Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study) (PILL-CVD)
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|ClinicalTrials.gov Identifier: NCT00632021|
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : August 1, 2017
Last Update Posted : September 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Heart Failure||Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||862 participants|
|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|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||March 2012|
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.
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.
- 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
- Number of Participants With Unplanned Hospitalizations and Emergency Department Visits [ Time Frame: Measured at Day 30 ]Unplanned hospitalizations and Emergency Department visits
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|
|Principal Investigator:||Sunil Kripalani, MD, MSc||Vanderbilt University Medical Center|
|Principal Investigator:||Jeffrey L. Schnipper, MD, MPH||Brigham and Women's Hospital|