Trial Outcomes & Findings for Pharmacist Intervention to Reduce Post-Hospitalization Utilization (NCT NCT04071951)

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

6478 participants

Primary outcome timeframe

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

Results posted on

2026-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Pharmacist Arm Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling Pharmacist-led Hospital Discharge Care Intervention: 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.	Usual Care Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.
Overall Study STARTED	3239	3239
Overall Study COMPLETED	3213	3215
Overall Study NOT COMPLETED	26	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacist Intervention to Reduce Post-Hospitalization Utilization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacist Arm n=3213 Participants Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling Pharmacist-led Hospital Discharge Care Intervention: 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.	Usual Care n=3215 Participants Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.	Total n=6428 Participants Total of all reporting groups
Age, Continuous	75.5 years STANDARD_DEVIATION 10.2 • n=5 Participants	75.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	75.5 years STANDARD_DEVIATION 10.2 • n=10 Participants
Sex: Female, Male Female	1586 Participants n=5 Participants	1577 Participants n=5 Participants	3163 Participants n=10 Participants
Sex: Female, Male Male	1627 Participants n=5 Participants	1638 Participants n=5 Participants	3265 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	8 Participants n=5 Participants	14 Participants n=10 Participants
Race (NIH/OMB) Asian	139 Participants n=5 Participants	118 Participants n=5 Participants	257 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	479 Participants n=5 Participants	475 Participants n=5 Participants	954 Participants n=10 Participants
Race (NIH/OMB) White	2303 Participants n=5 Participants	2367 Participants n=5 Participants	4670 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	286 Participants n=5 Participants	247 Participants n=5 Participants	533 Participants n=10 Participants
Study Site Cedars-Sinai Medical Center	1299 Participants n=5 Participants	1300 Participants n=5 Participants	2599 Participants n=10 Participants
Study Site Brigham and Women's Hospital	1914 Participants n=5 Participants	1915 Participants n=5 Participants	3829 Participants n=10 Participants

PRIMARY outcome

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

Population: note that to obtain outside hospital data, analysis was restricted to 4472 patients with fee-for-service Medicare (for whom all-hospital claims data was available)

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

Outcome measures

Outcome measures
Measure	Pharmacist Arm n=2230 Participants Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling Pharmacist-led Hospital Discharge Care Intervention: 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.	Usual Care n=2242 Participants Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.
Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Based on EHR Data and CMS Claims)	570 Participants	593 Participants

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. This outcome measure will analyze the outcome by whether patients received the intervention components (admission medication reconciliation, medication regimen review, actions to improve adherence, side effect management, drug level monitoring, discharge medication reconciliation, patient/caregiver education, motivational interviewing, post-discharge follow-up phone call, medication access, communication with PCP, communication with communication pharmacy, other). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has a diagnosis of congestive heart failure at admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has three or more high risk medications (anticoagulants, antiplatelets, insulin, oral hypoglycemics) prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by whether patient has 10 or more medications prior to admission. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by study site. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient medication adherence and literacy (as assessed by study pharmacists, in addition to using limited English proficiency as a proxy for low medication literacy). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient socioeconomic status (estimated via median income of home census tract). The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patients not taking BZRs prior to admission

A dichotomous variable for a new discharge prescription of BZRs among patients not taking BZRs prior to admission.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Patients taking BZRs prior to admission

A dichotomous variable for an increased dose prescription among patients taking BZRs prior to admission.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Fall-related injuries within 30 days of discharge of the index admission

The investigators define post-hospitalization fall-related injuries as healthcare utilization (hospitalization, ED visits, urgent care visits, or office visits) due to fall-related injuries within 30 days of discharge of the index admission. The investigators will link Medicare claims data to trial data to track this outcome at the individual patient level.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified by patient age groups. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge stratified according to time periods that had changes in the intervention and control arms. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge restricted to medication-related utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Hospitalization to the same hospital or ED visit within 7 days of discharge

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 7 days of discharge by hospitalization medication-related post-discharge utilization. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Death occurring within 30 days after hospital discharge

All-cause mortality rate and survival analysis through Day 30 after hospital discharge.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

A patient is readmitted to the same hospital (including observation stays) or has an ED visit within 30 days of discharge. The investigators will exclude foreseen readmissions, which include: transplants, chemotherapy or radiotherapy, treatment follow-up, rehabilitation care, and planned operations.

Outcome measures

Outcome data not reported

Adverse Events

Pharmacist Arm

Serious events: 1485 serious events

Other events: 0 other events

Deaths: 330 deaths

Usual Care

Serious events: 1438 serious events

Other events: 0 other events

Deaths: 334 deaths

Serious adverse events

Serious adverse events
Measure	Pharmacist Arm n=3239 participants at risk Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling Pharmacist-led Hospital Discharge Care Intervention: 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.	Usual Care n=3239 participants at risk Patients in this study will receive usual care. Clinically-indicated services, including pharmacist services, may be provided to control group patients.
General disorders 90-day post-discharge utilization	35.7% 1155/3239 • From the time of randomization (near hospital admission) up to 90 days after hospital discharge	34.1% 1104/3239 • From the time of randomization (near hospital admission) up to 90 days after hospital discharge
General disorders 30-day post-discharge utilization (same hospital)	20.4% 662/3239 • From the time of randomization (near hospital admission) up to 90 days after hospital discharge	20.6% 666/3239 • From the time of randomization (near hospital admission) up to 90 days after hospital discharge

Other adverse events

Adverse event data not reported

Additional Information

Joshua Pevnick

Cedars-Sinai Medical Center

Phone: 310.423.4683

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place