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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02031406
Other study ID # KL2TR000122-00034358
Secondary ID KL2TR000122
Status Terminated
Phase N/A
First received January 7, 2014
Last updated January 23, 2018
Start date January 2014
Est. completion date July 2014

Study information

Verified date January 2018
Source Cedars-Sinai Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

1. 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.

2. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 155
Est. completion date July 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Medication Adherence & Literacy to Predict Readmission
  • Post-discharge Pharmacist Counseling to Prevent Readmissions

Intervention

Other:
Post-discharge counseling on medication adherence & literacy


Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmissions 30 days
Secondary Medication Adherence Using the Morisky Medication Adherence Scale 30 days after discharge
Secondary Medication Literacy Using a novel measure of medication literacy 30 days