~1034 spots leftby Jun 2025

Educational Program for Alzheimer's Disease

(DPRESCRIBE-AD2 Trial)

Recruiting in Palo Alto (17 mi)
Overseen byJerry H Gurwitz, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Massachusetts, Worcester
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for older adults with Alzheimer's Disease who live in the community, have been diagnosed based on specific codes or are taking Alzheimer's medication, and may be receiving potentially inappropriate medications like sedatives or antipsychotics.

Inclusion Criteria

I have been diagnosed with Alzheimer's or related dementia and have been treated with specific medications for it in the last year.
I am 50 years old or older.
I have been prescribed antipsychotics, sedatives, or strong anticholinergics in the last 3 months.
See 1 more

Exclusion Criteria

Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider
On 'do not contact' list
I live in a nursing home or receive palliative care.

Treatment Details

Interventions

  • Educational Materials (Behavioural Intervention)
Trial OverviewThe study tests an educational program designed to inform patients with Alzheimer's and their caregivers about the risks of certain medications. The goal is to see if this education can reduce unnecessary or harmful prescriptions compared to usual care.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Two MailingsExperimental Treatment1 Intervention
A combined patient/caregiver and provider educational intervention with a second identical mailing, following the first within 45 days
Group II: Single MailingExperimental Treatment1 Intervention
A combined patient/caregiver and provider educational intervention with one mailing to each.
Group III: Usual CareActive Control1 Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
UMass Chan Medical SchoolWorcester, MA
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Who Is Running the Clinical Trial?

University of Massachusetts, WorcesterLead Sponsor
National Institute on Aging (NIA)Collaborator
Carelon ResearchCollaborator
Harvard Pilgrim Health CareCollaborator
Humana Healthcare Research, Inc.Collaborator

References