September 7, 2021
Author: Sonya Sutton
IMPACT Collaboratory mentioned in JAMA article about expanding evidence for clinical care of older adults
The efforts of the NIA IMPACT Collaoratory to enhance embedded pragmatic clinical trials (ePCTs) in people living with dementia was included in a recent JAMA viewpoint, “Expanding Evidence for Clinical Care of Older Adults Beyond Clinical Trial Traditions and Finding New Approaches.”
Authors Michael Steinman, MD, Cynthia M. Boyd, MD, MPH, and Kenneth E. Schmader, MD, explore alternative approaches to delivering evidence needed to inform care for older adults in the viewpoint piece. In addition to ePCTs, they discuss strategies for analyzing existing clinical trial data and observational evidence to extrapolate them to populations of interest.
In the viewpoint, they state that the IMPACT Collaboratory “…is facilitating development of a number of pragmatic trials embedded in health systems that address different aspects of care for older adults with dementia. Because such trials typically forgo dedicated research visits, measuring aspects of geriatric health status can be challenging. Nonetheless, creative strategies can be used to measure these important domains, such as brief telephone-based assessments of function and cognition, extraction of functional status data from Medicare annual health risk assessment forms, and use of existing data to construct frailty index models.”
Read the full article here.
Patient and Caregiver Relevant Outcomes iLibrary now available to help design pragmatic clinical trials
The NIA IMPACT Collaboratory Patient and Caregiver Relevant Outcomes (PCRO) Core has created the IMPACT PCRO iLibrary to help investigators seeking to develop pragmatic clinical trials in people living with Alzheimer’s disease and related dementias (AD/ADRD).
The IMPACT PCRO iLibrary is an online, searchable and interactive resource containing information on selected outcome measures derived from existing data sources for pragmatic trials enrolling people with AD/ADRD. The members of the PCRO core selected the outcome measures based on their relevance to the lived experience of people with AD/ADRD and their care partners. In addition, the selected outcomes have pragmatic characteristics that make them good candidates for use in embedded pragmatic clinical trials (ePCTs). Pragmatic outcome measures allow for efficient and uniform data capture across multiple sites and large diverse populations, while minimizing burden on people living with dementia or their care partners.
“The IMPACT PCRO iLibrary is a unique resource for investigators who lead pragmatic trials to improve outcomes for people living with dementia and their care partners,” Laura Hanson, MD, MPH, PCRO Core Leader.
“When designing a clinical trial, the first question is often, ‘What outcome are we trying to improve?” said Dr. Hanson. “When we began the work of the PCRO Core, we quickly recognized that it’s easy to find outcome measures, but really challenging to learn if these outcomes fit the needs of a pragmatic trial.”
Dr. Hanson led the effort to create the library supported by Project Manager Kathryn Wessell, MPH. They began by organizing information about potential outcome measures in existing data sources. PCRO Core Executive Committee Members, Joan Teno, MD, MS and Debra Saliba, MD, MPH, shared their expertise working with the Minimum Data Set for Nursing Homes (MDS), Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey, and claims data to create the initial version of the library. Spencer Hey, PhD, of the IMPACT Ethics and Regulation Core, used AirTable to create the library and developed an instructional video on how to use the resource. Other members of the PCRO Core who contributed to the library include:
- Antonia Bennet, PhD
- Amy Kelley, MD, MSHS
- Joshua Niznik, PharmD, PhD
- Christine Ritchie, MD, MSPH
- Sheryl Zimmerman, PhD
“The PCRO iLibrary will grow and expand with the broader IMPACT Collaboratory, as more ADRD investigators conduct ePCTs, and share what works to capture relevant outcomes,” said Dr. Hanson. “Within the next year, the PCRO iLibrary will expand to include selected patient or caregiver-reported outcomes rated for their pragmatic properties.”
Phase 2 of the PCRO iLibrary will also include collaboration with David Meyers, PHD, MPH, of the IMPACT Technical Data Core, to continue to expand the library.
To learn more about the PCRO iLibrary and use this resource, visit https://impactcollaboratory.org/pcro-library/.
Results from TRAIN-AD study published in JAMA Internal Medicine
A study team led by IMPACT’s Multiple Principal Investigator Susan Mitchell, PhD, MPH recently published results of a Trial to Reduce Antimicrobial Use in Nursing Home Residents with Alzheimer’s Disease and Other Dementias (TRAIN-AD). The journal article and an accompanying editorial were published in JAMA Internal Medicine on July 12th.
Mitchell and colleagues conducted a cluster randomized clinical trial of a multicomponent intervention designed to improve management of suspected urinary tract infections (UTIs) and lower respiratory infections (LRIs) for nursing home residents with advanced dementia. The trial was conducted at 28 Boston-area nursing homes (14 per arm). The intervention, which targeted nursing home care providers, integrated best practices from infection diseases and palliative care for management of suspected UTIs and LRIs in residents with advanced dementia. Researchers observed a clinically significant 33% reduction in antimicrobial courses for suspected lower respiratory infections (LRIs) and urinary tract infections (UTIs) among participants living in facilities assigned to the intervention. Although this result was underpowered to show a statistically significant reduction, the TRAIN-AD study was unique in that it completed a rigorous evaluation of an intervention to reduce antibiotics in people with advanced dementia.
The study team found that despite a comprehensive training approach that included an in-person seminar, online course, management algorithms, communication tips, and feedback reports and a high adherence to the training, the intervention did not significantly reduce antimicrobial use among nursing home residents with advanced dementia. However, both Mitchell’s team and the commentary authors noted the potential of the intervention to yield more significant results when scaled up and applied to a broader range of nursing home settings.
The study results were accompanied by an invited commentary from Shiwei Zhou, MD and Pretti N. Malani, MD, noting these strengths and describing the study as a “a low-cost, low risk, scalable intervention that is associated with a reduction in inappropriate antibiotic prescriptions is worthy of replication” from a stewardship perspective.
Read the full article here and commentary here.
Citation: Mitchell SL, D’Agata EMC, Hanson LC, et al. The trial to reduce antimicrobial use in nursing home residents with Alzheimer disease and other dementias (TRAIN-AD): a cluster randomized clinical trial. JAMA Intern Med. Published online July 12, 2021. doi:10.1001/jamainternmed.2021.3098
