An interventional study of Beta-blocker adherence after an AMI in Acute Myocardial Infarction (AMI), sponsored by Kaiser Permanente. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-09.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research
The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (AMI).
Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (AMI) to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were "pre-tested" with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.
Specific Aims:
Research Design and Methods:
We will conduct a randomized controlled trial within the 4 participating HMOs (Kaiser Permanente Northwest, Harvard Pilgrim Health Care, Health Partners, and Kaiser Permanente Georgia). Inpatient data will be used to identify patients with a primary discharge diagnosis of AMI 4-6 months before the extraction date. Practices will be block-randomized to the intervention group or to usual care. To increase repetition of the message, there will be two personalized mailings, occurring at 4-6 months post AMI, and at 9 months. The first message will include elements in the table below, and the repeat message will be shorter, but include similar information. The message will come from the patient's own health plan with the choice of specific individual (e.g. quality assurance department, medical director, or Chief of Cardiology) being informed by our qualitative work. This intervention will be done in collaboration with the cardiovascular care committees and quality assurance departments of participating Health Maintenance Organizations (HMOs).
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 836 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
None
Patients received two mailings about the importance of beta blocker use.
Behavioral: Beta-blocker adherence after an AMI
Patients received usual care.
The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries.
Also known as: Reminder mailing
Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date
The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription
Time frame: 9 months
| Milestone | Usual Care | Reminder Mailing |
|---|---|---|
| Started | 449 | 458 |
| Completed | 410 | 426 |
| Not completed | 39 | 32 |
| Withdrew: Died or lost health plan eligibility | 39 | 32 |
The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription
| Adjusted monthly % of days covered | Usual Care | Reminder Mailing |
|---|---|---|
| Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date | 66.37 ± 34.25 | 70.62 ± 32.03 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | — | — | — |
| Reminder Mailing | — | — | — |
| Age, Continuous(years) | Usual Care | Reminder Mailing | Total |
|---|---|---|---|
| Between 18 and 65 years | 53.72 ± 6.98 | 53.50 ± 7.68 | 53.61 ± 14.66 |
| >=65 years | 76.58 ± 7.21 | 77.64 ± 7.41 | 77.11 ± 14.62 |
| Age, Continuous(years) | Usual Care | Reminder Mailing | Total |
|---|---|---|---|
| Mean | 65.13 ± 13.46 | 64.78 ± 14.22 | 64.95 ± 27.68 |
| Sex: Female, Male(Participants) | Usual Care | Reminder Mailing | Total |
|---|---|---|---|
| Female | 153 | 143 | 296 |
| Male | 296 | 315 | 611 |
| Region of Enrollment(participants) | Usual Care | Reminder Mailing | Total |
|---|---|---|---|
| United States | 449 | 458 | 907 |
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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