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.
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.
From left: Dr. Steven George, Dr. Vincent Mor, and Dr. Angelo Volandes
In an interview at this year’s NIH Pragmatic Trials Collaboratory Steering Committee annual meeting, Drs. Steven George, Vincent Mor, and Angelo Volandes discussed the complexity of intervention delivery in pragmatic clinical trials and the impact it can have on researchers’ ability to discern trial results.
“Without delving deeply into the way in which an intervention can be integrated into an operating system in all of its detail, you will probably make a mistake, and that mistake can impact whether or not your intervention achieves its intended results,” Mor said.
Intervention delivery complexity should be considered early on for pragmatic trials. It is shaped by such factors as new workflows, special training of frontline staff, and the number of components in the intervention.
“We need to understand how we get from point A to point B to point Z, and that’s not something that we do in traditional efficacy trials,” said Volandes.
To characterize this complexity, the NIH Pragmatic Trials Collaboratory worked with its NIH Collaboratory Trial investigators to understand critical drivers of complexity that affected investigators’ ability to implement their interventions and discern treatment effects. The resulting Intervention Delivery Complexity Calculator addresses 6 domains:
Internal factors pertain primarily to the intervention itself:
The degree to which the intervention requires reengineering of existing workflows and tasks
The number of components in the intervention
The level of familiarity or extra training needed for those delivering the intervention
External factors are related to intervention delivery at the systems level:
The degree to which intervention delivery is dependent on the setting in which it is implemented
The number of healthcare systems and clinics involved in delivering the intervention
The number of steps between the intervention and the intended outcome
“We as investigators probably don’t think enough about how health systems operate,” Mor said. “Thinking about intervention delivery complexity can help us start to think about things from an operations context.”
The new tool will be used as part of onboarding trials in the NIH Pragmatic Trials Collaboratory and the National Institute on Aging’s IMPACT Collaboratory, which is focused on pragmatic trials for people living with dementia. The tool can be used during the trial review and funding process all the way through sustainability efforts after a trial has been completed.
George explained, “Intervention delivery complexity is strongly linked to sustainability efforts. Even if you can implement an embedded intervention as part of a trial, if it has a lot of external domain complexity, the intervention could be vulnerable after the trial is completed.”
“By understanding the complexity of intervention delivery, investigators could start thinking about scaled down versions of an intervention, which could help with sustainability,” he added.
The tool was developed to enable conversations with investigators and their teams to think through delivery of the intervention, identify the most complex domains, and consider whether something can be done to reduce complexity.
“The tool moves the idea of complexity regarding delivery of the intervention from something that was an abstract concept to something with structure,” George said.
Future versions of the tool could address the relationship between intervention complexity and adaptations in trials to explore impacts on implementation outcomes. More complex interventions may require a greater number of adaptations to be implemented. Sources of adaptation can include service setting adaptations, target audience adaptations, and mode of delivery adaptations, but there is little understanding about who is making the changes and why.
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.
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.
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.
In this Friday’s PCT Grand Rounds, Angelo Volandes of Dartmouth Health and James Tulsky of Dana-Farber Cancer Institute will present 
