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

NCT00632021 | Completed Results

• 2 other identifiers: 539R01HL089755
• Study Type: interventional
• Target: 862
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Heart Failure

Keywords

Low Health Literacy; Medication Errors; Cardiovascular Disease; Pharmacist; Care Transition

Outcome Measures

Primary Outcomes (1)

• Number of Serious Medication Errors as Determined by Interview and Medical Chart Review

  Number of clinically important medication errors per patient

  Measured at Day 30

Secondary Outcomes (1)

• Number of Participants With Unplanned Hospitalizations and Emergency Department Visits

  Measured at Day 30

Study Arms (2)

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

Interventions

Pharmacist Intervention for Low-Literacy in Cardiovascular Disease 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• 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.

  PMID: 20233982 BACKGROUND

• 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.

  PMID: 22751755 RESULT

• 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.

  PMID: 26883526 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Results Point of Contact

• Title: Research Coordinator
• Organization: Vanderbilt University Medical Center

Kathryn.m.goggins@vanderbilt.edu

6159364819

Study Officials

• Sunil Kripalani, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffrey L. Schnipper, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 10, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2012
• Last Updated: September 1, 2017
• Results First Posted: August 1, 2017

Record last verified: 2017-08

Locations

US (2)