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Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study)
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2009
First Received: March 6, 2008   Last Updated: July 16, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00632021
  Purpose

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 Intervention
Acute Coronary Syndrome
Heart Failure
Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Study Type: Interventional
Study Design: Health Services Research, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Number of serious medication errors [ Time Frame: Measured at Day 30 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of serious medication errors among participants with low health literacy [ Time Frame: Measured at Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 862
Study Start Date: April 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
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.
2: Experimental
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632021

Contacts
Contact: Sunil Kripalani, MD, MSc 615-936-3525 sunil.kripalani@vanderbilt.edu
Contact: Courtney Cawthon, MPH 615-936-1785 courtney.cawthon@vanderbilt.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jeffrey L. Schnipper, MD, MPH            
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Sunil Kripalani, MD, MSc            
Sponsors and Collaborators
Investigators
Principal Investigator: Sunil Kripalani, MD, MSc Vanderbilt University
Principal Investigator: Jeffrey L. Schnipper, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Sunil Kripalani, MD, MSc, Principal Investigator )
Study ID Numbers: 539, R01 HL089755-01
Study First Received: March 6, 2008
Last Updated: July 16, 2009
ClinicalTrials.gov Identifier: NCT00632021     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Low Health Literacy
Medication Errors
Cardiovascular Disease
Pharmacist
Care Transition

Study placed in the following topic categories:
Heart Failure
Heart Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Vascular Diseases
Ischemia

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

ClinicalTrials.gov processed this record on September 10, 2009