N/A
N=69
Aligning Medications With What Matters Most
Polypharmacy · Alzheimer Disease and Related Dementias
Bottom Line
View on ClinicalTrials.gov: NCT04938648 ↗Enrolled (actual)
69
Serious AEs
11.6%
Results posted
May 2023
Primary outcome: Primary: Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention — 101; 122; 132; 69 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacist-led deprescribing intervention (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention |
101; 122; 132; 69 | — |
| PRIMARY Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response |
22; 23; 4; 4; 1; 1 | — |
| PRIMARY Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP |
0; 0; 19; 21; 6; 2 | — |
| PRIMARY Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad |
0; 1; 6; 14; 8; 10 | — |
| PRIMARY Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention |
1; 3; 7; 11; 7; 5 | — |
| PRIMARY Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention |
9; 6; 8; 16; 5; 4 | — |
| PRIMARY Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports |
24; 26 | — |
| PRIMARY Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations |
23; 24 | — |
| SECONDARY Total Medication Count |
13.1; 12.5; 12.6; 12.4; -0.6; -0.2 | — |
| SECONDARY Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) |
34; 35; 27; 28 | — |
| SECONDARY Medication Regimen Complexity Index (MRCI) |
32.8; 29.7; 31.7; 31.7; -1.0; 1.2 | — |
| SECONDARY Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) |
25; 22; 18; 15 | — |
| SECONDARY Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) |
11; 8; 9; 7; 5; 6 | — |
| SECONDARY Family Caregiver Medication Administration Hassles Scale (FCMAHS) |
33.2; 37.3; 29.9; 31.3; -3.3; -2.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04938648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.