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

May 17, 2021: Dr. Vince Mor Receives Rosenberger Medal, Brown’s Highest Faculty Honor

Photo of Vincent Mor
Dr. Vincent Mor

Longtime NIH Collaboratory researcher Dr. Vincent Mor received Brown University’s Susan Colver Rosenberger Medal of Honor, the highest honor the university’s faculty can bestow, during commencement celebrations on May 2.

One of 2 recipients this year and among only 33 honorees since the award was established in 1919, Mor was recognized for his service, leadership, and research over 4 decades at Brown.

Read more about Dr. Mor’s recognition.

Dr. Mor was a co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), an NIH Collaboratory Demonstration Project. He now serves as a principal investigator of the IMPACT Collaboratory, a program funded by the National Institute on Aging to build the nation’s capacity to conduct embedded pragmatic clinical trials for people living with dementia and their care partners.

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

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.

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

July 7, 2020: PROVEN Primary Results Published

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).

June 12, 2020: 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)

Speaker

Susan L. Mitchell, MD, MPH
Senior Scientist
Hebrew SeniorLife
Hinda and Arthur Marcus Institute for Aging Research
Professor of Medicine
Harvard Medical School

Topic

A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial

Keywords

Embedded pragmatic trial; PROVEN; Advance care planning; Nursing homes; Video intervention; Medicare; Care preferences; Decision support tool; Minimum data set; Intention to treat

Key Points

  • The PROVEN trial was the first large-scale embedded pragmatic trial conducted in nursing homes.
  • The advance care planning (ACP) video intervention in PROVEN was meant as an adjunct to first-person discussions with the clinical care provider.
  • The levels of care preferences described in the ACP videos were life prolongation, limited care, and comfort care.
  • PROVEN’s primary outcome was the number of transfers to the hospital from the nursing home.

Discussion Themes

Widely adoptable, effective interventions to improve ACP in nursing homes remain elusive.

Of the challenges of conducting PCTs embedded in nursing homes, it is important not to overlook the real-world priorities of stakeholders. A high level of endorsement, from C-suite to frontline care providers, is needed before attempting such a trial.

While a priority for nursing home administrators is the number of residents who transfer to the hospital, an essential question for patients and palliative care experts is whether patients receive care that matches their goals and preferences. This is hard to ascertain in a pragmatic way.

Read more about the PROVEN trial, and learn about a new research initiative built on the success of the NIH Collaboratory: the National Institute on Aging’s IMPACT Collaboratory, which is directly funding pilots of embedded PCTs across diverse healthcare settings to improve the care of patients with dementia and their caregivers.

Tags

#pctGR, @Collaboratory1

June 10, 2020: PROVEN Trial Will Report Main Findings During NIH Collaboratory Grand Rounds

A co–principal investigator of the Pragmatic Trial of Video Education in Nursing Homes (PROVEN), a recently completed NIH Collaboratory Trial, will report the main outcomes of the study during NIH Collaboratory Grand Rounds this week.

The PROVEN team developed video-assisted decision support tools for advance care planning that showed efficacy in small randomized controlled trials. The goal of PROVEN was to evaluate the effectiveness of those video tools in real-world nursing home settings by embedding the intervention in 2 large healthcare systems that operate 492 nursing homes nationwide.

Dr. Susan Mitchell of Harvard Medical School will present “A Cluster Randomized Pragmatic Trial of an Advance Care Planning Video Intervention in Long-Stay Nursing Home Residents: Main Findings from the PROVEN Trial.” The Grand Rounds session will be held on Friday, June 12, at 1:00 pm eastern. Join the online meeting.

PROVEN is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Aging.

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