Medication Adverse EffectsPOP-MEDNCT06110156
Population Health Approach to Optimizing Medications in Older Adults
A study testing Patient-tailored deprescribing assessment and intervention in people with Medication Adverse Effects and Older Adults (65 Years and Older), run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adverse Effects, Older Adults (65 Years and Older), Polypharmacy
- What is being tested?
- Patient-tailored deprescribing assessment and intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Patients will be invited to enroll in the study if they are in the top decile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
- 65 years of age or older
- Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
- Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
- Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list
Who cannot join
- Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
- Patients with an organ transplant
- Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
- Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
- Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Population Health Approach to Optimizing and Deprescribing Medications in Older Adults
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
Read the detailed description
This pilot clinical trial will examine the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and enroll them and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
- Conditions
- Medication Adverse Effects, Older Adults (65 Years and Older), Polypharmacy, Polypharmacy Patients, Deprescribing
- Being tested
- Patient-tailored deprescribing assessment and intervention
- Keywords
- Older adults, Polypharmacy, Deprescribing
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-tailored deprescribing assessment and interventionBehavioural
Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors (clinical, socioeconomic), identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results of the comprehensive medication review with the primary care clinician. Once the primary care clinician has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling (including Motivational Interviewing) and will follow-up with the patient at least once per month via video visit or phone to assess side effects, adverse effects, and provide support.
| Study group | Role | What they receive |
|---|---|---|
| Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis) | Experimental | Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with a diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. Receives: Behavioral: Patient-tailored deprescribing assessment and intervention |
| Usual care (MCI and Dementia diagnosis) | No intervention | Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with a diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
| Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis) | Experimental | Patients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with NO diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. Receives: Behavioral: Patient-tailored deprescribing assessment and intervention |
| Usual care (no MCI and Dementia diagnosis) | No intervention | Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with NO diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of all-cause hospitalizations
Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.
Measured: 12 months after enrollment
Secondary outcomes (9)
Total number of medications
Total number of medications on the medication list, including prescription medications, over-the-counter medications, vitamins, and supplements at 12 months.
Measured: Baseline, 12 months
Total number of potentially inappropriate medications
Use of any potentially inappropriate medications, defined by the 2019 Beers Criteria Tables 2 and 7
Measured: Baseline, 12 months
Number of medications with a dose reduction >10% over 12 months
We will sum up the number of medications where the study participant has achieved at >10% dose reduction compared to baseline for each study participant at baseline and 12 months in both study arms.
Measured: 12 months
Number of medications discontinued for 90 days or more which are re-prescribed
We will sum up the number of medications where the study participant has had any re-prescription of medications which were discontinued for 90 days or more by 12 months in all study arms.
Measured: Baseline, 12 months
Number of times per day the patient is taking medications
Each study participant will be coded on a continuous scale the number of times a day medications are taken based on the prescription instructions at baseline and 12 months in all study arms.
Measured: Baseline, 12 months
Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
Measured: 12 months
Number of drug-related problems
We will compare the total number of drug-related problems (identified retrospectively by a pharmacist) at baseline and 12 months.
Measured: Baseline, 12 months
Number of potential pharmacy recommendations
We will compare the total number of potential pharmacist recommendations (identified retrospectively by a pharmacist) at baseline and 12 months.
Measured: Baseline, 12 months
Change in risk prediction model score
Each study participant's information will be run through the risk prediction model at the end of the study to see if there is a meaningful change (10% or more change) in the risk prediction score from baseline to the end of the study period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start19 May 2025
- Primary completion19 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Adverse EffectsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michelle Keller, Cedars-Sinai Medical Center
- Investigators
- Michelle Keller, PhD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110156
- Sponsor's protocol ID
- STUDY00002921
- Other IDs
- K01AG076865
- Acronym
- POP-MED
- Status last verified
- Mar 2026
- First submitted
- 26 Oct 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Health Approach to Optimizing and Deprescribing Medications in Older Adults
- ClinicalTrials.gov ID
- NCT06110156
- Acronym / sponsor ID
- POP-MED / STUDY00002921
- Conditions
- Medication Adverse Effects, Older Adults (65 Years and Older), Polypharmacy, Polypharmacy Patients, Deprescribing
- Keywords
- Older adults, Polypharmacy, Deprescribing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
Detailed description
This pilot clinical trial will examine the feasibility and acceptability of a medication management intervention that uses risk stratification to identify older adults (including older adults with Mild Cognitive Impairment or Alzheimer's Disease and Related Dementias) at greatest risk for polypharmacy-related adverse events. The intervention will use a risk prediction model to identify potential study participants for inclusion and enroll them and their care partners into a polypharmacy clinic. The study will stratify patients by cognitive impairment status. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis) | Experimental | Behavioral: Patient-tailored deprescribing assessment and interventionPatients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with a diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
| Usual care (MCI and Dementia diagnosis) | No intervention | –Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with a diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
| Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis) | Experimental | Behavioral: Patient-tailored deprescribing assessment and interventionPatients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors, identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results with the prescriber. Once the prescriber has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling and will follow-up with the patient at least once per month to assess side effects, adverse effects, and provide support. This arm specifically includes only patients with NO diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
| Usual care (no MCI and Dementia diagnosis) | No intervention | –Patients in the comparator arm will see their primary care clinician as needed. This arm specifically includes patients with NO diagnoses of Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) at enrollment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients will be invited to enroll in the study if they are in the top decile of risk selected by a risk prediction model of polypharmacy-related adverse events. The risk prediction model includes variables such as: age, sex, recent healthcare encounters, current and past medications, current and past lab tests, current and past diagnoses.
- 65 years of age or older
- Have a primary care clinician within the Cedars-Sinai Health System who uses MyCSLink (electronic health record used by Cedars-Sinai).
- Part of a Cedars-Sinai Health System population health registry (e.g., enrolled in an Accountable Care Organization, Medicare Advantage plan, or Primary Care First program)
- Diagnosis of Mild Cognitive Impairment or Dementia at baseline (for one intervention group) on the problem list
Key exclusion criteria (5 listed)
- Patients for whom there is an active substance use disorder (defined by a physician) and thus for whom the intervention may not be appropriate
- Patients with an organ transplant
- Visits with a Cedars-Sinai Medical Center pharmacist for a polypharmacy consult within the last 6 months
- Patients who previously indicated in the EHR that they wish to opt out of participating in research studies.
- Patients enrolled in CS360, a program for highly complex medical patients, who already receive polypharmacy services.
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 |
|---|---|---|
| Patient-tailored deprescribing assessment and interventionPatients are identified for enrollment via a risk prediction model and enrolled in a pharmacist-led polypharmacy clinic. The pharmacist will conduct a comprehensive medication review, which will include: medication reconciliation, assessment of patient risk factors (clinical, socioeconomic), identification of potentially inappropriate medications, identification of potential prescribing omissions, shared decision-making with the patient and/or caregiver, and confirmation of the results of the comprehensive medication review with the primary care clinician. Once the primary care clinician has approved the recommendations, the pharmacist will make the appropriate changes to the medication regimen, will provide tailored medication education and counseling (including Motivational Interviewing) and will follow-up with the patient at least once per month via video visit or phone to assess side effects, adverse effects, and provide support. | Behavioural | Patient-tailored deprescribing assessment and intervention (MCI and Dementia diagnosis), Patient-tailored deprescribing assessment and intervention (no MCI and Dementia diagnosis) |
Primary outcome
Number of all-cause hospitalizations
Time frame: 12 months after enrollment
Number of all-cause inpatient visits (including observation visits) 12 months after enrollment.
9 secondary outcomes
Total number of medications
Time frame: Baseline, 12 months
Total number of potentially inappropriate medications
Time frame: Baseline, 12 months
Number of medications with a dose reduction >10% over 12 months
Time frame: 12 months
Number of medications discontinued for 90 days or more which are re-prescribed
Time frame: Baseline, 12 months
Number of times per day the patient is taking medications
Time frame: Baseline, 12 months
Number of potential prescribing omissions (PPOs) based on the STOPP/START criteria
Time frame: 12 months
Number of drug-related problems
Time frame: Baseline, 12 months
Number of potential pharmacy recommendations
Time frame: Baseline, 12 months
Change in risk prediction model score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Medication Adverse Effects
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
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.
Michelle Keller, PhD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-tailored deprescribing assessment and intervention in people with Medication Adverse Effects and Older Adults (65 Years and Older), run by Cedars-Sinai Medical Center at 1 site 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of all-cause hospitalizations (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.