September 7, 2018: Spotlight on a New Demonstration Project: HiLo

Kidney transplantation is the preferred treatment for patients with end-stage renal disease (ESRD), but an insufficient organ supply renders dialysis the only viable treatment option for most patients. Though clinical outcomes among patients receiving dialysis have improved modestly in recent years, annual rates of hospitalization and mortality remain unacceptably high, and quality of life is poor. Poor outcomes are driven primarily by increased risk of cardiovascular disease (CVD), but interventions that improve outcomes in the general population by targeting traditional CVD risk factors have mostly failed in patients with ESRD. Current clinical practice guidelines advocate aggressive treatment of high serum phosphate to near-normal levels using dietary phosphate binders and restrictive diets. The benefits of this approach, however, are unproven, the optimal serum phosphate target remains unknown, and potential harms of aggressive treatment have not been definitively identified.

The Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo) plans to address these clinically important questions in a large, pragmatic, cluster-randomized trial that will evaluate the effects of liberalizing the serum phosphate target (“Hi”) versus maintaining aggressive phosphate control (“Lo”) for patients receiving treatment with maintenance hemodialysis.

 “The question at hand is something we grapple with on a daily basis in every dialysis facility across the country. Either answer will be important new information that will help us do a better job taking care of patients and hopefully improve their quality of life.”

HiLo is led by Myles Wolf, MD, of Duke University with support from the National Institute of Diabetes and Digestive and Kidney Diseases. Read more about HiLo.

September 6, 2018: Spotlight on a New Demonstration Project: ACP PEACE

Because many clinicians do not have the skill set to engage patients in conversations about advance care planning (ACP), many older Americans with advanced cancer receive aggressive interventions at the end of life that do not reflect their values, goals, and preferences. The ACP PEACE trial is investigating whether a comprehensive approach to ACP improves patient outcomes. The program will combine two evidence-based complementary interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). The goal is to provide both patients and clinicians with communication skills and tools so they can make informed decisions about end-of-life care.

“We’re doing an intervention where we include videos for patients about what the possible interventions are, and we’re also training the clinicians, the oncologists and their teams to have better communication about their goals of care and about treatment planning.” —James Tulsky, MD, Co-Principal Investigator of the ACP PEACE trial.

ACP-PEACE is one of the new NIH Collaboratory Demonstration Projects and is led by Drs. James A. Tulsky and Angelo Volandes with support from the National Institute on Aging. Read more about ACP PEACE.

James Tulsky from NIH Research Collaboratory on Vimeo.

 

September 5, 2018: Spotlight on a New Demonstration Project: GGC4H

Before the end of high school, more than half of all adolescents will use an illicit drug, about a quarter will meet the criteria for depression, and many others will engage in behaviors such as delinquency and violence. Guiding Good Choices is a universal evidence-based anticipatory guidance curriculum for parents of early adolescents that has been shown to reduce adolescent alcohol, tobacco, and marijuana use; depression; and delinquent behavior. Evidence-based parenting interventions shown to prevent these behavioral health concerns could improve adolescent health trajectories if implemented widely in pediatric primary care.

The Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (GGC4H: Guiding Good Choices for Health) is a cluster-randomized trial that will partner with pediatric primary care clinics to offer the training in three large, integrated healthcare systems serving socioeconomically diverse families.

“We already have an effective intervention, so we’re not trying to test whether it works or not; it’s really about getting the intervention into a population.”  —Richard Catalano, PhD, co-Principal Investigator of the GGC4H trial.

GGC4H is led by Richard Catalano, PhD, Margaret Kuklinski, PhD, and Stacy Sterling, DrPH, with support from the National Center for Complementary and Integrative Health. Read more about GGC4H.

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 28, 2018: Spotlight on a New Demonstration Project: Nudge

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management offer new opportunities to influence patients’ health behaviors and improve health outcomes.

“One of the real benefits of using technology is that it can be widely disseminated. Studying that dissemination process is really where we are in the field. So a pragmatic trial makes a lot of sense.” — Sheana Bull, PhD, MPH

The NIH Collaboratory is pleased to welcome the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) study to its portfolio of Demonstration Projects. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral “nudges” to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated healthcare delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia.

The Nudge study is led by co–principal investigators Drs. Sheana Bull and Michael Ho of the University of Colorado with support from the National Heart, Lung, and Blood Institute. Watch a video interview with Drs. Bull and Ho, and read more about Nudge.

 

August 20, 2018: Spotlight on a New Demonstration Project: EMBED

The NIH Collaboratory is pleased to introduce the Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED). Led by co–principal investigators Dr. Ted Melnick and Dr. Gail D’Onofrio of Yale University, and supported by the National Institute on Drug Abuse, EMBED is a pragmatic, multicenter, group-randomized trial that will implement and evaluate a user-centered clinical decision support tool to facilitate the initiation of buprenorphine/naloxone therapy for opioid use disorder in emergency departments.

The intervention consists of computerized treatment guidance for emergency department physicians and is embedded in the existing care delivery workflow. By conducting the study under real-world conditions and employing passive collection of structured data from the electronic health record, EMBED will use an innovative approach to address public health concerns about opioid use in the United States. Watch a video interview with Dr. Melnick, and read more about EMBED.

“This is an area where there is already good efficacy data for the practice of ED-initiated buprenorphine treatment for patients with opioid use disorder, but the practice is not part of routine care right now.” — Ted Melnick, MD, MHS

 

EMBED is 1 of 6 new large-scale clinical trials launched by the NIH Collaboratory in 2018. The Demonstration Projects are multicenter pragmatic trials that engage healthcare delivery systems in research partnerships to gather real-world evidence and answer clinical questions of major public health importance. Learn more about the Demonstration Projects.

August 9, 2018: New Interview with Dr. David Shurtleff about the NIH Collaboratory

In a recent video interview, Dr. David Shurtleff, acting director of the National Center for Complementary and Integrative Health (NCCIH), discusses the unique work of the Collaboratory in bringing together multiple NIH Institutes and Centers to develop best practices, methods, guidance, and tools for conducting rigorous pragmatic research.

“The Collaboratory has been transformative in how it’s developed a novel, supportive infrastructure to conduct pragmatic research in a way that allows it to be embedded within healthcare systems.” David Shurtleff, PhD

July 30, 2018: Learn More About the New NIH Collaboratory Demonstration Projects

Check out the new program materials from the Collaboratory:

Study information for the 6 new UG3 Demonstration Projects:

  • ACP PEACE: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
  • EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder
  • GGC4H: Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (Guiding Good Choices for Health)
  • Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
  • PRIM-ER: Primary Palliative Care for Emergency Medicine
  • HiLo: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis

In addition, the May 2018 Steering Committee Meeting materials are now available, including presentations from the UG3 and UH3 Demonstration Projects and the full-day intensive workshop “Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions.”

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

February 15, 2018: Timely Tips from Demonstration Project Principal Investigators

The NIH Collaboratory will soon welcome a new group of Demonstration Projects and guide them through the piloting and implementation phases of their embedded pragmatic clinical trials (ePCTs). We asked three seasoned principal investigators—Drs. Laura Dember, MD (TiME), Lynn DeBar, PhD (PPACT), and Jerry Jarvik, MD, MPH (LIRE)­—to share tips and advice for investigators who are new to ePCTs.

Download the PDF.

“Integrate really well with the key stakeholders from your sites.”
– Lynn DeBar, PhD

“Engage with senior mentors and people who have gone down this road before.” – Jerry Jarvik, MD, MPH

“Recognize that the perspectives of key stakeholders may be different than anticipated by investigators.” – Laura Dember, MD