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Alzheimer DiseaseD-PRESCRIBE-ADNCT05147428

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

A study testing Educational Materials in people with Alzheimer Disease, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Educational Materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14,442 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 1 Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Umass Chan Medical School

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

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)

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.

Being tested
Educational Materials
Keywords
Deprescribing, Dementia, Medication Safety
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational MaterialsOther

    Educational materials on inappropriate prescribing and deprescribing.

Study groups in NCT05147428
Study groupRoleWhat they receive
Patient-ProviderExperimentalBoth patients and providers will receive educational materials on inappropriate prescribing and deprescribing.
Receives: Other: Educational Materials
Provider OnlyExperimentalOnly providers will receive educational materials on inappropriate prescribing and deprescribing.
Receives: Other: Educational Materials
Usual CareNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (8)

  1. 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).

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. Percentage of Participants With Ambulatory Encounters

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

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. Switching Within Classes

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

    Measured: 6 months

  6. Percentage of Participants With Emergency Department Encounters

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

    Measured: 6 months

  7. Percentage of Participants With Hospitalizations

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

    Measured: 6 months

  8. Percentage of Participants With Non-acute Institutional Admissions

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2021
  2. Study start1 Jun 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
14,442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05147428
Sponsor's protocol ID
H00023453
Other IDs
4R33AG069794-02
Acronym
D-PRESCRIBE-AD
Status last verified
Nov 2024
First submitted
24 Nov 2021
Last updated
27 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh S, Li X, Cocoros NM, Antonelli MT, Avula R, Crawford SL, Dashevsky I, Fouayzi H, Harkins TP, Mazor KM, Michnick AI, Parlett L, Paullin M, Platt R, Rochon PA, Saphirak C, Si M, Zhou Y, Gurwitz JH. High-Risk Medications in Persons Living With Dementia: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1426-1433. doi: 10.1001/jamainternmed.2024.5632.

    PubMed 39432286

  • Singh S, Cocoros NM, Li X, Mazor KM, Antonelli MT, Parlett L, Paullin M, Harkins TP, Zhou Y, Rochon PA, Platt R, Dashevsky I, Massino C, Saphirak C, Crawford SL, Gurwitz JH. Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in the Elderly with Alzheimer's Disease (D-PRESCRIBE-AD): Trial protocol and rationale of an open-label pragmatic, prospective randomized controlled trial. PLoS One. 2024 Feb 12;19(2):e0297562. doi: 10.1371/journal.pone.0297562. eCollection 2024.

    PubMed 38346025

Questions about this trial

What is this clinical trial studying?

A study testing Educational Materials in people with Alzheimer Disease, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Dispensing of Inappropriate Medication Prescription (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05147428, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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