NCT03617380

Brief Summary

Many hospitals and medical groups have developed transitions of care (TOC) programs or procedures in an attempt to reduce hospital readmission and reutilization rates of patients discharged from the hospital. As healthcare's most accessible practitioners, Community Pharmacists have a unique opportunity to assist with reducing unnecessary hospital re-utilization (re-admissions and emergency department visits) after hospital discharge. The purpose of this study is to conduct and evaluate the implementation of a Community Pharmacy-based Transitions of Care (TOC) Program for high-risk post-discharge patients of PIH Health Hospital-Whittier (PIH). The primary objective will be to compare the proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge between patients randomly assigned to the PHARMD-TOC group vs. the historic rate at PIH. Secondary analyses will examine differences between groups and describe implementation details of the PHARMD-TOC model of patient care.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

July 31, 2018

Last Update Submit

February 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion Patients with Hospital Reutilization

    proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge

    30 days post hospital discharge

Study Arms (2)

PHARMD-TOC i

EXPERIMENTAL

PharmD Follow-Up Post Discharge

Other: PharmD TOC

USUAL CARE

ACTIVE COMPARATOR

Usual Post Discharge Procedures

Other: Usual Care

Interventions

patients participating Usual Care discharge services

USUAL CARE

patients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC)

PHARMD-TOC i

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Admission LACE Score: in moderate range (5 to 9) And
  • Taking high risk medication(s): anticoagulants, insulin, oral antiplatelet agents, oral hypoglycemic agents, opioid analgesics, digoxin Or Taking at least 5 medications AND have one of following: CHF, COPD, Asthma, Pneumonia, Diabetes, ESRD, Schizophrenia, Bi-Polar, Dizziness, History of Falls
  • And
  • Medical or Surgical Unit patients
  • Age \> 18 years
  • Being discharged to home (with or without Home Health services)
  • English and/or Spanish speaking
  • Will have access to a telephone post-discharge
  • Ability to give consent
  • Patient admitted to hospital through the emergency department, as a direct admission or as a transfer, or as an elective surgery patient

You may not qualify if:

  • \- Patients with observation status
  • Caremore Health Plan patients (Caremore has a separate post-discharge program)
  • Patients discharged and followed up by the PIH Coumadin Clinic
  • Patients discharged to Residential MD House Calls program
  • Patients discharged to Skilled Nursing Facility
  • Anyone with planned readmissions
  • Obstetrics patients
  • Hospice patients
  • Oncology patients
  • Anyone who does not meet provisions of protocol
  • Anyone unwilling or unable to give consent for study procedures and data access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Clinical Pharmacy

Study Record Dates

First Submitted

July 31, 2018

First Posted

August 6, 2018

Study Start

October 1, 2018

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02