A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2

NCT06368115 | Completed DMC

• 2 other identifiers: 000234534R33AG069794
• Study Type: interventional
• Target: 11,375
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Deprescribing; Dementia; Medication Safety

Outcome Measures

Primary Outcomes (1)

• Absence of Inappropriate Medication Prescription Dispensing

  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.

  9 months

Secondary Outcomes (5)

• Dose Change

  9 months

• Polypharmacy

  9 months

• Rates of Health Care and Emergency Care Utilization

  9 months

• Mortality

  9 months

• Switching within Classes

  9 months

Study Arms (3)

Single Mailing

EXPERIMENTAL

A combined patient/caregiver and provider educational intervention with one mailing to each.

Other: Educational Materials

Two Mailings

EXPERIMENTAL

A combined patient/caregiver and provider educational intervention with a second identical mailing, following the first within 45 days

Other: Educational Materials

Usual Care

NO INTERVENTION

Interventions

Educational Materials OTHER

Educational materials on inappropriate prescribing and deprescribing.

Single Mailing; Two Mailings

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \. Prescribing provider associated with most recent prescribing of target drug.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Aging (NIA): collaborator
• Harvard Pilgrim Health Care: collaborator
• Humana Healthcare Research, Inc.: collaborator
• Carelon Research: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jerry H Gurwitz, MD

  UMass Chan Medical School; UMass Memorial Medical Center;

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Family Medicine and Community Health, and Population & Quantitative Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)