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

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

December 3, 2021: Primary Care-Based Behavioral Treatment for Long Term Opioid Users with Chronic Pain: Primary Results and Lessons Learned from the PPACT Pragmatic Trial (Lynn DeBar, PhD MPH)

Speaker

Lynn DeBar, PhD MPH
Senior Scientist
Kaiser Permanente Washington Health Research Institute
Seattle, WA

Keywords

PPACT, Chronic pain, Opioid use, Patient reported outcome data, Patient-centered research, Cognitive behavioral therapy

Key Points

  • Chronic Pain is responsible for far more years lived with disability than a large number of other diseases and injuries, such as COPD, diabetes, dementia, stroke and others, combined.
  • PPACT was a cluster randomized study aimed at integrating interdisciplinary pain management methods into primary care to improve care for patients with chronic pain.
  • Participants had been prescribed long-term opioids for mixed chronic pain conditions.
  • Study intervention lasted 12 weeks and included cognitive behavioral therapy, yoga-based exercises, physical therapy, a medication review, and support from a primary care provider.
  • Participants in the treatment group of the PPACT study showed a modest reduction of pain that was sustained over a 12 month period.
  • The PPACT intervention was cost effective versus usual treatment methods.

Discussion Themes

An in-person enhanced enrollment session was conducted to give potential subjects a comprehensive overview of the study procedures. This enrollment session led to fewer people enrolling in the study, but of those that did, more completed the study.

The key to successful CBT is an interactive patient-centered approach.

 

Read more about the PPACT study.

 

Tags

#pctGR, @Collaboratory1

December 1, 2021: PCT Grand Rounds to Highlight Primary Results of PPACT Study

Head shot of Dr. Lynn DeBar
Dr. Lynn DeBar, principal investigator of PPACT

In this Friday’s PCT Grand Rounds, the principal investigator of the PPACT study, an NIH Collaboratory Trial, will announce the study’s primary results.

Principal investigator Dr. Lynn DeBar of the Kaiser Permanente Washington Health Research Institute, will present “Primary Care-Based Behavioral Treatment for Long Term Opioid Users With Chronic Pain: Primary Results and Lessons Learned From the PPACT Pragmatic Trial.” The Grand Rounds session will be held on Friday, December 3, at 1:00 pm eastern.

PPACT, or the Collaborative Care for Chronic Pain in Primary Care study, was a pragmatic, cluster randomized trial that enrolled 850 patients who were receiving long-term opioid therapy for chronic pain. Patients in the intervention group participated in weekly group sessions that taught a variety of pain self-management techniques. The strategy was compared with usual care.

Join the online meeting.

PPACT was supported within the NIH Collaboratory by the NIH Common Fund and by cooperative agreements from the National Institute of Neurological Disorders and Stroke.

Grand Rounds December 3: Primary Care-Based Behavioral Treatment for Long Term Opioid Users with Chronic Pain: Primary Results and Lessons Learned from the PPACT Pragmatic Trial

Speaker:
Lynn DeBar, PhD MPH
Senior Scientist
Kaiser Permanente Washington Health Research Institute
Seattle, WA

Topic: Primary Care-Based Behavioral Treatment for Long Term Opioid Users with Chronic Pain: Primary Results and Lessons Learned from the PPACT Pragmatic Trial

Date: Friday, December 3, 2021, 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.

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Choose ‘Computer Audio’ or ‘I will call in’.
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November 9, 2021: PPACT Study Finds Benefits of Cognitive Behavioral Therapy in Reducing Chronic Pain and Pain-Related Disability

Photo of Dr. Lynn DeBar
Dr. Lynn DeBar, principal investigator of PPACT

Patients who participated in a cognitive behavioral therapy (CBT) intervention as part of their regular care for chronic pain showed improved function and reduced pain compared to standard treatment, according to the results of the Pain Program for Active Coping and Training (PPACT) study. Although CBT did not reduce opioid use, patients who participated in a 12-week course on pain self-management led by primary care providers showed modest but sustained benefits that persisted for 12 months after the intervention.

Study results were published this month in the Annals of Internal Medicine.

The PPACT study, an NIH Collaboratory Trial, was a pragmatic, cluster randomized trial that enrolled 850 patients receiving long-term opioid therapy for chronic pain. Patients in the intervention group participated in 12 weekly, 90-minute group sessions that taught skills of muscle relaxation, guided imagery, cognitive restructuring, and yoga-based adapted movement. Patients in the usual care group continued to receive pharmacologic and nonpharmacologic treatment.

Figure from PPACT main outcomes paper
Source: Annals of Internal Medicine 2021 Nov 2. doi: 10.7326/M21-1436

Patients were followed for 12 months with primary outcome measures of pain impact on enjoyment of life, activity levels, and sleep. Researchers also assessed secondary outcome measures of pain-related disability and opioid use.

Compared to usual care, the CBT intervention reduced self-reported pain and pain-related disability and increased satisfaction with primary healthcare providers. Opioid use and dose remained the same in both the intervention group and the usual care group.

PPACT was supported within the NIH Collaboratory by the NIH Common Fund, the National Center for Complementary and Integrative Health (NCCIH), and the National Institute of Neurological Disorders and Stroke (NINDS). Learn more about the NIH Collaboratory Trials.

January 5, 2021: New Video Collection Highlights Advances in Electronic Health Records for Pragmatic Research

We are pleased to announce our new collection of short educational videos that highlight advances in the use of electronic health records (EHRs) in pragmatic clinical trials.

The videos are drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. Experts discuss the evolving regulatory context for EHRs, national policy priorities, and innovative uses of EHRs in several NIH Collaboratory Trials.

Video topics include:

Visit the EHR Workshop Video Modules page for access to all of the new videos.

December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory

Collection of Journal CoversNIH Collaboratory researchers in 2020 reported 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 more than 3 dozen articles in the peer-reviewed literature, including the primary results of the PROVEN and LIRE trials, the study design of ACP PEACE, insights into the COVID-19 pandemic from TSOS and EMBED, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

July 14, 2020: PIs of Completed NIH Collaboratory Trials Share Accomplishments

In 2012, the NIH Common Fund established the NIH Health Care Systems Research Collaboratory. The goal of the program is to improve the way clinical trials are conducted by creating an infrastructure for collaborative research with healthcare systems. The NIH Collaboratory launched with a Coordinating Center, Core Working Groups, and NIH Collaboratory Trials to conduct embedded pragmatic clinical trials (ePCTs) in partnership with healthcare system leaders and to work collaboratively with the NIH to solve problems as they arise, develop best practices, and share lessons and resources to with others conducting ePCTs.

Collaboratory Mission: Strengthen the national capacity to implement cost-effective large-scale research studies that engage healthcare delivery organizations as research partners.

With the first round of NIH Collaboratory Trials nearing completion, the project teams are beginning to publish results and share lessons with other researchers. We asked the principal investigators of the most recently completed projects to share insights about the important contributions of their studies.

Congratulations on finishing your NIH Collaboratory Trial: What do you think is the most important contribution of your study?

ABATE was conducted to determine whether routine bathing and showering with chlorhexidine soap would reduce multidrug-resistant organisms and bloodstream infections compared with usual care. The trial was conducted in 53 HCA Healthcare hospitals (194 non–critical care units) and included 340,000 patients in the intervention period.

Picture of Dr. Susan Huang
Dr. Susan Huang, Active Bathing to Eliminate (ABATE) Infection

“We found that there was no overall benefit to universal antiseptic bathing in non–intensive care units (ICUs). This is in stark contrast to the huge benefit demonstrated in ICUs in the REDUCE-MRSA trial, and may reflect the fact that non–critical care patients stay only a few days in the hospital and are less likely to develop infection. Nevertheless, we did find that antiseptic bathing and nasal decolonization reduced bloodstream infections and antibiotic-resistant organisms by over 30% in patients with devices outside of the ICU. This is important because they are 10% of the non-ICU population, but responsible for over half of bloodstream infections. They provide a valuable targeted population who appear to benefit from this intervention.”

LIRE was conducted to test the effectiveness of a simple and inexpensive intervention: inserting epidemiologic benchmarks into lumbar spine imaging reports. The goal of the trial was to reduce subsequent tests and treatments, including cross-sectional imaging (such as magnetic resonance imaging and computed tomography), opioid prescriptions, spinal injections, or surgery.

 

Dr. Jeffrey Jarvik, Lumbar Imaging with Reporting of Epidemiology (LIRE)

“I think that one of the most important contributions of the LIRE trial was demonstrating the feasibility of randomizing hundreds of thousands of patients to receive or not receive an intervention that we inserted into the radiology report. Before our trial began, there was a fair amount of skepticism about whether radiologists would accept routinely inserting prevalence information into their reports on a wide scale. We showed without a doubt that it was feasible.”

PPACT was designed to assess the potential benefit of helping patients adopt self-management skills for chronic pain, limit use of opioid medications, and identify factors amenable to treatment in the primary care setting in three Kaiser Permanente (Northwest, Georgia, and Hawaii) involving approximately 800 patients.

Dr. Lynn Debar, Collaborative Care for Chronic Pain in Primary Care (PPACT)

“We started a trial when everybody was still uncertain about what the trade-offs between external validity (and real-world issues that are important for implementation) and the rigor of internal validity. I don’t know if we got that right. There was an assumption that the trial needed to be cluster randomized, and I think it’s informative that only 1 of the 11 NIH-DOD-VA Pain Management Collaboratory trials was cluster randomized. We needed to be able to incubate, have embedded teams stay over time, and really shift the culture. Patients needed to get used to the idea of non-pharmacotherapy over several months, and we may have had more success if we had individually randomized our cohort. I learned a lot in this process.”

PROVEN was designed to evaluate the effectiveness of advance care planning video tools in the nursing home setting by partnering with 2 large healthcare systems that operate 492 nursing homes nationwide.

Dr. Susan Mitchell, Pragmatic Trial of Video Education in Nursing Homes (PROVEN)

“PROVEN found an ACP Video Program did not significantly impact hospital transfers, burdensome treatments, or hospice enrollment among nursing home residents with advanced illness, however intervention fidelity was low. Nonetheless, PROVEN was one of the first large pragmatic trials conducted in US nursing homes. Thus, I feel its greatest contribution was setting a foundation of knowledge for the field in terms of methodologies that enable pragmatic trials in this setting and challenges to overcome.”

STOP CRC was conducted to determine whether EHR-embedded tools and clinic staff training in how to implement a mailed fecal immunochemical test (FIT) outreach program could increase colorectal cancer screening uptake among patients with historically lower CRC screening rates and worse CRC outcomes, such as those with low income, or who are on Medicaid or underinsured. STOP CRC was conducted in 26 Federally Qualified Health Centers (FQHCs) in Oregon and California and involved approximately 41,000 patients.

Picture of Dr. Beverly Green
Dr. Beverly Green, Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC)

“The ability to work with FQHCs and their new electronic data systems was an important contribution. FQHC settings are not organized healthcare systems, such as Kaiser Permanente, where research is more routine. I think we contributed to the success of this type of research and enabled the FHQCs’ ability to do more of it.” — Dr. Beverly Green

Picture of Dr. Gloria Coronado
Dr. Gloria Coronado, Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC)

“Our study designed real-time electronic health record tools to allow clinics to mail cancer screening tests to adults who were overdue. We learned a lot about the challenges clinics faced in implementing the program. We shared our learnings with hundreds of additional community clinics in Washington, Oregon, California to help them anticipate and overcome these challenges.”— Dr. Gloria Coronado

TiME was conducted to determine whether treatment with hemodialysis sessions that are longer than many patients in the United States currently receive reduces the high rate of mortality among people being treated with thrice-weekly maintenance hemodialysis. The trial was conducted in 2 large US dialysis provider organizations, DaVita, Inc. and Fresenius Medical Care – North America, and included 266 outpatient dialysis facilities with 7035 patients.

Picture of Dr. Laura Dember
Dr. Laura Dember, Time to Reduce Mortality in End-Stage Renal Disease (TiME)

“TiME established a model for conducting real-world research for a group of patients for whom there is very little clinical trial data. Many of the approaches and lessons from TiME are now being applied to a new set of pragmatic trials in dialysis that are being conducted in the US and internationally. In my view, TiME’s greatest contribution was to create a foundation for ongoing efficient and rigorous evidence generation in dialysis.”

Data and resources from the NIH Collaboratory Trials are 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.

Primary Outcome Papers for TiME, ABATE, STOP CRC, PROVEN

December 18, 2019: NIH Collaboratory Shares New Findings and Fresh Insights in 2019

NIH Collaboratory researchers in 2019 continued to generate new knowledge and research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, large-scale analyses of data from the NIH Collaboratory Distributed Research Network, and results and innovative methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced nearly 3 dozen articles in the peer-reviewed literature, including the primary results of the ABATE Infection trial, confirmation by the TiME trial of the feasibility of embedding large pragmatic trials in clinical care, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ABATE Infection NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

STOP CRC NIH Collaboratory Trial

TiME NIH Collaboratory Trial

TSOS NIH Collaboratory Trial

Applying PRECIS Ratings to Collaboratory Pragmatic Trials

A new article published in the journal Trials provides a look at how the  Pragmatic–Explanatory Continuum Indicator Summary, or PRECIS, rating system can be applied to clinical trials designs in order to examine where a given study sits on the spectrum of explanatory versus pragmatic clinical trials.

The PRECIS-2 criteria are used to rate study designs as more or less “pragmatic” according to multiple domains that include participant eligibility, recruitment methods, setting, organization, analysis methods, primary outcomes, and more. In this context, “pragmatic” refers to trials that are designed to study a therapy or intervention in a “real world” setting similar or identical to the one in which the therapy will actually be used. Pragmatic trials stand in contrast to explanatory trials, which are typically designed to demonstrate the safety and efficacy of an intervention under highly controlled conditions and in carefully selected groups of participants, but which may also be difficult to generalize to larger or more varied populations.

Schematic of PRECIS-2 Wheel used to evaluate where a given trial design resides upon the explanatory-pragmatic spectrum.
PRECIS-2 Wheel.  Kirsty Loudon et al. BMJ 2015;350:bmj.h2147. Copyright 2015 by British Medical Journal Publishing Group. Used by permission.

Clinical trials are almost never wholly “explanatory” or wholly “pragmatic.” Instead, many studies exist somewhere on a spectrum between these two categories. However, understanding how these different attributes apply to trials can help researchers design studies that are optimally fit for purpose, whether that purpose is to describe a biological mechanism (as in an explanatory trial) or to show how effective an intervention is when used across a broad population of patients (as in a pragmatic trial).

In their article in Trials, authors Karin Johnson, Gila Neta, and colleagues  applied PRECIS-2 criteria to 5 pragmatic clinical trials (PCTs) being conducted through the NIH Collaboratory. Each trial was found to rate as “highly pragmatic” across the multiple PRECIS-2 domains, highlighting the tool’s potential usefulness in guiding decisions about study design, but also revealing a number of challenges in applying it and interpreting the results.

Study authors Johnson and Neta will be discussing their findings during the NIH Collaboratory’s Grand Rounds on Friday, January 22, 2016 (an archived version of the presentation will be available the following week).


Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016;17(1):32. doi: 10.1186/s13063-016-1158-y. PMID: 26772801. PMCID: PMC4715340.
You can read more about the NIH Collaboratory PCTs featured as part of this project at the following links:

ABATE (Active Bathing to Eliminate Infection)

LIRE (A pragmatic trial of Lumbar Image Reporting with Epidemiology)

PPACT (Collaborative Care for Chronic Pain in Primary Care)

STOP-CRC (Strategies & Opportunities to Stop Colon Cancer in Priority Populations)

TIME (Time to Reduce Mortality in End-Stage Renal Disease)
Additional Resources

An introductory slide set on PCTs (by study author Karin Johnson) is available from the Living Textbook:

Introduction to Pragmatic Clinical Trials
The University of Colorado Denver - Anschutz Medical Campus publishes an electronic textbook on pragmatic trials:

Pragmatic Trials: A workshop Handbook