Shared Decision-Making: Effects on Cardiac Risk Factor Modification Behavior
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Purpose
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
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Decision Making |
Behavioral: Decision Counseling Program (DCP) Behavioral: Coronary Artery Disease Decision Aid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes |
- Health Related Quality of Life [ Time Frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram ] [ Designated as safety issue: No ]
- Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use) [ Time Frame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram ] [ Designated as safety issue: No ]
- Intermediate outcome: adherence to cardiac risk factor modification behavior [ Time Frame: Repeated measure 2, 4, and 6 months after angiogram ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Prior to patients angiogram, and 2 months following angiogram ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 360 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 3
Decision Counseling Program(DCP) combined with Coronary Artery Disease Decision Aid (CAD-DA) described in Arm 2
|
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
Behavioral: 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. |
| No Intervention: 1 | |
|
Experimental: 2
Behavioral: 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. |
Behavioral: 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. |
Detailed Description:
As above
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Cornelia M Ruland, PhD | +47-2307-5460 | cornelia.ruland@rr-research.no |
| Contact: Liv Wensaas, RN, MNSc | +47-9177-4995 | liv.wensaas@rr-research.no |
| Norway | |
| Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic | Recruiting |
| Oslo, Norway | |
More Information
No publications provided
| Responsible Party: | Cornelia M. Ruland, professor, Rikshospitalet HF |
| ClinicalTrials.gov Identifier: | NCT00714935 History of Changes |
| Other Study ID Numbers: | S-07207a |
| Study First Received: | July 10, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
Risk Factors Risk Reduction Behavior Counseling |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013