Clinical trial NCT00714935: Shared Decision-making: Effects on Cardiac Risk Factor Modification Behavior
Official title: Effects of a Decision Aid for Patients With Coronary Artery Disease on Cardiac Risk Factor Modification Behavior and Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Decision Making
Keywords: Risk Factors
Risk Reduction Behavior
Counseling
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: As above

Eligibility criteria: 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

Primary outcomes:
measure: Health Related Quality of Life
timeFrame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
measure: Health outcomes (angina symptoms, body weight, cholesterol level, blood pressure, health service use)
timeFrame: Repeated measures prior to patients angiogram and 2, 4, and 6 months after angiogram
Secondary outcomes:
measure: Intermediate outcome: adherence to cardiac risk factor modification behavior
timeFrame: Repeated measure 2, 4, and 6 months after angiogram
measure: 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
timeFrame: Prior to patients angiogram, and 2 months following angiogram
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet,
city: Oslo
country: Norway
facility: Rikshospitalet HF University Hospital, Cardiac Outpatient Clinic
Study officials:
affiliation: Oslo University Hospital
name: Cornelia M Ruland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. University of Oslo, 2012