Disease, ChronicNCT03617380
PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program
A study testing PharmD TOC in people with Disease, Chronic, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease, Chronic
- What is being tested?
- PharmD TOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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)
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- 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
Who cannot join
- - 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
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- 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
About this study
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.
- Conditions
- Disease, Chronic
- Being tested
- Usual Care, PharmD TOC
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
patients participating Usual Care discharge services
PharmD TOCOther
patients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC)
| Study group | Role | What they receive |
|---|---|---|
| PHARMD-TOC i | Experimental | PharmD Follow-Up Post Discharge Receives: Other: PharmD TOC |
| USUAL CARE | Active comparator | Usual Post Discharge Procedures Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Patients with Hospital Reutilization
proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge
Measured: 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2018
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Why it stopped: transferred to different institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease, ChronicStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candi Morello, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617380
- Sponsor's protocol ID
- 171847
- Status last verified
- Feb 2020
- First submitted
- 31 Jul 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program
- ClinicalTrials.gov ID
- NCT03617380
- Acronym / sponsor ID
- 171847
- Conditions
- Disease, Chronic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: transferred to different institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHARMD-TOC i | Experimental | Other: PharmD TOCPharmD Follow-Up Post Discharge |
| USUAL CARE | Active comparator | Other: Usual CareUsual Post Discharge Procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- - 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
Key exclusion criteria (11 listed)
- - 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
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 |
|---|---|---|
| Usual Carepatients participating Usual Care discharge services | Other | USUAL CARE |
| PharmD TOCpatients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC) | Other | PHARMD-TOC i |
Primary outcome
Proportion Patients with Hospital Reutilization
Time frame: 30 days post hospital discharge
proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PharmD TOC in people with Disease, Chronic, run by University of California, San Diego.
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 10 inclusion and 11 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: withdrawn, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion Patients with Hospital Reutilization (time frame: 30 days post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2020.