Alzheimer Disease
Conditions
Keywords
Deprescribing, Dementia, Medication Safety
Brief summary
Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.
Interventions
OTHEREducational Materials
Educational materials on inappropriate prescribing and deprescribing.
Sponsors
University of Massachusetts, Worcester
National Institute on Aging (NIA)
Harvard Pilgrim Health Care
Humana Healthcare Research, Inc.
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: 1. Diagnosis of AD/ADRD based on a combination of AD/ADRD codes or treatment with a pharmacologic therapy used for AD (e.g., donepezil, rivastigmine, galantamine, and memantine) in the 365 days prior to or on cohort entry date. 2. Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months 3. Age ≥50 years of age as of cohort entry date 4. Continuous medical and pharmacy insurance coverage for at least the prior year Patient
Exclusion criteria
1. Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care. 2. Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider. 3. On "do not contact" list Provider Inclusion Criteria: 1\. Prescribing provider associated with most recent prescribing of target drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Inappropriate Medication Prescription Dispensing | 9 months | The primary outcome will be defined as absence of any dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 9 months following receipt of intervention. These 9 months are split into a 3-month black-out period followed by a six-month observation period, or days 91-270. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose Change | 9 months | Dose change (defined as \> 50% reduction in dose of the selected inappropriate medication), assessed at the participant level using health claims data (outpatient dispensing) during days 91-270. |
| Polypharmacy | 9 months | Proportion of patients with polypharmacy (defined as \>5 active prescriptions for different agents) during days 91-270. |
| Rates of Health Care and Emergency Care Utilization | 9 months | Rates of: emergency room visits; rates of hospitalizations; rates of non-acute institutional stays (e.g., skilled nursing facilities); and overall health care utilization (number of outpatient visits, days hospitalized, emergency department visits, and non-acute institutional days) during days 91-270. |
| Mortality | 9 months | In-hospital all-cause mortality during days 91-270. |
| Switching within Classes | 9 months | Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJerry H Gurwitz, MD
UMass Chan Medical School; UMass Memorial Medical Center;
Outcome results
None listed