Clinical trial NCT04071951: Pharmacist Intervention to Reduce Post-Hospitalization Utilization
Official title: A Multicenter RCT of Pharmacist-Directed Transitional Care to Reduce Post-Hospitalization Utilization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nonadherence, Patient
Polypharmacy
Readmission
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-08-28
Enrollment: 6478
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide)
timeFrame: Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)
Secondary outcomes:
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital)
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Receipt of Different Intervention Components
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: 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
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: 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
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital), Stratified by Whether Patient Has 10 or More Medications Prior to Admission
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Study Site
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Patient Medication Adherence and Literacy
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital) Stratified by Quintiles of Patient Socioeconomic Status (Estimated Via Median Income of Home Census Tract)
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate (%) of New BZR Discharge Prescriptions Among Patients Not Taking BZRs Prior to Admission
timeFrame: Patients not taking BZRs prior to admission
measure: Rate (%) of Increased BZR Dose Prescription Among Patients Taking BZRs Prior to Admission
timeFrame: Patients taking BZRs prior to admission
measure: Rate (%) of Post-hospitalization Fall-related Injuries as Healthcare Utilization (Hospitalization, ED Visits, Urgent Care Visits, or Office Visits)
timeFrame: Fall-related injuries within 30 days of discharge of the index admission
measure: Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified by Patient Age Groups
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified According to Time Periods That Had Changes in the Intervention and Control Arms
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate of 30 Day Post Hospitalization in ED Visits (Same Hospital) Restricted to Medication-related Utilization
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
measure: Rate of 7 Day Post-discharge Hospitalization Medication-related Post-discharge Utilization.
timeFrame: Hospitalization to the same hospital or ED visit within 7 days of discharge
measure: Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).
timeFrame: Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)
measure: 30-day, All-cause Mortality After Hospital Discharge
timeFrame: Death occurring within 30 days after hospital discharge
measure: 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.
timeFrame: Hospitalization to the same hospital or ED visit within 30 days of discharge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Associate Professor of Medicine
name: Joshua Pevnick
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.