December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory

A collage of journal covers with the label "NIH Pragmatic Trials Collaboratory 2025 Publications Roundup"In 2025, NIH Pragmatic Trials Collaboratory investigators published new study designs and trial results, shared insights from program leadership, and developed innovative methods in the design, conduct, implementation, and dissemination of pragmatic clinical trials. Their work included perspectives from the Coordinating Center, best practices from the Core Working Groups, and results from the NIH Collaboratory Trials.

The program contributed 45 articles to the peer-reviewed literature this year, including the primary results of the ACP PEACE, BackInAction, HiLo, INSPIRE, and PRIM‑ER trials. Cross-Core and cross-Trial collaborations led to the sharing of important lessons from the conduct of multiple NIH Collaboratory Trials.

The total number of published articles from the program reached 386.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Distributed Research Network

Core Working Groups

Biostatistics and Study Design Core

Community Health Improvement Core

Electronic Health Records Core

Ethics and Regulatory Core

Health Care Systems Interactions Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

ACP PEACE

ARBOR-Telehealth

BackInAction

BeatPain Utah

BEST-ICU

EMBED

FM-TIPS

GGC4H

GRACE

HiLo

I CAN DO Surgical ACP

IMPACt-LBP

INSPIRE

iPATH

LIRE

MOMs Chat & Care Study

NOHARM

Nudge

OPTIMUM

PRIM-ER

SPOT

TAICHIKNEE

May 19, 2025: Latest Podcast Episode Features the Results of ACP PEACE

In a new episode of our Rethinking Clinical Trials Podcast, Drs. Angelo Volandes and James Tulsky speak with host Dr. Adrian Hernandez about the results of the ACP PEACE study.

Listen and subscribe to the podcast on SoundCloud or Apple Podcasts.

ACP PEACE, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial testing the delivery of a video decision aid to older patients with advanced cancer together with goals-of-care communication skills training to oncology clinicians in 3 healthcare systems. The results of the study were published this month in JAMA Network Open.

May 13, 2025: Video Decision Aid and Clinician Communication Training Boost Advance Care Planning in Oncology Clinics

Headshots of Dr. James Tulsky and Dr. Angelo Volandes
Dr. James Tulsky and Dr. Angelo Volandes, principal investigators for ACP PEACE

A video decision aid for older patients with advanced cancer, coupled with communication skills training for clinicians, led to higher rates of documented advance care planning in oncology clinics, according to the ACP PEACE study.

The results of the study were published in the May issue of JAMA Network Open.

Many older adults with advanced cancer do not discuss treatment preferences or goals of care with their clinicians. Lack of communication about patients’ preferences can lead to patients receiving care that does not match their values.

ACP PEACE, an NIH Collaboratory Trial, was a stepped-wedge, cluster randomized trial testing the delivery of a video decision aid to patients together with goals-of-care communication skills training to oncology clinicians in 3 healthcare systems. The study included 13,800 patients at 29 clinics. Each clinic was randomly assigned to either the intervention or usual care at the beginning of the study. Due to the stepped-wedge design of the trial, all clinics were exposed to the intervention by the end of the study.

Logo for the ACP PEACE Demonstration Project

The intervention included an evidence-based, patient-facing video decision aid available in 25 languages. It also included a communication training program to improve clinicians’ skills in delivering serious news, responding to emotion, and eliciting patients’ goals. The primary outcome was documentation of advance care planning in the electronic health record, which could include documentation of a goals-of-care conversation, palliative care, hospice, or limitation of life-sustaining treatments.

The proportion of patients with documentation of advance care planning was greater with the ACP PEACE intervention than with usual care. The difference was attributable to a greater proportion of patients in the intervention phase having a goals-of-care conversation. There were no significant differences between the intervention and usual care for the documentation of palliative care, hospice, or limitation of life-sustaining treatments.

Read the full article.

“By focusing concurrently on both clinicians and patients—giving clinicians the skills to have these difficult conversations and preparing patients to engage with them—we were able to increase the number of documented goals-of-care conversations,” said James Tulsky, the Poorvu Jaffe Chair in Supportive Oncology at the Dana-Farber Cancer Institute and a co–principal investigator for ACP PEACE.

“If we are going to achieve shared decision-making, we need to bring everyone onto the same page,” Tulsky said.

Angelo Volandes, the Anna Gundlach Huber Professor in Medicine at the Geisel School of Medicine at Dartmouth and a co–principal investigator for ACP PEACE, highlighted the logistical challenge of conducting a large pragmatic clinical trial across 3 major healthcare systems during the COVID-19 pandemic.

“What made it work was a shared commitment—from frontline clinicians to healthcare system leaders—to ensure that older adults with advanced cancer had the opportunity to reflect on their values and have those conversations documented,” Volandes said.

“This trial wasn’t just about changing documentation rates, it was about changing the culture of communication, at scale,” he added.

ACP PEACE is supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute on Aging.

Learn more about ACP PEACE.

April 22, 2025: New Report Highlights Value of Informing Participants About Research Conducted Under a Waiver of Consent

Even in minimal-risk studies that do not use the standard consent process, there may be value in informing participants about the research. Such notifications should be considered the default for clinical trials conducted under a waiver of informed consent, argue the authors of a new report from the NIH Pragmatic Trials Collaboratory.

The open-access article was published online ahead of print this week in Learning Health Systems.

Pragmatic clinical trials conducted in the context of routine healthcare often meet the regulatory criteria for a waiver or alteration of the standard informed consent process. In such cases, researchers and reviewers might assume there is no reason to communicate information about the study to participants. However, providing information to participants, even in minimal-risk research conducted with a waiver of consent, can promote important ethical values.

Experts from the NIH Collaboratory’s Ethics and Regulatory Core teamed up with investigators from several of the NIH Collaboratory Trials to describe methods of informing participants in minimal-risk research.

The investigators used a variety of notification approaches in their studies, including letters and email campaigns, posters in waiting rooms and other common areas, conversations with clinicians, and presentations at staff meetings. The amount of information provided to participants ranged from a general statement that research was being conducted at the institution to detailed information about the study in question.

“When a study is approved with a waiver of research consent, investigators and review committees should consider on a case-by-case basis what information, if any, to disclose to participants, and how it will be disclosed,” the authors wrote. The costs, benefits, and feasibility of these approaches vary from study to study.

Communicating information to participants can promote several important goals:

  • The ethical principle of respect for persons
  • Participants’ understanding of the study and of research in general
  • Participants’ understanding of their contributions to the research
  • Participants’ ability to voice and discuss any concerns about the study
  • Participant engagement in research
  • Trust in research and researchers

“Providing information to the participants should thus be the default for trials conducted under a waiver of research consent,” the authors wrote.

Read the full report.

February 12, 2025: Results of ACP PEACE, an NIH Collaboratory Trial, in This Week’s PCT Grand Rounds

Logo for the ACP PEACE Demonstration ProjectIn this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present “A Cluster Randomized, Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults With Cancer (ACP-PEACE).”

The Grand Rounds session will be held on Friday, February 14, 2025, at 1:00 pm eastern.

ACP PEACE, an NIH Collaboratory Trial, is evaluating a comprehensive advance care planning program for older patients with advanced cancer that combines clinician communication skills training and patient video decision aids.

Volandes is a professor of medicine and the vice chair for research in the Department of Medicine at Dartmouth Health and the Geisel School of Medicine at Dartmouth. Tulsky is a professor of medicine at Harvard Medical School and the Poorvu Jaffe Chair of Supportive Oncology at the Dana-Farber Cancer Institute.

Join the online meeting.

July 26, 2022: Three NIH Collaboratory Trials Share Progress on Planning, Implementation, and Completion

At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 NIH Collaboratory Trials in different phases of the trial life cycle. IMPACt-LBP launched last fall and is completing its 1-year planning phase. ACP PEACE is nearing the end of its implementation phase. SPOT ended last year and published its main outcomes in February.

Learn more about these innovative NIH Collaboratory Trials in the brief video updates below.


Logo for the IMPACt-LBP NIH Collaboratory TrialIMPACt-LBP, currently in the 1-year planning phase, will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes. The study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center. Learn more about IMPACt-LBP.


Logo for the ACP PEACE NIH Collaboratory TrialACP PEACE, currently in the implementation phase, is testing an advance care planning program that combines clinician communication skills training and patient video decision aids. ACP PEACE is focused on patients with advanced cancer and their clinicians in oncology settings. The study is administered by the National Institute on Aging and is led by Drs. Angelo Volandes and James Tulsky of Harvard Medical School. Learn more about ACP PEACE.


SPOT NIH Collaboratory Trial logoSPOT, a recently completed pragmatic trial that published its main outcomes earlier this year, compared 2 low-intensity outreach programs—care management and dialectical behavior therapy skills training—to usual care in adults at risk of self-harm or suicidal behavior. The study was administered by National Institute of Mental Health and was led by Dr. Greg Simon of the Kaiser Permanente Washington Health Research Institute. Learn more about SPOT.

 

March 24, 2022: ACP-COVID Intervention Associated With Higher Rates of Advance Care Planning

Headshots of Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc
Left to right: Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc

A program consisting of video decision aids for patients and communication skills training for clinicians was associated with higher rates of documentation of advance care planning among older adults, especially African American and Hispanic patients, in a recent study from the NIH Pragmatic Trials Collaboratory.

The COVID-19 pandemic has led to disproportionately higher death rates among older adults and racial and ethnic minority groups. Improving access to advance care planning for these groups, as in other high-risk populations, could help patients receive care that reflects what matters most to them.

The Advance Care Planning: Communicating With Outpatients for Vital Informed Decisions (ACP-COVID) study was a pre-post, open-cohort nonrandomized controlled trial comparing rates of advance care planning documentation among older patients in an ambulatory care network of 22 clinics in the New York City metropolitan area. Outcomes were measured during a 6-month pre–COVID-19 baseline period, a 6-month period during the first wave of the COVID-19 public health emergency, and a 6-month intervention period.

The study’s results were published in JAMA Network Open.

Video decision aids were shared with all patients 65 years or older up to 2 weeks before an in-person or telehealth appointment in the participating clinics. The videos addressed choosing a healthcare proxy, having an advance care planning conversation, and information about COVID-19 and vaccinations. Communication skills training was offered to all clinicians in the practices.

Rates of advance care planning documentation were much higher during the intervention period compared with the 2 other study periods. In addition, African American and Hispanic patients were more likely than non-Hispanic White patients to have advance care planning documentation during the intervention period, groups which also had higher exposure to serious COVID-19 illness during the study.

Watch a recent COVID-19 Grand Rounds session about the ACP-COVID study.

ACP-COVID was supported within the NIH Pragmatic Trials Collaboratory by the NIH Common Fund through a cooperative agreement for the ACP-PEACE NIH Collaboratory Trial from the National Institute on Aging and by supplemental funding from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about ACP PEACE.

March 2, 2022: COVID-19 Grand Rounds to Share Findings of ACP COVID Study of Advance Care Planning

Headshots of Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc
Dr. Angelo Volandes, Dr. James Tulsky, and Sophia Zupanc

In this Friday’s COVID-19 Grand Rounds session, Dr. Angelo Volandes of Massachusetts General Hospital and Dr. James Tulsky and Sophia Zupanc of Dana-Farber Cancer Institute will present “ACP COVID: A Trial to Evaluate an Advance Care Planning Video and Communication Skills Training Intervention for Older Adults During an Evolving Pandemic.” The study is supported by a supplemental grant award to the investigators of ACP PEACE, an NIH Pragmatic Trials Collaboratory Trial.

The Grand Rounds session will be held on Friday, March 4, at 1:00 pm eastern. Join the online meeting.

The NIH Pragmatic Trials Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

August 2, 2021: Can a Primary Care Telehealth Intervention Change the Paradigm for Advance Care Planning?

A supplemental grant to the ACP PEACE study team will test the ability of a telehealth program to improve rates of advance care planning among older patients in primary care in a large healthcare system. Dr. Angelo Volandes and Dr. James Tulsky discussed the new study in a Zoom-based interview after the NIH Collaboratory’s annual steering committee meeting.

Volandes said colleagues contacted him early in the COVID-19 pandemic because they felt unprepared to have conversations with patients and their caregivers about advance care planning in primary care. So, he wondered, “What If we could create a telehealth program where we trained clinicians to have these conversations and also empowered patients and caregivers to better understand their options when it came time to making decisions about serious illness like COVID-19?” Volandes is a physician at Brigham and Women’s Hospital and an associate professor of medicine at Harvard Medical School.

The new study will expand on ACP PEACE, an NIH Collaboratory Trial, which is testing implementation of an advance care planning program that combines clinician communication skills training and patient video decision aids. ACP PEACE is focused on patients with advanced cancer and their clinicians in oncology settings.

Both the new study and ACP PEACE will assess how advance care planning practices changed after the start of the COVID-19 pandemic. View the full video.

“The fact that we’re studying time periods before and after COVID…will help us see the extent to which advance care planning shifted during this time period and will help us understand better the results we see in the oncology community [and] what’s happening in the primary care community,” said Tulsky, a co–principal investigator for both studies. Tulsky is chief of psychosocial oncology and palliative care at the Dana-Farber Cancer Institute and a professor of medicine at Harvard Medical School.

Tulsky added that the study team will learn the value of implementing advance care planning over telehealth. Also, he said, “many of the conversations oncologists are planning for are quite late in the course of care, and this is much earlier, and so we’ll see if that makes a difference.”

“Advance care planning isn’t going to be something just for the purview of people with an advanced serious illness…but rather this is something that we all will need to talk about,” said Volandes. “So I really do think this is going to be a culture shift for healthcare more broadly, but also we’re going to see healthcare systems start prioritizing it beyond, say, patients with advanced serious illness to make it the new normal for everybody.”

ACP PEACE is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging and receives logistical and technical support from the NIH Collaboratory Coordinating Center.

 

Screen shot of an interview with Dr. Angelo Volandes
Dr. Angelo Volandes