Nonadherence, PatientNCT04071951
Pharmacist Intervention to Reduce Post-Hospitalization Utilization
A study testing Pharmacist-led Hospital Discharge Care Intervention in people with Nonadherence, Patient and Polypharmacy, run by Cedars-Sinai Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Nonadherence, Patient, Polypharmacy, Readmission
- What is being tested?
- Pharmacist-led Hospital Discharge Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,478 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Dec 2019to Jan 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Multicenter RCT of Pharmacist-Directed Transitional Care to Reduce Post-Hospitalization Utilization
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:
Read more
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.
Read the 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.
- 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.
- 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.
- Conditions
- Nonadherence, Patient, Polypharmacy, Readmission
- Being tested
- Pharmacist-led Hospital Discharge Care Intervention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Hospital Discharge Care InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Arm | Experimental | Pharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 Study Site
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.
Measured: 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 Patient Medication Adherence and Literacy
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.
Measured: 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 Quintiles of Patient Socioeconomic Status (Estimated Via Median Income of Home Census Tract)
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.
Measured: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate (%) of New BZR Discharge Prescriptions Among 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.
Measured: Patients not taking BZRs prior to admission
Rate (%) of Increased BZR Dose Prescription Among Patients Taking BZRs Prior to Admission
A dichotomous variable for an increased dose prescription among patients taking BZRs prior to admission.
Measured: Patients taking BZRs prior to admission
Rate (%) of Post-hospitalization Fall-related Injuries as Healthcare Utilization (Hospitalization, ED Visits, Urgent Care Visits, or Office Visits)
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.
Measured: Fall-related injuries within 30 days of discharge of the index admission
Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified by Patient Age Groups
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.
Measured: Hospitalization to the same hospital or ED visit within 30 days of discharge
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
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.
Measured: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate of 30 Day Post Hospitalization in ED Visits (Same Hospital) Restricted to Medication-related Utilization
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.
Measured: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate of 7 Day Post-discharge Hospitalization Medication-related Post-discharge Utilization.
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.
Measured: Hospitalization to the same hospital or ED visit within 7 days of discharge
Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).
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.
Measured: Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)
30-day, All-cause Mortality After Hospital Discharge
All-cause mortality rate and survival analysis through Day 30 after hospital discharge.
Measured: Death occurring within 30 days 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.
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.
Measured: Hospitalization to the same hospital or ED visit within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start23 Dec 2019
- Primary completion28 Aug 2024
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nonadherence, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Josh Pevnick, Cedars-Sinai Medical Center
- Investigators
- Joshua Pevnick, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071951
- Sponsor's protocol ID
- Pro00053414
- Other IDs
- R01AG058911
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2019
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41842899Murry 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.
PubMed 35151310Pevnick 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.
PubMed 33932574
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter RCT of Pharmacist-Directed Transitional Care to Reduce Post-Hospitalization Utilization
- ClinicalTrials.gov ID
- NCT04071951
- Acronym / sponsor ID
- Pro00053414
- Conditions
- Nonadherence, Patient, Polypharmacy, Readmission
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6,478 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Arm | Experimental | Behavioral: Pharmacist-led Hospital Discharge Care InterventionPharmacist-Led Medication Reconciliation, Regimen Review, and Adherence and Literacy Assessment and Counseling |
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led Hospital Discharge Care InterventionPharmacists 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. | Behavioural | Pharmacist Arm |
Primary outcome
Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Based on EHR Data and CMS Claims)
Time frame: 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 (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
18 secondary outcomes
Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Same-hospital)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Study Site
Time frame: 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 Patient Medication Adherence and Literacy
Time frame: 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 Quintiles of Patient Socioeconomic Status (Estimated Via Median Income of Home Census Tract)
Time frame: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate (%) of New BZR Discharge Prescriptions Among Patients Not Taking BZRs Prior to Admission
Time frame: Patients not taking BZRs prior to admission
Rate (%) of Increased BZR Dose Prescription Among Patients Taking BZRs Prior to Admission
Time frame: Patients taking BZRs prior to admission
Rate (%) of Post-hospitalization Fall-related Injuries as Healthcare Utilization (Hospitalization, ED Visits, Urgent Care Visits, or Office Visits)
Time frame: Fall-related injuries within 30 days of discharge of the index admission
Rate of 30 Day Post-discharge Hospitalizations and ED Visits (Same Hospital) Stratified by Patient Age Groups
Time frame: Hospitalization to the same hospital or ED visit within 30 days of discharge
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
Time frame: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate of 30 Day Post Hospitalization in ED Visits (Same Hospital) Restricted to Medication-related Utilization
Time frame: Hospitalization to the same hospital or ED visit within 30 days of discharge
Rate of 7 Day Post-discharge Hospitalization Medication-related Post-discharge Utilization.
Time frame: Hospitalization to the same hospital or ED visit within 7 days of discharge
Rate (%) of 30-day Post-discharge Hospital Utilization With ED Visits, Observation Stays, and Inpatient Readmissions Counted Separately (Including Hospitals at Least Statewide).
Time frame: Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)
30-day, All-cause Mortality After Hospital Discharge
Time frame: Death occurring within 30 days 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.
Time frame: Hospitalization to the same hospital or ED visit within 30 days of discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41842899Pevnick 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.
- Derived from this study: PubMed 35151310Murry 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.
- Derived from this study: PubMed 33932574Pevnick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Pevnick principal investigator
Associate Professor of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led Hospital Discharge Care Intervention in people with Nonadherence, Patient and Polypharmacy, run by Cedars-Sinai Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Based on EHR Data and CMS Claims) (time frame: Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.