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

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00632021
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 862
• Locations: 2
• Arms: 2
• Duration (Months): 46
• Patients Per Site: 431
• Patients Per Site Per Month: 9.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; Heart Failure	Behavioral: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 862 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Pharmacist Intervention for Low-Literacy in Cardiovascular Disease
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Number of Serious Medication Errors as Determined by Interview and Medical Chart Review [Measured at Day 30]

   Number of clinically important medication errors per patient

Secondary Outcome Measures

1. Number of Participants With Unplanned Hospitalizations and Emergency Department Visits [Measured at Day 30]

   Unplanned hospitalizations and Emergency Department visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Sunil Kripalani, MD, MSc, Vanderbilt University Medical Center
• Principal Investigator: Jeffrey L. Schnipper, MD, MPH, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Sunil Kripalani, Associate Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00632021
• Other Study ID Numbers: 539; R01HL089755
• First Posted: Mar 10, 2008
• Last Update Posted: Sep 1, 2017
• Last Verified: Aug 1, 2017

• Keywords provided by Sunil Kripalani, Associate Professor, Vanderbilt University Medical Center: Low Health Literacy; Medication Errors; Cardiovascular Disease; Pharmacist; Care Transition
• Additional relevant MeSH terms: Acute Coronary Syndrome

Study Results

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 Detail	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.

Arm/Group Title	Control (Usual Care)	Intervention
Arm/Group Description	Control (usual care) arm	Intervention arm
Period Title: Overall Study
STARTED	432	430
COMPLETED	428	423
NOT COMPLETED	4	7

Baseline Characteristics

Arm/Group Title	Control (Usual Care)	Intervention	Total
Arm/Group Description	Control (usual care) arm	Intervention arm	Total of all reporting groups
Overall Participants	428	423	851
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (14)	61 (14)	60 (14)
Sex: Female, Male (Count of Participants)
Female	179 41.8%	173 40.9%	352 41.4%
Male	249 58.2%	250 59.1%	499 58.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%	3 0.7%	4 0.5%
Asian	4 0.9%	3 0.7%	7 0.8%
Native Hawaiian or Other Pacific Islander	1 0.2%	0 0%	1 0.1%
Black or African American	71 16.6%	77 18.2%	148 17.4%
White	335 78.3%	319 75.4%	654 76.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	16 3.7%	21 5%	37 4.3%
Region of Enrollment (Number of participants) [Number]
United States	428 100%	423 100%	851 100%
Study Site (Count of Participants)
Vanderbilt University Hospital	200 46.7%	197 46.6%	397 46.7%
Brigham and Women's Hospital	228 53.3%	226 53.4%	454 53.3%
Health literacy (sTOFHLA score) (Count of Participants)
Inadequate	39 9.1%	47 11.1%	86 10.1%
Marginal	38 8.9%	36 8.5%	74 8.7%
Adequate	340 79.4%	331 78.3%	671 78.8%
Missing	11 2.6%	9 2.1%	20 2.4%
Language (Count of Participants)
English	425 99.3%	414 97.9%	839 98.6%
Spanish	3 0.7%	9 2.1%	12 1.4%
Education (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	14	14	14
Income (Count of Participants)
<10K	17 4%	20 4.7%	37 4.3%
10K to <15K	24 5.6%	21 5%	45 5.3%
15K to <20K	19 4.4%	23 5.4%	42 4.9%
20K to <25K	47 11%	56 13.2%	103 12.1%
25K to <35K	49 11.4%	49 11.6%	98 11.5%
35K to <50K	56 13.1%	54 12.8%	110 12.9%
50K to <75K	60 14%	58 13.7%	118 13.9%
75K+	119 27.8%	105 24.8%	224 26.3%
Missing	37 8.6%	37 8.7%	74 8.7%
Cognition (Mini cog score) (Count of Participants)
Impaired	46 10.7%	52 12.3%	98 11.5%
Not impaired	380 88.8%	371 87.7%	751 88.2%
Missing	2 0.5%	0 0%	2 0.2%
Has primary care provider (Count of Participants)
Yes	392 91.6%	386 91.3%	778 91.4%
No	36 8.4%	37 8.7%	73 8.6%
Number of pre-admission medications (Medications) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Medications]	7	8	8
Comorbidities (participants) [Number]
Diabetes	195 45.6%	140 33.1%	335 39.4%
Hypertension	296 69.2%	306 72.3%	602 70.7%
Hypercholesterolemia	236 55.1%	234 55.3%	470 55.2%
Coronary artery disease	211 49.3%	225 53.2%	436 51.2%
Prior myocardial infarction	73 17.1%	100 23.6%	173 20.3%
Prior stroke or cerebrovascular event	41 9.6%	30 7.1%	71 8.3%
Prior coronary revascularization procedure	195 45.6%	203 48%	398 46.8%
Marital status (Count of Participants)
Married/cohabitating	256 59.8%	226 53.4%	482 56.6%
Single/living alone	172 40.2%	197 46.6%	369 43.4%
Insurance status (Count of Participants)
Medicare	162 37.9%	177 41.8%	339 39.8%
Medicaid	37 8.6%	44 10.4%	81 9.5%
Commercial	203 47.4%	167 39.5%	370 43.5%
Self-pay/other	26 6.1%	35 8.3%	61 7.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	Control (usual care) arm	Intervention arm
Measure Participants	428	423
Mean (Standard Deviation) [serious medication errors]	0.95 (1.36)	0.87 (1.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Equivalence
	Comments	In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Incidence Rate Ratio (IRR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
Description	Unplanned hospitalizations and Emergency Department visits
Time Frame	Measured at Day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Usual Care)	Intervention
Arm/Group Description	Control (usual care) arm	Intervention arm
Measure Participants	428	423
Hospital readmission	66 15.4%	61 14.4%
No readmission	362 84.6%	362 85.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Intervention
	Comments
	Type of Statistical Test	Equivalence
	Comments	The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cox Proportional Hazard
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.63 to 1.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Any adverse events related to study participation were collected by researchers and reported to the IRB appropriately.
Arm/Group Title	Control (Usual Care)		Intervention
Arm/Group Description	Control (usual care) arm		Intervention arm
All Cause Mortality
	Control (Usual Care)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/428 (0%)		0/423 (0%)
Serious Adverse Events
	Control (Usual Care)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/428 (0%)		0/423 (0%)
Other (Not Including Serious) Adverse Events
	Control (Usual Care)		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/428 (0%)		0/423 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.