In a study that used large language models (LLMs) to adjudicate documented goal-concordant care from longitudinal electronic health record (EHR) data, LLM-based ratings and rationales were broadly consistent with human adjudication. The study suggests that LLM-based tools show promise as complementary adjudicators of such records in research that would otherwise rely on labor-intensive manual chart review.
The proof-of-concept study used data from the ACP PEACE trial and one other pragmatic clinical trial of advance care planning interventions. ACP PEACE, an NIH Collaboratory Trial, evaluated the delivery of a video decision aid to patients together with goals-of-care communication skills training to oncology clinicians.
In the study, LLM-based ratings compared favorably with human ratings in a highly structured review of longitudinal records for goal-concordant care. However, the study also highlighted the subjectivity of such assessments. The authors stress that LLM-based tools should be viewed as complements to human review, rather than replacements, especially in complex and ambiguous cases.
The planning phase of a pragmatic clinical trial is a critical time when research teams can hone their research questions, build relationships with healthcare system and community partners, and test assumptions about the trial’s implementation in real-world settings. At the NIH Collaboratory’s 2026 Annual Steering Committee Meeting, we spoke with Angelo Volandes and Sebastian Tong about the role of feasibility assessment in planning a successful trial.
“I think the biggest challenge for the feasibility assessment for pragmatic trials is one that we probably don’t talk enough about, and that’s the tension between meeting the timetable, the milestones, and an honest discovery process,” said Volandes. Volandes is the Anna Gundlach Huber Professor in Medicine at the Geisel School of Medicine and a co–principal investigator for ACP PEACE, an NIH Collaboratory Trial.
“So, from a principal investigator’s perspective, the way I suggest to others that they navigate this is to treat it as an investigation: generate hypotheses, collect data,” he said.
“[In the NIH Collaboratory’s Core Working Groups], I was open about the problems we had with engaging in rural areas and minoritized populations, and I got a lot of feedback about how we best engage with community partners,” recalled Tong, an associate professor of family medicine at the University of Washington and a co–principal investigator for AIM-CP, an NIH Collaboratory Trial.
“I wouldn’t have gotten that if I hadn’t been open about the problems we were having,” Tong said.
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.
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.
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.
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.
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.
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.
“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.
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.
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.
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.
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.
IMPACt-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.
ACP 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, 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.
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.
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.
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.
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.