Skip to main content
OpenTrials
Completed

NCT Number: NCT05147428

A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease

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 educational interventions 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.

Completed

Looking for future studies?

Notify Me

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

Treatment and study plan

Educational Materials

Other

Educational materials on inappropriate prescribing and deprescribing.

Primary outcomes

  1. Time to Dispensing of Inappropriate Medication Prescription

    Time frame: 6 months

    The primary outcome will be defined as dispensing of the targeted inappropriate prescription class from day 91 to day 270 during the 6 months observation period following receipt of intervention, or days 91-270.

Secondary outcomes

  1. Dose Reduction

    Time frame: 6 months

    Dose reduction was measured as the percentage of patients who achieved a reduction in the patient-specific and medication-specific mean daily dose of the medication targeted for deprescribing of 50% or more during the 6-month study observation period compared with the mean daily dose for the 6-month period immediately preceding the date of mailing of the educational materials. Mean daily dose was calculated using days of supply, dispensed quantity, and unit strength of all dispensings occurring during the 6-month period of interest (either the 6-month study observation period or the 6-month period immediately preceding the date of the mailing).

  2. Percentage of Participants With Polypharmacy

    Time frame: 6 months

    Polypharmacy was defined as being dispensed 5 or more unique prescription medications, assessed on the last day of the 6-month study observation period. Polypharmacy was based on medications administered by any route (including topical or ocular medications) and included AD medications and the 3 medication classes targeted for deprescribing. A combination drug was considered a single medication for the purpose of this analysis.

  3. Percentage of Participants With Ambulatory Encounters

    Time frame: 6 months

    We assessed the occurrence of any ambulatory encounter over the 6-month observation period.

  4. Percentage of Participants Who Died

    Time frame: 6 months

    We assessed all-cause inpatient mortality in all study participants (n=12,787) during the 6-month study observation period.

  5. Switching Within Classes

    Time frame: 6 months

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

  6. Percentage of Participants With Emergency Department Encounters

    Time frame: 6 months

    We assessed the occurrence of any emergency department encounters over the 6-month observation period.

  7. Percentage of Participants With Hospitalizations

    Time frame: 6 months

    We assessed the occurrence of any hospitalizations over the 6-month observation period.

  8. Percentage of Participants With Non-acute Institutional Admissions

    Time frame: 6 months

    We assessed the occurrence of any non-acute institutional admissions over the 6-month observation period.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Elevance Health
  • Harvard Pilgrim Health Care
  • HealthCore, Inc.
  • Humana Co.Ltd.
  • National Institute on Aging (NIA)

Registry information

Official study title

D- PRESCRIBE-AD (The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly With Alzheimer's Disease Study)

Acronym: D-PRESCRIBE-AD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Nov 27, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.