Clinical trial NCT04502121: Preoperative Optimization of Cardiac Valve Patients' Expectations
Official title: Preoperative Optimization of Cardiac Valve Patients' Expectations - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Valve Disease
Keywords: Expectations
Preoperative intervention
placebo effect
cardiac valve surgery
clinical trial
recovery
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Heart Centre Rotenburg
name: Justus-Liebig University Gießen Medical Center
First posted: 2020-08-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Disability Index (PDI) from Baseline to one day pre-surgery to one week post-surgery to three months post-surgery
timeFrame: Baseline, one day pre-surgery, up to one week post-surgery, up to three months post-surgery
Secondary outcomes:
measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in Health Related Quality of Life (Short Form 12, SF-12) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in Patient health questionnaire screener (PHQ) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in Generalized Anxiety Disorder 7 (GAD-7) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in Anxiety (The Amsterdam Preoperative Anxiety and Information Scale, APAIS) from Baseline to one day pre-surgery
timeFrame: Baseline, one day pre-surgery
measure: Days the patient stays in the hospital, days at the intensive care unit
timeFrame: up to one week post-surgery
measure: Change of Concentration of Inflammatory marker C-reactive protein (CRP) in mg/l
timeFrame: Baseline, up to one day, two days and five days post-surgery
Other outcomes:
measure: Change in The Primary Appraisal Secondary Appraisal questionnaire (PASA) from Baseline to one day pre-surgery to one week post-surgery
timeFrame: Baseline, one day pre-surgery, up to one week post-surgery
measure: Change in Patients' Illness Perception (Brief Illness Perception Questionnaire, B-IPQ) from Baseline to 1 week post-surgery to 3 months after surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in patients' expectations (Expected Illness Perception Questionnaire, IPQ-E) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Change in patients optimism (Life-Orientation-Test Revised, LOT-R) from Baseline to one week post-surgery to three months post-surgery
timeFrame: Baseline, up to one week post-surgery, up to three months post-surgery
measure: Personality (Big Five Inventory, BFI-10)
timeFrame: Baseline
measure: Patients' experience with prior surgeries
timeFrame: Baseline
measure: Surgery procedure (planned and realized)
timeFrame: Baseline, up to one week post-surgery
Locations:
city: Marburg
country: Germany
facility: UKGM Marburg
Study officials:
affiliation: Clinical Psychology and Psychotherapy Dept. of Psychology, Philipps-University Marburg
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac surgery University Hospital Gießen und Marburg
name: Ardawan Rastan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.
citation: Juergens MC, Seekatz B, Moosdorf RG, Petrie KJ, Rief W. Illness beliefs before cardiac surgery predict disability, quality of life, and depression 3 months later. J Psychosom Res. 2010 Jun;68(6):553-60. doi: 10.1016/j.jpsychores.2009.10.004. Epub 2009 Dec 5.
citation: Laferton JA, Kube T, Salzmann S, Auer CJ, Shedden-Mora MC. Patients' Expectations Regarding Medical Treatment: A Critical Review of Concepts and Their Assessment. Front Psychol. 2017 Feb 21;8:233. doi: 10.3389/fpsyg.2017.00233. eCollection 2017.
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citation: 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.
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citation: Rector TS, Kubo SH, Cohn JN. Validity of the Minnesota Living with Heart Failure questionnaire as a measure of therapeutic response to enalapril or placebo. Am J Cardiol. 1993 May 1;71(12):1106-7. doi: 10.1016/0002-9149(93)90582-w. No abstract available.
citation: Rief, W., & Glombiewski, J. A. (2016). Erwartungsfokussierte Psychotherapeutische Interventionen (EFPI). Verhaltenstherapie, 26(1), 47-54.
citation: Salzmann, S., Laferton, J., Auer, C., Shedden-Mora, M., Wambach, K., & Rief, W. (2018). Patientenerwartungen optimieren: Beschreibung einer präoperativen Kurzintervention am Beispiel von Patienten vor einer Bypass-Operation. Verhaltenstherapie, 28(3), 157-165.
citation: Gaab, J. (2009). PASA-Primary Appraisal Secondary Appraisal-Ein Fragebogen zur Erfassung von situations-bezogenen kognitiven Bewertungen. Verhaltenstherapie, 19(2), 114-115.
citation: Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
citation: Scheier MF, Carver CS, Bridges MW. Distinguishing optimism from neuroticism (and trait anxiety, self-mastery, and self-esteem): a reevaluation of the Life Orientation Test. J Pers Soc Psychol. 1994 Dec;67(6):1063-78. doi: 10.1037//0022-3514.67.6.1063.
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