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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

11375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Single Mailing

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

Group Type EXPERIMENTAL

Educational Materials

Intervention Type OTHER

Educational materials on inappropriate prescribing and deprescribing.

Two Mailings

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

Group Type EXPERIMENTAL

Educational Materials

Intervention Type OTHER

Educational materials on inappropriate prescribing and deprescribing.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational Materials

Educational materials on inappropriate prescribing and deprescribing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months
3. Age ≥50 years of age as of cohort entry date
4. Continuous medical and pharmacy insurance coverage for at least the prior year

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

Exclusion Criteria

1. Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care.
2. Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider.
3. On "do not contact" list

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No