Bypass Surgery with Psychological and Spiritual Support (the BY.PASS Study): Results of a Pragmatic Trial Based on Patients’ Preference

Abstract

Background: Some general hospitals within the German health system provide supportive interventions, psychological as well as spiritual, to their patients. It remains to be proven if these interventions are effective when used in routine clinical practice. Aim: To evaluate the effectiveness of psychological and spiritual interventions on improving recovery following bypass surgery. Methods: The BY.PASS study is a pragmatic, patient preference trial (ISRCTN 07297983). Adult patients scheduled for elective coronary bypass surgery were enrolled. Patients were assigned to study conditions according to their personal preference: preference for psychological interventions, for spiritual interventions or for no intervention. Patients who were open for any kind of intervention were randomly assigned either to psychological or spiritual interventions. During a control period, patients were asked about their preference, but did not receive any interventions. Primary outcomes of the study were in-hospital morbidity and early mortality. Psychological measures served as secondary outcomes. Results: A total of 847 patients were enrolled. Patients of the control (n = 260) and the intervention group (n = 269) who explicitly wanted to have interventions were compared. No significant treatment effects either for morbidity (d = 0.08, 95% CI –0.09 to 0.25), or for mortality (OR = 1.81; 95% CI 0.50–6.57) could be found. A reduction of negative mood resulted from both interventions. Conclusions: Although the effects observed were small, the study can serve as a basis to discuss methodological as well as theoretical aspects of a pragmatic trial, based upon patients’ preferences.

Short‐term intervention to reduce anxiety before coronary artery bypass surgery – a randomised controlled trial

“…Previous publications identified the subjective need for psychosocial support (Rosendahl et al . , Sachs et al . ) although they did not examine the influence on clinical outcome.…”

“…There is indeed little information on patients' experiences and anxiety in this setting. Previous publications identified the subjective need for psychosocial support (Rosendahl et al 2013, Sachs et al 2014) although they did not examine the influence on clinical outcome.…”

“…Further, only a small number of randomised controlled trials assessed the role of emotional support. A study on psychological or spiritual support for CABG patients failed to reduce their anxiety; however, the effects were assessed only postoperatively (Rosendahl et al 2013). Extended attention from the surgeon with individualised oral information and visits twice a day was also not more effective in reducing preoperative anxiety than standard written information in 60 patients awaiting cardiac surgery (Bergmann et al 2001).…”

“…According to a survey in Germany, 62% of cardiac surgery patients would appreciate preoperative interventional psychosocial support by a psychologist or a chaplain (Rosendahl et al . ). Another German study found that 44% of almost 300 patients would need psychosocial support at the day of admission for cardiothoracic surgery (Sachs et al .…”

“…This leaves a narrow timeframe for a structured in-hospital psychoemotional support and presents a major challenge to an effective intervention Therefore, results of other studies which assume waiting periods of several weeks (Lamarche et al 1998, Arthur et al 2000 are difficult to compare. According to a survey in Germany, 62% of cardiac surgery patients would appreciate preoperative interventional psychosocial support by a psychologist or a chaplain (Rosendahl et al 2013). Another German study found that 44% of almost 300 patients would need psychosocial support at the day of admission for cardiothoracic surgery (Sachs et al 2014).…”