Trial Outcomes & Findings for Aligning Medications With What Matters Most (NCT NCT04938648)
NCT ID: NCT04938648
Last Updated: 2023-05-26
Results Overview
Dyads are comprised of the person living with dementia and their care partner. We will measure the proportion of dyads that opt out of the intervention versus the dyads that agree to participate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
A duration of approximately 8 months
Results posted on
2023-05-26
Participant Flow
Patients and care partners were enrolled as dyads. A total of 69 dyads were enrolled with available data obtained from the EHR only for the patients.
Participant milestones
| Measure |
Intervention
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
Delayed Intervention (Wait List Control)
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
| Measure |
Intervention
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
Delayed Intervention (Wait List Control)
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Overall Study
Patient admitted to SNF hospice/LTC
|
2
|
1
|
|
Overall Study
Patient too ill
|
0
|
1
|
|
Overall Study
Patient in rehab at the time of intervention
|
1
|
0
|
|
Overall Study
Patient did not have memory problems
|
1
|
1
|
|
Overall Study
Intervention could not be scheduled within protocol window
|
1
|
0
|
|
Overall Study
Care partner could not be reached
|
0
|
1
|
|
Overall Study
Patient no longer receiving care at an eligible clinic
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Aligning Medications With What Matters Most
Baseline characteristics by cohort
| Measure |
Intervention
n=34 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
Delayed Intervention (Wait List Control)
n=35 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.6 Years
STANDARD_DEVIATION 7.0 • n=93 Participants
|
82.1 Years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
81.4 Years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Total number of medicines
|
13.1 medications
STANDARD_DEVIATION 4.6 • n=93 Participants
|
12.5 medications
STANDARD_DEVIATION 5.5 • n=4 Participants
|
12.8 medications
STANDARD_DEVIATION 5.1 • n=27 Participants
|
PRIMARY outcome
Timeframe: A duration of approximately 8 monthsPopulation: This outcome is based on pre-randomization activities. The overall number of individual participants analyzed represents all potentially eligible patients identified that were further reviewed to confirm eligibility and interest in participating in the study.
Dyads are comprised of the person living with dementia and their care partner. We will measure the proportion of dyads that opt out of the intervention versus the dyads that agree to participate.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=424 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Declined to participate
|
132 Participants
|
—
|
|
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Agreed to participate
|
69 Participants
|
—
|
|
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Excluded
|
101 Participants
|
—
|
|
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Unable to reach
|
122 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the number of pharmacist's messages that receive an acknowledgment or response from the PCP based on Electronic Medical Record (EMR) review
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
1
|
22 Participants
|
23 Participants
|
|
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
2
|
4 Participants
|
4 Participants
|
|
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
3
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
1
|
0 Participants
|
0 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
2
|
19 Participants
|
21 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
3
|
6 Participants
|
2 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
≥4
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
2
|
6 Participants
|
14 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
3
|
8 Participants
|
10 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
1
|
0 Participants
|
1 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
4
|
3 Participants
|
3 Participants
|
|
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
≥5
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the amount of direct time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
61-70 mins
|
1 Participants
|
0 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
71-80 mins
|
0 Participants
|
1 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
11-20 mins
|
1 Participants
|
3 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
21-30 mins
|
7 Participants
|
11 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
31-40 mins
|
7 Participants
|
5 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
41-50 mins
|
8 Participants
|
5 Participants
|
|
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention
51-60 mins
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the amount of indirect time that it takes the pharmacist to complete the intervention. We will access from pharmacist's documentation in the Electronic Medical Record (EMR).
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
5-10 mins
|
9 Participants
|
6 Participants
|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
11-20 mins
|
8 Participants
|
16 Participants
|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
21-30 mins
|
5 Participants
|
4 Participants
|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
31-40 mins
|
0 Participants
|
2 Participants
|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
41-50 mins
|
3 Participants
|
0 Participants
|
|
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention
51-60 mins
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months after enrollmentPopulation: The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
Dyads are comprised of the person living with dementia and their care partner. We will measure the percentage of dyads who complete 2 of 2 pharmacist phone calls based on documented status reports
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports
|
24 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: 3 months after enrollmentPopulation: The overall number of participants analyzed represents the number of individual participants (patients). The sample size for the treated was 34, of these 27 received the intervention, and the sample size for the control subjects was 35 of these, 28 received the intervention with available data only for those who completed the intervention.
We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=27 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=28 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months after enrollmentPopulation: The sample size for 3-month and change measures were 27 for the treated and 28 for the control subjects with available data at 3 months.
We will measure the total medication count using data obtained from the EHR.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=34 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=35 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Total Medication Count
Baseline
|
13.1 medications
Standard Deviation 4.6
|
12.5 medications
Standard Deviation 5.5
|
|
Total Medication Count
3-month
|
12.6 medications
Standard Deviation 4.4
|
12.4 medications
Standard Deviation 5.4
|
|
Total Medication Count
Change
|
-0.6 medications
Standard Deviation 3.4
|
-0.2 medications
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline and 3 months after enrollmentThe feasibility of measuring this outcome will be determined as follows: Percentage of participants with data elements available vs. unavailable to calculate the pMRCI, within the existing electronic medical record systems. This study assessed the feasibility of measuring the pMRCI and not actually determining the pMRCI. The pMRCI is a validated, widely-used tool that measures medication regimen complexity to identify patients with expected difficulty managing their regimens. Scores are derived from weighted values of regimen components (eg, dosage formulations, frequencies, and specific instructions for use). Higher scores indicate greater medication regimen complexity.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=34 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=35 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)
Baseline
|
34 Participants
|
35 Participants
|
|
Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)
3-month
|
27 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months Baseline and 3 months after enrollmentPopulation: The sample size for 3-month and change measures were 27 for the treated and 28 for the control subjects with available data at 3 months.
The MRCI is a validated, widely-used tool that measures medication regimen complexity to identify patients with expected difficulty managing their regimens. The MRCI score is derived from weighted values of regimen components (eg, dosage formulations, frequencies, and specific instructions for use). The score has no upper limit, but higher scores indicate greater medication regimen complexity. Regimen components were combined to compute a total score and averaged.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=34 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=35 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Medication Regimen Complexity Index (MRCI)
Baseline
|
32.8 score on a scale
Standard Deviation 17.5
|
29.7 score on a scale
Standard Deviation 15.8
|
|
Medication Regimen Complexity Index (MRCI)
Change
|
-1.0 score on a scale
Standard Deviation 12.4
|
1.2 score on a scale
Standard Deviation 12.9
|
|
Medication Regimen Complexity Index (MRCI)
3-month
|
31.7 score on a scale
Standard Deviation 22.5
|
31.7 score on a scale
Standard Deviation 20.7
|
SECONDARY outcome
Timeframe: Baseline and 3 months after enrollmentPopulation: The FCMAHS was offered as an optional survey at baseline and 3 months with available data only for those who agreed to complete it. A total of 34 participants in the intervention group and 35 participants in the delayed control group were eligible to complete the survey. The sample size for the FCMAHS at baseline and 3 months are 25, 18 for the intervention group and 21, 15 for the delayed control group, respectively.
We will measure the response rate from care partners to complete the FCMAHS over the phone or electronically. The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=34 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=35 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Baseline
|
25 Participants
|
22 Participants
|
|
Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
3-month
|
18 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months after enrollmentPopulation: This was an optional survey given to participants at baseline and 3 months with available data only for those who agreed to complete it. The completion rate sample size for the delayed control group at baseline was 22; data from 1 participant is missing for this variable. The sample size for the 3-month measure was 18 for the treated and 15 for the control subjects with available data at 3 months.
We will measure the time it takes the care partner to complete the FCMAHS over the phone or electronically. The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=25 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=21 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Baseline · 0-5 mins
|
11 Participants
|
8 Participants
|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Baseline · 6-10 mins
|
9 Participants
|
7 Participants
|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Baseline · 11 or more mins
|
5 Participants
|
6 Participants
|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
3-month · 6-10 mins
|
9 Participants
|
5 Participants
|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
3-month · 11 or more mins
|
4 Participants
|
3 Participants
|
|
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
3-month · 0-5 mins
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 months after enrollmentPopulation: This was an optional survey given to participants at baseline and 3 months with available data only for those who agreed to complete it. The completion rate sample size for the delayed control group at baseline was 22; data from 1 participant is missing for this variable. The sample size for 3 months and change measures was 18 for the treated and 15 for the control subjects with available data at 3 months.
The FCMAHS is a validated caregiver-reported outcome measure that assesses burden associated with medication administration. The instrument consists of 24 items and four subscales: Information Seeking/Information Sharing (9 items), Safety Issues (5 items), Scheduling Logistics (7 items) and Polypharmacy (3 items). The total score range is 0-120 with higher scores indicating greater perceived hassle associated with managing some or all aspects of another person's medication regimen.
Outcome measures
| Measure |
Proportion of Dyads That Opt Out of the Intervention
n=25 Participants
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will be randomly assigned to receive a telehealth visit with a clinical pharmacist immediately after receiving the brochure or at 3 months to discuss 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 to the PCP.
|
Delayed Intervention (Wait List Control)
n=21 Participants
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Change
|
-3.3 Score on a scale
Standard Deviation 18.8
|
-2.5 Score on a scale
Standard Deviation 14.4
|
|
Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Baseline
|
33.2 Score on a scale
Standard Deviation 19.2
|
37.3 Score on a scale
Standard Deviation 25.8
|
|
Family Caregiver Medication Administration Hassles Scale (FCMAHS)
3-Month
|
29.9 Score on a scale
Standard Deviation 16.2
|
31.3 Score on a scale
Standard Deviation 23.6
|
Adverse Events
Intervention
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Intervention (Wait List Control)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=34 participants at risk
The intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
Delayed Intervention (Wait List Control)
n=35 participants at risk
The delayed intervention consists of the following:
1. mailing deprescribing educational materials to care partners and people living with dementia (PLWD);
2. three months after mailing the deprescribing educational materials, dyads will receive a telehealth visit with a clinical pharmacist to discuss 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 to the PCP.
Pharmacist-led deprescribing intervention: 1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
|
|---|---|---|
|
General disorders
Hospitalization
|
11.8%
4/34 • 60 days
|
0.00%
0/35 • 60 days
|
|
General disorders
ED Visit
|
8.8%
3/34 • 60 days
|
5.7%
2/35 • 60 days
|
|
General disorders
Observation
|
2.9%
1/34 • 60 days
|
0.00%
0/35 • 60 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place