- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454824
e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most (e-ALIGN)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
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
-
-
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
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)
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. |
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
Time Frame: 1 month after sending 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
Time Frame: 1 month after sending message
|
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
Time Frame: 1 month after sending message
|
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
Time Frame: 3 months after sending 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
Time Frame: 3 months after sending message
|
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
Time Frame: 3 months after sending message
|
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
Time Frame: 3 months after sending message (for patients who do NOT have a pharmacist visit)
|
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
Time Frame: 3 months after sending message (for people who do NOT have a pharmacist visit)
|
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
Collaborators
Investigators
- Principal Investigator: Ariel Green, MD, MPH, PhD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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