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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54AG063546-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention consists of the following:
|
|
| Delayed Intervention (wait list control) | Active Comparator | The delayed intervention consists of the following:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led deprescribing intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | A duration of approximately 8 months |
| 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 | 3 months after enrollment |
| 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 | 3 months after enrollment |
| 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 | 3 months after enrollment |
| 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). | 3 months after enrollment |
| Feasibility as Assessed by the Indirect Time Required by the Pharmacist to Complete the Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Total Medication Count | We will measure the total medication count using data obtained from the EHR. | Baseline and 3 months after enrollment |
| Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI) |
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Inclusion Criteria:
Care partners:
- Family or other companions age 21 years or greater who regularly help the patient with managing medications
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Green, MD, MPH, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Aurora | Colorado | 80014 | United States | ||
| Johns Hopkins Bayview Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16091574 | Background | Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716. | |
| 27570871 | Background | Alzheimer's Association. 2016 Alzheimer's disease facts and figures. Alzheimers Dement. 2016 Apr;12(4):459-509. doi: 10.1016/j.jalz.2016.03.001. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The intervention consists of the following:
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 |
| FG001 | Delayed Intervention (Wait List Control) | The delayed intervention consists of the following:
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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics data were collected for patients only. Baseline data were not collected from care partners.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The intervention consists of the following:
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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | A duration of approximately 8 months |
|
60 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The intervention consists of the following:
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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ariel Green | Johns Hopkins University | (410) 550-6733 | ariel@jhmi.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2021 | Mar 15, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
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.
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Not provided
|
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).
| 3 months after enrollment |
| 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 | Baseline and 3 months after enrollment |
| 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) | 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. |
| Baseline and 3 months after enrollment |
| 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. | Baseline and 3 months Baseline and 3 months after enrollment |
| 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. | Baseline and 3 months after enrollment |
| 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. | Baseline and 3 months after enrollment |
| 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. | Baseline and 3 months after enrollment |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| 23305822 | Background | Lin PJ, Fillit HM, Cohen JT, Neumann PJ. Potentially avoidable hospitalizations among Medicare beneficiaries with Alzheimer's disease and related disorders. Alzheimers Dement. 2013 Jan;9(1):30-8. doi: 10.1016/j.jalz.2012.11.002. |
| 26502320 | Background | Kelley AS, McGarry K, Gorges R, Skinner JS. The burden of health care costs for patients with dementia in the last 5 years of life. Ann Intern Med. 2015 Nov 17;163(10):729-36. doi: 10.7326/M15-0381. Epub 2015 Oct 27. |
| 24259639 | Background | Willson MN, Greer CL, Weeks DL. Medication regimen complexity and hospital readmission for an adverse drug event. Ann Pharmacother. 2014 Jan;48(1):26-32. doi: 10.1177/1060028013510898. Epub 2013 Nov 5. |
| 32552857 | Background | Bayliss EA, Shetterly SM, Drace ML, Norton J, Green AR, Reeve E, Weffald LA, Wright L, Maciejewski ML, Sheehan OC, Wolff JL, Gleason KS, Kraus C, Maiyani M, Du Vall M, Boyd CM. The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial. Trials. 2020 Jun 18;21(1):542. doi: 10.1186/s13063-020-04482-0. |
| Background | Group Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020 |
| 15266038 | Background | George J, Phun YT, Bailey MJ, Kong DC, Stewart K. Development and validation of the medication regimen complexity index. Ann Pharmacother. 2004 Sep;38(9):1369-76. doi: 10.1345/aph.1D479. Epub 2004 Jul 20. |
| 12810899 | Background | Travis SS, Bernard MA, McAuley WJ, Thornton M, Kole T. Development of the family caregiver medication administration hassles scale. Gerontologist. 2003 Jun;43(3):360-8. doi: 10.1093/geront/43.3.360. |
| Patient in rehab at the time of intervention |
|
| Patient did not have memory problems |
|
| Intervention could not be scheduled within protocol window |
|
| Care partner could not be reached |
|
| Patient no longer receiving care at an eligible clinic |
|
| Withdrawal by Subject |
|
| BG001 | Delayed Intervention (Wait List Control) | The delayed intervention consists of the following:
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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total number of medicines | Mean | Standard Deviation | medications |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| 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). | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | Baseline and 3 months after enrollment |
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | 3 months after enrollment |
|
|
|
| Secondary | Total Medication Count | We will measure the total medication count using data obtained from the EHR. | 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. | Posted | Mean | Standard Deviation | medications | Baseline and 3 months after enrollment |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline and 3 months after enrollment |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3 months Baseline and 3 months after enrollment |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and 3 months after enrollment |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline and 3 months after enrollment |
|
|
|
| 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. | This was an optional survey. 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 3 months after enrollment |
|
|
|
| 0 |
| 34 |
| 6 |
| 34 |
| 0 |
| 34 |
| EG001 | Delayed Intervention (Wait List Control) | The delayed intervention consists of the following:
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 | 0 | 35 | 2 | 35 | 0 | 35 |
| ED Visit | General disorders | Systematic Assessment |
|
| Observation | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| 3 |
|
| 3 |
|
| ≥4 |
|
| 3 |
|
| 4 |
|
| ≥5 |
|
| 31-40 mins |
|
| 41-50 mins |
|
| 51-60 mins |
|
| 61-70 mins |
|
| 71-80 mins |
|
| 21-30 mins |
|
| 31-40 mins |
|
| 41-50 mins |
|
| 51-60 mins |
|
| 3-month |
|
|
| Change |
|
|
| 3-month |
|
|
| Change |
|
|
| 6-10 mins |
|
| 11 or more mins |
|
| 3-month |
|
|
| 3-Month |
|
|
| Change |
|
|