People with Alzheimer’s disease and other forms of dementia are frequently prescribed medications such as sleeping pills, antipsychotic medication and drugs for bladder control. Sometimes it is too much.
According to Jerry Gurwitz, MD, potentially inappropriate or excessive prescribing is a “morbidity multiplier,” which can lead to adverse drug events, falls, worsening cognitive impairment and emergency hospitalizations.
Dr. Gurwitz, the Dr. John Meyers Professor of Primary Care Medicine, professor of medicine, chief of the Division of Geriatric Medicine and executive director of the Meyers Primary Care Institute, said physicians may not be aware of all the drugs a patient with Alzheimer’s is taking or the drug side effects the patient is experiencing.
He is leading a team that was recently awarded an $814,000 planning grant from the National Institute on Aging to enhance patient/caregiver communication with their health care provider about medications, which may help reduce inappropriate prescribing to people living with Alzheimer’s or other dementias.
“There haven’t really been any studies to this scale in people with Alzheimer’s disease that have focused on patients and caregivers to improve medication safety,” Gurwitz said. Smaller studies have been done that prescribed using educational materials, but this study is setting the stage for pragmatic clinical trials, each enrolling more than 20,000 patients who are members of two large national health plans.
The study, known as D-PRESCRIBE-AD, which stands for Developing a Program to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer’s disease, will enroll community-dwelling health plan members with Alzheimer’s disease, and who have evidence of inappropriate, unsafe prescribing by their physicians.
The study design will be a prospective, cluster randomized, comparative effectiveness intervention trial using three arms: a combined patient/caregiver and provider educational intervention; a provider-only intervention; and usual care. The implementation phase will last four years.
Consumer-focused educational material targeting inappropriate prescribing and how to talk with one’s physician about medications will be adapted from earlier studies.
Information sent to providers in the first two arms would specify drugs prescribed to a patient that may be of concern and ask them to consider speaking with the patient about whether these therapies could be changed.
Gurwitz said the overarching hypothesis is that inappropriate prescribing to patients with Alzheimer’s disease can be addressed through enhanced communication between the patient/caregiver and the health care provider.
“Physicians are overwhelmed with stuff right now,” Gurwitz said. “So we think the innovative part of this project is, we’re trying to activate or empower the patient and the caregiver to interact with the health care provider to change something for the better.” He said he didn’t think a physician just getting a letter would be as effective.
The planning grant, which began Oct. 1, sets ambitious milestones to be completed by July in order to receive funding and authorization to begin the clinical trial phase. Educational materials need to be finalized and tested for ease of use and acceptability by caregivers, health plans and prescribers. Researchers need to clarify how they will identify people who will get the intervention and how outcomes will be measured, relying on administrative health plan data.
Gurwitz said secondary outcomes will include prevalence of polypharmacy (using five or more different medications), rates of emergency room visits, rates of hospitalizations, rates of skilled nursing facility stays, overall health care utilization, and mortality.
The study also aims to create a plan for disseminating findings and an implementation toolkit for health plans and health care systems that would like to adopt the intervention.
In addition to Gurwitz as principal investigator, the research team members from UMMS include: Sonal Singh, MD, MPH, associate professor of family medicine & community health; Kathleen Mazor, EdD, professor of medicine and associate director of the Meyers Primary Care Institute; and Sybil Crawford, PhD, professor of medicine.
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