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Pragmatic clinical trials: An update on NIA-funded real-world research to improve patient care

Marcel SALIVE,
Health Scientist Administrator,
Division of Geriatrics and Clinical Gerontology (DGCG)
.

As faithful readers may remember from my blog post several years ago, pragmatic clinical trials enable researchers to identify and test interventions in real-world situations and settings, such as hospitals, clinics, or physician practices. Because they are connecting with older adults where they already live and receive care, these types of clinical trials may allow for testing in more diverse older adult populations. This is critical for ensuring research findings translate to meaningful improvements in health outcomes for older adults.

NIH supports innovative pragmatic trials

NIA, along with other NIH Institutes and Centers (ICs), funds pragmatic clinical trials through the NIH Common Fund’s Health Care Systems Research Collaboratory, which has coordinated more than 20 large trials involving 20 health care systems and 800,000 participants over the past 10 years. Here are just a few of the aging-related studies funded by the Collaboratory:

  • NOHARM – A cluster-randomized trial to evaluate the effectiveness of an intervention to treat postoperative pain with nondrug approaches in 18 facilities within four health care systems. This study is funded through the NIH HEAL (Helping to End Addiction Long-term℠) Initiative to accelerate research to address the opioid crisis.
  • ACP PEACE – A pragmatic trial to evaluate an intervention that involves training clinicians in communication skills and providing patients with video decision aids about advance care planning in 36 oncology clinics within three health care systems.
  • PROVEN – This cluster-randomized trial showed that an advance care planning video program for nursing home patients was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. However, the health system collaboration developed in this trial has been subsequently leveraged for other pragmatic trials.

NIA expands its efforts in funding diverse pragmatic trials

NIA has also begun supporting other pragmatic trials on aging-related topics. One area of support involves research on the implementation of blood pressure control (and the effects of blood pressure control on cognitive function). NIA is funding three trials, each in two phases, to evaluate the effectiveness of a shared decision-making approach to hypertension control with the aim of lowering the risk of dementia and cognitive decline. The trials are being conducted across seven states in diverse settings, including primary care clinics and large health care systems. The intervention was developed based on results from the SPRINT-MIND study, which examined the connection between blood pressure control and dementia risk.

Funding for pragmatic trials is available: Let’s hear your ideas!

NIA is working with other NIH ICs to continue supporting the NIH Common Fund’s Health Care Systems Research Collaboratory and funding additional embedded pragmatic trials. We encourage applications for funding to conduct efficient, large-scale pragmatic trials or implementation studies that focus on improving health outcomes for underserved U.S. patient populations. NIA also supports the IMbedded Pragmatic Alzheimer's disease and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory to enhance America’s capacity to conduct pragmatic clinical trials of interventions within health care systems for people living with dementia and their care partners.

At a recent workshop covering concepts in the design, conduct, and implementation of embedded pragmatic clinical trials hosted by the Collaboratory, I presented on “writing a compelling grant application.” Visit the link to learn more about designing and conducting pragmatic trials.

If you are interested, please apply for the funding opportunity announcement from the NIH Health Care Systems Research Collaboratory. Please contact me or comment below with your questions!

Comments

Submitted by Yvonne Grant on September 02, 2021

Question:
In your large scale pragmatic research (chronic diseases) how do you currently ensure representation of the highest risk and most vulnerable populations?
Historically, this population is typically served by Federally Qualified Community Health Centers (who serve the under-insured and un-insured), populations with the greatest prevalence of multiple chronic diseases.

Pragmatic trial applicants are encouraged to enroll based on broad eligibility criteria to maximize diversity. Their inclusion plans are examined by peer reviewers and NIH staff to ensure that they are justified in terms of the scientific goals and research strategy. Both NIA and the NIH Health Care Systems Research Collaboratory have funded trials that involve the care of high risk and vulnerable individuals served by Federally Qualified Health Centers. 

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