A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease (D-PRESCRIBE-AD)

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)

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 Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: Educational Materials

• Study Type: Interventional
• Enrollment (Actual): 14442
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	6 months
Percentage of Participants With Ambulatory Encounters	We assessed the occurrence of any ambulatory encounter over the 6-month observation period.	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.	6 months
Switching Within Classes	Switching of agents within the following targeted drug classes: sedative/ hypnotics, antipsychotics, highly anticholinergic agents.	6 months
Percentage of Participants With Emergency Department Encounters	We assessed the occurrence of any emergency department encounters over the 6-month observation period.	6 months
Percentage of Participants With Hospitalizations	We assessed the occurrence of any hospitalizations over the 6-month observation period.	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.	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Aging (NIA); Harvard Pilgrim Health Care; HealthCore, Inc.; Humana Co.Ltd.; Elevance Health
• Investigators: Principal Investigator: Jerry H Gurwitz, MD, UMass Chan Medical School; UMass Memorial Medical Center; Meyers Health Care Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dementia; Deprescribing; Medication Safety
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: H00023453; 4R33AG069794-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No