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Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study) (PILL-CVD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00632021
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : August 1, 2017
Last Update Posted : September 1, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Many people who have recently left the hospital have difficulties managing their medications, and medication errors are common. Patients with low health literacy levels may have a particularly difficult time understanding medication dosing and instructions. This study will evaluate a literacy-focused program that provides educational assistance from pharmacists at the time of hospital discharge to people hospitalized with heart problems.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Heart Failure Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Detailed Description:

After hospital discharge, many people experience difficulty in managing their medication regimens. This can be due to medication dosing changes, challenges in adjusting new medications with those that were taken previously, inadequate discharge instructions from hospital personnel, and inadequate follow-up. Difficulty with medication management can lead to medication errors that result in harmful side effects, poor disease control, hospital readmission, or even death. People with low health literacy often have greater difficulty with understanding and managing their medication regimens and as a result they experience more medication use errors. Although research shows that many medication errors could be prevented or lessened through improved doctor communication and patient-centered treatment programs, little research has been done on the effectiveness of such programs among low-literacy patients or of such programs during key transition times like hospital discharge. Getting pharmacists involved with patient care before hospital discharge may prevent unnecessary and dangerous medication errors from occurring once patients leave the hospital. Because of the severity of heart conditions and the likelihood of serious adverse effects from non-compliance with heart medications, this study will evaluate people admitted to the hospital for acute coronary syndromes or heart failure. The purpose of this study is to evaluate the effectiveness of a health literacy-focused, pharmacist-delivered program at reducing medication errors in heart patients during the first month after hospital discharge.

This study will enroll people admitted to the hospital who have acute coronary syndromes or heart failure. Participants will be randomly assigned to either the pharmacist-delivered program or usual care. Participants assigned to the intervention group will receive a pharmacist-assisted medication review while in the hospital, counseling from a pharmacist at the time of hospital discharge, a low-literacy education tool that details the discharge medications, a follow-up phone call 1 to 4 days after discharge, and additional phone calls as needed. Participants receiving usual care will receive a doctor-assisted medication review and nurse-provided guidance on medication usage at the time of hospital discharge. Approximately 30 days after hospital discharge, study researchers will call all participants to collect information on serious medication errors, health care utilization, and disease-specific quality of life.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 862 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Study Start Date : May 2008
Primary Completion Date : September 2009
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Patients will receive usual care at hospital discharge, which generally includes physician reconciliation of medications and a nurse-provided explanation of how to take medications at the time of discharge.
Experimental: 2
Participants will receive pharmacist-led medication reconciliation, pharmacist counseling prior to discharge, a follow-up telephone call 1-4 days after discharge, and additional telephone support as needed.
Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Before hospital discharge, a pharmacist will provide medication reconciliation and counseling on how to take medications. Participants will receive a follow-up phone call 1 to 4 days after hospital discharge to discuss any medication problems, and additionally as needed.

Outcome Measures

Primary Outcome Measures :
  1. Number of Serious Medication Errors as Determined by Interview and Medical Chart Review [ Time Frame: Measured at Day 30 ]
    Number of clinically important medication errors per patient

Secondary Outcome Measures :
  1. Number of Participants With Unplanned Hospitalizations and Emergency Department Visits [ Time Frame: Measured at Day 30 ]
    Unplanned hospitalizations and Emergency Department visits

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Admitted to a participating study hospital
  • Diagnosis of acute coronary syndromes or heart failure

Exclusion Criteria:

  • Too ill to participate
  • Corrected visual acuity worse than 20/200
  • Severe hearing impairment
  • Patient is not being discharged to their home
  • No regular telephone number
  • Not fluent in English or Spanish
  • Unintelligible speech
  • In police custody
  • Caregiver manages all medications
  • Delirium or severe dementia
  • Psychotic illness
  • Already participating in a conflicting study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632021

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Sunil Kripalani, MD, MSc Vanderbilt University Medical Center
Principal Investigator: Jeffrey L. Schnipper, MD, MPH Brigham and Women's Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunil Kripalani, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00632021     History of Changes
Other Study ID Numbers: 539
R01HL089755 ( U.S. NIH Grant/Contract )
First Posted: March 10, 2008    Key Record Dates
Results First Posted: August 1, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017

Keywords provided by Sunil Kripalani, Vanderbilt University Medical Center:
Low Health Literacy
Medication Errors
Cardiovascular Disease
Care Transition

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Acute Coronary Syndrome
Heart Diseases
Myocardial Ischemia
Vascular Diseases