Skip to content

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

Pharmacist Intervention for Low-Literacy in Cardiovascular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00632021
Acronym
PILL-CVD
Enrollment
862
Registered
2008-03-10
Start date
2008-05-31
Completion date
2012-03-31
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Heart Failure

Keywords

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

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.

Interventions

BEHAVIORALPharmacist 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.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Serious Medication Errors as Determined by Interview and Medical Chart ReviewMeasured at Day 30Number of clinically important medication errors per patient

Secondary

MeasureTime frameDescription
Number of Participants With Unplanned Hospitalizations and Emergency Department VisitsMeasured at Day 30Unplanned hospitalizations and Emergency Department visits

Countries

United States

Participant flow

Recruitment details

Adults admitted to Vanderbilt University Hospital or Brigham and Women's Hospital for acute coronary syndromes or acute decompensated heart failure were enrolled between May 2008 and September 2009. We enrolled and randomized 862 patients. Eleven patients withdrew consent or died in the hospital, leaving 851 patients in the analysis.

Pre-assignment details

This was a randomized, controlled trial with concealed allocation and blinded outcome assessors. We enrolled and randomized 862 patients (430 intervention and 432 usual care). Eleven patients (7 intervention and 4 usual care) withdrew consent or died in the hospital, leaving 851 patients in the intention-to-treat analysis.

Participants by arm

ArmCount
Control (Usual Care)
Control (usual care) arm
428
Intervention
Intervention arm
423
Total851

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal/death47

Baseline characteristics

CharacteristicInterventionControl (Usual Care)Total
Age, Continuous61 years
STANDARD_DEVIATION 14
59 years
STANDARD_DEVIATION 14
60 years
STANDARD_DEVIATION 14
Cognition (Mini cog score)
Impaired
52 Participants46 Participants98 Participants
Cognition (Mini cog score)
Missing
0 Participants2 Participants2 Participants
Cognition (Mini cog score)
Not impaired
371 Participants380 Participants751 Participants
Comorbidities
Coronary artery disease
225 participants211 participants436 participants
Comorbidities
Diabetes
140 participants195 participants335 participants
Comorbidities
Hypercholesterolemia
234 participants236 participants470 participants
Comorbidities
Hypertension
306 participants296 participants602 participants
Comorbidities
Prior coronary revascularization procedure
203 participants195 participants398 participants
Comorbidities
Prior myocardial infarction
100 participants73 participants173 participants
Comorbidities
Prior stroke or cerebrovascular event
30 participants41 participants71 participants
Education14 years14 years14 years
Has primary care provider
No
37 Participants36 Participants73 Participants
Has primary care provider
Yes
386 Participants392 Participants778 Participants
Health literacy (sTOFHLA score)
Adequate
331 Participants340 Participants671 Participants
Health literacy (sTOFHLA score)
Inadequate
47 Participants39 Participants86 Participants
Health literacy (sTOFHLA score)
Marginal
36 Participants38 Participants74 Participants
Health literacy (sTOFHLA score)
Missing
9 Participants11 Participants20 Participants
Income
<10K
20 Participants17 Participants37 Participants
Income
10K to <15K
21 Participants24 Participants45 Participants
Income
15K to <20K
23 Participants19 Participants42 Participants
Income
20K to <25K
56 Participants47 Participants103 Participants
Income
25K to <35K
49 Participants49 Participants98 Participants
Income
35K to <50K
54 Participants56 Participants110 Participants
Income
50K to <75K
58 Participants60 Participants118 Participants
Income
75K+
105 Participants119 Participants224 Participants
Income
Missing
37 Participants37 Participants74 Participants
Insurance status
Commercial
167 Participants203 Participants370 Participants
Insurance status
Medicaid
44 Participants37 Participants81 Participants
Insurance status
Medicare
177 Participants162 Participants339 Participants
Insurance status
Self-pay/other
35 Participants26 Participants61 Participants
Language
English
414 Participants425 Participants839 Participants
Language
Spanish
9 Participants3 Participants12 Participants
Marital status
Married/cohabitating
226 Participants256 Participants482 Participants
Marital status
Single/living alone
197 Participants172 Participants369 Participants
Number of pre-admission medications8 Medications7 Medications8 Medications
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants1 Participants4 Participants
Race (NIH/OMB)
Asian
3 Participants4 Participants7 Participants
Race (NIH/OMB)
Black or African American
77 Participants71 Participants148 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
21 Participants16 Participants37 Participants
Race (NIH/OMB)
White
319 Participants335 Participants654 Participants
Region of Enrollment
United States
423 Number of participants428 Number of participants851 Number of participants
Sex: Female, Male
Female
173 Participants179 Participants352 Participants
Sex: Female, Male
Male
250 Participants249 Participants499 Participants
Study Site
Brigham and Women's Hospital
226 Participants228 Participants454 Participants
Study Site
Vanderbilt University Hospital
197 Participants200 Participants397 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 4280 / 423
other
Total, other adverse events
0 / 4280 / 423
serious
Total, serious adverse events
0 / 4280 / 423

Outcome results

Primary

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

Number of clinically important medication errors per patient

Time frame: Measured at Day 30

ArmMeasureValue (MEAN)Dispersion
ControlNumber of Serious Medication Errors as Determined by Interview and Medical Chart Review0.95 serious medication errorsStandard Deviation 1.36
InterventionNumber of Serious Medication Errors as Determined by Interview and Medical Chart Review0.87 serious medication errorsStandard Deviation 1.18
95% CI: [0.77, 1.09]
Secondary

Number of Participants With Unplanned Hospitalizations and Emergency Department Visits

Unplanned hospitalizations and Emergency Department visits

Time frame: Measured at Day 30

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Unplanned Hospitalizations and Emergency Department VisitsHospital readmission66 Participants
ControlNumber of Participants With Unplanned Hospitalizations and Emergency Department VisitsNo readmission362 Participants
InterventionNumber of Participants With Unplanned Hospitalizations and Emergency Department VisitsHospital readmission61 Participants
InterventionNumber of Participants With Unplanned Hospitalizations and Emergency Department VisitsNo readmission362 Participants
95% CI: [0.63, 1.28]

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026