News

Hey and Taljaard co-authors on review of pragmatic clinical trials

Posted on by Sonya Sutton

A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing

March 28, 2021

IMPACT Collaboratory members Spencer Hey, PhD and Monica Taljaard, PhD are among the authors of a review of pragmatic clinical trials recently published online in the Journal of Clinical Epidemiology and covered in a blog post from the US GRADE network. The first author of the study is Stuart G. Nicholls, PhD, of the Ottawa Hospital Research Institute.

The researchers identified 4,337 eligible trials in their review of data collected from MEDLINE, Web of Science, ClinicalTrials.gov and full text between January 2014 and April 2019. They found diversity in research areas, but only 22% of the trials identified were labeled as pragmatic in the title, abstract or full text of the document. In addition, the authors estimated one-fifth of trials under-accrued by at least 15%. They concluded that there is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches.

The US GRADE Network blog developed an infographic to share the findings of the review.

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Source: US GRADE Network Blog

IMPACT-C team shares findings on study of vaccine hesitancy in frontline nursing home staff

Posted on by Sonya Sutton

The IMPACT-C supplement award recently shared the results of their “town hall” style discussions with frontline nursing home staff in a journal article and podcast.

The findings were shared in the Journal of the American Geriatrics Society on March 25th. The study included one hundred and ninety three staff from 50 facilities who participated in 26 meetings between December 30, 2020 and January 15, 2021. Most staff reported getting information about the vaccine from friends or social media. Concerns about how rapidly the vaccines were developed and side effects, including infertility or pregnancy related concerns, were frequently raised. There were no differences in concerns raised by discipline. Questions about returning to prior activities after being vaccinated were common and offered the opportunity to build on positive emotions to reduce vaccine hesitancy.

IMPACT-C study team members Sarah Berry, Kimberly Johnson, and David Gifford also discussed the research on the March 25th GeriPal Podcast.  The podcast discussion was around the devastating impact of COVID on nursing homes and the effects and update rates of vaccine among patients and staff in nursing home.

Click here to read the full journal article.

Click here to listen to the podcast.

IMPACT Collaboratory Funds Four Pilot Study Awards

Posted on by Sonya Sutton

The NIA IMPACT Collaboratory is happy to announce the recipients of its second cycle (2A) of the IMPACT Pilot Grant award program. Recipients were selected from an impressive group of competitive applications.

IMPACT Collaboratory Pilot Grant Award Recipients (RFA 2020)

Joan Carpenter, PhD, CRNP, University of Maryland School of Nursing

Implementation of a Telehealth Palliative Care Model for Persons with Dementia

Richard Fortinsky, PhD, University of Connecticut Health Center

Pilot Pragmatic Clinical Trial to Embed Tele-Savvy into Health Care Systems

Jennifer Gabbard, MD, Wake Forest School of Medicine

Using Telemedicine to Improve Engagement in Advance Care Planning in Patients with Cognitive Impairment or Unrecognized Dementia

Ariel Green, MD, MPH, PhD, Johns Hopkins University School of Medicine

ALIGN: Aligning Medications with What Matters Most

Additional details on these recipients and their pilot studies can be found on Pilot Grants Awardees Page at this link.

About the IMPACT Pilot Grant Program

The IMPACT Collaboratory funds several one-year pilot studies annually, which are meant to generate the preliminary data necessary to design and conduct future full-scale, stage 4 effectiveness ePCTs funded through other grant mechanisms. Awards are for single Principal Investigator applications for one year and are non-renewable. In response to the coronavirus disease (COVID-2019) outbreak, in this award cycle, the IMPACT Collaboratory prioritized applications proposing pilot ePCTs of telemedicine, telehealth, and remote technologies interventions aimed at improving the health care, unmet needs, quality of life, and/or health outcomes for people living with AD/ADRD and their care partners. The IMPACT Collaboratory encourages applications that address dementia care for people of all backgrounds and promote health equity.

Currently Accepting Applications for 2021 IMPACT Pilot Grant Program

Award applications for the current awards cycle opened February 1, 2021. The application process is a 2-step competitive process. The first step, a mandatory LOI, is due no later than Friday, March 5, 2021.  Selected investigators will be invited to submit a full application.

IMPACT Collaboratory featured in New York Times opinion piece on effects of COVID-19 on people living with dementia with quotes from Harrison, Karlawish, and Berry

Posted on by Erin Luers

The NIA IMPACT Collaboratory has been featured in a New York Times opinion piece about the effects of COVID-19 restrictions on people living with dementia and their caregivers. Jill Harrison, PhD, Executive Director of the IMPACT Collaboratory, and Jason Karlawish, MD, the leader of the Ethics & Regulation Core are quoted, as is Sarah Berry, MD, MPH, the multiple PI of IMPACT-C, a COVID-19 supplement to the IMPACT Collaboratory. Dr. Harrison’s quote “We are Going to Keep you Safe, Even if It Kills Your Spirit” serves as the title.

“Dr. Karlawish thinks that blanket bans on dementia caregivers are akin to taking away a wheelchair from a person with physical disabilities. ‘And that’s a brutal metaphor,’ he said. ‘But all of a sudden, the people who would come there and help their minds function were taken away.’ Some geriatricians describe this separation as unfortunate and damaging, but necessary. Others believe that we should have allowed for a gentler nursing home quarantine, one that recognizes caregivers as ‘essential’ parts of dementia health care.

Jill Harrison, an executive director of the National Institute on Aging’s IMPACT Collaboratory, thinks the instinct to lock everything down reflects a broader tendency in dementia care to prioritize physical safety above all else… ‘I always call it surplus safety,’ Dr. Harrison told me. ‘It’s essentially like, we are going to keep you safe, even if it kills your spirit.’”

Read the full piece here.

IMPACT Collaboratory announces three new funding opportunities

Posted on by Sonya Sutton

The NIA IMPACT Collaboratory is pleased to announce three new funding opportunities; Pilot Grants Cycle 3A, and funding opportunities for two new programs, Demonstration Projects and Health Care Systems (HCS) Scholars . These three funding opportunities will support research and training aimed at increasing the nation’s capacity to conduct pragmatic clinical trials (ePCTs) of non-pharmacological interventions within health care systems to improve the care of people living with Alzheimer's disease and related dementias (AD/ADRD) and their care partners.

Demonstration Projects Program

The IMPACT Collaboratory will fund up to two Demonstration Projects (maximum duration 24 months) designed as full-scale, Stage IV effectiveness ePCT (based on the NIH Stage Model) that test non-pharmacological interventions for people living with AD/ADRD and their care partners embedded within and linked to the needs of a health care system. The goal of the Demonstration Projects is to generate evidence on effective care delivery practices that can be expanded and/or implemented in other systems. Interventions must be linked to the needs of a health care system. The intervention will typically encompass relatively simple system changes or direct patient outreach, or successfully piloted programs ready for testing at scale. Preference will be given to applications for Demonstration Projects that address dementia care for populations traditionally marginalized or underrepresented in clinical trials and those that promote health equity.

HCS Scholars Program

The new Health Care Systems (HCS) Embedded Research Scholars Program offers junior and senior investigators an opportunity to work directly with health care systems interested in improving the care provided to people living with dementia (PLWD) and their care partners. The goals of the HCS Scholars Program are to embed investigators in health care systems to:

  • Establish mutually beneficial partnerships to improve the care of PLWD and care partners
  • Train investigators about health care settings needs and how new programs are successfully introduced at all levels of the organization
  • Engage HCS in learning more about what it means to conduct ePCTs and provide resources for understanding opportunities for improvement in dementia care or evaluation of related quality improvement projects
  • Strengthen collaborations between investigators and HCS that may lead to pilot studies or demonstration projects.

Pilot Grant Program –Cycle 3A

The IMPACT Collaboratory funds several one-year pilot studies annually; these are meant to generate the preliminary data necessary to design and conduct a future full-scale Stage IV effectiveness ePCT (based on the NIH Stage Model) funded through other grant mechanisms (National Institutes of Health or other sources). The IMPACT Collaboratory will consider applications for pilot ePCTs that test non-pharmacological interventions embedded in health care system(s) for people living with AD/ADRD and their care partners. All applications should make a convincing case that the pilot ePCT proposed can be scaled up to a full-scale, Stage IV effectiveness ePCT as the next step.

Please check upcoming events for webinars for each opportunity, as well as the IMPACT Twitter feed and mailing list for additional updates.

Health Care Systems Core leaders discuss vision for the IMPACT Learning Health Network

Posted on by Sonya Sutton

The NIA IMPACT Health Care Systems Core recently launched its Learning Health Network, to connect health care practice and research for people living with dementia and their care partners. The Learning Health Network is a consortium of individuals, organized into 4 unique communities representing unique settings of care for people living with Alzheimer’s disease and related dementias and their care partners.  The goal is to bridge the gap between research and practice by facilitating relationship-building and information sharing between researchers and members of the various care settings.  The Learning Health Network is in its beginning phase, with current efforts aimed at building the 4 unique communities:

  • Long-term Care (nursing homes, assisted living, and other settings that provide around-the-clock care for persons living with dementia)
  • Healthcare Settings (Clinics, ACOs, MA Plans, Integrated Delivery Systems)
  • Hospitals/Emergency Departments
  • Community-based Organizations (Meals on Wheels, Hospice, Senior Centers, Adult Day Centers)

Health Care Systems Core Leaders Eric B. Larson, MD, MPH and  Leah Hanson, PhD are leading the efforts for the Learning Health Network, and recently shared their goals and vision for the network, describing the Learning Health Network as an opportunity to create a transformative and bi-directional relationship between stakeholders working to improve dementia care.

“The idea of a learning health network is foundational to health care systems,” said Larson. We need bi-directional communication, so that research informs practice, and practice informs research. It’s not just “we” educating “them”. We will educate each other about the settings and how we can work with them.”

Hanson recognized the importance of listening to each other as well. “If researchers are operating in a silo and conduct an amazing intervention and we roll out in real world, but it doesn’t work, then it doesn’t help,” she said. “We have to consider those factors in design of research studies. We believe this network is the way to bring people together.”

Larson and Hanson said they believe that groups like the Learning Health Network will prove to be especially helpful when dealing with crises like the COVID-19 pandemic.

“In our system, people are sharing and engaging with each other in ways they never have before,” said Hanson.  “We did a weekly call at our health care system when COVID first started, with large clinician engagement. People want to learn what is happening, and being set up to easily share information will help that process.”

Larson and Hanson said that their hope is that for a small investment of time, members of the Learning Health Network can gain access to thought leaders and experts while also educating researchers about how to improve care in real-world settings. Both core leaders recently presented with two other members of the Core for a Grand Rounds webinar and follow-up podcast about the Core and the Learning Health Network.

New IMPACT Funding Opportunity: 2021 Career Development Award

Posted on by Erin Luers

For scientists pursuing careers in embedded pragmatic clinical trials for people living with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) and their care partners.

Informational Webinars
Tuesday, January 19, 2021 at 2:00 pm ET: Registration closed.
Wednesday, February 3, 2021 at 3:00 pm ET: Registration closed.

Application Period Opens
January 18, 2021

Proposals Due
April 2, 2021 @ 5pm ET

Read full Request for Applications (RFA)

The NIA IMPACT Collaboratory (U54AG063546) is pleased to announce the request for applications for the 2021 IMPACT Career Development Award. We encourage applications from early-stage investigators interested in a research career that includes conducting embedded pragmatic clinical trials (ePCTs) of non-pharmacologic interventions within healthcare systems (HCS) for people living with Alzheimer’s disease (AD) and AD-related dementias (ADRD) and their care partners. The recent $300 million increase in National Institutes of Health funding for AD/ADRD research, reflects the urgency and opportunities for investigators focused in this area.

Conducting ePCTs in AD/ADRD within HCS requires unique research skills, yet the field is relatively nascent. The number of investigators capable of rigorously designing and executing ePCTs in partnership with HCS and other key stakeholders remains limited, and those that have intersecting expertise in AD/ADRD populations are even fewer. Thus, a critical objective of the IMPACT Collaboratory is to build the nation’s capacity to conduct impactful ePCTs in AD/ADRD by training a workforce of investigators prepared to carry on this work well into the future.

The IMPACT Collaboratory funds up to four career development awards (CDAs) annually. These CDAs seek to support the development of early-stage MD, PhD, or equivalent researchers who seek careers conducting ePCTs for people living with AD/ADRD and their care partners. The IMPACT Collaboratory prioritizes applications that address dementia care for people of all backgrounds and promote health equity. CDAs are funded for two years. Each award will provide $100,000 annually in direct costs with an indirect cost rate capped at 8%. Awardees are required to devote a minimum of 75% effort toward the goals of the award.

A set of frequently asked questions (FAQ) regarding this award is available at https://impactcollaboratory.org/CDA-grant-faq/. Additionally, please email IMPACTcollaboratory@hsl.harvard.edu with any questions.

Goldfeld examines constrained randomization to evaulate the vaccine rollout in nursing homes

Posted on by Sonya Sutton

Keith Goldfeld, member of the Executive Committee of the IMPACT Design & Statistics Core (DSC), is part of the IMPACT Collaboratory study examining the rollout of COVID-19 vaccine in nursing homes. He recently authored a blog post describing the statistical approach to the study.

The effort involves a cluster randomized trial (CRT) to evaluate the effectiveness of a wide-ranging outreach program designed to encourage nursing home residents to get their shots. The focus is on facilities that have relatively high proportions of African-American and Latinx residents, because these facilities have been among the least successful in the past in convincing residents to get vaccinated. The outcome measure of the trial, which will be measured at the individual level, will be the probability of vaccination within 5 weeks of being available at the nursing home.

Read the full blog post at: https://www.rdatagen.net/post/2020-12-22-constrained-randomization-to-evaulate-the-vaccine-rollout-in-nursing-homes/