What side effects are associated with this type of intervention?

The most common side effects associated with treatments focusing on medication reconciliation, adherence, and polypharmacy management include adverse drug events (ADEs) due to drug-drug interactions, which can lead to increased toxicity or reduced efficacy of medications. Patients may also experience specific side effects related to their medications, such as gastrointestinal issues, dizziness, or fatigue. The use of multiple medications (polypharmacy) heightens the risk of these side effects and can complicate the management of chronic conditions.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of readmissions; however, interventions similar to those studied in the PHARM-DC trial, such as pharmacist-led medication management, have shown promise. These interventions focus on medication reconciliation, adherence, and managing polypharmacy, which can help reduce readmissions. While the FDA does not approve these interventions as 'drugs,' they are recognized as effective strategies in clinical practice to improve patient outcomes post-discharge.

What other types of research exist?

Promising alternatives to PHARM-DC for reducing readmissions in 2024 include: 1) Telehealth-based medication management programs that provide remote monitoring and follow-up consultations, 2) Integrated care models that involve collaboration between primary care physicians, specialists, and pharmacists, 3) Use of artificial intelligence and machine learning to predict high-risk patients and tailor interventions, 4) Enhanced patient education and self-management programs using digital platforms, and 5) Community health worker interventions to support medication adherence and address social determinants of health.

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Pharmacist Intervention to Reduce Post-Hospitalization Utilization

N/A

Waitlist Available

Led By Joshua Pevnick

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

10 or more prescription medications at admission

Must not have

Expected post-discharge setting not conducive to the studied medication management intervention (e.g. SNF, rehabilitation facility)

Patients admitted with a suspected or confirmed diagnosis of COVID-19.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hospitalization to the same hospital or ed visit within 7 days of discharge

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a pharmacist-led program to help older adults manage their medications after leaving the hospital. It aims to reduce readmissions and emergency visits by ensuring patients take their medicines correctly and safely.

Who is the study for?

This trial is for older adults (55+) who are at risk of medication issues after leaving the hospital. They must be taking more than 10 prescription meds or over three high-risk meds like blood thinners or diabetes drugs. It's not for those without stable housing, discharged out-of-state, in hospice care, previously enrolled, under certain specialists' care, or with COVID-19.

What is being tested?

The study tests a pharmacist-led program to manage medications when patients leave the hospital. The goal is to see if this helps reduce emergency visits and readmissions within 30 days post-discharge. Patients are randomly chosen to either get this extra pharmacy help or usual care.

What are the potential side effects?

Since this trial involves a service (medication management) rather than a drug, traditional side effects aren't expected. However, there may be unintended consequences related to changes in medication use as advised by pharmacists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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This criterion does not apply to me.

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I am taking 10 or more prescription medications.

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I am currently admitted to a hospital ward.

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I am 55 years old or older.

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I am taking 3 or more high-risk medications like blood thinners or diabetes drugs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My post-hospital care will not support the study's medication plan.

Select...

I am admitted with a suspected or confirmed COVID-19 diagnosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hospitalization to the same hospital or ed visit within 30 days of discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hospitalization to the same hospital or ed visit within 30 days of discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and hospitalization to the same hospital or ed visit within 30 days of discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide)

Secondary study objectives

30-day, All-cause Mortality After Hospital Discharge

Rate (%) of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Among Patients Who Were Enrolled and Received the Intervention, Compared to Patients Who Were Eligible Yet Not Enrolled During the Study Period.

Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pharmacist ArmExperimental Treatment1 Intervention

Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling

Group II: Usual CareActive Control1 Intervention

Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for reducing readmissions, particularly those similar to the PHARM-DC trial, involve pharmacist-led interventions focusing on medication reconciliation, adherence, and polypharmacy management. Medication reconciliation ensures that patients' medication lists are accurate and complete, preventing potential drug interactions and errors. Medication adherence strategies help patients take their medications correctly, improving therapeutic outcomes. Polypharmacy management involves optimizing medication regimens to reduce the burden of taking multiple drugs, which can decrease the risk of adverse drug events. These mechanisms are crucial for readmissions patients as they help prevent complications that could lead to hospital readmissions, thereby improving patient safety and reducing healthcare costs.

The impact of the clinical pharmacist-led interventions in China: A systematic review and Meta-Analysis.