Ho 2013.
| Methods | Multi‐centre randomised trial | |
| Participants | 253 participants with acute coronary syndrome (ACS) (intervention 129; control 124) 4 Veterans Affairs (VA) medical centres USA Year of study: July 2010 to March 2013. |
|
| Interventions | The intervention comprised four components: 1. Quote "Medication reconciliation: Within 7 to 10 days of hospital discharge, a pharmacist met/phoned patients to address medication problems or adverse effects and reconcile differences in medications between the pre‐hospital and post‐discharge regimens.The pharmacist also provided patients with a pill box for those who did not have one and instructed the patient on how to fill the pill box. 1 month later, the pharmacist called the patient to assess any interim new medications as well as adverse effects to medications and/or adherence issues, and synchronised refill dates of cardiac medications. The pharmacist answered any other questions related to medications, emphasising the importance of continuing to take medications as prescribed. 2. Patient Education: At 1 week and 1 month post‐discharge visit and thereafter by automated voice messages and telephone calls a pharmacist provided education about their medicines when requested by the patient. 3. Collaborative Care: The pharmacist notified the patient’s primary care clinician and/or cardiologist (if the patient had one) that the patient was enrolled in the adherence intervention by having them co‐sign the pharmacists’ initial enrolment note in the computerised medical record. 4. VoiceMessaging: The voice messaging system contacted patients regularly with medication reminders (monthly) and medication refill reminders (timed to refill due dates)" Duration: 12 months |
|
| Outcomes | % achieving target blood pressure Systolic blood pressure (BP) Diastolic BP Mean Low Density Lipoprotein cholesterol |
|
| Notes | Funding source: This study was funded by a Veterans Health Administration Health Service Research & Development (HSR&D) Investigator Initiated Award (grant IIR 08‐302). Dr Bosworth was supported by a senior career scientist award (Research Career Scientist Award VA HSR&D 08‐027). Conflict of interest: The funding agency had no role in design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Eligible patients with ACS were randomised using blocked randomisation stratified by study site in a 1:1 ratio to intervention or usual care. |
| 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 of participants and personnel (performance bias) All Outcomes/Outcome 1 | Unclear 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 of outcome assessment (detection bias) All Outcomes/Outcome 1 | Low risk | Quote: "3 BP measurements were taken in standard fashion by someone blinded to study group assignment". |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was performed. Between group attrition < 10%. |
| Selective reporting (reporting bias) | Low risk | Main results reported |
| Other bias | Low risk | None |