Optimizing Expectations in Cardiac Surgery Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Bypass Graft Surgery (CABG); Patients' Expectations; Coronary Heart Disease	Behavioral: Expectation Manipulation Intervention; Behavioral: Supportive Therapy	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	124 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients
Study Start Date :	July 2011
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	April 2015

Arms and Interventions

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Arm	Intervention/treatment
No Intervention: Standard Medical Care; Patients receive standard treatment protocol for Coronary Artery Bypass Graft Surgery
Active Comparator: Attention Control Group; 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; 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).
Experimental: Expectation Manipulation Intervention; In addition to standard medical care patients' expectations prior to surgery are targeted in a brief psycho-educational 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.

Outcome Measures

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Primary Outcome Measures :

1. Disability 6 months after surgery, controlled for baseline disability (Pain Disability Index; PDI) [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :

1. 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). [ Time Frame: From 10 days before surgery untill 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)
2. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ]
3. Change in Physical Activity (International Physical Activity Questionnaire; IPAQ) from Baseline (an expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery ]
4. Change in Health Related Quality of Life (SF-12) from Baseline (expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery ]
5. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ]
6. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ]
7. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ]
8. Change in Working ability from Baseline (expected average of 10 days before surgery) to 6 months after surgery. [ Time Frame: From 10 days before surgery to 6 months after surgery. ]
9. Satisfaction wiht the intervention. [ Time Frame: Expected average of 1 day before surgery (but after the intervention). ]
10. Cardiothoracic surgeons' rating of the surgery success [ Time Frame: Expected average of 1 day after surgery ]
11. Additional treatments during follow-up [ Time Frame: 6 months after surgery ]
    Additional Treatments, rehospitalizations, cardiac sport groups, rehabilitations programms, etc.
12. Blinded Expert Rating of medical and psychological status at follow-up [ Time Frame: 6 months after surgery ]
13. Change in Sleep Quality from 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ]
14. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery. ]
    cortisol, inflammatory processes, catecholamines
15. Patient Pre-/Peri-/Postoperative Health Status retrospectively collected from patient file [ Time Frame: 6 months after surgery ]

    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

16. Patients' experience with prior surgeries [ Time Frame: Baseline (expected average of 10 days before surgery) ]
    Rating of experience with own prior surgeries. Rating of experience with surgeries of close others.
17. Enriched Social Support Inventory [ Time Frame: Baseline (expected average 10 days before surgery) ]
18. Occurrence of major life events since surgery [ Time Frame: 6 months after surgery ]
19. 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. [ Time Frame: From 10 days before surgery to 1 day before surgery to 10 days after surgery to 6 months after surgery ]
20. Satisfaction with the intervention [ Time Frame: 6 months after surgery ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
Philipps University of Marburg
Marburg, Hessen, Germany, 35032

Sponsors and Collaborators

Philipps University Marburg Medical Center

Investigators

Principal Investigator:	Winfried Rief, Prof. Dr.	Department of Clinical Psychology and Psychothearpy, Philipps University of Marburg
Principal Investigator:	Rainer Moosdorf, Prof. Dr.	Department of Cardiac and Thoracic Vessel Surgery, Heart Centre, Philipps University of Marburg

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Auer CJ, Laferton JAC, Shedden-Mora MC, Salzmann S, Moosdorf R, Rief W. Optimizing preoperative expectations leads to a shorter length of hospital stay in CABG patients: Further results of the randomized controlled PSY-HEART trial. J Psychosom Res. 2017 Jun;97:82-89. doi: 10.1016/j.jpsychores.2017.04.008. Epub 2017 Apr 19.

Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.

Responsible Party:	Winfried Rief, Prof. Dr. Winfried Rief, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier:	NCT01407055 History of Changes
Other Study ID Numbers:	DFG RI574/21-1
First Posted:	August 1, 2011
Last Update Posted:	February 3, 2016
Last Verified:	February 2016

Keywords provided by Winfried Rief, Philipps University Marburg Medical Center:

Coronary Artery Bypass Graft Surgery (CABG); Patients' Expectations; Coronary Heart Disease; Illness Perception Intervention; Randomized Controlled Trial

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia	Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases