implementation science

Grand Rounds January 9, 2026: Pragmatic Care Embedded Randomization: Insights From the KP-VACCINATE Megatrial (Ankeet S. Bhatt, MD, MBA, ScM)

Posted on by Sophia Ramirez

Speaker

Ankeet S. Bhatt, MD, MBA, ScM
Cardiologist, Kaiser Permanente San Francisco Medical Center
Research Scientist, Kaiser Permanente Northern California Division of Research
Assistant Professor, Kaiser Permanente Bernard J. Tyson School of Medicine
Adjunct Professor, Stanford University School of Medicine

Keywords

Vaccination; Learning Health System; Implementation Science; Nudges; Influenza; Cardiovascular

Key Points

  • Every year, influenza leads to over 500,000 deaths and 3-5 million severe cases globally. It increases the risk of cardiovascular (CV) events like myocardial infarction and heart failure. Though health guidelines strongly recommend annual influenza vaccination, rates remain suboptimal globally and persistent inequities exist. There’s an urgent need for novel, effective, and scalable strategies to improve influenza vaccination rates.
  • The KP-VACCINATE trial is one of the largest ever conducted, randomizing over 3.6 million patients in under 30 days. It included several pragmatic elements, such as coordination with existing vaccine promotion efforts; randomization performed by operational health system teams; and endpoint capture fully embedded in the electronic health record.
  • The study team assessed the effect of a cardiovascular-focused nudge communication on influenza vaccination rates and found that there was no effect. Despite the negative results, the trial establishes that pragmatic and rapid randomization of communication strategies is operationally feasible at scale with routine healthcare workflows in the US.

Discussion Themes

The study team targeted a larger-than-usual population in order to 1) demonstrate the feasibility of randomization within a large-scale health system, and 2) be well-powered for subgroup analyses that could help tailor future interventions.

Dr. Bhatt viewed the negative result as an illustration of the importance of design and context for interventions based in behavioral science, rather than an indication that nudges are ineffective.

Future directions may include involvement of the broader care team, with primary care providers and specialty providers playing a potentially critical role in nudging patients towards vaccine uptake.

Grand Rounds November 14, 2025: IMPACT-BP: A Community-Based Intervention for Sustainable Blood Pressure Control in Rural KwaZulu-Natal, South Africa (Mark Siedner, MD, MPH)

Posted on by Sophia Ramirez

Speaker

Mark Siedner, MD, MPH
Professor of Medicine, Harvard Medical School
Faculty, Africa Health Research Institute

Keywords

Hypertension; Blood Pressure; Community-Based; Implementation Science; Global Health

Key Points

  • Hypertension (HTN) is the leading preventable cause of death globally. Dr. Siedner’s research typically revolves around HIV, but he turned his attention to HTN after publishing a study on the convergence of infectious and non-communicable disease epidemics in rural South Africa. Unlike HIV, he noted, HTN control remains poor.
  • The overarching goals of the IMPACT-BP study were to determine causes for poor HTN control in rural South Africa; co-develop an intervention with partners and end-users to address those causes; and implement and evaluate a novel model of care to improve blood pressure (BP) and increase disease control rates.
  • They began by designing and determining the acceptability of and conducting a readiness assessment for a community-based hypertension control program. The decision to pursue a community-based care model was informed by decades of successful HIV care programs and innovative HTN care programs.
  • The program had 3 main elements: Patients monitored their BP at home; community health workers (CHWs) visited patients to collect data, address challenges, and deliver medicines; and nurses managed care remotely with mobile health tools and decision support. Program goals included enhancing patient efficacy and self-empowerment; decongesting clinics and decreasing wait times; and task-shifting away from overburdened nurses.
  • Once the program had been designed and assessed, the study team conducted a randomized trial to determine its effectiveness. The primary outcome was the change in systolic BP from enrollment to 6 months.
  • Participants were randomized to 3 arms: Standard of care; “CHW,” which included self-monitoring of BP, home visits and medicine delivery by CHWs, and remote management of BP by nurses; and “eCHW+,” which differed from the “CHW” arm in that BP readings were automatically sent to nurses and the CHWs were less involved.
  • Though the “eCHW+” arm was slightly more successful, the study team observed 8 – 10mm HG reductions in systolic BP and roughly 30% improvements in BP control in both intervention arms.
  • This was a multidimensional intervention that sought to address multiple barriers to care. The team faced many real-world challenges, including a community health worker labor dispute, persistent nationwide power outages, destructive weather, and a carjacking spree.
  • Next, the study team will estimate the fidelity, sustainability, acceptability, and cost-effectiveness of the program. Future directions may include an expansion to multimorbidity care; expansion of the model to urban settings; and transportability to the U.S.

Discussion Themes

When it comes to translating these lessons and insights for care coordination in a U.S. setting, a focus on convenience for healthcare workers and for patients will continue to be crucial.

Though eCHW+ arm was successful, participant feedback indicated that the human element was central to intervention acceptability. Participants felt they were getting a tremendous amount of support from their community health workers, and some expressed anger at the possibility of the intervention ending.

Dr. Siedner noted that he sees the success of the trial more as proof of principle that there are fundamental steps we can take to improve chronic disease care than the unveiling of a one-size-fits-all model.

With a trusted healthcare system and provider providing the right kind of health education, this study demonstrates that you can get people to engage in treatment of an asymptomatic disease.

Grand Rounds May 30, 2025: Embedding Randomization Into Clinical Care in Learning Healthcare Systems: Insights From the KP-VACCINATE Trial (Ankeet S. Bhatt, MD, MBA, ScM)

Posted on by Sophia Ramirez

Speaker

Ankeet S. Bhatt, MD, MBA, ScM
Cardiologist, Kaiser Permanente San Francisco Medical Center
Research Scientist, Kaiser Permanente Northern California Division of Research
Adjunct Professor, Stanford University School of Medicine

Keywords

Nudges; Behavioral Science; Vaccination; Influenza; Implementation Science

Key Points

  • Implementation science is the scientific study of methods and strategies that facilitate the uptake of evidence-based practice and research into regular use by practitioners and policymakers.
  • While many implementation science interventions have targeted patients and providers, relatively few have been scaled at the system level with the ability to be replicated in other healthcare delivery systems. Dr. Bhatt’s team was interested in using a cyclical framework to address this gap in the evidence.
  • Behavioral science emerged as a promising area for this project. In recent years, the practice of employing nudges – subtle changes in design that can impact human behavior without restricting choice – has gained traction in the tech sector and in the public eye more broadly.
  • Dr. Bhatt’s team had worked with a group of Danish researchers on a sequence of nationwide clinical trials: NUDGE-FLU, NUDGE-FLU-2, and NUDGE-FLU-CHRONIC. These trials improved influenza vaccination rates in Denmark through randomization to different behavioral science-informed messaging strategies.
  • Vaccination rates in the U.S. have been stagnant for many years, and most systems are not reaching the minimum target of 70% compliance. Dr. Bhatt’s team, inspired by the NUDGE trials’ success, launched the Kaiser Permanente VACCination Improvement with Nudge-based CardiovAscular Targeted Engagement (KP-VACCINATE) Trial.
  • KP-VACCINATE is a fully embedded, randomized clinical trial assessing the effectiveness and timing of cardiovascular-focused nudge communication when it comes to vaccine uptake in a diverse U.S. population. It was developed in collaboration with Danish partners from the NUDGE trials and will be one of the largest clinical trials ever completed.
  • At the time of presentation, KP-VACCINATE was an ongoing, a 4-arm, 1:1:1:1 randomized clinical trial. The primary outcome is influenza vaccination rates assessed with 6 co-primary outcomes. Patients in Arm 1 receive nudges at Touchpoints 1 & 2; patients in Arm 2 receive nudges at Touchpoint 1; patients in Arm 3 receive nudges at Touchpoint 2; and patients in Arm 4 receive usual care.
  • This model is embedded in an integrated healthcare delivery system and may be readily transferable to other areas of patient, clinician, and health system engagement. Seamless collaboration between the research and operational teams was paramount for stakeholder engagement, implementation, and subsequent analysis.

Discussion Themes

In the interest of pragmatic systemwide inclusion, inclusion criteria were broad and most exclusion criteria pertained to an inability to receive health care system outreach. They also allowed for local adaptation to a unified protocol.

One barrier to conducting this kind of research is that not all healthcare systems are receptive to A/B randomization. When socializing KP-VACCINATE with operational teams, Dr. Bhatt pointed out that many health systems already conduct this kind of testing, albeit informally. Healthcare operates on incomplete evidence; decisions are made based on an integration of clinician judgement and the data we have on hand. This approach could improve systems’ ability to assess these strategies and integrate them into usual care.

January 11, 2024: BeatPain Utah Study Team Uses Implementation Mapping Approach to Plan Hybrid Trial

Posted on by Damon Seils

In a new article from the NIH Pragmatic Trials Collaboratory, the BeatPain Utah study team describes the "implementation mapping" they used to plan for trial implementation. The comprehensive, systematic approach enabled the team to craft an implementation plan for a complex telehealth intervention and to identify outcomes for evaluating the success of the implementation strategies.

The article was published this month in Implementation Science Communications.

BeatPain Utah, an NIH Collaboratory Trial, is studying real-world implementation of a telehealth physical therapy strategy for patients with chronic back pain in primary care clinics of federally qualified health centers. During the 1-year planning phase described in the article, the study team developed a logic model, based in part on the Consolidated Framework for Implementation Research (CFIR), to identify contextual factors across several domains that could influence e-referral and telehealth implementation in the trial.

In this ongoing type 1 hybrid effectiveness-implementation trial, the implementation strategies developed through the mapping exercise are being evaluated as part of the trial.

BeatPain Utah is supported within the NIH Pragmatic Trials Collaboratory through the NIH HEAL Initiative under an award administered by the National Institute of Nursing Research. Learn more about BeatPain Utah.

November 29, 2023: NIH Offers Methods Webinar on Implementation Science With Insights From Behavioral Economics

Posted on by Damon Seils

The NIH Office of Disease Prevention will continue its Methods: Mind the Gap webinar series on Friday, December 8, with "Supercharging Implementation Science With Insights From Behavioral Economics." Rinad Beidas, chair and Ralph Seal Paffenbarger Professor of Medical Social Sciences at the Feinberg School of Medicine at Northwestern University, will lead the webinar.

The Methods: Mind the Gap series explores research design, measurement, intervention, data analysis, and other methods of interest in prevention science. The December 8 session will describe efforts to use tools from implementation science and behavioral economics to improve implementation of evidence-based practices.

Register in advance to join the online presentation. Registration is required.

August 3, 2023: NCI’s David Chambers Discusses Role of Implementation Science in Pragmatic Research

Posted on by Gina Uhlenbrauck

This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic trials.

Why Implementation Science Is Important in Pragmatic Research

Chambers described the overlap between implementation science and pragmatic research and how this creates several benefits. Implementation science gives a heightened focus on how to get interventions to be as accessible, well used, and beneficial as possible to populations within the systems and communities in which people are seeking and receiving healthcare.

“The earlier researchers can think about their interventions being used beyond the trial, the better,” Chambers explained. “Implementation science helps to provide a lens for multiple levels of change that may be needed, including supports for patients and families, clinicians, clinics, systems, policymakers, and other key decision-makers.”

Furthermore, implementation science methods can save time in identifying barriers and facilitators for delivering interventions with high quality-knowledge which can be applied toward the ultimate use of interventions.

Chambers encourages researchers to embrace the dynamism that is reflected in our health systems, which is particularly apt for research conducted in the setting of routine care. “It is a given that there will be deviations from the design of an intervention and its implementation, so how can researchers learn from this?” he said.

In terms of sustaining an intervention, a more dynamic approach is needed to how the intervention and the context will change over time, he explained. “Too often we think of sustainment in terms of fixing things in their original state. Sustainment needs to think about how to build in evolution-medicine and our practices are evolving.”

Role of the NIH Pragmatic Trials Collaboratory

According to Chambers, the NIH Pragmatic Trials Collaboratory provides a natural setting for implementation activities because of the close partnerships between the investigative teams and the health systems and community settings where the research occurs. As a result, the program is poised for ongoing learning from the strategies health systems are using to implement a range of different interventions.

There is also an opportunity for pooling lessons across the NIH Collaboratory Trials, such as common measures that can be used to better characterize adaptation, understanding perspectives and needs of patients and clinicians, and approaches related to long-term sustainment or deimplementation of interventions.

Increasingly for NIH Collaboratory trials, issues related to implementation are baked into both the design of interventions and the approach used to test the interventions, which is a testament to the program’s ongoing progress in encouraging the use of implementation science concepts and methods.

Learn more about the NIH Collaboratory’s Implementation Science Core.

How NIH Is Advancing Implementation Science

For over 20 years, NIH has recognized the gaps in knowledge needed for successful implementation of evidence-based interventions. Across NIH institutes, centers, and offices, they have discussed the common challenges observed when investigators saw a positive result in their trial and were frustrated that it could not be replicated and scaled up in the real world.

NIH funds dissemination and implementation research grants and has a standing review panel, the Science of Implementation in Health and Healthcare, focused on this area where any applicant to NIH can suggest that their grant be reviewed. In addition, NIH supports training opportunities in the field and cohosts an annual scientific conference in partnership with AcademyHealth.

NIH continues to explore the interface between effectiveness and implementation, think about deimplementation, and work on tackling misinformation, all towards advancing how to better apply the evidence generated in research to optimize population health and healthcare.

July 5, 2023: This Week’s PCT Grand Rounds to Highlight IMPLEMENT-HF Study

Posted on by Damon Seils

Headshot of Dr. Ankeet Bhatt
Dr. Ankeet Bhatt

In this Friday’s PCT Grand Rounds, Ankeet Bhatt of the Kaiser Permanente Northern California Division of Research will present “Implementing Virtual Strategies Across an Integrated Healthcare System: The IMPLEMENT-HF Study.”

The Grand Rounds session will be held on Friday, July 7, 2023, at 1:00 pm eastern.

Dr. Bhatt is an associate physician at the Kaiser Permanente San Francisco Medical Center and a research scientist at the Kaiser Permanente Northern California Division of Research. The IMPLEMENT-HF study tested the implementation of a virtual care team guided strategy to optimize guideline-directed medical therapy for hospitalized patients with heart failure with reduced ejection fraction.

Join the online meeting.

May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance

Posted on by Damon Seils

EMBED logoOrganizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.

The study’s findings were published recently in Implementation Science Communications.

EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial tested the effectiveness of a clinical decision support tool integrated into the electronic health record in improving rates of buprenorphine initiation in the emergency department for the treatment of opioid use disorder. The intervention led to a modest increase in buprenorphine initiation and little impact on patient outcomes.

A secondary aim of the study was to identify determinants of adopting, implementing, and maintaining the clinical decision support tool at the trial sites. Among the key determinants were:

  • establishing buprenorphine initiation as a cultural norm within healthcare organizations;
  • organizational commitment to implementing and sustaining the intervention;
  • clinician training and support on opioid use disorder and buprenorphine initiation in emergency departments;
  • availability of referral resources to link patients who were initiated on buprenorphine in the emergency to ongoing treatment; and
  • the ability to tailor the intervention to clinic workflows that fit the resources and characteristics of the local clinic.

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.

Read the full report.

Grand Rounds April 7, 2023: A Nudge Towards Cardiovascular Health: Incorporating Insights From Behavioral Science to Improve Cardiovascular Care Delivery (Srinath Adusumalli, MD, MSHP, MBMI, FACC)

Posted on by Hannah Webster

Speaker

Srinath Adusumalli, MD, MSHP, MBMI, FACC
Adjunct Assistant Professor of Medicine, Perelman School of Medicine
Adjunct Professor of Healthcare Management, The Wharton School
Affiliated Faculty, Center for Health Incentives and Behavioral Economics
Staff Cardiologist, Hospital of the University of Pennsylvania and Philadelphia VAMC University of Pennsylvania
Senior Medical Director, Enterprise

Keywords

Pragmatic trials, cardiovascular medicine, cardiovascular care delivery, behavioral science, electronic health records, implementation science

Key Points

  • A nudge is a subtle change in design that is intended to impact human behavior. They are intended to remind, guide, or motivate a decision, and they should be transparent. Dr. Srinath Adusumalli described a nudge as something that helps make the right choice an easier choice.
  • Nudges and other behavioral interventions are prevalent in industries like business and entertainment, but there is an opportunity for nudges in medicine and health care delivery.
  • Launched in 2016, the Penn Medicine Nudge Unit is the world’s first behavioral design team embedded within a health system. It works to improve health care value and outcomes, advance the science of designing interventions to change behavior and evaluate and disseminate the impact of interventions. The team then worked to incorporate an implementation science lens for designing interventions for scale to the health system.
  • The health behavior is supported by a technology backbone, including the Penn Medicine EHR and other systems that bring insight and nudge within workflows. The context and stakeholder input have been key in developing and implementing nudges.
  • Useful nudge principles are limitations of information provisions, inertia or status quo bias, choice overload, loss aversion or framing, social ranking and the limits of willpower.
  • Implementing the nudge tool within the Penn Medicine revealed several positive impacts, including referral rates increasing significantly via the implementation of a default pathway.
  • The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making.
  • The randomized controlled trial Effect of Nudges to Clinicians, Patients or Both to Increase Statin Prescribing published in JAMA found that the clinician nudge and the combined nudge interventions significantly increased the proportion patients prescribed a statin compared with usual care but the patient nudge had no impact.
  • Key considerations for developing and implementing a nudge include the right information and guidelines, the right individual to receive the nudge, the right intervention format, the best channel for the nudge and the best time in a provider’s workflow to receive the nudge.
  • Key learnings from the studies highlighted included the need for more transparency as to the reason for a nudge, limiting the number of choices in CDS intervention, passive CDS is often ineffective and it is critical to provide the path for the individual to immediately act.
  • New frontiers in nudging include integrating nudges and behavioral science with applied machine learning, phenotyping patient and clinician behavior to more precisely target single or combination nudges, the simplification and automation of downstream actions, and the alignment of incentive and behaviors across health care actors, including systems and payers.

Discussion Themes

– In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology. There is opportunity for more evidence to be developed and to implement lessons that have been learned.

– Behavioral science tools, such as these EHR-integrated nudges, must be modified to fit within different settings and EHR systems, but they often provide a strong foundation for other contexts. Customizing existing tools to different systems can save significant time and resources in developing behavioral health tools.

Tags

#pctGR, @Collaboratory1

April 5, 2023: This Friday’s PCT Grand Rounds Highlights Applications of Behavioral and Implementation Science in Cardiovascular Medicine

Posted on by Damon Seils

Headshot of Dr. Srinath AdusumalliIn this Friday’s PCT Grand Rounds, Srinath Adusumalli of the University of Pennsylvania will present “A Nudge Towards Cardiovascular Health: Applications of Behavioral and Implementation Science in Cardiovascular Medicine.” The Grand Rounds session will be held on Friday, April 7, 2023, at 1:00 pm eastern.

Dr. Adusumalli is an adjunct assistant professor of medicine and an adjunct professor of healthcare management at the University of Pennsylvania. He is the senior medical director of enterprise virtual care and retail health for CVS Health, where he drives clinical initiatives to support the company’s virtual strategy.

Join the online meeting.