Trial Outcomes & Findings for HMO Research Network CERT: Acute Myocardial Infarction (NCT NCT00211172)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

836 participants

Primary outcome timeframe

9 months

Results posted on

2014-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual care patients were not contacted by the study.	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).
Overall Study STARTED	449	458
Overall Study COMPLETED	410	426
Overall Study NOT COMPLETED	39	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Usual care patients were not contacted by the study.	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).
Overall Study Died or lost health plan eligibility	39	32

Baseline Characteristics

HMO Research Network CERT: Acute Myocardial Infarction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=449 Participants Usual care patients were not contacted by the study.	Reminder Mailing n=458 Participants 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).	Total n=907 Participants Total of all reporting groups
Age, Continuous Between 18 and 65 years	53.72 years STANDARD_DEVIATION 6.98 • n=5 Participants	53.50 years STANDARD_DEVIATION 7.68 • n=7 Participants	53.61 years STANDARD_DEVIATION 14.66 • n=5 Participants
Age, Continuous >=65 years	76.58 years STANDARD_DEVIATION 7.21 • n=5 Participants	77.64 years STANDARD_DEVIATION 7.41 • n=7 Participants	77.11 years STANDARD_DEVIATION 14.62 • n=5 Participants
Age, Continuous	65.13 years STANDARD_DEVIATION 13.46 • n=5 Participants	64.78 years STANDARD_DEVIATION 14.22 • n=7 Participants	64.95 years STANDARD_DEVIATION 27.68 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants	143 Participants n=7 Participants	296 Participants n=5 Participants
Sex: Female, Male Male	296 Participants n=5 Participants	315 Participants n=7 Participants	611 Participants n=5 Participants
Region of Enrollment United States	449 participants n=5 Participants	458 participants n=7 Participants	907 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Usual Care n=410 Participants Usual care patients were not contacted by the study.	Reminder Mailing n=426 Participants 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).
Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date	66.37 Adjusted monthly % of days covered Standard Deviation 34.25	70.62 Adjusted monthly % of days covered Standard Deviation 32.03

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reminder Mailing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David H. Smith

Kaiser Permanente Center for Heatlh Research

Phone: 503-335-6302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place