Optimizing Expectations in Cardiac Surgery Patients

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407055
• Other study ID #: DFG RI574/21-1
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2011
• Last updated: February 2, 2016
• Start date: July 2011
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery (CABG)
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Patients' Expectations

Intervention

Behavioral:
• Expectation Manipulation Intervention
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.
• Supportive Therapy
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).

Locations

Country	Name	City	State
Germany	Philipps University of Marburg	Marburg	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Laferton JA, Shedden Mora M, Auer CJ, Moosdorf R, Rief W. Enhancing the efficacy of heart surgery by optimizing patients' preoperative expectations: study protocol of a randomized controlled trial. Am Heart J. 2013 Jan;165(1):1-7. doi: 10.1016/j.ahj.2012.10.007. Epub 2012 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI)		6 months after surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Satisfaction wiht the intervention.		Expected average of 1 day before surgery (but after the intervention).	No
Secondary	Cardiothoracic surgeons' rating of the surgery success		Expected average of 1 day after surgery	No
Secondary	Additional treatments during follow-up	Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.	6 months after surgery	No
Secondary	Blinded Expert Rating of medical and psychological status at follow-up		6 months after surgery	No
Secondary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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)	No
Secondary	Enriched Social Support Inventory		Baseline (expected average 10 days before surgery)	No
Secondary	Occurrence of major life events since surgery		6 months after surgery	No
Secondary	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	No
Secondary	Satisfaction with the intervention		6 months after surgery	No

External Links

•   Homepage of the transregional DFG research unit FOR 1328: Expectation and conditioning as basic processes of the placebo and nocebo response: From neurobiology to clinical applications