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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL089755 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Unplanned hospitalizations and Emergency Department visits | Measured at Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Kripalani, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Jeffrey L. Schnipper, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Vanderbilt University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20233982 | Background | 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. | |
| 22751755 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Usual Care) | Control (usual care) arm |
| FG001 | Intervention | Intervention arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Nashville |
| Tennessee |
| 37232 |
| United States |
| 26883526 | Derived | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Usual Care) | Control (usual care) arm |
| BG001 | Intervention | Intervention arm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Number of participants |
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| Study Site | Count of Participants | Participants |
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| Health literacy (sTOFHLA score) | Short Test of Functional Health Literacy in Adults | Count of Participants | Participants |
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| Language | Count of Participants | Participants |
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| Education | Median | Inter-Quartile Range | years |
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| Income | Count of Participants | Participants |
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| Cognition (Mini cog score) | Count of Participants | Participants |
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| Has primary care provider | Count of Participants | Participants |
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| Number of pre-admission medications | Median | Inter-Quartile Range | Medications |
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| Comorbidities | Number | participants |
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| Marital status | Count of Participants | Participants |
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| Insurance status | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Serious Medication Errors as Determined by Interview and Medical Chart Review | Number of clinically important medication errors per patient | Posted | Mean | Standard Deviation | serious medication errors | Measured at Day 30 |
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| Secondary | Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Unplanned hospitalizations and Emergency Department visits | Posted | Count of Participants | Participants | Measured at Day 30 |
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30 days
Any adverse events related to study participation were collected by researchers and reported to the IRB appropriately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Control (Usual Care) | Control (usual care) arm | 0 | 428 | 0 | 428 | 0 | 428 |
| EG001 | Intervention | Intervention arm | 0 | 423 | 0 | 423 | 0 | 423 |
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| Title | Organization | Phone | Extension | |
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| Research Coordinator | Vanderbilt University Medical Center | 6159364819 | Kathryn.m.goggins@vanderbilt.edu |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
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| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Brigham and Women's Hospital |
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| Marginal |
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| Adequate |
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| Missing |
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| Spanish |
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| 10K to <15K |
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| 15K to <20K |
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| 20K to <25K |
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| 25K to <35K |
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| 35K to <50K |
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| 50K to <75K |
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| 75K+ |
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| Missing |
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| Not impaired |
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| Missing |
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| No |
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| Hypertension |
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| Hypercholesterolemia |
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| Coronary artery disease |
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| Prior myocardial infarction |
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| Prior stroke or cerebrovascular event |
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| Prior coronary revascularization procedure |
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| Single/living alone |
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| Medicaid |
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| Commercial |
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| Self-pay/other |
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