Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior

Coronary Artery Disease Clinical Trial

Official title:

Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714935
• Other study ID #: S-07207a
• Status: Completed
• Phase: N/A
• First received: July 10, 2008
• Last updated: November 3, 2015
• Start date: April 2008
• Est. completion date: March 2010

Study information

• Verified date: November 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Decision Aids (DA) to inform patients about health care options and help them to participate in their care choices are widely advocated. The main argument for offering patients a choice is that patients' preferences vary, and health professionals cannot always know what is "best" for an individual, specially when different outcomes have different benefits and risk profiles. The standard modes of treatment for patients with coronary artery disease (CAD) are coronary artery bypass graft (CABG) surgery, medication, and angioplasty. All three treatments for CAD work better when combined with cardiac risk factor modification behavior (CRFMB). CRFMB is important for the general public, but it is even more important for people with CAD because people with CAD have more at stake. In this RCT study we will evaluate the effectiveness of a CAD-DA with and witout an additional decision counseling program (DCP) on health outcomes and quality of life to improve enhancement of adherence to cardiac risk modification behavior. The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, for CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors. It provides patients with information about what they can you do to prevent the disease from progressing. The DCP is designed to systematically guide patients through the process of deciding what cardiac risk modification behaviors are important for them to carry out. A RCT where 360 CAD patients > 18 of age scheduled for an angiogram at Rikshospitalet University Hospital in Norway (RH) will be randomly assigned to: (1) CAD-DA group where subjects will receive, for take home, the CAD-DA prior to their scheduled angiogram; (2) DCP group where subjects in addition to the CAD-DA will receive an individual decisional counseling program (DCP) from a trained nurse counselor in their homes prior to their angiogram; and (3) the control group who will receive "usual care". Data will be collected at four points: at the initial visit (T1), 2 months (T2), 4 months (T3) and 6 (T4) months after angiogram

Description:

As above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: March 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Scheduled for an angiogram

• Able to read, write, and speak Norwegian

• Live within approximately 100 km of Oslo

• Have a telephone

Exclusion Criteria:

• Cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Decision Making
• Myocardial Ischemia

Intervention

Behavioral:
• Decision Counseling Program (DCP)
An individual decisional counseling program (DCP) to help them comprehend the information, adjust this information to their personal illness history and elicit their preferences for cardiac risk fctor modification behavior in light of this personalized information
• Coronary Artery Disease Decision Aid
Coronary Artery Disease Decision Aid (CAD-DA) presented as a booklet called: "Making Choices: Life Changes to Lower Your Risk of Heart Disease and Stroke" The CAD-DA is developed by the Ottawa Health Research Institute and Division of Clinical Epidemiology at Montreal General Hospital, in CAD patients facing the decision of making lifestyle changes to lower their cardiac risk factors and provides patients with information about what they can you do to prevent the disease from progressing.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet,	Oslo
Norway	Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Wensaas L. Effects of a decision aid with and without additional decisional counseling for patients being examined for coronary artery disease on cardiac risk reduction behavior and health outcomes : A randomized controlled trial. Doctoral thesis. Univers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life		Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram	No
Primary	Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)		Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram	No
Secondary	Intermediate outcome: adherence to cardiac risk factor modification behavior		Repeated measure 2, 4, and 6 months after angiogram	No
Secondary	Mediating variables: knowledge, decisional conflict, intention to adhere to cardiac risk factor modification behavior, perceived susceptibility and severity of CAD progression, and benefits and barriers of cardiac risk factor modification behavior		Prior to patients angiogram, and 2 months following angiogram	No

External Links

•   Wensaas L. Doctoral thesis. University of Oslo