e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most

NCT07454824 | Recruiting

• 2 other identifiers: IRB00506634R01AG077011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal of this study is to pilot an intervention in which older adults with mild cognitive impairment and dementia and the older adult's care partners are identified in primary care and provided with educational materials through the patient portal to engage the participant in deprescribing. The multicomponent intervention, e-Align, includes delivery of educational information through the patient portal, and a pharmacist-led intervention to align medications with patient and care partner goals and reduce use of central nervous system (CNS) potentially inappropriate medicines (PIM). This work will establish the preliminary data, methods, and partnerships to undertake a multisite embedded pragmatic clinical trial. The resulting triadic-based behavioral intervention will promote patient and care partner engagement, and foster care that aligns with patients' values, and promote improved health and well-being outcomes for people with cognitive impairment and the patient's care partners through deprescribing.

Conditions

Dementia; Potentially Inappropriate Medication Use; Mild Cognitive Impairment (MCI)

Keywords

deprescribing; polypharmacy; potentially inappropriate medications; dementia; cognitive impairment

Outcome Measures

Primary Outcomes (3)

• Number of patients who open the patient portal message

  The investigators will assess the number of patients and/or care partners who read the patient portal message sent by the study team, which invites the participant to meet with a clinical pharmacist for deprescribing.

  1 month after sending message

• Number of patients who watch the video

  The investigators will assess the number of patients who click and watch the educational video about CNS-PIM and deprescribing.

  1 month after sending message

• Acceptability of educational video assessed by survey

  The investigators will assess the acceptability of the educational video by administering a survey to participants. The survey will ask participants to rate various features of the video on a 5-point Likert scale, where a higher score indicates greater acceptability.

  1 month after sending message

Secondary Outcomes (5)

• Number of patients or care partners that discussed deprescribing with any clinicians after receiving the message

  3 months after sending message

• Number of PCPs who send the referral

  3 months after sending message

• Number of patients who schedule the pharmacist visit

  3 months after sending message

• Number of patients who deprescribe ≥1 CNS-PIM after receiving the message

  3 months after sending message (for patients who do NOT have a pharmacist visit)

• Number of patients who start ≥1 CNS-PIM after receiving the message

  3 months after sending message (for people who do NOT have a pharmacist visit)

Study Arms (1)

Patient Portal Deprescribing Intervention

EXPERIMENTAL

e-ALIGN will be piloted via the patient portal. The intervention will provide patients and care partners with an educational video on the risks of Central Nervous System-Potentially Inappropriate Medications (CNS-PIM) through the patient portal, MyChart. It will also offer the participant the opportunity to discuss deprescribing options with the patient's primary care physician (PCP) or to receive a referral to discuss deprescribing options with a clinical pharmacist who is embedded in the primary care practice. Patients who meet with the pharmacist will have two visits (intervention and follow-up). Patients who do not meet with a pharmacist will have a routine visit with the patient's PCP. Each participant will be on study (intervention period and additional follow-up) for approximately 3 months.

Other: e-ALIGN Patient-Portal Deprescribing

Interventions

e-ALIGN Patient-Portal Deprescribing OTHER

The intervention will consist of educational materials about deprescribing, which will be sent to the patient prior to the scheduled primary care visit.

Patient Portal Deprescribing Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients: Age ≥65, with a diagnosis of MCI or dementia based on ICD-10 codes and ≥1 active CNS-PIM, who are active patient portal users.
• Care partners:
• Family or other companions \>21 years who regularly help the patient with managing medications.

You may not qualify if:

• As the trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Community Physicians

Baltimore, Maryland, 21209, United States

RECRUITING

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Ariel Green, MD, MPH, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel Green, MD, MPH, PhD

CONTACT

410-550-6733; ariel@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants cannot be masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

US (1)