Trial Outcomes & Findings for ALIGN: Aligning Medications With What Matters Most (Demonstration) (NCT NCT06335953)
NCT ID: NCT06335953
Last Updated: 2026-08-06
Results Overview
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
474 participants
Primary outcome timeframe
3 months
Results posted on
2026-08-06
Participant Flow
People living with dementia (PLWD) were enrolled independently or together with a care partner. A total of 360 PLWD patients were enrolled and 114 care partners, with available data obtained from the EHR only for the patients. Pharmacists and primary care physicians (PCPs) delivered the intervention and were not considered enrolled study participants.
Unit of analysis: clinics
Participant milestones
| Measure |
Intervention
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
|
Delayed Intervention (Waitlist Control)
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners. Waitlist control group will receive the pharmacist-led component 3 months after the mailing.
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
|
|---|---|---|
|
Overall Study
STARTED
|
286 11
|
188 10
|
|
Overall Study
PLWD
|
214 11
|
146 10
|
|
Overall Study
Care Partners
|
72 11
|
42 10
|
|
Overall Study
COMPLETED
|
146 11
|
101 10
|
|
Overall Study
NOT COMPLETED
|
140 0
|
87 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ALIGN: Aligning Medications With What Matters Most (Demonstration)
Baseline characteristics by cohort
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Total
n=360 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.84 Years
STANDARD_DEVIATION 7.21 • n=20 Participants
|
78.12 Years
STANDARD_DEVIATION 7.36 • n=20 Participants
|
77.97 Years
STANDARD_DEVIATION 7.26 • n=40 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=20 Participants
|
88 Participants
n=20 Participants
|
221 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=20 Participants
|
58 Participants
n=20 Participants
|
139 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
211 Participants
n=20 Participants
|
145 Participants
n=20 Participants
|
356 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
94 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
149 Participants
n=20 Participants
|
87 Participants
n=20 Participants
|
236 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Cognitive status
Dementia
|
64 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
101 Participants
n=40 Participants
|
|
Cognitive status
Mild Cognitive Impairment (MCI)
|
150 Participants
n=20 Participants
|
109 Participants
n=20 Participants
|
259 Participants
n=40 Participants
|
|
Total number of medicines
|
13.92 medications
STANDARD_DEVIATION 7.02 • n=20 Participants
|
13.62 medications
STANDARD_DEVIATION 6.03 • n=20 Participants
|
13.80 medications
STANDARD_DEVIATION 6.63 • n=40 Participants
|
|
Total number of Central Nervous System-active Potentially Inappropriate Medications (CNS-PIMs)
|
1.07 medications
STANDARD_DEVIATION 1.41 • n=20 Participants
|
0.87 medications
STANDARD_DEVIATION 1.16 • n=20 Participants
|
0.99 medications
STANDARD_DEVIATION 1.32 • n=40 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Per protocol analysis
The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Outcome measures
| Measure |
Intervention
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Stop One or More Medications - Per Protocol
|
103 Participants
|
73 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
Outcome measures
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Stop One or More Medications - Intention-to-Treat
|
138 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Per protocol analysis
The secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed per protocol and reported as count of participants. The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point. New medications started will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Start One or More New Medications - Per Protocol
|
111 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point. New medications started will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Start One or More New Medications - Intention-to-Treat
|
149 Participants
|
87 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Per protocol analysis
The secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants. Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Per Protocol
|
24 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
|
32 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Per protocol analysis
The secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants. The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Per Protocol
|
21 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 monthsThe secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants. The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point. Discontinued PIM will be measured using data obtained from the EHR.
Outcome measures
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
|
28 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Per protocol analysis
Total medication count will be measured using data obtained from the EHR, analyzed per protocol and reported as mean and standard deviation.
Outcome measures
| Measure |
Intervention
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Total Number of Medications - Per Protocol
|
0.34 medications
Standard Deviation 2.75
|
0.32 medications
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: 3 monthsTotal medication count will be measured using data obtained from the EHR, analyzed by intention-to-treat and reported as mean and standard deviation.
Outcome measures
| Measure |
Intervention
n=214 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
Delayed Intervention (Waitlist Control)
n=146 Participants
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
Pharmacist-led deprescribing intervention: The intervention consists of the following strategies: 1) Pharmacists will participate in a 20-minute webinar and receive a laminated tip sheet about the study; 2) Eligible patients and their care partners will receive a single deprescribing educational brochure by mail; 3) Patients and their care partners will have a single telemedicine visit in which the pharmacist will perform medication reconciliation and identify potential adverse effects and concerns related to medicines; 4) The pharmacist will send the PCP up to 3 deprescribing recommendations in the EHR using a standardized template; 5) With the PCP's approval, the pharmacist will call the patient or care partner to implement the deprescribing recommendations and document changes in the EHR.
|
|---|---|---|
|
Total Number of Medications - Intention-to-Treat
|
0.21 medications
Standard Deviation 2.54
|
0.32 medications
Standard Deviation 1.73
|
Adverse Events
Intervention
Serious events: 9 serious events
Other events: 0 other events
Deaths: 2 deaths
Delayed Intervention (Waitlist Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=214 participants at risk
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners;
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
|
Delayed Intervention (Waitlist Control)
n=146 participants at risk
The intervention consists of the following:
1. Mailing a deprescribing educational brochure to PLWD and care partners. Waitlist control group will receive the pharmacist-led component 3 months after the mailing.
2. PLWD and/or care partners will receive a single telehealth visit in which an embedded clinical pharmacist discusses the benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences;
3. Pharmacist-primary care provider (PCP) communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP.
|
|---|---|---|
|
General disorders
Hospitalization
|
0.47%
1/214 • Number of events 1 • From the pharmacist intervention visit (within 4 weeks after screening for intervention group; approximately 3 months for delayed intervention group) through 3 months post pharmacist visit.
The reporting plan included chart reviews of participants experiencing potential AEs in each study group (intervention and waitlist control). All deaths among participants in the intervention and control groups were reviewed. In addition, every third hospitalization and emergency department visit in these groups was reviewed to determine whether a potential SAE occurred within 3 months of a medication adjustment by the pharmacist. No AEs were collected for care partners.
|
0.00%
0/146 • From the pharmacist intervention visit (within 4 weeks after screening for intervention group; approximately 3 months for delayed intervention group) through 3 months post pharmacist visit.
The reporting plan included chart reviews of participants experiencing potential AEs in each study group (intervention and waitlist control). All deaths among participants in the intervention and control groups were reviewed. In addition, every third hospitalization and emergency department visit in these groups was reviewed to determine whether a potential SAE occurred within 3 months of a medication adjustment by the pharmacist. No AEs were collected for care partners.
|
|
General disorders
ED Visit
|
3.7%
8/214 • Number of events 8 • From the pharmacist intervention visit (within 4 weeks after screening for intervention group; approximately 3 months for delayed intervention group) through 3 months post pharmacist visit.
The reporting plan included chart reviews of participants experiencing potential AEs in each study group (intervention and waitlist control). All deaths among participants in the intervention and control groups were reviewed. In addition, every third hospitalization and emergency department visit in these groups was reviewed to determine whether a potential SAE occurred within 3 months of a medication adjustment by the pharmacist. No AEs were collected for care partners.
|
0.00%
0/146 • From the pharmacist intervention visit (within 4 weeks after screening for intervention group; approximately 3 months for delayed intervention group) through 3 months post pharmacist visit.
The reporting plan included chart reviews of participants experiencing potential AEs in each study group (intervention and waitlist control). All deaths among participants in the intervention and control groups were reviewed. In addition, every third hospitalization and emergency department visit in these groups was reviewed to determine whether a potential SAE occurred within 3 months of a medication adjustment by the pharmacist. No AEs were collected for care partners.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place