Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study) (PILL-CVD)
Primary Purpose
Acute Coronary Syndrome, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Sponsored by
About this trial
This is an interventional health services research trial for Acute Coronary Syndrome focused on measuring Low Health Literacy, Medication Errors, Cardiovascular Disease, Pharmacist, Care Transition
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
Sites / Locations
- Brigham and Women's Hospital
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
1
2
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Serious Medication Errors as Determined by Interview and Medical Chart Review
Number of clinically important medication errors per patient
Secondary Outcome Measures
Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
Unplanned hospitalizations and Emergency Department visits
Full Information
NCT ID
NCT00632021
First Posted
March 6, 2008
Last Updated
August 2, 2017
Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00632021
Brief Title
Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study)
Acronym
PILL-CVD
Official Title
Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Heart Failure
Keywords
Low Health Literacy, Medication Errors, Cardiovascular Disease, Pharmacist, Care Transition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
862 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Serious Medication Errors as Determined by Interview and Medical Chart Review
Description
Number of clinically important medication errors per patient
Time Frame
Measured at Day 30
Secondary Outcome Measure Information:
Title
Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
Description
Unplanned hospitalizations and Emergency Department visits
Time Frame
Measured at Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Kripalani, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey L. Schnipper, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20233982
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.
Results Reference
background
PubMed Identifier
22751755
Citation
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.
Results Reference
result
PubMed Identifier
26883526
Citation
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.
Results Reference
derived
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Pharmacist Intervention to Decrease Medication Errors in Heart Disease Patients (The PILL-CVD Study)
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