ICD-Pieces

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.

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

April 4, 2024: ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease

Posted on by Damon Seils

Dr. Miguel Vazquez, principal investigator for ICD-Pieces

A primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care, according to the ICD-Pieces study.

The results of the study were published this week in the New England Journal of Medicine.

ICD-Pieces, an NIH Collaboratory Trial, was a cluster randomized, pragmatic clinical trial testing an intervention that used an electronic health record–based algorithm and practice facilitators in 141 primary care practices. The study team randomly assigned more than 11,000 adults to receive either the intervention or usual care. The large, diverse study population—of whom 20% were Black and almost 20% were Hispanic or Latino—was representative of the population with chronic kidney disease, type 2 diabetes, and hypertension in the United States.

In the intervention group, the study team used an algorithm to identify patients in the electronic health record in real time. Practice facilitators then worked with the participating primary care providers and patients to meet blood pressure targets, promote use of appropriate medications, achieve goals for blood glucose control, and engage in other guideline-directed care. The intervention period lasted 12 months, and the primary outcome was hospitalization for any reason.

At the end of the study, the hospitalization rates were similar between the intervention group and the usual care group. Rates of key secondary outcomes, such as emergency department visits and cardiovascular events, were also similar between the groups.

Read the full article.

“Although we did not observe a difference in the primary outcome, we believe the study is an important step in advancing our understanding of how to conduct pragmatic trials embedded in healthcare systems,” said Dr. Miguel Vazquez, the principal investigator for ICD-Pieces and a professor of internal medicine at UT Southwestern Medical Center in Dallas.

The study team identified and enrolled a large number of patients, including a large proportion of patients who are members of racial and ethnic groups that are usually underrepresented in clinical trials, Vazquez explained. Moreover, the intervention was delivered across 4 large healthcare systems using a variety of electronic health record systems, there was fidelity in intervention delivery, and there was robust capture of outcomes in a diverse population with multiple chronic conditions.

Vazquez also emphasized the value of conducting the ICD-Pieces study as an NIH Collaboratory Trial.

“The opportunity to work within the NIH Pragmatic Trials Collaboratory was essential for the successful completion of our trial,” Vazquez said. “Access to the expertise from the Coordinating Center and ongoing interactions with investigators from other projects provided critical knowledge to conduct our study embedded in large health systems,” he added.

ICD-Pieces is supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute of Diabetes and Digestive and Kidney Diseases.

Learn more about ICD-Pieces.

June 21, 2023: Results of ICD-Pieces to Be Presented in This Week’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Miguel Vazquez and Dr. George "Holt" OliverIn this Friday’s PCT Grand Rounds, Miguel Vazquez of the University of Texas Southwestern Medical Center and George “Holt” Oliver of the Parkland Center for Clinical Innovation will present “Improving Delivery of Care for Chronic Kidney Disease, Diabetes, and Hypertension,” including results from the ICD-Pieces NIH Collaboratory Trial.

The Grand Rounds session will be held on Friday, June 23, 2023, at 1:00 pm eastern.

ICD-Pieces, an NIH Collaboratory Trial, used a novel information technology platform to identify patients with concurrent chronic kidney disease, diabetes, and hypertension and deliver evidence-based interventions to improve patient outcomes. The study is supported within the NIH Collaboratory under an award from the National Institute of Diabetes and Digestive and Kidney Diseases.

Dr. Vazquez is a professor of internal medicine at the University of Texas Southwestern Medical Center and Dr. Oliver is vice president of clinical informatics at the Parkland Center for Clinical Innovation.

Join the online meeting.

July 14, 2022: Solving Unexpected Challenges in Pragmatic Trial Data Collection

Posted on by Elizabeth Mccamic

Headshot of Dr. Keith MarsoloDuring the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.

The panelists included Drs. Ted Melnick (EMBED), Holt Oliver (ICD-Pieces), Margaret Kuklinski (GGC4H), and Andrea Cheville (NOHARM).

During the discussion, panelists shared lessons learned from collecting electronic health record (EHR) data during large pragmatic clinical trials across multiple health systems. Common challenges included:

  • Privacy concerns and not having the ability to collect deidentified patient or clinician demographic information
  • Working across health systems that use different EHR platforms and collecting data consistently across sites
  • Turnover of IT staff at participating sites and changes in site data agencies during the study period
  • Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected
  • Overcoming technical barriers with practice workflows and integrating with IT systems

The panelists shared solutions and possible best practices for future studies, including the need for planning, coordinating, and testing before study launch, the importance of being able to pivot and change directions as problems arise, being open to alternative data collection methods such as surveys to augment findings, and having the right team at the right time to be responsive to problems, which for one study meant having informaticists and expert EHR builders embedded in the trial team.

Panelists identified two key policy and infrastructure changes that would help trials be successful in the future. These changes include development of a national unique patient identifier across health systems and incentivizing EHR vendors to find common ground to better support research.

The Electronic Health Records Core continues to learn from experiences of the program’s NIH Collaboratory Trials and shares emerging information, resources, and EHR-related recommendations to improve future pragmatic research.

View slides from the discussion panel.

Learn more

View video collection that highlights advances in Electronic Health Records for pragmatic research.

Watch the August 2021 Interview with Electronic Health Record Core leaders Drs. Rachel Richesson and Keith Marsolo

June 16, 2022: ICD-Pieces Credits Communication and Collaboration for a Successful Trial

Posted on by terren.green@duke.edu

ICD-Pieces, an NIH Pragmatic Trials Collaboratory NIH Collaboratory Trial, aims to improve care for patients with a triad of co-existing conditions: chronic kidney disease, diabetes, and hypertension. Dr. Miguel Vazquez, principal investigator of the ICD-Pieces project, discussed the study in an interview after the NIH Collaboratory’s annual Steering Committee meeting.

 

 

ICD-Pieces uses a novel information technology platform to identify patients and deliver evidence-based interventions to improve patient outcomes. Vazquez explained the goal of the study is to reduce emergency department visits, cardiovascular events, and deaths in this patient population. ICD-Pieces has finished enrollment and data collection and is currently analyzing data for its final outcomes.

ICD-Pieces faced several challenges during the course of the study. Vazquez explained, “in the area of recruitment, we enlisted the collaboration of the different sites in helping to enroll more patients.” He said it was important to “have a regular conversation with the different health systems” in order to identify eligible patients. Turnover within the health systems also presented a challenge for the study. “The most important step was to maintain the dialogue with the local health systems and identify local champions to help us to move forward.”

“One of the most important and immediate accomplishments of this study was to advance the research infrastructure that can now be used for other embedded pragmatic trials,” Vazquez said. The ICD-Pieces study was successful in identifying patients with chronic kidney disease, diabetes, and hypertension. “In this day and age it is so important that we include in our trials the patients who actually have the conditions that we want to study.”

Reflecting on the course of the ICD-Pieces study, Vazquez said, “there were some things that we could not have anticipated in terms of planning.” He acknowledged the importance of the NIH Pragmatic Trials Collaboratory in “providing the critical mass of other investigators and trials that are addressing the same questions so we can learn from each other. The Collaboratory was one of the most valuable resources that we had to be able to not only plan, but conduct our study.”

View the full video.

Headshot of Dr. Miguel Vazquez

April 1, 2022: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (Miguel A. Vazquez, MD; George (Holt) Oliver, MD, PhD)

Posted on by terren.green@duke.edu

Speaker

Miguel A. Vazquez, MD
Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX

George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovation
Dallas, TX

Keywords

ICD-Pieces; Chronic kidney disease (CKD); EHR data collection; Diabetes; Hypertension

Key Points

  • ICD-Pieces focuses on the chronic conditions of Diabetes, Hypertension, and CKD. These conditions are common, under-recognized, and can have serious complications.
  • PIECES is an information technology software developed to help facilitate primary care practices provide comprehensive evidence-based care for patients with these chronic conditions.
  • Researchers enrolled 11,000 patients with CKD in the study. The interventions included controlling blood pressure with medication, avoiding hypoglycemia, use of statins, and avoidance of NSAIDs.
  • Interventions were determined to be feasible. Outcomes for study populations are to be determined with further analysis of the data.

Discussion Themes

Pragmatic trials are often practical laboratories for implementation science.

An inherent challenge of collecting data from the EHR record is delay. It may help to have part of the study team embedded in the clinical trial for the data collection aspect, or possibly to collect the data at the time of intervention rather than waiting.

 

Read more about ICD-Pieces.

 

 Tags

#pctGR, @Collaboratory1

March 29, 2022: PCT Grand Rounds to Highlight Experiences From ICD-Pieces

Posted on by Damon Seils

Headshots of Dr. Miguel Vazquez and Dr. George (Holt) OliverIn this Friday’s PCT Grand Rounds, researchers from ICD-Pieces, an NIH Pragmatic Trials Collaboratory Trial, will present aggregate outcomes from the study and share experiences from trial implementation.

Dr. Miguel Vazquez of the University of Texas Southwestern Medical Center and Dr. George (Holt) Oliver of the Parkland Center for Clinical Innovation will present “ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems.” The Grand Rounds session will be held on Friday, April 1, at 1:00 pm eastern.

ICD-Pieces is a pragmatic trial of a collaborative primary care–nephrology care model for patients with chronic kidney disease in a predominantly minority population. The study is implementing a novel technology platform (Pieces) that enables the use of electronic health record data to improve chronic kidney disease care within primary care practices or medical homes in the community.

Join the online meeting.

ICD-Pieces is supported within the NIH Collaboratory by the NIH Common Fund and by a cooperative agreement from the National Institute of Diabetes and Digestive and Kidney Diseases.

Grand Rounds April 1: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems (Miguel A. Vazquez, MD; George (Holt) Oliver, MD, PhD)

Speakers:

Miguel A. Vazquez, MD
Professor of Medicine
University of Texas Southwestern Medical Center
Dallas, TX

George (Holt) Oliver, MD, PhD
Vice President Clinical Informatics
Parkland Center for Clinical Innovation
Dallas, TX

 

Topic: ICD-Pieces: Improving Care for CKD, Diabetes and Hypertension in Health Systems

Date: Friday, April 1, 2022, 1:00-2:00 p.m. ET

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January 19, 2021: Using Claims and CMS Files: New Enhancements in the Living Textbook

Posted on by Karen Staman

Many of the NIH Collaboratory NIH Collaboratory Trials use data from claims and research-identifiable files from the Centers for Medicare and Medicaid Services (CMS) to support their research. We have enhanced the Living Textbook and added new sections to better present the wealth of information on how to acquire, use, and link CMS data for research.