Alzheimer DiseaseNCT06347172
Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges
A study testing Nudge Intervention in people with Alzheimer Disease and Mild Cognitive Impairment, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- Nudge Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 15 Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Primary care providers will be the primary unit of identification and randomization.
Primary care providers inclusion criteria:
- Providers within Brigham and Women's Hospital primary care practices
- Having prescribed at least one of the high-risk medications of interest
Eligible patients will be identified through this providers within the health care system.
Patient inclusion criteria:
- At least 65 years of age
- Prescribed at least 90 pills of one of the high-risk medications of interest in the last 180 days in the EHR system, which most guidelines consider chronic use, and have a diagnosis of dementia in the EHR.
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.
Read the detailed description
The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Being tested
- Nudge Intervention
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudge InterventionBehavioural
PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR.
| Study group | Role | What they receive |
|---|---|---|
| Nudge internvention | Experimental | PCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder.
Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR. Receives: Behavioral: Nudge Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of the Percentage of Eligible PCPs or Their PLWD/Care Partners Who View or Click on Information on or Before the Primary Care Provider Visit, up to 10 Days
This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days
Measured: On or before the primary care provider visit, up to 10 days
Secondary outcomes (2)
Number of Patients With Nudges That Fire as Intended: Fidelity
Number of patients who had provider EHR alerts that fired as intended, measured among patients who had a completed target visit (n=99) within EHR data.
Measured: On the primary care provider visit date
Discontinuation or Prescribed Reduction in Medication
Discontinuation or prescribed reduction in dose of at least one high-risk medication of interest within 60 days after the visit using data from the EHR system, measured on the patient-level as the number of patients who have medications discontinued or have a prescribed reduction.
Measured: Within 60 days on or after the primary care provider visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Aug 2024
- Primary completion14 Oct 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
- Investigators
- Julie Lauffenburger, PharmD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347172
- Sponsor's protocol ID
- 2024p000278
- Other IDs
- U54AG063546
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2024
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deprescribing in Patients Living With Dementia With Caregiver and Provider Nudges
- ClinicalTrials.gov ID
- NCT06347172
- Acronym / sponsor ID
- 2024p000278
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Brown University, National Institute on Aging (NIA)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to demonstrate the feasibility of implementing a deprescribing nudge intervention using pragmatic methods, confirm that outcomes can be feasibly measured and evaluated at scale in a subsequent embedded pragmatic clinical trial (ePCT), and explore representativeness of persons living with dementia and care partners identified.
Detailed description
The PCP nudge will consist of: a 'pre-commitment' EHR nudge triggered when a PCP opens a patient encounter (i.e., prompt to first have a discussion and then later deprescribe) and a brief message within the in-basket prior to upcoming visits including information about their patient. The patient living with dementia (PLWD)/care partner nudge will include an electronic message delivered prior to upcoming visits (in their primary language recorded in the EHR) that includes a recommendation for the PLWD (and care partner, if available) to discuss medications with the PCP at the visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nudge internvention | Experimental | Behavioral: Nudge InterventionPCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder. Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nudge InterventionPCPs will receive an enhanced EHR alert (nudge) that triggers when a PCP opens an encounter for an eligible patient living with dementia (PLWD). The nudge will provide information about the risks of continued medication use as well as tips and tools to help providers discuss medication discontinuation with patients and care partners. Additionally, the providers will receive a brief message in their in-basket 10 days before the patient's appointment as a reminder. Eligible PLWD of a randomized PCP will receive the nudge intervention which includes a brief recommendation for the PLWD (and care partner, if available) via the linked patient portal prior to upcoming visits (unless explicitly opted out by the PCP) to discuss medications with the PCP at the visit and link to a general handout about medications, unless explicitly opted out by the PCP. For PLWD without a portal account, the handout will be sent to their mailing address recorded in the EHR. | Behavioural | Nudge internvention |
Primary outcome
Composite of the Percentage of Eligible PCPs or Their PLWD/Care Partners Who View or Click on Information on or Before the Primary Care Provider Visit, up to 10 Days
Time frame: On or before the primary care provider visit, up to 10 days
This is the primary progression criteria for the study, measured on the patient level. This is measured as a composite of the number of eligible PCPs or their PLWD/care partners who view or click on information on or before the primary care provider visit, up to 10 days
2 secondary outcomes
Number of Patients With Nudges That Fire as Intended: Fidelity
Time frame: On the primary care provider visit date
Discontinuation or Prescribed Reduction in Medication
Time frame: Within 60 days on or after the primary care provider visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Lauffenburger, PharmD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudge Intervention in people with Alzheimer Disease and Mild Cognitive Impairment, run by Brigham and Women's Hospital 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 30 Jul 2026. 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 30 Jul 2026). 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?
Composite of the Percentage of Eligible PCPs or Their PLWD/Care Partners Who View or Click on Information on or Before the Primary Care Provider Visit, up to 10 Days (time frame: On or before the primary care provider visit, up to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.