Preoperative Optimization of Cardiac Valve Patients' Expectations

Study Overview
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Brief Summary
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Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.

Official Title
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Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial

Conditions
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Cardiac Valve Disease

Intervention / Treatment
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* Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled for elective cardiac valve procedure Age 18 or above Fluency in German Informed consent Exclusion Criteria: Comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition Participation in other research programs: in agreement with Coordinating Investigator patient can participate substudies, if this do not interfere with the main study Emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly allocated to the intervention group (IG) or the control group (SOC). The intervention group will receive a psychological preoperative intervention to optimize expectations (in addition to standard medical care). The control group will receive the standard of care only.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (IG)<br> | Behavioral: EXPECT: Preoperative optimization of cardiac valve patient's expectations<br>* The psychological, preoperative intervention follows a treatment manual. Patients get a personal intervention one day before surgery (30-40 minutes). It includes the development of an individual, subjectively perceived disease model, the treatment outcome expectations and the personalized outcome expectancy. Additionally they get two booster telephone calls 4 and 8 weeks after the surgery to recall the discussed topics and to talk about their recovery process (10-15 minutes).<br>|
| No Intervention: Standard of Care (SOC)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery | Items range from 0 (no disability at all) - 10 (total disability). Consequently higher scores mean a worse outcome. | Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery | Items range from 0 (no restriction), 1 (nearly not restricted) - 5 (very strongly restricted). Consequently higher scores mean a worse outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | 
| Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery | There are different item scales. The item scale of the first item (General health perceptions) ranges from 1 (excellent) to 5 (bad). The item scales of the second and third item (limitations in physical activities because of health problems) range from 1 (yes, absolutely restricted) to 2 (yes, a bit restricted) to 3 (no, not restricted at all). The item scales of the items 4-7 (limitations in usual role activities because of physical health or emotional problems) are just yes and no. The item scale of the eighth item (bodily pain) ranges from 1 (Absolutely not) to 5 (a lot). The item scales of the items 9-12 (general mental health, vitality and limitations in social activities because of physical or emotional problems) range from 1 (always) to 5 (never). | Baseline, up to one week post-surgery, up to three months post-surgery | 
| Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery | Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | 
| Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery | Items range from 1 (not at all) - 4 (nearly everyday). Consequently higher scores mean a worse outcome. | Baseline, up to one week post-surgery, up to three months post-surgery | 
| Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery | Items range from 1 (not at all) - 5 (extremely). Higher scores mean patients are more interested in information and do have greater worries. | Baseline, one day pre-surgery | 
| Days the patient stays in the hospital, days at the intensive care unit |  | up to one week post-surgery | 
| Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l | Change from baseline to postoperative day 1 (POD1) to approx. POD2 to approx. POD 5; higher scores mean a worse outcome. | Baseline, up to one day, two days and five days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Expectations, Preoperative intervention, placebo effect, cardiac valve surgery, clinical trial, recovery