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OpenTrials
Completed

NCT Number: NCT06368115

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Patient 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:

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

Treatment and study plan

Educational Materials

Other

Educational materials on inappropriate prescribing and deprescribing.

Primary outcomes

  1. 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

  1. Dose Change

    Time frame: 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.

  2. Polypharmacy

    Time frame: 9 months

    Proportion of patients with polypharmacy (defined as >5 active prescriptions for different agents) during days 91-270.

  3. Rates of Health Care and Emergency Care Utilization

    Time frame: 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.

  4. Mortality

    Time frame: 9 months

    In-hospital all-cause mortality during days 91-270.

  5. Switching within Classes

    Time frame: 9 months

    Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Carelon Research
  • Harvard Pilgrim Health Care
  • Humana Healthcare Research, Inc.
  • National Institute on Aging (NIA)

Registry information

Official study title

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)

Acronym: DPRESCRIBE-AD2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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