Pharmacist Intervention to Reduce Post-Hospitalization Utilization

NCT04071951 | Active Not Recruiting Results

• 2 other identifiers: Pro00053414R01AG058911
• Study Type: interventional
• Target: 6,478
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Polypharmacy; Readmission; Nonadherence, Patient

Outcome Measures

Primary Outcomes (1)

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Based on EHR Data and CMS Claims)

  A patient is readmitted to a hospital (including observation) or has an ED visit within 30 days of discharge (including all hospitals at least statewide), excluding foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations

  Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)

Secondary Outcomes (18)

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital)

  Hospitalization to the same hospital or ED visit within 30 days of discharge (including other facilities in the system using the same electronic health record instance)

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Receipt of Different Intervention Components

  Hospitalization to the same hospital or ED visit within 30 days of discharge

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Whether Patient Has a Diagnosis of Congestive Heart Failure at Admission

  Hospitalization to the same hospital or ED visit within 30 days of discharge

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has Three or More High Risk Medications (Anticoagulants, Antiplatelets, Insulin, Oral Hypoglycemics) Prior to Admission

  Hospitalization to the same hospital or ED visit within 30 days of discharge

• Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has 10 or More Medications Prior to Admission

  Hospitalization to the same hospital or ED visit within 30 days of discharge

Study Arms (2)

Pharmacist Arm

EXPERIMENTAL

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

Behavioral: Pharmacist-led Hospital Discharge Care Intervention

Usual Care

NO INTERVENTION

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

Interventions

Pharmacist-led Hospital Discharge Care Intervention BEHAVIORAL

Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls. Pharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone.

Pharmacist Arm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to a medical ward, AND
• \> 55 years AND
• ≥ 10 prescription medications at admission
• ≥ 3 high-risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) at admission

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Pevnick JM, Kennelty K, Nguyen AT, Amer K, Berdahl CT, Cook-Wiens G, Fanikos J, Fiskio J, Gotanda H, Guan J, Henreid AJ, Keller MS, Ko EM, Leang DW, Malkhasian Y, Matta L, Moriarty D, Murry L, Muske A, Nuckols TK, Oche O, Ortiz AS, Phung E, Qureshi N, Shane R, Wu S, Schnipper JL; PHARM-DC Group. Pharmacist-Led Discharge Care to Reduce Postdischarge Health Care Utilization: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260719. doi: 10.1001/jamanetworkopen.2026.0719.

  PMID: 41842899 DERIVED

• Murry LT, Keller MS, Pevnick JM, Schnipper JL, Kennelty KA; PHARM-DC Group. A qualitative dual-site analysis of the pharmacist discharge care (PHARM-DC) intervention using the CFIR framework. BMC Health Serv Res. 2022 Feb 12;22(1):186. doi: 10.1186/s12913-022-07583-5.

  PMID: 35151310 DERIVED

• Pevnick JM, Keller MS, Kennelty KA, Nuckols TK, Ko EM, Amer K, Anderson L, Armbruster C, Conti N, Fanikos J, Guan J, Knight E, Leang DW, Llamas-Sandoval R, Matta L, Moriarty D, Murry LT, Muske AM, Nguyen AT, Phung E, Rosen O, Rosen SL, Salandanan A, Shane R, Schnipper JL. The Pharmacist Discharge Care (PHARM-DC) study: A multicenter RCT of pharmacist-directed transitional care to reduce post-hospitalization utilization. Contemp Clin Trials. 2021 Jul;106:106419. doi: 10.1016/j.cct.2021.106419. Epub 2021 Apr 28.

  PMID: 33932574 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Joshua Pevnick
• Organization: Cedars-Sinai Medical Center

pevnickj@cshs.org

310.423.4683

Study Officials

• Joshua Pevnick

  Associate Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: December 23, 2019
• Primary Completion: August 28, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 2, 2026
• Results First Posted: October 29, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)