Clinical trial NCT05147428: A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Deprescribing
Dementia
Medication Safety
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Harvard Pilgrim Health Care
name: Humana Co.Ltd.
name: Elevance Health
name: HealthCore, Inc.
First posted: 2021-12-07
Enrollment: 14442
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Dispensing of Inappropriate Medication Prescription
timeFrame: 6 months
Secondary outcomes:
measure: Dose Reduction
timeFrame: 6 months
measure: Percentage of Participants With Polypharmacy
timeFrame: 6 months
measure: Percentage of Participants With Ambulatory Encounters
timeFrame: 6 months
measure: Percentage of Participants Who Died
timeFrame: 6 months
measure: Switching Within Classes
timeFrame: 6 months
measure: Percentage of Participants With Emergency Department Encounters
timeFrame: 6 months
measure: Percentage of Participants With Hospitalizations
timeFrame: 6 months
measure: Percentage of Participants With Non-acute Institutional Admissions
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Umass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School; UMass Memorial Medical Center; Meyers Health Care Institute
name: Jerry H Gurwitz, MD
role: PRINCIPAL_INVESTIGATOR
References: