Acute Myocardial Infarction (AMI)
Conditions
Keywords
Acute Myocardial Infarction (AMI), Heart Attack, Adherence, Beta-blocker, Behavior change
Brief summary
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.
Detailed description
Specific Aims: 1. Assess the persistence of beta blocker use for post-acute myocardial infarction (AMI) patients following a direct to patient intervention designed to increase rates of evidence-based long-term use of medications (beta blockers, lipid lowering agents, aspirin and ACE inhibitors) that increase survival following AMI. 2. Describe patient and system characteristics associated with differences in impact of the intervention 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).
Interventions
BEHAVIORALBeta-blocker adherence after an AMI
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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Acute Myocardial Infarction (AMI) from 12/1/03 to 5/31/04 * Beta-blocker dispensing following AMI * Beta-blocker dispensing prior to intervention date
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date | 9 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care patients were not contacted by the study. | 449 |
| Reminder Mailing 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. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors \[ACEIs\], and aspirin). | 458 |
| Total | 907 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Died or lost health plan eligibility | 39 | 32 |
Baseline characteristics
| Characteristic | Usual Care | Reminder Mailing | Total |
|---|---|---|---|
| Age, Continuous >=65 years | 76.58 years STANDARD_DEVIATION 7.21 | 77.64 years STANDARD_DEVIATION 7.41 | 77.11 years STANDARD_DEVIATION 14.62 |
| Age, Continuous Between 18 and 65 years | 53.72 years STANDARD_DEVIATION 6.98 | 53.50 years STANDARD_DEVIATION 7.68 | 53.61 years STANDARD_DEVIATION 14.66 |
| Age, Continuous | 65.13 years STANDARD_DEVIATION 13.46 | 64.78 years STANDARD_DEVIATION 14.22 | 64.95 years STANDARD_DEVIATION 27.68 |
| Region of Enrollment United States | 449 participants | 458 participants | 907 participants |
| Sex: Female, Male Female | 153 Participants | 143 Participants | 296 Participants |
| Sex: Female, Male Male | 296 Participants | 315 Participants | 611 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date | 66.37 Adjusted monthly % of days covered | Standard Deviation 34.25 |
| Reminder Mailing | Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date | 70.62 Adjusted monthly % of days covered | Standard Deviation 32.03 |