial is designed to test whether a primary care–based behavioral intervention the Pain Program for Active Coping and Training (PPACT)—will provide a “more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment” than usual care for patients on chronic opioid treatment (Debar et al 2018). Learn more about this innovative trial in the article in Contemporary Clinical Trials. You can also download a trial snapshot.

Full Citation: DeBar L, Benes L, Bonifay A, et al. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial. Contemporary Clinical Trials. 2018;67:91-99. doi:10.1016/j.cct.2018.02.015

January 19, 2018: New Research Methods Resources Website on Group- or Cluster-Randomized Studies

The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.

December 7, 2017: Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video

In a new video in the Living Textbook, Dr. Greg Simon describes the differences between individual, cluster, and stepped-wedge randomization using props, including marbles, Play-Doh, and glassware.

“In the end, it’s all about randomly assigning who gets which treatment, or who gets which treatment when, so that we’re able to make some un-biased judgement about which treatment is really better.” —Greg Simon, MD

November 3, 2017: Dr. Miguel Vazquez Shares Lessons From the Improving Chronic Disease Management with Pieces (ICD-Pieces) Trial

In this interview, Dr. Miguel Vazquez gives an update on the first years of the Improving Chronic Disease Management with Pieces (ICD-Pieces) trial. Dr. Vazquez discussed the status of his trial, challenges and surprises, and advice he has for new investigators.

“Try to really learn from others who have done this—even if you are the first one doing your specific trial with your specific questions. It was helpful for us to learn from the other Collaboratory projects; they had already faced some problems, and we were able to anticipate and develop solutions proactively.” – Dr. Miguel Vazquez

Read more from Dr. Vazquez in the full interview (PDF).