NCT00211172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
836

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

October 9, 2014

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Results QC Date

August 5, 2009

Last Update Submit

October 7, 2014

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Acute Myocardial Infarction (AMI)Heart AttackAdherenceBeta-blockerBehavior change

Outcome Measures

Primary Outcomes (1)

  • 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

    9 months

Study Arms (2)

Beta-blocker adherence after an AMI

EXPERIMENTAL

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

Behavioral: Beta-blocker adherence after an AMI

Usual care

NO INTERVENTION

Patients received usual care.

Interventions

Beta-blocker adherence after an AMIBEHAVIORAL

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.

Also known as: Reminder mailing
Beta-blocker adherence after an AMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kaiser Permanente-Georgia

Atlanta, Georgia, 30305, United States

Location

Harvard Pilgrim Healthcare

Boston, Massachusetts, 02115, United States

Location

Health Partners

Minneapolis, Minnesota, 55440-1309, United States

Location

Kaiser Permanent Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (1)

  • 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.

    PMID: 18332291RESULT

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Results Point of Contact

Title
David H. Smith
Organization
Kaiser Permanente Center for Heatlh Research
david.h.smith@kpchr.org
503-335-6302

Study Officials

  • David H Smith, PhD

    Kaiser Permanent Center for Health Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2003

Primary Completion

December 1, 2005

Study Completion

May 1, 2009

Last Updated

October 9, 2014

Results First Posted

October 9, 2014

Record last verified: 2011-07

Locations

US(4)