Demonstration Project

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 14, 2023: BeatPain Utah Pragmatic Trial Featured in This Friday’s PCT Grand Rounds

Posted on by Damon Seils

Headshots of Dr. Julie Fritz and Dr. Guilherme Del FiolIn this Friday’s PCT Grand Rounds, Julie Fritz and Guilherme Del Fiol of the University of Utah will present “BeatPain Utah Pragmatic Clinical Trial: Partnering With Community Health Centers Within a Socio-Technical Framework.”

The Grand Rounds session will be held on Friday, June 16, 2023, at 1:00 pm eastern.

BeatPain Utah, an NIH Collaboratory Trials, 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. The study is supported by the NIH through the NIH Heal Initiative under an award from the National Institute of Nursing Research.

Dr. Fritz is a distinguished professor of physical therapy and athletic training and Dr. Del Fiol is a professor of biomedical informatics—both at the University of Utah.

Join the online meeting.

June 6, 2023: INSPIRE NIH Collaboratory Trial Principal Investigators Share Update at Annual Steering Committee Meeting

Posted on by Karen Staman

In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in Bethesda, Maryland, Richard Platt, MD, MS (co–principal investigator) and Shruti Gohil, MD, MPH (lead investigator) of the INSPIRE NIH Collaboratory Trial shared the status of the trials, discussed recent lessons learned, described the impact they hope their trials will have on the future of healthcare, and reflected on the impact the NIH Collaboratory has had on their trials thus far.

Status Update

Headshot of Dr. Richard Platt
Richard Platt, MD

Shruti Gohil, MD, MPH

INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) is implementing 2 separate cluster-randomized trials to study the effectiveness of a patient/infection/hospital-specific clinical decision support program in improving antibiotic prescribing for non–critically ill patients who are hospitalized with abdominal infections or skin and soft tissue infections. The purpose of the trials is to reduce unnecessary broad-spectrum antibiotic use in non–intensive care unit inpatients.

The 12-month trial is currently in month 5, and the team has already seen a downward inflection in broad-spectrum antibiotic use.

Lessons Learned

Due to the urgent public health threat of antibiotic resistance, healthcare systems are actively seeking ways to support clinicians in judicious antibiotic prescribing. As a result, although the target recruitment was 60 hospitals out of approximately 200, 92 hospitals at HCA Healthcare requested enrollment.

"We have the privilege of being with a health system that has a strong leadership structure that is patient-safety oriented, and quality improvement is a top-notch priority," Gohil said, describing the unusual overenrollment.

The INSPIRE team determined that the trial could be shortened from 18 months to 12 by using all 92 hospitals.

"We determined that the higher number of hospitals wanting to participate gave us the opportunity to understand the usefulness of this decision support tool as quickly as possible and honor the commitment of the partner health system," Platt said. "Their view is, if it works, we want to use it everywhere as soon as possible," he said.

Impact of the Trial on Real-World Healthcare

Dr. Gohil explained that she hopes not only to reduce unnecessary prescribing of broad-spectrum antibiotics, but also to learn about how digital health can transform healthcare and its delivery.

“We have a tool that not only flags a low-risk patient, but is doing it based on data from the [electronic medical record] system, and is calculating risk specific to a patient, specific to a disease, and specific to a type of bacteria, and one that is unique to a hospital. It captures all that information and presents it to a clinician to make good judgments about antibiotic selection,” Gohil said. She hopes this work will be a step towards future systems that could be “savvy enough and real-time enough deliver high precision care tailored for individual patients as  part of an embedded learning system.”

Impact of the NIH Pragmatic Trials Collaboratory on INSPIRE

The INSPIRE intervention includes a clinical decision support tool to help clinicians make a guideline-concordant decision on antibiotic use based on a patient's personalized risk. At the time of the trial’s launch, the FDA introduced a new guidance on Clinical Decision Support Software to support determinations regarding whether a software would be considered a device and therefore subject to FDA oversight.

“It was really helpful to have the Ethics and Regulatory Core do a deep dive with us on the FDA guidance on clinical decision support and help determine that our software was not considered a device,” Platt said.

The INSPIRE NIH Collaboratory Trial is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute of Allergy and Infectious Diseases (NIAID).

All of the materials from the 2023 Steering Committee meeting are now available.

January 24, 2023: INSPIRE Intervention Goes Live, Will Use Predictive Algorithm to Reduce Unnecessary Antibiotic Prescribing

Posted on by Damon Seils

Headshot of Dr. Shruti Gohil
Dr. Shruti Gohil

The INSPIRE NIH Collaboratory Trial went live this month, with a new order entry screen being activated in the electronic health record at 51 hospital sites randomized to the intervention.

Congratulations to lead investigator Dr. Shruti Gohil, co–principal investigators Dr. Susan Huang and Dr. Richard Platt, and the INSPIRE team!

INSPIRE is studying the effectiveness of a personalized clinical decision support program in improving antibiotic prescribing for non–critically ill patients hospitalized with abdominal infections or skin and soft tissue infections. The trial is comparing routine care under hospital-based antibiotic stewardship programs with an enhanced program that adds a predictive algorithm to reduce unnecessary prescribing of extended-spectrum antibiotics.

The computerized provider order entry system at sites in the intervention group prompts physicians when the antibiotic they select is discordant with the estimated need for that antibiotic. The 18-month study will evaluate approximately 53,000 patients with abdominal infections and approximately 37,000 patients with skin or soft tissue infections.

Headshot of Dr. Susan Huang
Dr. Susan Huang

Headshot of Dr. Richard Platt
Dr. Richard Platt

Learn more about INSPIRE.

INSPIRE is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute of Allergy and Infectious Diseases (NIAID).

November 29, 2022: INSPIRE NIH Collaboratory Trial Joins the NIH Pragmatic Trials Collaboratory

Posted on by Damon Seils

Headshot of Dr. Shruti Gohil
Dr. Shruti Gohil

The NIH Pragmatic Trials Collaboratory is excited to welcome the INSPIRE NIH Collaboratory Trial to its portfolio of innovative, large-scale pragmatic clinical trials embedded in healthcare systems.

INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) will implement the INSPIRE-ASP Trials for Abdominal and Skin and Soft Tissue Infections. These 2 cluster randomized trials will study the effectiveness of a personalized clinical decision support program in improving antibiotic prescribing for non–critically ill patients who are hospitalized with abdominal infections or skin and soft tissue infections.

Although fewer than 5% of such patients have an antibiotic-resistant infection, more than half receive extended-spectrum antibiotics. Tools to support clinicians in judicious antibiotic prescribing are needed to curb the urgent public health threat of antibiotic resistance. According to the Centers for Disease Control and Prevention, more than 2.8 million antimicrobial-resistant infections occur each year in the United States alone, and more than 35,000 people die as a result.

Dr. Shruti Gohil will serve as INSPIRE’s lead investigator. Gohil is an assistant professor of medicine at the University of California, Irvine, and associate medical director of epidemiology and infection prevention at UCI Health. Dr. Susan Huang, professor of medicine at UC Irvine, and Dr. Richard Platt, professor and chair of population medicine at the Harvard Pilgrim Health Care Institute, are the co–principal investigators for the project.

Headshot of Dr. Susan Huang
Dr. Susan Huang

Headshot of Dr. Richard Platt
Dr. Richard Platt

The INSPIRE NIH Collaboratory Trial is supported within the NIH Pragmatic Trials Collaboratory by a grant from the National Institute of Allergy and Infectious Diseases (NIAID).

Huang and Platt are experienced investigators in the NIH Collaboratory. Huang was principal investigator of the ABATE Infection NIH Collaboratory Trial. Platt is a member of the program’s Coordinating Center leadership and cochair of the Distributed Research Network.

Learn more about the NIH Collaboratory Trials.

July 26, 2022: Three NIH Collaboratory Trials Share Progress on Planning, Implementation, and Completion

Posted on by Damon Seils

At this year’s annual meeting of the NIH Pragmatic Trials Collaboratory Steering Committee, we interviewed investigators from 3 NIH Collaboratory Trials in different phases of the trial life cycle. IMPACt-LBP launched last fall and is completing its 1-year planning phase. ACP PEACE is nearing the end of its implementation phase. SPOT ended last year and published its main outcomes in February.

Learn more about these innovative NIH Collaboratory Trials in the brief video updates below.

Logo for the IMPACt-LBP NIH Collaboratory TrialIMPACt-LBP, currently in the 1-year planning phase, will evaluate implementation of the American College of Physicians guideline for low back pain, which involves multidisciplinary collaborative care that includes doctors of chiropractic and physical therapists. The study will measure the effects of first-contact patient referral to these clinicians on physical function, pain, opioid prescriptions, and other patient-level outcomes. The study is administered by the National Center for Complementary and Integrative Health with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development. The project is led by Drs. Christine Goertz, Adam Goode, and Hrishikesh Chakraborty of Duke University and Dr. Jon Lurie of Dartmouth Hitchcock Medical Center. Learn more about IMPACt-LBP.

Logo for the ACP PEACE NIH Collaboratory TrialACP PEACE, currently in the implementation phase, is testing an advance care planning program that combines clinician communication skills training and patient video decision aids. ACP PEACE is focused on patients with advanced cancer and their clinicians in oncology settings. The study is administered by the National Institute on Aging and is led by Drs. Angelo Volandes and James Tulsky of Harvard Medical School. Learn more about ACP PEACE.

SPOT NIH Collaboratory Trial logoSPOT, a recently completed pragmatic trial that published its main outcomes earlier this year, compared 2 low-intensity outreach programs—care management and dialectical behavior therapy skills training—to usual care in adults at risk of self-harm or suicidal behavior. The study was administered by National Institute of Mental Health and was led by Dr. Greg Simon of the Kaiser Permanente Washington Health Research Institute. Learn more about SPOT.

 

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

January 21, 2022: Primary Palliative Care for Emergency Medicine (Corita R. Grudzen, MD, MSHS, FACEP)

Posted on by terren.green@duke.edu

Speaker

Corita R. Grudzen, MD, MSHS, FACEP
Professor, Emergency Medicine and Population Health
Associate Dean, Clinical Sciences
Deputy Director, Clinical and Translational Science Institute
Vice Chair for Research, Emergency Medicine
Ronald O. Perelman Department of Emergency Medicine
NYU Grossman School of Medicine

Keywords

Palliative Care; Stepped-Wedge study design; Emergency Department (ED); Gagne Index; PRIM-ER

 

Key Points

  • The Emergency Department is increasingly seeing older adults with serious illness rather than patients with acute trauma.
  • Primary Palliative Care for Emergency Medicine (PRIM-ER) is a stepped-wedge study partnership of 18 health systems in 33 EDs designed to change the culture and norms of emergency care to promote palliative care at home or hospice rather than admittance to the hospital.
  • The study used the Gagne Index greater than 6 to identify patients at high risk of short-term mortality. Patients with dementia did not need to meet the Gagne Index criteria to be included in the study.
  • A baseline survey, training of 2,470 emergency providers, and study intervention has been completed at all 33 sites.
  • Only .2% of ED patients in the study were admitted to hospice after their ED visit.  At 12 months post ED visit, 30% of dementia patients had died whereas 15.6% of the non-dementia chronic disease patients had died. Data analysis is ongoing.

Discussion Themes

Stepped-wedge studies present timing issues and COVID-19 increased these problems. A cluster randomized design may have been easier to implement.

 

The PRIM-ER study was considered quality improvement by the IRB, so no human subjects approval from the IRB was required.

 

The PRIM-ER next step will be developing tools for patients with dementia regarding palliative care in the ED.

 

Learn more about the PRIM-ER study.

 

Tags

#pctGR, @Collaboratory1

April 11, 2022: TSOS Implements Suicide Assessment and Monitoring Method in Pragmatic Clinical Trial

Posted on by terren.green@duke.edu

The Trauma Survivors Outcomes and Support (TSOS) trial, an NIH Pragmatic Trials Collaboratory Trial, successfully implemented a large-scale suicide assessment and monitoring method in a pragmatic clinical trial focused on collaborative mental healthcare for traumatic injury survivors. Study intervention and monitoring methods are detailed in a recent publication in Psychiatry.

TSOS researchers analyzed data collected at 25 trauma centers from 635 patients experiencing posttraumatic stress disorder (PTSD) as the result of a traumatic injury. The study used a randomized stepped-wedge design and assigned 370 patients to a control group and 265 to an intervention group.

Patients in the intervention group received proactive injury care management, psychopharmacology, and psychotherapy for PTSD and depression. All patients in both groups were evaluated at 4 timepoints: baseline and 3, 6, and 12 months after injury.

Study personnel interacting with patients participated in a 1-day training workshop to learn study methods and skills for the management of acute suicidal ideation or suicidal intent. Among other measures to assess PTSD symptoms, alcohol use, and physical function, the study team administered the Patient Health Questionnaire (PHQ-9) to screen for suicidal ideation and depression.

Source: Psychiatry. 2022; Spring. doi:10.1080/00332747.2021.1991200.

Patients from both the intervention and control groups who indicated suicidal ideation on the PHQ-9 received calls, texts, and voice messages from study personnel and referral for additional care from a clinician. Study personnel reached out to 161 control and 107 intervention group patients.

The intervention group showed a small but not significant reduction in suicidal ideation compared to the control group.

Lack of a significant treatment effect may be due to the outreach and additional care received by patients in the control group. This level of additional care could be considered a minor intervention for the control group.

Future studies may learn more about treatment differences between control and intervention groups by incorporating implementation process assessments into the design of pragmatic trials.

TSOS was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Learn more about the NIH Collaboratory Trials.

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