A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2 - Trial NCT06368115
Access comprehensive clinical trial information for NCT06368115 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Massachusetts, Worcester and is currently Not yet recruiting. The study focuses on Alzheimer Disease. Target enrollment is 10000 participants.
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Study Focus
Sponsor & Location
University of Massachusetts, Worcester
Timeline & Enrollment
N/A
Jun 01, 2024
Jun 01, 2025
Primary Outcome
Absence of Inappropriate Medication Prescription Dispensing
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06368115
Non-Device Trial