The Impact of Patient Involvement in Decision-Making About Heart Disease Prevention

Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00315978

Enrollment

120

Registered

2006-04-19

Start date

2003-06-30

Completion date

2004-02-29

Last updated

2007-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Risk Assessment, Decision Support Technique, Physician-Patient Relations, Prevention and Control

Brief summary

The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.

Detailed description

Background: Low utilization of effective CHD prevention strategies may be due to many factors, but chief among them is the lack of patient involvement in prevention decisions. We undertook this study to test the effectiveness of an individually-tailored, computerized decision aid about CHD on patients' discussions with their doctor and their plans for CHD prevention. Methods: We conducted a pilot randomized trial in a convenience sample of adults with no previous history of cardiovascular disease to test the effectiveness of an individually-tailored, computerized decision aid about CHD prevention against a risk factor list that patients could present to their doctor.

Interventions

DEVICEHeart-to-Heart Decision Aid

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* presenting for routine medical care with regular medical provider * able to understand, speak, and read English

Exclusion criteria

* prior history of cardiovascular disease * history of serious medical illness that would limit candidacy for screening * previous participation in intensive risk modification as part of diabetes study in our clinic * no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate

Design outcomes

Primary

Measure	Time frame
Discussion with provider about CHD risk reduction	—
Stated plans for CHD risk reduction	—

Secondary

Measure	Time frame
Knowledge about CHD prevention	—
Perception of CHD risk	—
Interest in participating in decision-making	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026