Clinicians treating older patients know that most have multiple chronic conditions, or MCCs, for which they receive multiple interventions. In fact, about 75 percent of people 65 and older have two or more chronic conditions—such as heart disease, diabetes, chronic lung disease, arthritis, and some cancers—which significantly affect their health and well-being. Guidance based on clinical research is critical to treating people with MCCs, as treatment for one condition may have negative effects on coexisting conditions and may interact with other treatments.
“Treatments for chronic conditions are usually developed and tested in people who only have a single condition,” said Dr. Marcel Salive, medical officer in the Geriatrics Branch of NIA’s Division of Geriatrics and Clinical Gerontology. “But, when a person has two or three chronic diseases, the treatments for the individual diseases can often interfere with one another and cause additional problems for patients.”
NIH Common Fund RFA for clinical trials
To address this important issue, the NIH Common Fund , which supports cross-cutting, trans-NIH programs, will fund pragmatic clinical trials focusing on treating MCCs in older adults. In August 2013, an NIH Request for Applications  (RFA) invited applications for demonstration projects that must be conducted across two or more healthcare systems (HCS) and as part of the NIH HCS Research Collaboratory .
“The goal of these direct-to-practice clinical trials is to develop strategies that work in real-world environments,” said Dr. Salive. “We are looking for robust treatments, preventive actions, or organizational changes that apply broadly to patient populations and can be used reliably in several health systems.”
The cooperative agreements established through the RFA will support a 1-year planning phase (UH2), with possible rapid transition to an implementation phase (UH3). The UH2/UH3 application must be submitted as a single application, and the NIH asks applicants to pay special attention to the specific instructions for each phase. The deadline for applications is December 2, 2013, and initial awards are expected to be made in July 2014.
Recently awarded grants
NIA by itself issued an RFA in July 2012 for secondary analysis of data on people with MCCs. The Institute awarded four R21 grants in late August, 2013 from this RFA, and the National Center for Complementary and Alternative Medicine made one award:
- Jerry H. Gurwitz, University of Massachusetts Medical School, Worcester. Impact of Comorbidity Dyads on Heart Failure Treatment in Older Persons  (1R21AG045320-01)
- Veronique L. Roger, Mayo Clinic, Rochester, MN. Multi-morbidity in Heart Failure  (1R21AG045228-01)
- Linda J. Simoni-Wastila, University of Maryland School of Pharmacy, Baltimore. COPD Treatment in Older Adults with Depression  (1R21AG045573-01)
- Mary E. Tinetti, Yale University School of Medicine, New Haven, CT. Health Outcome Effects of Common Medications in Elders with Multiple Conditions  (1R21AG045148-01 MPI)
- William B. Weeks, Geisel School of Medicine at Dartmouth, Hanover, NH. Effect of chiropractic on costs of Medicare patients with multiple comorbidities  (1R21AT008287-01)
“There are several themes among these grants, including new ways to conceptualize and study MCCs, a focus on universal outcomes, and methods and techniques to understand how drug safety and effectiveness may differ for specific disease combinations,” said Dr. Salive. “We hope these awards will lead to definitive studies that will help transform clinical care.”
Consensus Panel recommendations for MCC treatments
In related activities, NIA and the Agency for Healthcare Research and Quality convened a Consensus Panel in September 2011 to recommend a core set of outcome measures for evaluating and determining the need for and success of MCC treatments that could be widely used in research and in healthcare delivery. In addition to measurement of gait speed, the panel recommended three possible composite outcome assessments that could be administered in a physician’s office or clinic, focusing on function in the following areas:
- General health
- Physical function
- Mental health
- Social role
Depending on the results, clinicians could follow up with additional questions and diagnostic tools to determine the most pressing issues and devise a plan to treat or alleviate symptoms. The recommended composite outcome measures can be found in Universal Outcome Measures for Older Persons with Multiple Chronic Conditions , Journal of the American Geriatrics Society, December 2012.
“In developing the outcome measures, we placed a high priority on what would be easy to administer and easy for patients to understand and complete,” said Dr. Salive. “Ultimately, we hope this research will point the way to more coordinated, effective care for the whole patient.”