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HMO Research Network CERT: Acute Myocardial Infarction

Primary Purpose

Acute Myocardial Infarction (AMI)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beta-blocker adherence after an AMI
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction (AMI) focused on measuring Acute Myocardial Infarction (AMI), Heart Attack, Adherence, Beta-blocker, Behavior change

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente-Georgia
  • Harvard Pilgrim Healthcare
  • Health Partners
  • Kaiser Permanent Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Beta-blocker adherence after an AMI

Usual care

Arm Description

Patients received two mailings about the importance of beta blocker use.

Patients received usual care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
October 7, 2014
Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00211172
Brief Title
HMO Research Network CERT: Acute Myocardial Infarction
Official Title
The HMO Research Network CERT: Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Specific Aims: 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction (AMI)
Keywords
Acute Myocardial Infarction (AMI), Heart Attack, Adherence, Beta-blocker, Behavior change

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
836 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beta-blocker adherence after an AMI
Arm Type
Experimental
Arm Description
Patients received two mailings about the importance of beta blocker use.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients received usual care.
Intervention Type
Behavioral
Intervention Name(s)
Beta-blocker adherence after an AMI
Other Intervention Name(s)
Reminder mailing
Intervention Description
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.
Primary Outcome Measure Information:
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Smith, PhD
Organizational Affiliation
Kaiser Permanent Center for Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente-Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30305
Country
United States
Facility Name
Harvard Pilgrim Healthcare
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Health Partners
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55440-1309
Country
United States
Facility Name
Kaiser Permanent Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18332291
Citation
Smith DH, Kramer JM, Perrin N, Platt R, Roblin DW, Lane K, Goodman M, Nelson WW, Yang X, Soumerai SB. A randomized trial of direct-to-patient communication to enhance adherence to beta-blocker therapy following myocardial infarction. Arch Intern Med. 2008 Mar 10;168(5):477-83; discussion 483; quiz 447. doi: 10.1001/archinternmed.2007.132.
Results Reference
result

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HMO Research Network CERT: Acute Myocardial Infarction

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