HMO Research Network CERT: Acute Myocardial Infarction

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT00211172
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 836
• Locations: 4
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 209
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocardial Infarction (AMI)	Behavioral: Beta-blocker adherence after an AMI	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 836 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: The HMO Research Network CERT: Acute Myocardial Infarction
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Dec 1, 2005
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Beta-blocker adherence after an AMI Patients received two mailings about the importance of beta blocker use.	Behavioral: Beta-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.; Other Names: Reminder mailing
No Intervention: Usual care Patients received usual care.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente-Georgia	Atlanta	Georgia	United States	30305
2	Harvard Pilgrim Healthcare	Boston	Massachusetts	United States	02115
3	Health Partners	Minneapolis	Minnesota	United States	55440-1309
4	Kaiser Permanent Center for Health Research	Portland	Oregon	United States	97227

Sponsors and Collaborators

• Kaiser Permanente
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: David H Smith, PhD, Kaiser Permanent Center for Health Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT00211172
• Other Study ID Numbers: 2 U18 HS01391-04
• First Posted: Sep 21, 2005
• Last Update Posted: Oct 9, 2014
• Last Verified: Jul 1, 2011

• Keywords provided by Kaiser Permanente: Acute Myocardial Infarction (AMI); Heart Attack; Adherence; Beta-blocker; Behavior change
• Additional relevant MeSH terms: Myocardial Infarction; Infarction; Adrenergic beta-Antagonists

Study Results

Participant Flow

Arm/Group Title	Usual Care	Reminder Mailing
Arm/Group Description	Usual care patients were not contacted by the study.	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).
Period Title: Overall Study
STARTED	449	458
COMPLETED	410	426
NOT COMPLETED	39	32

Baseline Characteristics

Arm/Group Title	Usual Care	Reminder Mailing	Total
Arm/Group Description	Usual care patients were not contacted by the study.	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 of all reporting groups
Overall Participants	449	458	907
Age (years) [Mean (Standard Deviation) ]
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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.13 (13.46)	64.78 (14.22)	64.95 (27.68)
Sex: Female, Male (Count of Participants)
Female	153 34.1%	143 31.2%	296 32.6%
Male	296 65.9%	315 68.8%	611 67.4%
Region of Enrollment (participants) [Number]
United States	449 100%	458 100%	907 100%

Outcome Measures

1. Primary Outcome

Title	Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Reminder Mailing
Arm/Group Description	Usual care patients were not contacted by the study.	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).
Measure Participants	410	426
Mean (Standard Deviation) [Adjusted monthly % of days covered]	66.37 (34.25)	70.62 (32.03)

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected
Arm/Group Title	Usual Care		Reminder Mailing
Arm/Group Description	Usual care patients were not contacted by the study.		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).
All Cause Mortality
	Usual Care		Reminder Mailing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		Reminder Mailing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Usual Care		Reminder Mailing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.