Pharmacist Intervention to Reduce Post-Hospitalization Utilization

Cedars-Sinai Medical Center

Status: Active, not recruiting

Conditions: Polypharmacy; Nonadherence, Patient; Readmission

Treatments: Behavioral: Pharmacist-led Hospital Discharge Care Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04071951

Pro00053414

R01AG058911 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a randomized trial testing a peri- and post-discharge pharmacist-led medication management intervention on post-discharge utilization, including both readmissions and emergency department visits within 30 days of discharge. The intervention incorporates evidence addressing three main areas: medication reconciliation, medication adherence, and polypharmacy.

This study uses a pragmatic trial randomized at the patient level and conducted in two large hospitals to achieve the following aims, each of which has been designed using the RE-AIM framework:

Aim 1: To test the effect of PHARM-DC on post-discharge utilization among patients most at risk for post-discharge ADEs: recently discharged older adults taking >10 medications or >3 high-risk medications using a prospective, randomized, pragmatic multi-site study.

Aim 2: To study barriers and facilitators of implementing PHARM-DC using a qualitative study.

Aim 3: To analyze the costs of PHARM-DC, including the incremental cost per readmission averted and the net incremental cost from the health system perspective using a time-and-motion study and a cost-effectiveness analysis.

Full description

There are three components to this study: (1) the prospective, randomized, controlled trial (RCT), which includes a pharmacist-led hospital discharge care intervention, (2) the qualitative study, which involves focus groups and interviews, and (3) a cost-effectiveness study, which involves a review of the literature and a time-and-motion study component.For all three studies, there are two sites: CSMC and Brigham and Women's Hospital in Boston. Additionally, Dr. Kennelty of University of Iowa will participate in the qualitative study.1. For the RCT: Eligible patients will be identified through the use of a daily Epic report using inclusion/exclusion criteria. Patients will be randomized by a study coordinator to the intervention arm or control arm. For the control arm, patients will receive usual care, which includes medication reconciliation at hospital admission. For the intervention arm, pharmacy staff will address medication reconciliation at hospital discharge, medication review, and medication adherence. Most intervention activities will occur during the hospital stay or during a post-discharge phone call. We estimate a total number of 4,888 patients per study arm.

2. For the qualitative study: This is a qualitative study employing focus groups aimed at understanding implementation barriers and facilitators. Dr. Kennelty and study staff will conduct 3-day site visits to hold focus groups and/or interviews regarding intervention expectations, how the intervention is being implemented, barriers/facilitators to adoption and implementation, and adaptations made during delivery. Towards the end of the trial, Dr. Kennelty and study staff will use phone interviews to determine any changes to the implementation of PHARM-DC that occurred during the RCT, as well as to understand whether and how institutions will address the maintenance of PHARM-DC after the study ends. We estimate that up to 180 people may participate in this qualitative study.

3. For the cost-effectiveness study: This is a time-and-motion study aimed at understanding how much time during the day pharmacists spend on activities related to the hospital discharge (and post-discharge) interventions. During the trial, we will use time and motion methodology to understand how much pharmacist time is needed for PHARM-DC. Coupled with data on post-discharge utilization, this will enable us to conduct economic analyses.

Enrollment: 6,478 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to a medical ward, AND
• > 55 years AND
• ≥ 10 prescription medications at admission

OR

• ≥ 3 high-risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) at admission

Exclusion criteria

• Expected discharge to another state, acute care facility, psychiatric facility, or locked facility (including locked skilled nursing facility, jail, or prison) OR
• Expected AMA or left hospital against medical advice (AMA) OR
• Homeless OR
• On hospice OR
• Already enrolled into study within the past year OR
• Patients admitted by admitting or attending Primary Medical Doctors who have a specialty that is not Internal Medicine or Family Medicine OR
• Expected to receive pharmacist-led peri- and post-discharge medication management regardless of the trial OR
• Expected post-discharge setting not conducive to the studied medication management intervention (e.g. SNF, rehabilitation facility) OR
• Patients admitted with a suspected or confirmed diagnosis of COVID-19.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,478 participants in 2 patient groups

Pharmacist Arm

Experimental group

Description:

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

Treatment:

Behavioral: Pharmacist-led Hospital Discharge Care Intervention

Usual Care

No Intervention group

Description:

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