- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02031406
Impact of Pharmacist Post-discharge Phone Calls on Hospital Readmission and Patient Medication Literacy and Adherence
A significant portion of avoidable healthcare expenditures has been attributed to preventable hospital readmissions; thus, reducing hospital readmission rates has become a national healthcare agenda item. Despite much study of this topic, efforts to date have not been especially fruitful in either predicting which patients will require hospital readmission. Preventing readmissions has been even more difficult.
We recently examined a pharmacist intervention that assessed patients' medication literacy and adherence at hospital admission. In this retrospective data, low medication adherence levels were predictive of hospital readmission. There was a non-significant trend between low medication literacy and increased hospital readmissions.
We have now decided to prospectively study this intervention. Prospective study will allow for several improvements on our prior work.
- We have consulted the literature to more carefully examine existing instruments to measure medication adherence and literacy. Based on this review, and based on our prior results, we have made adjustments to these instruments which should improve reliability, validity, and granularity.
- In our retrospective work, our intervention of pharmacist counseling was not randomized. Although there were large differences in readmission rates between the patients selected to receive counseling and those who were not thought to require it, there may have been unmeasured confounding variables. Randomizing this intervention will greatly enhance the likelihood that we are comparing two similar groups of patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 91604
- Cedars-Sinai Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
≥10 chronic prescription medications On anticoagulants Diagnosis of CHF, AMI On narrow therapeutic index drugs E.g. valproic acid, phenytoin, lithium, digoxin History of transplant AND not admitted by transplant team
Exclusion Criteria:
Trauma patients Pediatric patients History of transplant and admitted to the transplant team Patients admitted from or discharged to a SNF or hospice Non-English speaking patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
No extra post-discharge pharmacist counseling is explicitly provided to patients, although some patients may receive it depending on their care setting
|
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Experimental: Post-discharge pharmacist counseling
Patients will receive post-discharge telephonic pharmacist counseling at around 72 hours after hospital discharge.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Readmissions
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence
Time Frame: 30 days after discharge
|
Using the Morisky Medication Adherence Scale
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30 days after discharge
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Medication Literacy
Time Frame: 30 days
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Using a novel measure of medication literacy
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30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Josh Pevnick, MD, MSHS, Cedars-Sinai Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KL2TR000122-00034358
- KL2TR000122 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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