Grand Rounds Archive

Grand Rounds February 14, 2025: A Clustered-Randomized Stepped-Wedge Pragmatic Trial to Enhance Goals-of-Care Communication for Older Adults with Cancer (ACP PEACE) (Angelo Volandes, MD, MPH; James A. Tulsky, MD)

Posted on by Sophia Ramirez

Speakers

Angelo Volandes, MD, MPH
Vice Chair of Research, Department of Medicine
Dartmouth Health
Professor of Medicine, Geisel School of Medicine

James A. Tulsky, MD
Poorvu Jaffe Chair, Department of Supportive Oncology
Dana-Farber Cancer Institute
Professor of Medicine, Harvard Medical School

Keywords

Palliative Care; Goals of Care; Advanced Care Planning; Cancer; Oncology

Key Points

  • Cancer is one of the leading causes of death for people age 65 and older, and patients have diverse preferences for medical care. However, most patients are unfamiliar with advance care planning (ACP) and clinicians are often unprepared to discuss it. Ultimately, many patients do not have goals-of-care (GOC) conversations with their providers, leading to billions of dollars in unwanted (and painful) interventions.
  • The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE) trial tested a pair of interventions – ACP Decisions and Vitaltalk – to help prepare clinicians and elderly patients to have GOC conversations.
  • ACP Decisions consists of short, accessible video decision aids that aim to help patients share in decision making. They offer a scalable, speedy strategy to improve GOC, and were associated with an increase in GOC conversations in smaller trials.
  • Vitaltalk is a communication training for clinicians discussing goals of care in serious illness. It is evidence-based, designed around the idea that learning new skills requires practice, observation, and feedback. Vitaltalk is associated with documented improvement in conversation quality.
  • ACP PEACE was a large, pragmatic, multicenter stepped-wedge trial that compared an intervention period and a control period, AKA usual care. The trial occurred across three healthcare systems (A, B, and C) and began with 36 clinics, 6 months before the onset of the COVID-19 pandemic. In April 2020, the trial was re-randomized across 29 clinics.
  • Participants were 65 and older with advanced cancer. The primary endpoint was documentation of a GOC conversation.
  • The study team found a 6.8% increase in ACP documentation during the intervention period, driven by a 6.9% increase in documented GOC conversations. There was no statistically significant increase in documentation of referrals to palliative care or to hospice. There was no statistically significant decrease in the limitation of life-sustaining treatments.
  • The results varied significantly by healthcare system. In Healthcare System A, documentation decreased by nearly 8% over the course of the study – whereas in Healthcare Systems B and C, it increased by 11% and 8.3%, respectively.
  • The researchers considered whether GOC conversation documentation was the right target. There has been a conversation in palliative care about how helpful these documents are; goal-aligned medical care (goal concordance) might be a better target.
  • Volandes and Tulsky noted that the approach to pragmatic clinical trials should better reflect the shifting nature of healthcare in the U.S. Researchers in this space must be better stewards of limited resources, so that interventions are sustainable and outcomes are useful to decision-makers.

Discussion Themes

Efforts to enhance rigor in intervention development may prevent effective interventions from getting to scale. Leaders in this space need to make it easier to get implement and test interventions, even if that means they aren’t perfectly optimized.

Right now, researchers are disincentivized to move quickly during the UG3 start-up year. Funders could incentivize research teams to move more quickly, e.g., by encouraging them to use leftover funds to conduct another study.

People in healthcare don’t see 10 years ahead – they see 1 to 2 years ahead. If pragmatic trials are meant to inform decision makers, it’s incumbent on researchers to provide the information healthcare systems need in a manner that is not outdated.

Ongoing partnerships with appropriate health systems can provide a platform for more efficient intervention implementation across different areas of healthcare. For instance, the research team conducted three other trials in Healthcare System C within the time it took them to complete ACP PEACE.

Grand Rounds February 7, 2025: Improving Symptom Control in Pediatric Cancer Patients With SSPedi and SPARK (Lillian Sung, MD, PhD)

Posted on by Sophia Ramirez

Speaker

Lillian Sung, MD, PhD
Canada Research Chair in Pediatric Oncology Supportive Care
Division of Haematology/Oncology
Chief Clinical Data Scientist
The Hospital for Sick Children
Ontario, Canada

Keywords

Cancer; Pediatrics; Cancer Symptoms; Symptom Control

Key Points

  • Symptom control in pediatric cancer patients is very poor; almost all children undergoing treatment for cancer will experience difficult symptoms, including fatigue, changes in hunger, pain, and nausea or vomiting.
  • The Multinational Association for Supportive Care in Cancer issued ambitious goals for care of cancer patients in 2030, including routine symptom screening to facilitate timely individualized care and pairing symptom identification with evidence-based treatment.
  • With this goal in mind, the research team developed Symptoms Screening and Pediatrics tool, or SSPedi. SSPedi is a validated instrument for measuring self-reported symptoms that is simple, quick, and designed for use in clinical care.
  • They integrated SSPedi with care pathways through SPARK (Supportive care Prioritization Assessment and Recommendations for Kids), a web-based application that the team used to enroll patients and remind them to report their symptoms via SSPedi.
  • The researchers conducted two randomized controlled trials (RCTs): A cluster RCT in the United States, from July 2021 to August 2023, and an inpatient RCT in Canada, from July 2018 to September 2023. In both cases, they randomized cancer patients, aged 8 to 18, to either symptom screening or usual care. In the U.S. study, they worked with the sites to adapt 14 care pathways.
  • Their primary outcome was the patient’s symptom severity, measured by their SSPedi score.
  • In both trials, the research team found a reduction in symptom severity for the intervention group. The benefits were more pronounced in the U.S. trial, with statistically significant improvements for 12 out of 15 symptoms (compared to 8 out of 15 in the Canadian trial).
  • In the U.S. study, symptom-specific interventions (i.e., treatment was clearly provided to address a given symptom) were most common for hurt or pain; changes in hunger; constipation; peripheral neuropathy; feelings of disappointment or sadness; and nausea and vomiting. The first four symptoms were also identified as being documented or treated more often in the Canadian study, in addition to feelings of crankiness or anger.
  • The research team concluded, following both the Canadian and U.S. studies, that symptom screening improves symptom control and that there was strong support for its integration into routine care.
  • There were a couple of additional takeaways from the U.S. study: 1) Care pathway use has independent effects on improving symptoms and 2) symptom screening was associated with increased emergency department visits – likely due to identification of symptoms requiring medical attention.

Discussion Themes

Despite launching right before the COVID-19 pandemic and the labor-intensive process of adapting the care pathways for each individual site, the team completed accrual for the U.S.-based-study about a year ahead of schedule. Dr. Sung attributed this to enthusiastic support from the sites around operationalizing supportive care and a study design which allowed patients to be enrolled remotely and report their symptoms remotely.

Pragmatic trials are a team sport. Having a range of expertise and experience can provide a research team with an advantage that makes all the difference. For example, Dr. Sung’s team had a connection to Epic Systems leadership, which facilitated a partnership between the two groups and allowed them to pilot SSPedi in remote care management.

Grand Rounds January 31, 2025: Advancing Rural Back Pain Outcomes Using Rehabilitation Telehealth (ARBOR-Telehealth): Early Progress and Lessons Learned (Richard L. Skolasky, ScD; Kevin H. McLaughlin, DPT)

Posted on by Sophia Ramirez

Speakers

Richard L. Skolasky, ScD
Professor, Johns Hopkins School of Medicine
Department of Orthopaedic Surgery

Kevin H. McLaughlin, DPT
Assistant Professor, Johns Hopkins School of Medicine
Department of Physical Medicine and Rehabilitation

Keywords

Back Pain; Rural Health; Telehealth

Key Points

  • Low back pain (LBP) is the most common cause of disability globally and in the U.S. It’s the largest driver of U.S. healthcare spending growth and a top non-cancer reason for opioid prescriptions.
  • Physical therapy (PT) is a first-line treatment for LBP. It may include exercise, hands-on interventions, and modalities. These methods are cost-effective and decrease the risk of opioid use and surgery. However, due to barriers around the requisite travel, missed work, etc., only 7 – 13% of patients with LBP attend PT.
  • LBP patients in rural areas, where there are higher rates of opioid use and high-impact chronic pain, attend PT less frequently. PT is less accessible than it is in metropolitan areas; there are up to 40% fewer therapists per person; and the travel distance required to get to a clinic is farther.
  • PT was provided virtually (AKA telerehabilitation) during the pandemic, but the effectiveness of telerehabilitation for chronic LBP is unknown. Notably, not all components of PT can be delivered by video visit.
  • The research team’s aims include examining the effectiveness of risk-informed telerehabilitation in reducing LBP-related disability and comparing the prevalence of opioid use among those receiving telerehabilitation and education at 12 weeks.
  • The team is currently in the enrollment phase. They will begin disseminating their results in September 2028.
  • The research team randomized half the group to risk-informed telerehabilitation and the other half to an educational control group. Both groups received best practice advice through the study website, and the control group received eight video visits with a physical therapist over two months.
  • Community engagement strategies include a patient advisory panel and stakeholder advisory committee made up of physical therapists, primary care providers, and rural and public health advocates.

Discussion Themes

One challenge to flag for future studies is that many patients requested virtual appointments outside of office hours. However, the therapists weren’t able to accommodate these requests.

Another challenge is the inconsistent quality of calls between participants. Most folks have access to a smart device; not everyone has access to a desktop, laptop, or tablet, which are preferred for video calls. To address this, the research team is sending participants a phone stand in advance. They also provide basic exercise equipment, including resistance bands and a yoga mat.

While some patients feel a lack of connection with their therapists via telerehabilitation, others have reported that they felt the connection was stronger given the one-on-one nature of the appointments.

Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Posted on by Sophia Ramirez

Speaker

Jeffrey H. Samet, MD, MA, MPH
John Noble Professor in General Internal Medicine & Professor of Public Health
Boston University Chobanian and Avedisian School of Medicine and School of Public Health
Boston Medical Center

Keywords

Opioid Epidemic; Evidence-Based Practices; NIH HEAL Initiative; MOUD; OEND; Harm Reduction

Key Points

  • Over roughly 20 years, opioid overdose (OD) mortality in the U.S. increased tenfold: from a little over 8,000 in 1999 to over 80,000 in 2022. Health authorities urged medical professionals to address the crisis through stigma reduction, uptake of opioid use disorder (OUD) treatment, and other evidence-based practices (EBPs).
  • The goal of the HEALing Communities Study (HCS) was to reduce opioid OD through implementation of EBPs, including overdose education and naloxone distribution (OEND); access to medications for OUD (MOUD); and safer opioid prescribing and dispensing practices.
  • The research team conducted the cluster randomized trial in 67 communities across Ohio, Kentucky, New York, and Massachusetts – a total study population of about 10 million. HCS is the largest implementation science study funded by NIDA.
  • The primary objective of HCS was to compare the number of opioid OD deaths in adults during the comparison period (July 2021 – June 2022) between the intervention and control communities. Secondary outcomes included the rates of naloxone distribution; access to or utilization of MOUD; opioid + stimulant OD deaths; and non-fatal overdose events.
  • The intervention involved 3 pathways for implementing OUD EBPs: community engagement; the Opioid Reduction Continuum of Care Approach (ORCCA), consisting of a menu of strategies to support implementation of EBPs; and community-based health communications campaigns. Multi-level partnerships, Dr. Samet noted, are critical to the success of community-engaged research.
  • Between the intervention group and the control group, there was no difference in the number of opioid OD deaths. OD deaths involving opioids and psychostimulants (excluding cocaine) decreased by 37% in the intervention group, and there was a 15% reduction in nonfatal overdoses.
  • Factors that may have impacted results included the complex array of strategies; a limited period of time in which to achieve full benefits from the implementation of EBPs; COVID-19-related demands on coalition members and healthcare personnel; increasing rates of fentanyl in the drug supply with stimulant contamination; and statistical power.
  • Limitations included the fact that control communities could still access non-HCS funds to address the opioid epidemic and a variation in the affected population size within each community.

Discussion Themes

The research team had 18 months to get the intervention up and running; when the comparison period began, they were at 35% implementation – lower than their goal. This was partially a product of the stakes; the death toll of the opioid epidemic was high and the team was motivated to make quick progress. The COVID-19 pandemic also slowed things down.

Dr. Samet emphasized that the HCS team wasn’t testing whether MOUD and OEND worked; there is significant evidence demonstrating that these strategies are effective. Rather, the team was testing whether communities adopted them and if they had an effect on OD reduction.

When the team shared the results back with community partners, they heard anecdotal reports about the positive effects their partners had witnessed in their communities.

Engagement coalitions formed across communities. Ohio and Kentucky utilized existing coalitions while New York and Massachusetts built new ones. Dr. Samet noted that each of the four states performed well in different realms.

Grand Rounds January 17, 2025: Design for Diversity: Designing Studies for Representativeness and Generalizability (Christopher J. Lindsell, PhD)

Posted on by Sophia Ramirez

Speaker

Christopher J. Lindsell, PhD
Professor and co-Chief, Biostatistics, Duke University
Director, Data Science and Biostatistics, DCRI
Director, Biostatistics and Bioinformatics, CTSI
Editor in Chief, Journal of Clinical and Translational Science

Keywords

Study Design; Diversity; Health Disparities; Evidence Generation

Key Points

  • Health disparities are factors that contribute to preventable differences in health status and outcomes. They can be environmental, sociocultural, behavioral, and biological. These are preventable differences with adverse effects for populations.
  • When research teams don’t consider factors that change outcomes for certain populations but not others, research can contribute to a difference in health status and outcomes. A flawed evidence generation system compounds the problem.
  • One popular solution is to measure and adjust for diversity variables; however, research teams often get the variable wrong or use it incorrectly.
  • By designing for diversity, research teams can begin to address the generalizability of evidence; develop an understanding of factors that contribute to success or failure of interventions among diverse populations; and remove the evidence generation system as a contributor to health disparities.
  • Designing for diversity is an optimization problem. Historically, study designs have been optimized for the researcher; Dr. Lindsell proposed that researchers optimize for the participant.
  • Research that is optimized for the participant is rigorous and flexible; safe and practical; and complete and simple. Participants should be embedded in every part of the research process. This can be difficult – there are tradeoffs involved – but it is effective.
  • The interface between data generation and data use is crucial. Making systems that work to bring in the right information and systems that use that information appropriately are two pieces of the same puzzle.
  • Dr. Lindsell included a call to ditch the ordinary subgroup analysis, noting that groups are not binary and not all groups have meaning. He suggested a focus on interaction terms.

Discussion Themes

Institutions should be supporting research teams in their ability to achieve diversity; this should be a matter of course, rather than something to be achieved without support and then celebrated as a remarkable accomplishment.

Looking forward, as data infrastructure becomes increasingly robust, research teams and communities may be able to collaborate to build a more complete understanding of individuals’ health states and who may be in need of an intervention.

Grand Rounds January 10, 2025: FM-TIPS Community Engagement Methods for Recruitment (Dana Dailey PT, PhD; Heather Schacht Reisinger, PhD)

Posted on by Sophia Ramirez

Speakers

Dana Dailey PT, PhD
Assistant Research Scientist
Physical Therapy and Rehabilitation Science
University of Iowa
Associate Professor, Physical Therapy Department
St. Ambrose University

Heather Schacht Reisinger, PhD
Director, Implementation Science Center
Associate Director for Engagement, Integration, and Implementation
Institute for Clinical and Translational Science
Professor, Division of General Internal Medicine at the University of Iowa

Keywords

Community-Engaged Research; Recruitment

Key Points

  • The Fibromyalgia TENS in Physical Therapy (FM-TIPS) study sought to test the feasibility and effectiveness of adding Transcutaneous Electrical Nerve Stimulation (TENS) to standard physical therapy (PT) care in a real-world PT setting. Their primary outcome was the change in movement pain, from baseline to 50 days.
  • By February 2022, the team had activated 25 active PT clinics across seven Midwestern states. In February 2023, the team received a diversity supplement for community engagement and brought on a Community Engagement Coordinator.
  • After developing a community engagement process and implementing six community engagement strategies, inquiries about the study increased significantly, screening rates held steady, and enrollment rates increased. These effects were more pronounced in targeted clinics.
  • Engagement with the clinics, clinicians, and community had a significant impact on the pragmatic trial. Dr. Dailey noted that clinicians felt more supported and seen as a part of both the clinic and the community. Conversations with participants were also fruitful, helping the researchers understand how participants were feeling when they weren’t in therapy.
  • Clinical research in community physical therapy clinics is not common, and there was a steep learning curve for many of the physical therapists involved. Community support helped them navigate screening and enrollment.
  • The study team developed individualized clinic plans through inquiry of clinicians and clinics. This feedback helped them identify organizations to collaborate with, local events, etc.
  • Process building, including implementation and complete documentation of outcome measures, was important to site evaluation. As a result of these activities, the research team was able to carry lessons over into low-enrolling clinics, adapt, and make productive changes.

Discussion Themes

When researchers think about pragmatic trials involving clinics, Dr. Reisinger noted, it becomes difficult to delineate the concepts of “community members” and “participants.” For example, it’s important to also think about clinicians also as community members who are living and working in those spaces, and who have a deep knowledge of and commitment to their community. All of that knowledge will be important to decision-making.

Intensive and responsive community engagement was made possible for this pragmatic trial by the diversity supplement, which enabled the team to hire two full-time community engagement coordinators. At the rate they were going before they implemented community engagement, the study team would not have hit their enrollment target; in the end, they exceeded it.

Researcher teams should always be adaptive and flexible when doing community engagement, even when it comes to documentation.

Grand Rounds December 13, 2024: Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial (Gbenga Ogedegbe, MD, MPH, FACP)

Posted on by Sophia Ramirez

Speaker

Gbenga Ogedegbe, MD, MPH, FACP
Dr. Adolph & Margaret Berger Professor of Population Health
NYU Grossman School of Medicine
Director, Institute for Excellence in Health Equity (IEHE)
NYU Langone Health

Keywords

Hypertension; Racial Disparities; Case Management; Telemonitoring

Key Points

  • There are significant racial disparities when it comes to stroke outcomes in the U.S., with Black and Hispanic populations experiencing poorer outcomes than Caucasian populations. A major predictor for these disparities is hypertension (HTN); controlling HTN is key to secondary stroke prevention.
  • Home Blood Pressure Telemonitoring (HBPTM) and Nurse Case Management (NCM) have proven efficacy in addressing multilevel barriers to HTN control. However, their effectiveness remains untested in stroke patients, and their implementation is sub-optimal in Black and Hispanic patients.
  • The research team looked at the comparative effectiveness of HBPTM alone versus HBPTM plus telephone-based NCM when administered to Black and Hispanic stroke survivors with uncontrolled hypertension. They measured within-patient change in systolic blood pressure (SBP) from baseline to 12 months and the rate of recurrent stroke at 24 months.
  • This was a multisite, practice-based, comparative effectiveness randomized clinical trial conducted at six public hospitals and three academic medical centers in New York City. About 225 patients were randomized to each of the two arms.
  • The study population was defined by low-income, minoritized communities with significant comorbidity. This is a departure from much of the existing literature, Dr. Ogedegbe noted, in which patient populations tend to be more insured, more highly educated, and have higher employment rates.
  • The research team found that both groups experienced significant SBP reduction at both the six-month and 12-month mark. The telehealth intervention that combined HBPTM with NCM led to greater SBP reduction than HBPTM alone. There was no significant difference in the rate of recurrent stroke between the two groups across a 24-month period.
  • These findings provide strong empirical evidence for widespread implementation in low-income stroke survivors with multiple comorbidities. Policymakers can use this evidence to implement these strategies in minority patients with stroke and uncontrolled hypertension.
  • Implementation challenges will include coverage of HBPM, which varies among private payers and Medicaid programs; clinical support services for use; access to the internet, to transmit data for virtual care; and integration of data into electronic medical records.

Discussion Themes

To effectively address inequities in hypertension, researchers must partner with policymakers, payers, and community-based organizations ahead of time, with a focus on team-based care.

Sustainment can be an Achilles Heel for embedded trials, as programs that have been shown to be successful aren’t always covered by insurance. Chronic disease management with team-based care is a good step that practices can invest in in the interim.

The fidelity to the NCM intervention, measured by the participation in 20 NCM calls and the compliance with HBPTM, was around 68% – a decent figure given the challenges of conducting a trial in a real-world setting, Dr. Ogedegbe noted.

Front-line doctors were instrumental in helping the research teams onboard the sites and think through recruitment.

Grand Rounds December 6, 2024: Opportunities and Challenges in the Use of Large Language Models for Post-Marketing Surveillance of Medical Products (Michael E. Matheny, MD, MS, MPH)

Posted on by Sophia Ramirez

Speaker

Michael E. Matheny, MD, MS, MPH
Director, Center for Improving the Public’s Health Through Informatics
Professor of Biomedical Informatics, Biostatistics, and Medicine
Vanderbilt University Medical Center
Staff Scientist, Geriatrics Research Education and Clinical Care Service
Associate Director, VA ORD VINCI
Tennessee Valley Healthcare System VA

Keywords

Artificial Intelligence; Large Language Models; Surveillance; Medical Products

Key Points

  • Increasingly, leaders in many disciplines are finding new applications for Artificial Intelligence (AI). Within healthcare, this technology is being used to support clinical decision-making; imaging processing; drug discovery; clinical trials; and as Ambient and Autonomous AI.
  • Large Language Models (LLMs) are a subset of generative AI. Since 2012, LLMs have emerged as a promising new technology with rapid growth, evolution of capacity and reach, and many potential applications in healthcare and clinical research.
  • There is significant interest in using LLMs to assist with patient trial matching, clinical trial planning, and the development of trial protocols and consent documents.
  • Another key area that LLMs could provide support in is medical product safety surveillance, with potential applications in adverse event detection, probabilistic phenotyping, and information synthesis.
  • The post-marketing surveillance space utilizes an ecosystem of healthcare data, imaging, radiology reports, insurance, structured data, medical literature, and social media. These sources could be integrated to conduct LLM reasoning and extractions.
  • Key challenges in safe and effective use of LLMs for this purpose include the lack of evaluation for medical product surveillance, the complexities of prompt engineering, hallucination risk (i.e., false positives), and the fact that evolving models over time challenge stable performance estimates.

Discussion Themes

 A segment of the clinical workforce could be trained to be “super users,” partnering with development teams in order to make sure that these tools are working appropriately in a clinical environment.

There is substantial interest in using LLMs to support clinical decision-making. However, studies have shown that the quality of the AI output can influence the performance of the clinicians. Especially in high-risk clinical environments, any drift in those algorithms could result in adverse clinical outcomes. The life cycle approach to conceptualization, development, implementation, surveillance, and maintenance will be necessary to achieve and maintain performance.

Grand Rounds November 22, 2024: Tranexamic Acid Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: HeLiX Trial (Paul J. Karanicolas, MD, PhD, FRCSC)

Posted on by Sophia Ramirez

Speaker

Paul J. Karanicolas, MD, PhD, FRCSC
Associate Professor of Emergency Medicine and Epidemiology
The Edmond Odette Cancer Centre @ Sunnybrook Health Sciences Centre
Professor of Surgery
University of Toronto

Keywords

Liver Cancer; Liver Resection; Blood Transfusions

Key Points

  • Liver resection is a major operation. Though it’s become safer over the past several decades, it requires blood transfusion in 20-40% of patients. Bleeding and blood transfusion are associated with substantial post-operative morbidity and an increase in mortality, re-operation, and re-admission rates.
  • A 2012 meta-analysis found that tranexamic acid (TXA) use in surgery was associated with lower blood transfusion rates. However, most of the trials included in the analysis involved cardiac and orthopedic surgery. There was limited evidence to suggest that TXA offered similar protective effects for liver resection patients.
  • The research team designed a pragmatic trial of adult patients undergoing cancer-related liver resection. Their primary outcome was the receipt of blood transfusion over the first seven days during or following surgery.
  • They randomized 1,384 participants to either a TXA arm or a placebo arm over eight years. They found that administration of TXA had no impact on blood transfusion, interoperative bleeding, or total blood loss; however, it increased the incidence of any surgical complications and major adverse events, with a possible increase in venous thromboembolism (VTE).
  • These findings were discordant with most existing evidence. Possible explanations included chance (unlikely, given the narrow confidence interval); a differing mechanism of bleeding in liver resection patients; and a difference in the dose or timing of TXA (also unlikely).
  • Based on this trial, the study team concluded that 1) TXA does not reduce blood transfusion or bleeding in patients undergoing liver resection; 2) TXA increases adverse events in this context with a signal towards increased VTE; and 3) TXA should not be used routinely in patients undergoing liver resection.
  • More work is necessary to determine whether TXA is beneficial and safe in other types of major oncologic surgery.

Discussion Themes

After some debate, the research team designed their trial to include all liver resection patients as opposed to only patients receiving major liver resections. Only 1/3 of patients have a major operation, and all liver resection patients have at least a 15% risk for bleeding and blood transfusion.

They landed on receipt of blood transfusion as the primary outcome because of the strong association between transfusion and other patient-important outcomes and due to the limited nature of blood transfusions as a resource.

Dr. Karanicolas reflected that the team should have collected adverse events data differently, grouping the complications into more meaningful categories; currently, they are limited in their ability to interpret the complications data.

The study team intentionally did not build an efficacy stopping rule into the trial due to concerns about bias. Having seen the trial through to the end, they had stronger evidence when they arrived at their surprising conclusion.

Grand Rounds November 15, 2024: Pragmatic Randomized Trial of Smartphone-Based Nudges to Reduce Distracted Driving Among US Auto Insurance Customers (M. Kit Delgado, MD, MS)

Posted on by Sophia Ramirez

Speaker

M. Kit Delgado, MD, MS
Associate Professor of Emergency Medicine and Epidemiology
Faculty Director, Penn Medicine Nudge Unit

Keywords

Distracted Driving; Auto Insurance; Smartphones

Key Points

  • Distracted driving leads to over 800,000 crashes, over 400,000 injuries, and over 3,000 deaths per year. Though most people understand the dangers of texting while driving, it doesn’t always stop them from engaging with their cell phones while on the road.
  • Dr. Delgado applied a heuristic model of human decision-making to explain this disparity. Using a case example from his time working in an Emergency Department, he illustrated how status quo bias, automaticity, present bias, recency bias, overconfidence bias, and social distance/norms all contributed to the failure of self-control and the resulting crash.
  • The research team partnered with Progressive Auto Insurance to determine whether a usage-based insurance program, redesigned with behavioral economic insights, reduces handheld phone use while driving. They tracked active cell phone usage using telematics.
  • The study had six arms: business as usual; weekly social comparison feedback (WSCF); a delayed standard financial incentive (SFI); WSCF + delayed SFI; WSCF + reframed SFI; and WSCF + doubled, reframed SFI. The delayed SFI was dispensed at the end of the intervention whereas the reframed SFI was dispensed weekly; the total amount of cash was the same.
  • Drivers in the fourth arm (WSCF + delayed SFI) saw a 15% reduction in active cell phone usage; drivers in the fifth arm (WSCF + reframed SFI) saw a 21% reduction. Doubling the financial incentive did not further improve the outcome. Notably, neither WCSF nor the SFI alone led to a significant decrease in active cell phone use when compared to the control.
  • For most participants, the effects of the intervention waned after the intervention period ended. However, there were a few positive outliers that maintained lower rates of active cell phone usage in the post-intervention period. The study team interviewed the outliers and identified a few key situational strategies that could help maintain long-term effects.
  • The study team designed a second trial with interventions that incrementally incorporated takeaways from the interviews, including the provision of a phone mount, access to commitment + habit-building tips, and gamification. This stacking design was intended to make it easier to do the right thing and provide motivation for incremental improvements.
  • They found that adding behaviorally-designed gamification, the participant’s level increasing or decreasing based on goal attainment and leaderboard competition, led to a 20% reduction in active phone use. The addition of a modest financial incentive on top of the gamification arm led to a 28% reduction. This time, the effects were sustained after the interventions ended.

Discussion Themes

The advantages of working with an industry sponsor include reach, ability to scale, and implementation opportunity. The downsides include limitations on what you can test, lengthy contracting processes, and some constraints around what data can be published. Dr. Delgado noted that, for this kind of work, the pros outweighed the cons.

The post-intervention evaluation period ranged from four to eight weeks due to limitations around enrollment and a maximum observation period.

One challenge was distinguishing between passenger trips and driver trips – a driver may let a passenger use their phone while driving, for example. They gave participants the option to retroactively reclassify trips and found that the reclassification rate was about 1%, even after incentives entered the picture.