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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Mild Cognitive Impairment (MCI); Potentially Inappropriate Medication Use
• Intervention / Treatment: Other: e-ALIGN Patient-Portal Deprescribing

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariel Green, MD, MPH, PhD; Phone Number: 410-550-6733; Email: ariel@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Recruiting
      • Johns Hopkins Community Physicians
      • Contact: Ariel Green, MD, MPH, PhD
      • Contact: Phone Number: 410-550-6733; Email: ariel@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient Portal Deprescribing Intervention; 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; The intervention will consist of educational materials about deprescribing, which will be sent to the patient prior to the scheduled primary care visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients or care partners that discussed deprescribing with any clinicians after receiving the message	Study team will follow up to assess if deprescribing was discussed with a clinician after receiving the patient portal message by conducting a review of patients' chart.	3 months after sending message
Number of PCPs who send the referral	Study team will assess how many PCPs send a referral to clinical pharmacy for patients who have been identified as candidates for deprescribing.	3 months after sending message
Number of patients who schedule the pharmacist visit	The investigators will determine the number of patients and/or care partners who schedule a visit with a clinical pharmacist for deprescribing CNS-PIM following receipt of the patient portal message.	3 months after sending message
Number of patients who deprescribe ≥1 CNS-PIM after receiving the message	For those who do not schedule a pharmacist visit, the investigators will evaluate the number of patients who deprescribed at least 1 CNS-PIM after receiving the patient portal 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	For those who do not schedule a pharmacist visit, the investigators will evaluate the number of patients who add at least 1 CNS-PIM to the medication regimen after receiving the patient portal message.	3 months after sending message (for people who do NOT have a pharmacist visit)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ariel Green, MD, MPH, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): February 6, 2027

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: dementia; deprescribing; polypharmacy; cognitive impairment; potentially inappropriate medications
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: IRB00506634; R01AG077011 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No