Acute Coronary Syndrome, Heart Failure
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Measured at Day 30 | Unplanned 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
| Arm | Count |
|---|---|
| Control (Usual Care) Control (usual care) arm | 428 |
| Intervention Intervention arm | 423 |
| Total | 851 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal/death | 4 | 7 |
Baseline characteristics
| Characteristic | Intervention | Control (Usual Care) | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 14 | 60 years STANDARD_DEVIATION 14 |
| Cognition (Mini cog score) Impaired | 52 Participants | 46 Participants | 98 Participants |
| Cognition (Mini cog score) Missing | 0 Participants | 2 Participants | 2 Participants |
| Cognition (Mini cog score) Not impaired | 371 Participants | 380 Participants | 751 Participants |
| Comorbidities Coronary artery disease | 225 participants | 211 participants | 436 participants |
| Comorbidities Diabetes | 140 participants | 195 participants | 335 participants |
| Comorbidities Hypercholesterolemia | 234 participants | 236 participants | 470 participants |
| Comorbidities Hypertension | 306 participants | 296 participants | 602 participants |
| Comorbidities Prior coronary revascularization procedure | 203 participants | 195 participants | 398 participants |
| Comorbidities Prior myocardial infarction | 100 participants | 73 participants | 173 participants |
| Comorbidities Prior stroke or cerebrovascular event | 30 participants | 41 participants | 71 participants |
| Education | 14 years | 14 years | 14 years |
| Has primary care provider No | 37 Participants | 36 Participants | 73 Participants |
| Has primary care provider Yes | 386 Participants | 392 Participants | 778 Participants |
| Health literacy (sTOFHLA score) Adequate | 331 Participants | 340 Participants | 671 Participants |
| Health literacy (sTOFHLA score) Inadequate | 47 Participants | 39 Participants | 86 Participants |
| Health literacy (sTOFHLA score) Marginal | 36 Participants | 38 Participants | 74 Participants |
| Health literacy (sTOFHLA score) Missing | 9 Participants | 11 Participants | 20 Participants |
| Income <10K | 20 Participants | 17 Participants | 37 Participants |
| Income 10K to <15K | 21 Participants | 24 Participants | 45 Participants |
| Income 15K to <20K | 23 Participants | 19 Participants | 42 Participants |
| Income 20K to <25K | 56 Participants | 47 Participants | 103 Participants |
| Income 25K to <35K | 49 Participants | 49 Participants | 98 Participants |
| Income 35K to <50K | 54 Participants | 56 Participants | 110 Participants |
| Income 50K to <75K | 58 Participants | 60 Participants | 118 Participants |
| Income 75K+ | 105 Participants | 119 Participants | 224 Participants |
| Income Missing | 37 Participants | 37 Participants | 74 Participants |
| Insurance status Commercial | 167 Participants | 203 Participants | 370 Participants |
| Insurance status Medicaid | 44 Participants | 37 Participants | 81 Participants |
| Insurance status Medicare | 177 Participants | 162 Participants | 339 Participants |
| Insurance status Self-pay/other | 35 Participants | 26 Participants | 61 Participants |
| Language English | 414 Participants | 425 Participants | 839 Participants |
| Language Spanish | 9 Participants | 3 Participants | 12 Participants |
| Marital status Married/cohabitating | 226 Participants | 256 Participants | 482 Participants |
| Marital status Single/living alone | 197 Participants | 172 Participants | 369 Participants |
| Number of pre-admission medications | 8 Medications | 7 Medications | 8 Medications |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 71 Participants | 148 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 16 Participants | 37 Participants |
| Race (NIH/OMB) White | 319 Participants | 335 Participants | 654 Participants |
| Region of Enrollment United States | 423 Number of participants | 428 Number of participants | 851 Number of participants |
| Sex: Female, Male Female | 173 Participants | 179 Participants | 352 Participants |
| Sex: Female, Male Male | 250 Participants | 249 Participants | 499 Participants |
| Study Site Brigham and Women's Hospital | 226 Participants | 228 Participants | 454 Participants |
| Study Site Vanderbilt University Hospital | 197 Participants | 200 Participants | 397 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 428 | 0 / 423 |
| other Total, other adverse events | 0 / 428 | 0 / 423 |
| serious Total, serious adverse events | 0 / 428 | 0 / 423 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Number of Serious Medication Errors as Determined by Interview and Medical Chart Review | 0.95 serious medication errors | Standard Deviation 1.36 |
| Intervention | Number of Serious Medication Errors as Determined by Interview and Medical Chart Review | 0.87 serious medication errors | Standard Deviation 1.18 |
Number of Participants With Unplanned Hospitalizations and Emergency Department Visits
Unplanned hospitalizations and Emergency Department visits
Time frame: Measured at Day 30
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Hospital readmission | 66 Participants |
| Control | Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | No readmission | 362 Participants |
| Intervention | Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | Hospital readmission | 61 Participants |
| Intervention | Number of Participants With Unplanned Hospitalizations and Emergency Department Visits | No readmission | 362 Participants |