PolypharmacyALIGNNCT04938648
Aligning Medications With What Matters Most
A study testing Pharmacist-led deprescribing intervention in people with Polypharmacy and Alzheimer Disease and Related Dementias, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypharmacy, Alzheimer Disease and Related Dementias
- What is being tested?
- Pharmacist-led deprescribing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2021to 2 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente
Aurora, Colorado, 80014
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Align: Aligning Medications With What Matters Most
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.
Read the 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.
- 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.
- To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
- Being tested
- Pharmacist-led deprescribing intervention
- Keywords
- Deprescribing
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led deprescribing interventionBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Pharmacist-led deprescribing intervention |
| Delayed Intervention (wait list control) | Active comparator | 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. Receives: Behavioral: Pharmacist-led deprescribing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 3 months after enrollment
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).
Measured: 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
Measured: 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)
Measured: 3 months after enrollment
Secondary outcomes (6)
Total Medication Count
We will measure the total medication count using data obtained from the EHR.
Measured: Baseline and 3 months after enrollment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start3 Jun 2021
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Ariel Green, MD, MPH, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938648
- Sponsor's protocol ID
- IRB00286353
- Other IDs
- 5U54AG063546-02
- Acronym
- ALIGN
- Status last verified
- May 2026
- First submitted
- 15 Jun 2021
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16091574Alzheimer'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.
PubMed 27570871Lin 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.
PubMed 23305822Kelley 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.
PubMed 26502320Willson 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.
PubMed 24259639Bayliss 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.
PubMed 32552857Group Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020
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.
PubMed 15266038Travis 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.
PubMed 12810899
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Align: Aligning Medications With What Matters Most
- ClinicalTrials.gov ID
- NCT04938648
- Acronym / sponsor ID
- ALIGN / IRB00286353
- Keywords
- Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Aging (NIA)
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Posted 26 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- To determine the feasibility of measuring the secondary outcome, the Family Caregiver Medication Administration Hassles Scale (FCMAHS), a caregiver-reported outcome measure.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Pharmacist-led deprescribing interventionThe 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. |
| Delayed Intervention (wait list control) | Active comparator | Behavioral: Pharmacist-led deprescribing interventionThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led deprescribing intervention1) 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 | Behavioural | Delayed Intervention (wait list control), Intervention |
Primary outcome
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3 months after enrollment
We will measure the acceptance rates for the pharmacist's recommendations as documented in the Electronic Medical Record (EMR)
6 secondary outcomes
Total Medication Count
Time frame: Baseline and 3 months after enrollment
Percentage of Participants With Data Elements Available to Calculate the Medication Regimen Complexity Index (pMRCI)
Time frame: Baseline and 3 months after enrollment
Medication Regimen Complexity Index (MRCI)
Time frame: Baseline and 3 months Baseline and 3 months after enrollment
Response Rate for the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Time frame: Baseline and 3 months after enrollment
Time to Complete the Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Time frame: Baseline and 3 months after enrollment
Family Caregiver Medication Administration Hassles Scale (FCMAHS)
Time frame: Baseline and 3 months after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16091574Boyd 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.
- Background: PubMed 27570871Alzheimer'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.
- Background: PubMed 23305822Lin 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.
- Background: PubMed 26502320Kelley 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.
- Background: PubMed 24259639Willson 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.
- Background: PubMed 32552857Bayliss 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.
- BackgroundGroup Health Research Institute. The Chronic Care Model. Available at http://www.improvingchroniccare.org/index.php?p=CCM_Gallery&s=149. Accessed August 21, 2020
- Background: PubMed 15266038George 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.
- Background: PubMed 12810899Travis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel Green, MD, MPH, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led deprescribing intervention in people with Polypharmacy and Alzheimer Disease and Related Dementias, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by Proportion of Dyads That Opt Out of the Intervention (time frame: A duration of approximately 8 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04938648, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.