Optimizing Expectations in Cardiac Surgery Patients

Philipps University

Status and phase: Completed; Phase 2

Conditions: Coronary Heart Disease; Coronary Artery Bypass Graft Surgery (CABG); Patients' Expectations

Treatments: Behavioral: Expectation Manipulation Intervention; Behavioral: Supportive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01407055

DFG RI574/21-1

Details and patient eligibility

About

The purpose of this study is to evaluate the potential benefit of targeting patients' expectations before coronary artery bypass graft surgery through a brief psychoeducational intervention.

Full description

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention.It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient's expectation. Targeting patients' expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients' outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group ("supportive therapy"). The main goal is to enhance positive expectations (surgery 'non-specific effects') about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient's expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients' expectations.

Enrollment: 124 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled on the elective waiting list for first time coronary artery bypass graft surgery wiht the use of heart-lung-apparatus at the Department of Cardiovascular Surgery, Medical School, University of Marburg
• Sufficient knowledge of German language
• Ability to give informed consent

Exclusion criteria

• Emergency surgery
• Presence of a serious comorbid psychiatric condition
• Presence of a life threatening comorbid medical condition
• Current participation in other research

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

124 participants in 3 patient groups

Standard Medical Care

No Intervention group

Description:

Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery

Attention Control Group

Active Comparator group

Description:

In addition to standard medical care patients receive a comparable amount of therapist´s attention (common and unspecific factors = supportive therapy) to the intervention group, without targeting patients' expectations.

Treatment:

Behavioral: Supportive Therapy

Expectation Manipulation Intervention

Experimental group

Description:

In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention.

Treatment:

Behavioral: Expectation Manipulation Intervention