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

Study Overview
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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 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.

Official Title
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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)

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Other: Educational Materials


Participation Criteria
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Eligibility Criteria
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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: 1. Prescribing provider associated with most recent prescribing of target drug.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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; (2) a provider only educational intervention; and (3) usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-Provider<br>Both patients and providers will receive educational materials on inappropriate prescribing and deprescribing. | Other: Educational Materials<br>* Educational materials on inappropriate prescribing and deprescribing.<br>|
| Experimental: Provider Only<br>Only providers will receive educational materials on inappropriate prescribing and deprescribing. | Other: Educational Materials<br>* Educational materials on inappropriate prescribing and deprescribing.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Change | 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. | 9 months | 
| Polypharmacy | Proportion of patients with polypharmacy. (defined as >5 active prescriptions for different agents) during days 91-270. | 9 months | 
| Rates of Health Care and Emergency Care Utilization | 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. | 9 months | 
| Mortality | In-hospital all-cause mortality during days 91-270. | 9 months | 
| Switching within Classes | Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing, Dementia, Medication Safety