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

University of Massachusetts, Worcester14,442 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Patient 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 Patient 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

Outcomes

Primary Outcomes

Time to Dispensing of Inappropriate Medication Prescription

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.

Time frame: 6 months

Secondary Outcomes

Dose Reduction

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).

Time frame: 6 months

Percentage of Participants With Polypharmacy

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.

Time frame: 6 months

Percentage of Participants With Ambulatory Encounters

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

Time frame: 6 months

Percentage of Participants Who Died

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

Time frame: 6 months

Switching Within Classes

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

Time frame: 6 months

Percentage of Participants With Emergency Department Encounters

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

Time frame: 6 months

Percentage of Participants With Hospitalizations

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

Time frame: 6 months

Percentage of Participants With Non-acute Institutional Admissions

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

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes