Nudge

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

Posted on by Damon Seils

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

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

Posted on by Karen Staman

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 19, 2025: Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Chat 4 Heart Health logoIn this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull will present “Texting for Behavior Change: Lessons Learned Across 2 Interventions to Improve Chronic Care Management.”

The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern.

This Grand Rounds session will report the results of Chat 4 Heart Health, an NIH Collaboratory Trial. The trial evaluated the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors. The presenters will also share insights from Nudge, another NIH Collaboratory Trial, which tested a variety of text messaging strategies to encourage patients to refill their cardiovascular medications.

Ho is a senior clinician investigator at Kaiser Permanente Colorado’s Institute for Health Research. Bull is a professor of community and behavioral health at the Colorado School of Public Health.

Join the online meeting.

December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

A graphic showing a collection of journal covers.In 2024, experts from the NIH Pragmatic Trials Collaboratory published the results of newly completed studies, shared insights from program leadership, and developed innovative methods in the design, conduct, and analysis 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 more than 30 articles to the peer-reviewed literature this year, including the primary results of the ICD-Pieces and Nudge trials. Several 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 surpassed 340.

Coordinating Center

Cross-Core and Cross-Trial Collaborations

Core Working Groups

Biostatistics and Study Design Core

Electronic Health Records Core

Ethics and Regulatory Core

Community Health Improvement Core

Implementation Science Core

Patient-Centered Outcomes Core

NIH Collaboratory Trials

ABATE Infection

BackInAction

BeatPain Utah

EMBED

FM-TIPS

GGC4H

GRACE

I CAN DO Surgical ACP

ICD-Pieces

LIRE

NOHARM

Nudge

OPTIMUM

PRIM-ER

PROVEN

SPOT

STOP CRC

TSOS

December 5, 2024: Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications at 12 Months

Posted on by Damon Seils

Headshots of Dr. Michael Ho and Dr. Sheana Bull
Dr. Michael Ho and Dr. Sheana Bull, principal investigators for Nudge

Text message–based reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care in the recently completed Nudge trial.

The results of the study were published online ahead of print in JAMA.

Nudge, an NIH Collaboratory Trial, was a randomized, pragmatic clinical trial embedded in 3 healthcare systems testing a variety of text messaging strategies to encourage patients to refill their cardiovascular medications. Poor medication adherence is common among patients with chronic conditions, and poor adherence to cardiovascular medications is associated with higher rates of adverse health outcomes, including hospitalization and mortality.

The study team randomly assigned 9501 patients who delayed refilling their cardiovascular medications to receive either usual care or 1 of 3 text message interventions: (1) a generic text message reminder to refill medication; (2) a text message reminder that incorporated “behavioral nudges”; and (3) a behavioral nudge text message reminder plus a chatbot that used preprogrammed algorithms to assess common barriers to medication adherence. The primary outcome was the proportion of days covered in the 365 days after randomization for all cardiovascular medication classes for which the patient had a refill gap at baseline.

Screenshot of the title page of the article published in JAMA.At the end of the trial, there were no statistically significant differences in the proportion of days covered with medication between the study groups. There were also no differences in emergency department visits, hospitalizations, and mortality. In a post hoc analysis exploring medication adherence in the first 3 months after a refill gap, the study team saw modest improvement in refill adherence with the text messaging strategies compared with usual care.

Read the full article.

Given that most patients refilled their medications within 30 days of receiving a reminder text message, the authors concluded that the lack of benefit after 30 days may be related to “intervention decay” that has been seen with other interventions. “Additional interventions need to be rigorously tested to try to improve adherence to chronic cardiovascular medications,” they wrote.

Nudge was supported within the NIH Pragmatic Trials Collaboratory by a grant award from the National Heart, Lung, and Blood Institute.

“The feedback and guidance from the NIH Collaboratory’s Cores were instrumental to overcoming the challenges we faced in completing this project,” said Michael Ho, co–principal investigator for Nudge and a senior clinician investigator at Kaiser Permanente Colorado’s Institute for Health Research.

Learn more about Nudge.

July 2, 2024: NIH Collaboratory Fellows Share Updates From the Program

Posted on by Elizabeth Mccamic

During the NIH Pragmatic Trials Collaboratory’s 2024 Annual Steering Committee Meeting in May, 2 of the program’s research fellows described their research and discussed the value of the fellowship experience.

Lindsay Ballengee, a physical therapist and doctoral student in population health sciences at Duke University, said her fellowship research builds on previous NIH Collaboratory work on the intervention delivery complexity tool.

“We surveyed members of this Collaboratory and others to find out where they landed on the different domains of intervention delivery complexity and any changes they made during their trial process,” Ballengee said. “We are analyzing that data and hope to use it to inform other pragmatic trials about the different domains of complexity and how those might come into play when implementing in future trials.”

Kaitlyn McLeod, a cardiovascular disease fellow at the University of Michigan, has worked on 2 projects during her fellowship. One project is helping the Health Equity Core better understand how health equity has been integrated into NIH Collaboratory Trials. The second project is taking the health equity framework and applying it to the Nudge study, an NIH Collaboratory Trial, where McLeod has been looking at how the area deprivation index is an effect modifier for the trial’s primary outcome.

Ballengee and McLeod agreed that one of the strengths of the NIH Collaboratory fellowship is the open learning environment and mentoring that is available from investigators and leaders.

“The most valuable experience from being a part of the Collaboratory has been not only being able to build upon previous work and put my own spin on it and ask my own questions, but just the openness of the members of the Collaboratory to mentoring and brainstorming and them really wanting to see me grow as an investigator and fellow,” Ballengee said.

November 15, 2023: In This Friday’s PCT Grand Rounds, Results From the Nudge NIH Collaboratory Trial

Posted on by Damon Seils

In this Friday's PCT Grand Rounds, Michael Ho and Sheana Bull of the University of Colorado will present "Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results From the Nudge Study."

The Grand Rounds session will be held on Friday, November 17, 2023, at 1:00 pm eastern.

Nudge is an NIH Collaboratory Trial. Ho is a professor of medicine and Bull is a professor of community and behavioral health at the University of Colorado. They are the co–principal investigators of Nudge.

Join the online meeting.

June 13, 2022: Nudge Trial Overcomes Challenges, Completes Enrollment

Posted on by Elizabeth Mccamic

Michael Ho, MD, PhD
Michael Ho, MD, PhD

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we asked Drs. Sheana Bull and Michael Ho to update us on the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) NIH Collaboratory Trial. Nudge is using population-level pharmacy data to deliver nudges via cell phone text messaging and artificially intelligent interactive chat to improve medication adherence and patient outcomes in 3 integrated healthcare delivery systems.

What is the current status of the Nudge trial?
The Nudge study has completed enrollment at all 3 of its participating healthcare systems (VA Eastern Colorado Health Care System, Denver Health, and UCHealth, Aurora, Colorado). Follow-up has been completed for the VA, Denver Health follow-up was completed on May 27, and UCHealth follow-up will continue until April 11, 2023. A pharmacist and research staff continue to engage with questions from participants at UCHealth. Data for final analysis will be pulled for the VA and Denver Health sites in fall 2022.

What challenges have you faced, and how have you dealt with them?

Sheana Bull, PhD, MPH
Sheana Bull, PhD, MPH

The onset of COVID-19 greatly delayed enrolling at the UCHealth site since there were not enough resources to devote to implementing the intervention. Additionally, there were administrative difficulties at UCHealth in adding participants via SureScripts due to concerns about time management and payment for IT professionals.

What impact do you hope your trial will have on real-world healthcare?
Text messaging is increasingly becoming part of standard of care for many health care systems. We hope our trial will encourage more healthcare systems to integrate text messaging and chatbots specifically for medication adherence and other health behaviors. Participants have engaged more with messages that are more personalized and include a chatbot, which may mean patients feel more empowered to discuss their medication needs when a mechanism seems more invested in their well-being.

How has being part of the NIH Pragmatic Trials Collaboratory shaped your project?
It was very helpful to have the NIH Pragmatic Trials Collaboratory weigh in on our IRB and statistical plan during the UG3 [planning] year. In the UH3 [implementation] phase, it has been helpful to participate in the various NIH Pragmatic Trials Collaboratory Core calls and share our experiences and learn from others.

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

Posted on by Damon Seils

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 28, 2018: Spotlight on a New NIH Collaboratory Trial: Nudge

Posted on by Damon Seils

More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management offer new opportunities to influence patients’ health behaviors and improve health outcomes.

“One of the real benefits of using technology is that it can be widely disseminated. Studying that dissemination process is really where we are in the field. So a pragmatic trial makes a lot of sense.” — Sheana Bull, PhD, MPH

The NIH Collaboratory is pleased to welcome the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) study to its portfolio of NIH Collaboratory Trials. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral “nudges” to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated healthcare delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia.

The Nudge study is led by co–principal investigators Drs. Sheana Bull and Michael Ho of the University of Colorado with support from the National Heart, Lung, and Blood Institute. Watch a video interview with Drs. Bull and Ho, and read more about Nudge.