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

Heart Failure Clinical Trial

— PILL-CVD  

Official title:

Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632021
• Other study ID #: 539
• Secondary ID: R01HL089755
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: December 11, 2013
• Start date: May 2008
• Est. completion date: March 2012

Study information

• Verified date: December 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: March 2012
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kripalani S, Roumie CL, Dalal AK, Cawthon C, Businger A, Eden SK, Shintani A, Sponsler KC, Harris LJ, Theobald C, Huang RL, Scheurer D, Hunt S, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Bates DW, Williams MV, Schnipper JL; PILL-CVD (Pharmacist Interve — View Citation

Schnipper JL, Roumie CL, Cawthon C, Businger A, Dalal AK, Mugalla I, Eden S, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Bates DW, Johnson DC, Labonville S, Gregory D, Kripalani S; PILL-CVD Study Group. Rationale and design of the Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) study. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):212-9. doi: 10.1161/CIRCOUTCOMES.109.921833. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious medication errors		Measured at Day 30	Yes
Secondary	Unplanned health care utilization	Unplanned hospitalizations and Emergency Department visits	Measured at Day 30	No