Featured Projects and Grantees
Mayday and Donaghue Make Grant to VA for Pain Management
The 2009 Program for Research Leadership, a grant program that supports transdisciplinary teams to conduct research on an important health issue while exploring the best ways to move knowledge into practice, was awarded to Robert Kerns, PhD and his team of researchers at Yale University Department of Psychiatry and the West Haven VA Hospital. The solicitation and funding of the grant was a collaboration between The Mayday Fund and the Donaghue Foundation, each foundation working together throughout the process of reviewing letters of intent and applications, and developing a unified funding agreement and process to monitor the grant over its four-year term. The award is for $200,000 a year for four years.
For many years, clinicians and researchers have worked toward developing a comprehensive, multidisciplinary, integrated, system-wide approach to pain management that reduces pain and suffering for veterans experiencing acute and chronic pain. In 2008, VHA adopted a 'stepped care' model of pain management as its single standard of pain care. As the name suggests, the model embraces different levels or steps of pain care. It starts with all-inclusive access to pain assessment and treatment services within primary care clinics. It continues with readily available secondary consultation services offering specialized pain care. The final 'step' is represented by tertiary interdisciplinary pain care services offering pain consultation and evaluation by an interdisciplinary team.
Through this grant, a team of clinicians and researchers will be able to evaluate the process of implementing this new process of care. The research team has complementary expertise to examine the implementation process both within and across the various steps of pain care and to disseminate study findings at a national level. Identifying factors critical to successful implementation and maintenance of the stepped care model will greatly benefit VHA as it launches this national program, and will be instrumental in the improvement of pain management services for all veterans.
System-wide implementation of stepped pain model represents an important advance that will assure equitable access to optimal care for our nation's heroes'. This project will provide a unique and important opportunity to critically evaluate the process of change including a variety of clinician supports, processes for building teams, and methods of promoting not only dissemination of our findings but actual knowledge uptake.
It's a family affair.....to prevent diabetes
The first Donaghue Program for Research Leadership grant has been awarded to the Yale Center for Clinical Investigation, in partnership with the Fair Haven Community Health Center.
The grant funded a four-year clinical outcome trial to demonstrate that interventions targeting obesity can improve health outcomes for inner-city women at risk for Type 2 diabetes. William V. Tamborlane, MD., Professor and Chief Pediatric Endocrinologist at the Yale School of Medicine, will lead the project along with a team of practitioners based at Fair Haven Community Health Center headed by Anne Camp, MD, Diabetes Program Director.
The team will be examing whether the risk of diabetes can be markedly reduced by an intensive healthy lifestyle program that can then be replicated in clinics across the country. The study will offer nutrition education, behavior modification instruction, and a structured exercise program. Participants will attend sessions three to four times per week, conducted both in Spanish and English, and behavior modifications will focus on the entire family in an effort to ensure lasting change. Participants will be encouraged to bring their children to each session to take part in fitness games and activities.
The Donaghue Program for Research Leadership is a Connecticut-focused grant program that will support transdisciplinary teams of health researchers led by a senior investigator who has demonstrated leadership in innovative and useful health research and in transferring knowledge gained from research into clinical and/or public health practice. The overall goal of the program is to fund rigorous health research while creating opportunities for team members to learn or demonstrate new approaches to translating knowledge from research. Therefore, the grant project must contain three components: research, knowledge uptake, and team building. This is a four year award granting approximately $200,000 per year.
Breastfeeding education and support trial for obese woman
With his Clinical and Community Health Issues Program grant, Rafael Pérez-Escamilla, PhD, Professor in the Department of Nutritional Sciences at the University of Connecticut, is currently evaluating an intervention which provides specialized training to help obese women breastfeed exclusively. “One-third of women in the United States are obese, with much higher rates among Blacks and Hispanics, and obese women are less likely to breastfeed their infants than their normal-weight counterparts — a significant public health concern given the benefits of breastfeeding for mother and child.”
As part of his study, obese, pregnant, low-income women considering breastfeeding are being recruited at Hartford Hospital and randomly assigned to receive either standard care or breastfeeding peer counseling provided by local women who have been trained in breastfeeding management at the Hispanic Health Council and who have successfully breastfeed a child. Intervention group participants receive prenatal home visits, breastfeeding support in the maternity ward, as well as a series of postpartum home visits, and telephone follow-up’s from their peer counselors. “Our findings will significantly improve our understanding of how to promote breastfeeding among obese women,” says Pérez-Escamilla.
At the study’s conclusion, Pérez-Escamilla hopes “to deliver a best practices clinical and community based breastfeeding support model for obese women…that will be particularly useful to health care providers and administrators who educate and support pregnant women and new mothers about the impact of their infant feeding decisions.”
Cranberry to Prevent UTIs
Kalpana Gupta, MD, MPH, received funding from the Donaghue Foundation for a pilot study to assess the feasibility of using cranberry in a standardized, capsulated form to prevent urinary tract infections (UTIs). If the results show that this approach is feasible, they will be used to design a placebo-controlled trial of the efficacy of cranberry.
The study included two phases: a three-month observational period during which urine was to be collected from each study participant on a regular schedule, followed by a six-month intervention period when participants would be randomized to receive no cranberry capsules, two 400 mg capsules once daily, or two 400 mg capsules twice daily.
The researchers encountered unanticipated recruitment challenges in doing the study. Dr. Gupta, who left Yale for a position as Chief, Infectious Diseases at the Boston VA Health Care System, and Dr. Manisha Juthani-Mehta, Assistant Professor of Internal Medicine and Infectious Disease, who replaced her as the primary investigator, discuss some of the challenges of recruiting organizations and individuals in clinical research.
Why did you change your recruitment methods?
Dr. Juthani-Mehta: Originally, we thought it would be easier to obtain clean urine specimens with residents of assisted living facilities than with really debilitated patients in nursing homes. We also thought that since these people were capable of making decisions for themselves, it would be less complicated than having to get consent from family members.
Dr. Gupta: What we found was that although people in assisted living facilities are considered cognitively intact, the range of cognitive ability is huge. When we tried to enroll people, we worried whether many of them really understood the consent form they were signing. Frequently, family members weren’t available if the participant wanted to confer with them; nor were they legally authorized to make decisions. So we decided to enroll people in nursing homes who, although more debilitated, had legal health care representatives. That way, we knew the consent was valid.
How did you get consent from family members?
Dr. Gupta: We asked the sites to designate a staff person who knew the family to make the first phone call; that way, the initial contact wasn’t with a stranger and the family member wasn’t turned off right from the start.
Dr. Juthani-Mehta: We followed up with a phone call to see if they had any other questions. We also mailed them information and spoke with everyone, as often as they needed.
Are these problems inherent in research with an older population?
Dr. Juthani-Mehta: In my experience, you can get an 80 or 85% participation rate in this age group in observational studies, such as chart reviews. But the minute you say you’re going to do something with the resident, the rate drops to 50%.
So it was very important to fully explain the risks and benefits to family members. Many were enthusiastic because they’d heard or read about cranberry in the lay press. Yet, they still might say: “My mother is 90, she’s been through enough.” Or, “Every little thing agitates her if I’m not by her side; it’s hard enough for staff to do what’s necessary without adding more.”
Were there problems at the nursing homes?
Dr. Juthani-Mehta: It was usually pretty easy to get buy-in from the head administrator, the director of nurses and the medical director or medical board. But we encountered challenges with the staff.
Dr Gupta: For example, there were logistical problems at the actual nursing area. Nurses asked, “How will this work? Where are you going to sit?”
To minimize additional work for nursing home staff, we offered to have our own research nurse collect urine samples. But staff told us: “It’s better to have the people who actually care for these residents do the collection, because the residents know them.”
The nursing aides bore the brunt of this decision; they have tough jobs where a lot is expected of them. We struggled with ways to make the extra work worth their while. The change also meant we had to consider quality control.
How did you reach out to staff?
Dr. Juthani-Mehta: We could only give them tokens of appreciation, so we brought in coffee and donuts, lunch or gift cards. And we found that if there’s at least one person on the ground committed to the project – not the administrator who is rarely there or the medical director who comes in once a month – the project will work.
Were there other obstacles?
Gupta: We had to simplify the protocol but every time we made a change, we had to go back to the IRB. There was a lot of productive dialog, but it slowed down the process.
Did recruitment problems affect the research?
Dr. Juthani-Mehta: We enrolled fewer subjects than planned, and more of them came from the nursing home level. We’re doing data analysis now and, fortunately, the smaller sample size will be sufficient to meet our main objectives.
If you were writing this proposal today, how would you change it?
Dr. Juthani-Mehta: Many investigators underestimate the amount of time, energy and money that’s needed for recruitment. You have to build in extra numbers of subjects; whatever number you want, multiply it by three or four; you also have to factor in the staff time it takes to go to more facilities.
Dr. Gupta: Even before I wrote the proposal, I’d probably try to find facilities that were willing to participate. I’d also want to solidify the research process at the nursing home before I submitted the application to the IRB. To try this at the assisted living level, we’d have to design a consent process that gets the subject and the family member involved, even if the subject isn’t legally impaired.
Is there an overall lesson you take away from your experience?
Dr. Gupta: We were trying to apply our research methods to a clinical setting. The problem is that there is no existing infrastructure – extra staff time and even physical space – in the clinical setting. We didn’t appreciate this fully in our initial proposal. It’s funny: once we got in and realized we couldn’t separate our research staff from their clinical staff, marketing, people management and business skills became necessary, rather than scientific expertise.
Made to Stick
More than 110 people attended the Made to Stick lecture and workshop presented by the Connecticut Council for Philanthropy and the Donaghue Foundation, and generously sponsored by the Bank of America, on November 13 at the Hartford Club. Based on the principles of the best-selling book that he co-authored with his brother, Made to Stick, Chip Heath, Professor at Stanford University’s Graduate School of Business, explored why some ideas – from urban legends to public education campaigns – 'stick' with the public, while others are hardly noticed. He also provided practical ways that any organization can better communicate and connect with the public. All participants received a copy of Made to Stick.
For more information about Chip and Dan Heath’s ideas on communication, see http://www.madetostick.com/. For more information about the Connecticut Council for Philanthropy, go to www.ctphilanthropy.org.
The Hastings Center
The Hastings Center has convened a three-year project in 2007 that will produce a revised, updated, and expanded version of an historic Center publication: Guidelines on the Termination of Life-Sustaining Treatment and the Care of the Dying (1987).
The project will research and describe the practices, policies, and other systems that support communications and decision making and promote access to palliative care, hospice care, and other services for clinicians, policymakers, and experts responsible for providing, regulating, or improving end of life care, as well as journalists, scholars, dying patients and their families.
The Guidelines project working group held a plenary meeting in New York City on January 22-23, 2007. On July 23-24, 2007, the Rehabilitation Institute of Chicago hosted a research consultation where project leaders met with representatives of disability communities nationwide to explore issues of disability relevant to end of life care. The project’s leaders are now drafting text, planning further consultations, and exploring publication and dissemination options that will promote awareness and use of the new guidelines by professionals and the public.
This project is co-funded by the Donaghue Foundation and the Sussman Charitable Trust.
To learn more about The Hastings Center project, go to end of life care link.
