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

NCT ID: NCT00632021

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 862 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2012-03-31

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.

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.

Conditions

Acute Coronary Syndrome; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sunil Kripalani

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Kripalani, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Jeffrey L. Schnipper, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20233982 (View on PubMed)

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 Intervention for Low Literacy in Cardiovascular Disease) Study Group. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012 Jul 3;157(1):1-10. doi: 10.7326/0003-4819-157-1-201207030-00003.

Reference Type: RESULT

PMID: 22751755 (View on PubMed)

Bell SP, Schnipper JL, Goggins K, Bian A, Shintani A, Roumie CL, Dalal AK, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Labonville SA, Johnson D, Neal EB, Kripalani S; Pharmacist Intervention for Low Literacy in Cardiovascular Disease (PILL-CVD) Study Group. Effect of Pharmacist Counseling Intervention on Health Care Utilization Following Hospital Discharge: A Randomized Control Trial. J Gen Intern Med. 2016 May;31(5):470-7. doi: 10.1007/s11606-016-3596-3.

Reference Type: DERIVED

PMID: 26883526 (View on PubMed)

Other Identifiers

R01HL089755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

539

Identifier Type: -

Identifier Source: org_study_id