Aligning Medications With What Matters Most (NCT04938648) | Clinical Trial Compass
CompletedNot Applicable
Aligning Medications With What Matters Most
United States138 participantsStarted 2021-06-03
Plain-language summary
The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 65 or greater
* Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes
* At least one other chronic condition
* Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed)
* Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician
Care partners:
\- Family or other companions age 21 years or greater who regularly help the patient with managing medications
Exclusion Criteria:
* As both the pilot and the planned pragmatic trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded.
* Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial has already been completed, has the data been published yet, and could you help me understand what the results showed about whether this type of pharmacist-led medication review was practical and well-received by patients and caregivers dealing with dementia?
2My loved one with dementia is already taking many medications — based on what you know about this trial's approach of aligning medications with personal values and priorities, is there a similar pharmacist-consultation process available to us right now through our regular care team?
3This study focused on whether it was even feasible to run this kind of pharmacist-and-primary-care-provider coordination — does that mean we still don't have strong evidence that it actually reduces harm from too many medications, and if so, what evidence-based alternatives exist for managing polypharmacy in someone with Alzheimer's?
4The trial involved pharmacists reaching out to both the primary care provider and the patient-caregiver pair by phone — given my loved one's current condition and our schedule, would that kind of ongoing pharmacist contact realistically be manageable for us if a similar program were offered?
5Could you review my loved one's current medication list with us using the same kind of 'what matters most' framework this trial was studying, even outside of a formal research setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Timeframe: A duration of approximately 8 months
2
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
Timeframe: 3 months after enrollment
3
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
Timeframe: 3 months after enrollment
4
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
Timeframe: 3 months after enrollment
5
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
Timeframe: 3 months after enrollment
6
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
Timeframe: 3 months after enrollment
7
Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports