Alzheimer Disease and Related Dementias, Polypharmacy
Conditions
Keywords
Deprescribing
Brief summary
The Aligning Medications with What Matters Most (ALIGN) study will assess the feasibility and preliminary efficacy of a deprescribing intervention to reduce medication regimen complexity and treatment burden for people living with dementia (PLWD) and their care partners.
Detailed description
People living with dementia (PLWD) use more medications and have more complex medication regimens than people without dementia. Medication regimen complexity is a major source of burden for family caregivers of PLWD and has been associated with numerous adverse outcomes. Therefore, the investigators propose a novel intervention, ALIGN: Aligning Medications with What Matters Most, to optimize prescribing and reduce medication regimen complexity by focusing on what matters most to the patient and caregiver, beyond rigid adherence to clinical practice guidelines. ALIGN is informed by learnings from OPTIMIZE, the investigator team's patient-centered, pragmatic deprescribing intervention for PLWD in primary care that is currently being prospectively evaluated. OPTIMIZE consists of a patient-level intervention comprised of a deprescribing educational brochure, and a clinician-level intervention comprised of a deprescribing educational session for primary care providers (PCPs), deprescribing "tip sheets" and clinic-level feedback on rates of potentially inappropriate medication prescribing in PLWD. ALIGN builds on OPTIMIZE by more explicitly addressing the informational and decisional needs of caregivers through a shared decision making process facilitated by clinical pharmacists. The investigators propose a pilot study to assess the feasibility and acceptability of ALIGN in two different health care systems, and to identify the most appropriate primary outcome measure for a subsequent embedded pragmatic trial (ePCT). Target enrollment is 60 patient-care partner dyads. Patients will be aged ≥65 years with dementia and \>5 chronic medications. Primary outcomes are intervention feasibility and acceptability among patients, care partners and PCPs; and feasibility of the patient-level Medication Regimen Complexity Index and Family Caregiver Medication Administration Hassles Scale at baseline and 3 months. Findings from this pilot study will guide the design, implementation and subsequent evaluation of ALIGN in an ePCT, laying the groundwork to reduce medication regimen complexity and burden for PLWD and their caregivers in diverse primary care settings. This proposed pragmatic intervention has the following aims: Specific Aim 1: To assess the feasibility and acceptability of ALIGN in two different health care systems, to guide the subsequent evaluation of the effectiveness of the intervention in an embedded pragmatic trial (ePCT). Specific Aim 2: To determine the feasibility of the primary and secondary outcome measures for the subsequent ePCT. 1. To determine the feasibility of measuring the primary outcome, the patient-level Medication Regimen Complexity Index (pMRCI), within the existing electronic health record (EHR) systems, and to compare it with a more pragmatic measure, chronic medication count, as the primary outcome measure for the ePCT. 2. To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
Interventions
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
Sponsors
Johns Hopkins University
Kaiser Permanente
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patient and care partner dyads are randomly assigned to receive the pharmacist-led intervention immediately after an educational mailing or to a delayed intervention control group that will receive the pharmacist-led component 3 months after the mailing.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 65 or greater * Diagnosis of dementia from International Classification of Diseases (ICD) -9 or ICD-10 codes * At least one other chronic condition * Five or more chronic medications (to include all prescription and over-the-counter medications, both scheduled and as needed) * Have a primary care physician at the pilot clinic who has enrolled in the study; this will be defined as having had at least 1 previous visit with that physician Care partners: \- Family or other companions age 21 years or greater who regularly help the patient with managing medications
Exclusion criteria
* As both the pilot and the planned pragmatic trial will be based in primary care, individuals residing in long term care facilities or enrolled in hospice will be excluded. * Individuals who cannot converse comfortably in English will be excluded because the FCMAHS has not been validated in other languages.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention | A duration of approximately 8 months | 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. |
| Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 3 months after enrollment | 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 |
| Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 3 months after enrollment | We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review |
| Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 3 months after enrollment | We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review |
| Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 3 months after enrollment | 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). |
| Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 3 months after enrollment | 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). |
| Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports | Baseline and 3 months after enrollment | 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 |
| Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations | 3 months after enrollment | We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Medication Count | Baseline and 3 months after enrollment | We will measure the total medication count using data obtained from the EHR. |
| Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) | Baseline and 3 months after enrollment | The 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. |
| Medication Regimen Complexity Index (MRCI) | Baseline and 3 months Baseline and 3 months after enrollment | 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. |
| Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline and 3 months after enrollment | 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. |
| Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline and 3 months after enrollment | 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. |
| Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline and 3 months after enrollment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAriel Green, MD, MPH, PhD
Johns Hopkins University
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 35 |
| Total | 69 |
Baseline characteristics
| Characteristic | Intervention | Total | Delayed Intervention (Wait List Control) |
|---|---|---|---|
| Age, Continuous | 80.6 Years STANDARD_DEVIATION 7 | 81.4 Years STANDARD_DEVIATION 7.9 | 82.1 Years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 61 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) White | 14 Participants | 32 Participants | 18 Participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 19 Participants |
| Total number of medicines | 13.1 medications STANDARD_DEVIATION 4.6 | 12.8 medications STANDARD_DEVIATION 5.1 | 12.5 medications STANDARD_DEVIATION 5.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 35 |
| other Total, other adverse events | 0 / 34 | 0 / 35 |
| serious Total, serious adverse events | 6 / 34 | 2 / 35 |
Outcome results
Primary
Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations
We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations | 23 Participants |
| Delayed Intervention (Wait List Control) | Acceptability Will be Assessed by the Acceptance Rates for the Pharmacist's Recommendations | 24 Participants |
Primary
Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports
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
Time frame: Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports | 24 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by Percentage of Dyads Who Complete 2 of 2 Pharmacist Phone Calls Based on Documented Status Reports | 26 Participants |
Primary
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
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.
Time frame: A duration of approximately 8 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention | Excluded | 101 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention | Unable to reach | 122 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention | Declined to participate | 132 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention | Agreed to participate | 69 Participants |
Primary
Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete 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).
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 31-40 mins | 7 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 51-60 mins | 3 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 21-30 mins | 7 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 61-70 mins | 1 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 41-50 mins | 8 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 71-80 mins | 0 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 11-20 mins | 1 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 71-80 mins | 1 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 11-20 mins | 3 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 21-30 mins | 11 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 31-40 mins | 5 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 41-50 mins | 5 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 51-60 mins | 3 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Direct Time Required by the Pharmacist to Complete the Intervention | 61-70 mins | 0 Participants |
Primary
Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete 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).
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 5-10 mins | 9 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 11-20 mins | 8 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 21-30 mins | 5 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 31-40 mins | 0 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 41-50 mins | 3 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 51-60 mins | 2 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 41-50 mins | 0 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 5-10 mins | 6 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 31-40 mins | 2 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 11-20 mins | 16 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 51-60 mins | 0 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention | 21-30 mins | 4 Participants |
Primary
Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad
We will measure the number of contacts between pharmacist and PCP and dyad based on Electronic Medical Record (EMR) review
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 2 | 6 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 4 | 3 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 3 | 8 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | ≥5 | 10 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 1 | 0 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | ≥5 | 0 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 1 | 1 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 2 | 14 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 3 | 10 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and Dyad | 4 | 3 Participants |
Primary
Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP
We will measure the number of contacts between pharmacist and PCP based on Electronic Medical Record (EMR) review
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 1 | 0 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 2 | 19 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 3 | 6 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | ≥4 | 2 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | ≥4 | 5 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 1 | 0 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 3 | 2 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Contacts Between Pharmacist and PCP | 2 | 21 Participants |
Primary
Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response
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
Time frame: 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 1 | 22 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 2 | 4 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 3 | 1 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 1 | 23 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 2 | 4 Participants |
| Delayed Intervention (Wait List Control) | Feasibility as Assessed by the Number of Pharmacist Messages to the Primary Care Provider (PCP) That Receive an Acknowledgment or Response | 3 | 1 Participants |
Secondary
Family Caregiver Medication Administration Hassles Scale (FCMAHS)
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.
Time frame: Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 33.2 Score on a scale | Standard Deviation 19.2 |
| Proportion of Dyads That Opt Out of the Intervention | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-Month | 29.9 Score on a scale | Standard Deviation 16.2 |
| Proportion of Dyads That Opt Out of the Intervention | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Change | -3.3 Score on a scale | Standard Deviation 18.8 |
| Delayed Intervention (Wait List Control) | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 37.3 Score on a scale | Standard Deviation 25.8 |
| Delayed Intervention (Wait List Control) | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-Month | 31.3 Score on a scale | Standard Deviation 23.6 |
| Delayed Intervention (Wait List Control) | Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Change | -2.5 Score on a scale | Standard Deviation 14.4 |
Secondary
Medication Regimen Complexity Index (MRCI)
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.
Time frame: Baseline and 3 months Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Medication Regimen Complexity Index (MRCI) | Baseline | 32.8 score on a scale | Standard Deviation 17.5 |
| Proportion of Dyads That Opt Out of the Intervention | Medication Regimen Complexity Index (MRCI) | 3-month | 31.7 score on a scale | Standard Deviation 22.5 |
| Proportion of Dyads That Opt Out of the Intervention | Medication Regimen Complexity Index (MRCI) | Change | -1.0 score on a scale | Standard Deviation 12.4 |
| Delayed Intervention (Wait List Control) | Medication Regimen Complexity Index (MRCI) | Baseline | 29.7 score on a scale | Standard Deviation 15.8 |
| Delayed Intervention (Wait List Control) | Medication Regimen Complexity Index (MRCI) | 3-month | 31.7 score on a scale | Standard Deviation 20.7 |
| Delayed Intervention (Wait List Control) | Medication Regimen Complexity Index (MRCI) | Change | 1.2 score on a scale | Standard Deviation 12.9 |
Secondary
Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)
The 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.
Time frame: Baseline and 3 months after enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) | Baseline | 34 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) | 3-month | 27 Participants |
| Delayed Intervention (Wait List Control) | Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) | Baseline | 35 Participants |
| Delayed Intervention (Wait List Control) | Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) | 3-month | 28 Participants |
Secondary
Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
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.
Time frame: Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 25 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 18 Participants |
| Delayed Intervention (Wait List Control) | Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 22 Participants |
| Delayed Intervention (Wait List Control) | Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 15 Participants |
Secondary
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
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.
Time frame: Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 0-5 mins | 11 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 6-10 mins | 9 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 11 or more mins | 5 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 0-5 mins | 5 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 6-10 mins | 9 Participants |
| Proportion of Dyads That Opt Out of the Intervention | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 11 or more mins | 4 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 6-10 mins | 5 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 0-5 mins | 8 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 0-5 mins | 7 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 6-10 mins | 7 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | 3-month | 11 or more mins | 3 Participants |
| Delayed Intervention (Wait List Control) | Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS) | Baseline | 11 or more mins | 6 Participants |
Secondary
Total Medication Count
We will measure the total medication count using data obtained from the EHR.
Time frame: Baseline and 3 months after enrollment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Proportion of Dyads That Opt Out of the Intervention | Total Medication Count | Baseline | 13.1 medications | Standard Deviation 4.6 |
| Proportion of Dyads That Opt Out of the Intervention | Total Medication Count | 3-month | 12.6 medications | Standard Deviation 4.4 |
| Proportion of Dyads That Opt Out of the Intervention | Total Medication Count | Change | -0.6 medications | Standard Deviation 3.4 |
| Delayed Intervention (Wait List Control) | Total Medication Count | Baseline | 12.5 medications | Standard Deviation 5.5 |
| Delayed Intervention (Wait List Control) | Total Medication Count | 3-month | 12.4 medications | Standard Deviation 5.4 |
| Delayed Intervention (Wait List Control) | Total Medication Count | Change | -0.2 medications | Standard Deviation 1.7 |