Demonstration Project

October 5, 2021: New Article Identifies Challenges and Prerequisites for Using Electronic Health Record Systems for Pragmatic Research

Posted on by Karen Staman

JAMIA Cover

In a new NIH Collaboratory study, 20 NIH Collaboratory Trials responded to a survey about challenges encountered when using the electronic health record (EHR) for pragmatic clinical research. The goal of the study was to elucidate challenges and develop solutions—or prerequisites for pragmatic research—to enable healthcare system leaders, policy makers, and EHR designers to improve the national capacity for generating real-world evidence.

The article was published in the Journal of American Medical Informatics Association (JAMIA).

The challenges identified by the projects fell into 6 broad themes, including inadequate collection of patient-centered data, lack of functionality for structured data collection, lack of standardization, lack of resources to support customization, difficulties aggregating data from multiple sites, and difficult and inefficient access to EHR data.

Researchers from the NIH Collaboratory’s EHR Core and colleagues from the Patient-Centered Outcomes and the Health Care Systems Interactions Core Working Groups discussed the issues and iterated possible solutions. The authors developed the following prerequisites for the conduct of pragmatic research:

  • Integrate collection of patient-centered data into EHR systems
  • Facilitate structured research data collection by leveraging standard EHR functions, usable interfaces, and standard workflows
  • Support creation of high-quality research data by using standards
  • Ensure adequate IT staff to support embedded research
  • Create aggregate, multidata type resources for multisite trials
  • Create reusable and automated queries

The authors argue for the ability to tailor EHR systems to enable the collection of patient-centered outcomes and the extraction of high-quality, standardized data. Although the primary uses of the data are for clinical care and billing, high-quality data from the EHR also have the potential to improve clinical care and population health by providing reliable evidence and to support pragmatic research and learning within and across healthcare systems.

Read the full article.

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961.

 

September 30, 2021: BeatPain Utah and GRACE Awarded Continuation to Implementation Phase

Posted on by Damon Seils

The NIH Collaboratory is pleased to announce that the BeatPain Utah and GRACE NIH Collaboratory Trials received approval this month to transition from the planning phase to the implementation phase of their studies. As projects funded through the NIH HEAL Initiative’s PRISM program, these pragmatic clinical trials embedded in healthcare systems are directly addressing the US opioid crisis by exploring the implementation of novel, nonpharmacologic interventions for pain management.

Congratulations to the BeatPain Utah and GRACE principal investigators and their study teams for reaching this important milestone!

BeatPain Utah: Nonpharmacologic Pain Management in FQHC Primary Care Clinics

Headshot of Dr. Julie Fritz
Dr. Julie Fritz

BeatPain Utah is a pragmatic trial of nonpharmacologic pain management interventions in primary care clinics of US federally qualified health centers in Utah. The interventions will be designed to overcome barriers specific to rural and lower-income communities through innovative use of telehealth resources. The study is administered by the National Institute of Nursing Research and is being conducted by Dr. Julie Fritz of the University of Utah.

 

 

 

 

GRACE: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

Headshots of Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah
Left to right: Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa, and Nirmish Shah

The GRACE trial is a hybrid effectiveness–implementation trial of guided relaxation and acupuncture for pain associated with chronic sickle cell disease in 3 large healthcare systems. The study is administered by the National Center for Complementary and Integrative Health and is being conducted by Drs. Ardith Doorenbos, Judith Schlaeger, Robert Molokie, Miriam Ezenwa of the University of Illinois Chicago and Dr. Nirmish Shah of Duke University.

 

The PRISM program (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) is a component of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The NIH Collaboratory serves as the PRISM Resource Coordinating Center and is supported by the National Center for Complementary and Integrative Health. Support is also provided by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

March 17, 2021: Cultural and Linguistic Adaptations: Results of a Survey of PRISM NIH Collaboratory Trials

Posted on by Karen Staman

To better understand efforts at cultural and linguistic adaptions in clinical trials focused on pain, members of the NIH Collaboratory’s Patient-Centered Outcomes Core recently conducted a survey of the PRISM NIH Collaboratory Trials (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing), which are part of NIH’s Helping to End Addiction Long-term Initiative℠, or NIH HEAL Initiative℠.

"Having culturally valid patient-reported outcome instruments is extremely important to the conduct of embedded pragmatic trials. For the results to be valid, the intended audience needs to understand both the measure and what is being asked of them. This is critical for trials centered on pain because pain-related outcomes are best described by the person who is experiencing the symptoms."  —Emily O’Brien, PhD, Co-Chair of the Patient-Centered Outcomes Core

The results are published in the Cultural Adaptation and Linguistic Translation section of the Patient-Reported Outcomes Chapter in the Living Textbook.
For more information on the PRISM projects, study snapshots are accessible from each NIH Collaboratory Trial page and the links below:

  • BackInAction: Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
  • FM TIPS: Fibromyalgia TENS in Physical Therapy Study
  • OPTIMUM: Group-based Mindfulness for Patients with Chronic Low Back Pain in the Primary Care Setting
  • NOHARM: Nonpharmacologic Options in Postoperative Hospital-based and Rehabilitation Pain Management

Note that the 2 newest PRISM projects, GRACE and BeatPain Utah, are still in the design phase and were not included in this round of interviews.

November 5, 2020: NIH HEAL Initiative Common Data Elements Published in the Living Textbook

Posted on by Karen Staman

Logo for the NIH HEAL InitiativeThe Helping to End Addiction Long-Term Initiative℠, or NIH HEAL Initiative℠, has created common data elements (CDEs) to facilitate cross-study comparisons for pain, improve interoperability of findings for patient-reported outcomes, and compare results across trials. The core CDEs were published recently in the NIH Collaboratory’s Living Textbook. They include CDEs for adult acute pain, adult chronic pain, and pediatric acute and chronic pain, and represent patient-reported outcomes that HEAL Initiative clinical trials are required to collect.

“Having common measures to capture the patient’s perspective regarding pain will enable researchers to compare meaningful data across pain conditions, in diverse populations, and in multiple research studies, including in pragmatic clinical research. This should greatly increase our understanding of pain and how best to treat it.”

      —Emily O’Brien, PhD, co–principal investigator of the NIH Collaboratory Patient-Centered Outcomes Core

The NIH Collaboratory serves as the resource coordinating center for 6 NIH Collaboratory Trials funded through the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) program, a component of the NIH HEAL Initiative:

Because the PRISM studies are pragmatic clinical trials embedded in healthcare systems, it may not be feasible for investigators to collect all the required CDEs, as the trials need to be incorporated into clinical workflow with as little burden as possible. The NIH Collaboratory’s Patient-Centered Outcomes Core Working Group will work with the NIH Collaboratory Trials to understand and document which patient-reported outcome measures are collected and the perceived burden associated with collecting them.

Learn more in the Choosing PRO Measures chapter of the Living Textbook.

Grand Rounds October 9: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)

Speaker:

Myles Wolf, MD, MMSc
Division of Nephrology, Department of Medicine
Duke Clinical Research Institute
Duke University School of Medicine

Topic: Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
Date: Friday, October 9, 2020, 1:00-2:00 p.m. ET

Meeting Info: To check whether you have the appropriate players installed for UCF (Universal Communications Format) rich media files, go to https://dukemed.webex.com/dukemed/systemdiagnosis.php.

To join the online meeting:
Go to https://dukemed.webex.com/dukemed/j.php?MTID=me3404f6c28e0458f1d40142cbaf90fa5

You must log in to the URL first.
Click ‘Audio Conference’
Choose ‘I will call in’, select the Toll number.
Dial in using the information from the dialog box that appears.
Be certain to use the Access Code AND the Attendee ID.

Troubleshooting:
If the URL above does not work, go to dukemed.webex.com and enter:
Meeting Number: 120 711 6379
Meeting Password: 1234

For Audio ONLY:
Call-in toll number (US/Canada): 1-650-479-3207
Access code: 120 711 6379

NOTE: For Toll-free users, the call-back (call me) services are also available.

September 8, 2020: LIRE Trial Finds No Change in Healthcare Utilization, Small Drop in Opioid Prescriptions

Posted on by Damon Seils

Photo of Jeffrey Jarvik
Dr. Jerry Jarvik, principal investigator of LIRE

Inserting benchmark prevalence information about common imaging findings into spine image reports did not reduce spine-related healthcare utilization but did slightly reduce subsequent opioid prescriptions. These were the main findings of the Lumbar Imaging With Reporting of Epidemiology (LIRE) trial, an NIH Collaboratory Trial.

The report was published this month in JAMA Network Open.

Spine imaging often has incidental findings that can lead to unnecessary tests and treatments. Prior observational research suggested that placing information about the prevalence of common findings in spine imaging reports may help reassure physicians and patients about such findings and reduce subsequent, unnecessary healthcare interventions.

LIRE was a stepped-wedge, cluster randomized trial of an intervention that placed age- and modality-appropriate epidemiological benchmark information about common imaging findings in lumbar spine imaging reports. The intervention did not reduce spine-related healthcare utilization overall.

In prespecified secondary analyses, the intervention slightly reduced subsequent opioid prescriptions, and patients for whom computed tomography was the imaging modality had lower spine-related healthcare utilization.

LIRE was supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Read more about the LIRE trial.

July 24, 2020: TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial (Leslie J. Crofford, MD; Kathleen Sluka, PT, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Leslie J. Crofford, MD
Wilson Family Chair and Professor of Medicine
Vanderbilt University Medical Center

Kathleen Sluka, PT, PhD
Kate Daum Research Professor
Department of Physical Therapy and Rehabilitation Science
University of Iowa

Topic

TENS in Fibromyalgia: From Fundamental Neurobiology to Pragmatic Trial

Keywords

Fibromyalgia; Musculoskeletal pain; Neuropathic pain; Transcutaneous electrical nerve stimulation (TENS); Physical therapy; Nonpharmacologic pain treatment; PRISM; Patient-reported outcomes (PROs)

Key Points

  • Fibromyalgia (FM) is a condition of widespread pain that is worsened with physical activity. It involves chronic musculoskeletal and visceral pain and is often accompanied by fatigue, depression, or anxiety.
  • Transcutaneous electrical nerve stimulation (TENS) is a technique that uses a device to deliver an electric impulse through the skin. Treatment with TENS has been shown to improve resting and movement-evoked pain and fatigue.
  • While physical therapists generally are trained in the use of TENS, the technique remains underused in clinical practice.
  • The goal of the FM TIPS pragmatic trial is to determine, in a real-world clinical setting, whether physical therapy combined with TENS for patients with FM is more effective than physical therapy alone. The study is being piloted in 24 sites across 5 physical therapy health systems.

Discussion Themes

While COVID-19 has had an impact on piloting the FM TIPS study, some kind of physical therapy will be possible through telemedicine. Other challenges include that conducting embedded research in physical therapy clinics is new, and there are multiple different EHR systems in use across the partnering clinics.

The recently published results from Fibromyalgia Activity Study With TENS (FAST) showed that TENS can be safely used in addition to other treatments to improve pain and fatigue in women with fibromyalgia in the setting of a randomized controlled trial.

Read more about the Fibromyalgia TENS in Physical Therapy Study (FM TIPS) NIH Collaboratory Trial and watch a brief interview with the PIs of the study.

FM TIPS is one of the NIH HEAL Initiative’s PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) studies.

Tags

#pctGR, @Collaboratory1

July 7, 2020: PROVEN Primary Results Published

Posted on by Karen Staman

Congratulations to Drs. Vincent Mor, Susan Mitchell, and Angelo Volandes and their team for the publication of their article in JAMA Internal Medicine reporting the primary results of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Trial.

Vincent Mor
Dr. Vincent Mor, Co-PI of PROVEN

Dr. Susan Mitchell, Co-PI of PROVEN

Dr. Angelo Volandes
Dr. Angelo Volandes, Co-PI of PROVEN

PROVEN was the first large-scale embedded pragmatic clinical trial conducted in nursing homes. The intervention was an advance care planning video, meant as an adjunct to first-person discussions with the clinical care provider to help people understand their options for end-of-life care, including life prolongation, limited care, and comfort care. PROVEN’s primary outcome was the number of transfers to the hospital from the nursing home over 12 months among long-stay residents with advanced illness. Secondary outcomes included hospital transfers, burdensome treatments, and hospice use among residents with or without advanced illness.

Although the video program was effective in previous small randomized trials, it was not effective in the PROVEN trial in reducing either the primary or secondary outcomes. The authors suggest that implementation error may explain the findings: intervention fidelity was low, only 1 in 5 targeted residents were shown the video, and implementation of the intervention was highly variable across facilities. The authors state that the results are “sobering,” that creative approaches are needed to change care in nursing homes, and that the perspectives of key stakeholders should be considered.

“For pragmatic trialists and implementation scientists focused on the nursing home setting, the highest level of health care system readiness and endorsement from senior and local leadership must be present before embarking on [pragmatic clinical trials]; otherwise, low implementation fidelity may compromise interpretation of its findings.” — Mitchell et al. 2020 JAMA Internal Med

Drs. Mitchell and Mor are also co–principal investigators of the National Institute on Aging (NIA) IMPACT Collaboratory (Imbedded Pragmatic Alzheimer’s Disease [AD] and AD-Related Dementias [AD/ADRD] Clinical Trials),  which is similar to the NIH Collaboratory in that it aims to build the nation’s capacity to conduct pragmatic clinical trials embedded within healthcare systems. The population of interest for the IMPACT Collaboratory is people living with dementia and their caregivers.

Data and resources from PROVEN will be posted on the NIH Collaboratory’s Data and Resource Sharing page in the coming months. As part of the program’s commitment to sharing, all NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code.

See the June 12, 2020, Grand Rounds webinar for a presentation of the PROVEN results: A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial (Susan Mitchell, MD, MPH).

April 23, 2020: New Workshop Summary on the Design and Analysis of Pragmatic Clinical Trials

Posted on by Karen Staman

In 2019, NIH Health Care Systems Research Collaboratory held a comprehensive workshop to explore and discuss statistical issues encountered with embedded pragmatic clinical trials (ePCTs). The new Workshop Summary describes panel discussions with the principal investigators and statisticians of NIH Collaboratory Trials and the challenges and solutions encountered during the design and analysis of their trials.

The 4 panel discussions covered the following topics:

  • Measurement and Data: Outcomes, Exposures, and Subgroups Based on EHR Data
  • To Cluster or Not to Cluster?
  • Choosing a Parallel Group or Stepped-Wedge Design
  • Unique Complications

This Workshop Summary also provides lessons learned and recommends tools to help others design and analyze future ePCTs. For more on the design and analysis of pragmatic clinical trials, see the tools provided by the Biostatistics and Study Design Core and Living Textbook chapters on Experimental Designs and Randomization Schemes and Analysis Plans.

February 28, 2020: Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Posted on by Gina Uhlenbrauck

Speakers

Vincent Mor, PhD
Florence Pirce Grant University Professor
Department of Health Services Policy & Practice
Brown University School of Public Health

Leah Tuzzio, MPH
Research Associate
Kaiser Permanente Washington Health Research Institute

Jeffrey (Jerry) G. Jarvik MD MPH
Professor, Radiology, Neurological Surgery and Health Services
Adjunct Professor, Pharmacy and Orthopedics & Sports Medicine
University of Washington

Topic

Preparing for the Unknown: Conducting Pragmatic Research in Real-World Contexts

Keywords

Embedded research; Implementation; Healthcare systems; Nursing homes; Radiology reports; Electronic health records; Data collection; Pragmatic clinical trials

Key Points

  • Early engagement between study teams and health system leaders and staff can help ease the embedded intervention into the clinical workflow. Consider, for example, who will deliver the intervention and how difficult it will be to implement.
  • In the pilot phase, show that you can implement the intervention effectively. For example, demonstrate that you can collect the outcome data you will need within the pilot’s time frame. Ensure that your study questions are important to the partner healthcare system.

Discussion Themes

It is essential to anticipate, identify, and make a plan to address changes in the healthcare system as your trial is being conducted.

Among the NIH Collaboratory Trials, many have good measures of how much site-to-site variation there is, which helps to understand what the preconditions are for high levels of implementation.

Use the pilot study to maximize acceptability, maintain affordability, and consider the scalability of the intervention.

These topics and more are on the Living Textbook of Pragmatic Clinical Trials. Plan to hear the next topics in the Living Textbook Grand Rounds series.

Tags
#pctGR, @Collaboratory1