Ho 2014.
Study characteristics | ||
Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: 2‐sided confidence interval Open‐label not reported |
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Participants | N recruited = 253 patients N randomised = 253 participants (124 control, 129 intervention) N reported outcomes = 241 participants) (119 control, 122 intervention) Mean age 64 yrs, 98% men INCLUSION CRITERIA "Patients admitted with ACS as the primary reason for hospital admission and used the VA for their usual care" EXCLUSION CRITERIA “1) patients admitted for primary non‐cardiac diagnosis who developed ACS as a secondary condition 2) planned discharge to nursing home or skilled nursing facility 3) irreversible, noncardiac medical condition likely to affect 6‐month survival or inability to execute study protocol 4) lack of telephone or cell phone 5) VA not a primary source of care in the future 6) fill medications at non‐VA pharmacy 7) pregnancy” COUNTRY/SETTING: 4 Department of Veterans Affairs (VA) medical centers (Denver, Colorado; Little Rock, Arkansas; Seattle,Washington; and Durham, NorthCarolina), USA STUDY PERIOD: "Recruitment began July 1, 2010, in Denver and Seattle; September 1, 2010, in LittleRock; and July 1, 2011, in Durham." |
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Interventions | Number of study centres: 4 “Department of Veterans Affairs medical centers located in Denver (CO), Seattle (WA), Durham (NC), and Little Rock (AK)” INTERVENTION GROUP “standard ACS hospital discharge instructions, a discharge medication list, and educational information about cardiac medications” and “1) pharmacist‐led medication reconciliation and tailoring, 2) patient education, 3) collaborative care between pharmacist and a patient’s primary care clinician and/or cardiologist, and 4) 2 types of voice messaging (educational and medication refill reminder calls)” CONTROL GROUP “standard ACS hospital discharge instructions, a discharge medication list, and educational information about cardiac medications” |
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Outcomes | TIME OF OUTCOME MEASUREMENTS: 12‐month clinic visit PRIMARY OUTCOMES: “Proportion of patients adherent to medication regimens based on a mean proportion of days covered (PDC) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications (clopidogrel, B‐blockers, statins, and ACEI/ARB)” SECONDARY OUTCOMES: “Proportion of patients reaching blood pressure goals (<140/90mmHg) and LDL‐C goals (<100mg/dL) at 12 months” |
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Notes | Commercial funding/non‐commercial funding/other funding: “This study was funded by a Veterans Health Administration Health Service Research & Development Investigator Initiated Award. Dr. Bosworth was supported by a senior career scientist award.” Stated aim for study: “To test a multifaceted intervention to improve adherence to cardiac medications” |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Eligible patients with ACS were randomized using blocked randomization stratified by study site in a 1:1 ratio to INT or UC” |
Allocation concealment (selection bias) | Low risk | “The allocation sequence was concealed until a patient consented to participate and was generated centrally using the graphical user interface implemented for the study” |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Of 253 patients, 241 (95.3%) completed the study (122 in INT and 119 in UC)" |
Selective reporting (reporting bias) | Low risk | All outcomes reported |