Optimizing Expectations in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

Conditions
-----------------
Coronary Artery Bypass Graft Surgery (CABG), Patients' Expectations, Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Expectation Manipulation Intervention
* Behavioral: Supportive Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Medical Care<br>Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery | |
| Active Comparator: Attention Control Group<br>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. | Behavioral: Supportive Therapy<br>* Supportive therapy employs common factors such as elicitation of affect, reflective listening, feeling understood, but provides no explicit theoretical formulation to the patient. Supportive therapy thus provides a control condition for common factors and therapist attention but lacks the specific intervention part. It will be delivered in the same frequency and at the same time points as the Expectation Manipulation Intervention (2 individual sessions, 2 phone calls).<br>|
| Experimental: Expectation Manipulation Intervention<br>In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational intervention. | Behavioral: Expectation Manipulation Intervention<br>* The Expectation Manipulation Intervention targets patients' expectations prior to surgery (2 individual sessions, 2 phone calls). Main goal is to enhance positive outcome expectancies, as well as to improve patients' control expectations about possible side effects of the surgery and about their personal management of their coronary heart disease. Further EMI tries to correct dysfunctional beliefs about the coronary heart disease and tries to minimize fears about expected negative consequences.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI) |  | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patients' Expectations from Baseline/Pre-Intervention (expected average of 10 days before surgery) to hospital admission/Post-Intervention (expected average of 1 day before surgery). | Prospective Illness Perception 6 months after surgery (Expected Illness Perception Questionnaire; IPQ-E), Positive Health Expectation Scale (PHES), Expected Disability (PDI-E) | From 10 days before surgery untill 1 day before surgery | 
| Change in Cardiac Anxiety (Cardiac Anxiety Questionnaire; CAQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery | 
| Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery. |  | From 10 days before surgery to 6 months after surgery | 
| Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery. |  | From 10 days before surgery to 6 months after surgery | 
| Change in physical symptoms, subjective side effects and post-surgery complaints (Generic Assessment of Side Effects Scale; GASE-P)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery | 
| Change in Hospital Anxiety and Depression Scale (HADS)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. | 
| Change in Beliefs about Medications (Beliefs about Medications Questionaire; BMQ)from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. | 
| Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery. |  | From 10 days before surgery to 6 months after surgery. | 
| Satisfaction wiht the intervention. |  | Expected average of 1 day before surgery (but after the intervention). | 
| Cardiothoracic surgeons' rating of the surgery success |  | Expected average of 1 day after surgery | 
| Additional treatments during follow-up | Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc. | 6 months after surgery | 
| Blinded Expert Rating of medical and psychological status at follow-up |  | 6 months after surgery | 
| Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. | 
| Change in neuroendocrine and immunological measures from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. | cortisol, inflammatory processes, catecholamines | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. | 
| Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file | From Patient file: Left ventricular ejection fraction (EF), Body Mass Index, Blood pressure, Smoking status, Cardiac Operative Risk (EuroSCORE), New York Heart Association classification (NYHA), Canadian Cardiovascular Society grading of angina pectoris (CCS), Number of diseased coronary vessels, Previous myocardial infarctions, extra-cardiac arteriopathy, non-cardiac comorbidities, surgery procedure, surgery complications and in-hospital post surgery complications, time spent on the intensive care unit, inpatient days until discharge | 6 months after surgery | 
| Patients' experience with prior surgeries | Rating of experience with own prior surgeries. Rating of experience with surgeries of close others. | Baseline (expected average of 10 days before surgery) | 
| Enriched Social Support Inventory |  | Baseline (expected average 10 days before surgery) | 
| Occurrence of major life events since surgery |  | 6 months after surgery | 
| Change in Patients' Illness Perception (Brief Illness Perception Questionnaire (B-IPQ) from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. |  | From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery | 
| Satisfaction with the intervention |  | 6 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Bypass Graft Surgery (CABG), Patients' Expectations, Coronary Heart Disease, Illness Perception Intervention, Randomized Controlled Trial