HMO Research Network CERT: Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Kaiser Permanente.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00211172
First received: September 13, 2005
Last updated: February 24, 2009
Last verified: September 2005

September 13, 2005
February 24, 2009
October 2003
December 2005   (final data collection date for primary outcome measure)
Medication Adherence, measured by proportion of days covered and medication discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Medication Adherence, measured by proportion of days covered and medication discontinuation
Complete list of historical versions of study NCT00211172 on ClinicalTrials.gov Archive Site
Healthcare utilization and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Healthcare utilization and mortality
Not Provided
Not Provided
 
HMO Research Network CERT: Acute Myocardial Infarction
The HMO Research Network CERT: Acute Myocardial Infarction

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 (heart attack).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an 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:

  1. Assess the persistence of beta blocker use for post-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 MI, 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 HMOs.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Acute Myocardial Infarction
Behavioral: Beta-blocker adherence following a myocardial infarction
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.
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
907
September 2010
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

Clinical diagnosis of Acute Myocardial Infarction (AMI) from 12/1/03 to 5/31/04 and beta-blocker dispensing following AMI and prior to intervention date.

Exclusion Criteria:

None

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211172
2 U18 HS01391-04
Not Provided
David Smith, Kaiser Permanente Center for Health Research
Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: David H Smith, PhD Kaiser Permanent Center for Health Research
Kaiser Permanente
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP