D- PRESCRIBE-AD Phase 2(The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly With Alzheimer's Disease Study: Trial 2)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11,375
- Locations
- 1
- Primary Endpoint
- Absence of Inappropriate Medication Prescription Dispensing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient Inclusion Criteria:
- •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.
- •Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months
- •Age ≥50 years of age as of cohort entry date
- •Continuous medical and pharmacy insurance coverage for at least the prior year
Exclusion Criteria
- •Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care.
- •Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider.
- •On "do not contact" list
- •Provider Inclusion Criteria:
- •1. Prescribing provider associated with most recent prescribing of target drug.
Arms & Interventions
Usual Care
Single Mailing
A combined patient/caregiver and provider educational intervention with one mailing to each.
Intervention: Educational Materials (Other)
Two Mailings
A combined patient/caregiver and provider educational intervention with a second identical mailing, following the first within 45 days
Intervention: Educational Materials (Other)
Outcomes
Primary Outcomes
Absence of Inappropriate Medication Prescription Dispensing
Time Frame: 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 Outcomes
- Rates of Health Care and Emergency Care Utilization(9 months)
- Switching within Classes(9 months)
- Dose Change(9 months)
- Mortality(9 months)
- Polypharmacy(9 months)
Investigators
Jerry Gurwitz
Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences
University of Massachusetts, Worcester