Adults undergoing inpatient surgery commonly develop both severe perioperative anxiety [1-5] (28%-70% of patients) and postoperative pain (54%-74% with moderate-to-severe pain at discharge), [6,7] both of which may significantly affect patient outcomes [8-11]. Nonpharmacological interventions such as distraction techniques, guided imagery, music, and art have been found to be inexpensive complements to pharmacologic treatments, effectively reducing both anxiety and acute and chronic pain [12-14] in pediatric [15] and hospitalized nonsurgical adult patients [16-19] when administered routinely by a dedicated child life specialist comfort coach. However, the impact of nonpharmacological interventions and the role of a comfort coach in an adult surgical setting has not been evaluated.

Certified child life specialists are frontline health care professionals trained to provide psychosocial care to pediatric patients and families facing stressful medical experiences. Child life specialists conduct thorough assessments and build therapeutic relationships with patients and families to support them to cope and protect emotional safety. Individualized interventions include fostering healing environments, therapeutic play, nonpharmacological pain management, procedural preparation, diagnosis teaching, sibling support, medical play, and bereavement support. Child life specialists obtain a bachelor’s degree with an emphasis on psychology, education, and human development. They complete comprehensive clinical training, pass a certification exam, and maintain certification through targeted continuing education [20].

Child life specialists work with pediatric patients to teach individualized coping strategies to mitigate anxiety and manage both acute and chronic pain. Play is the universal language of all children, and play-based coping strategies foster expression and promote a sense of control and mastery. Nonpharmacological interventions effective in pediatric and adolescent patients include calm breathing techniques, distraction, guided imagery, art, muscle relaxation, music, environmental modification, and comfort positioning [20]. The child life specialist’s role has resulted in reduced pain, anxiety, use of analgesics, and length of stay [16]. We often assume that adults can handle medical stressors and employ coping skills, but many adults do not have such skills established [21]. In addition, this has resulted in underestimating adult patients’ pain effects [22] and often not addressing pain with known effective nonpharmacological interventions in combination with pain medication [13]. Building on the effectiveness and essential skills that have been dedicated to pediatric patients can facilitate opportunities for adult patients to reframe health care experiences and provide coaching through pain and anxiety, adding to their coping skills to support comfort. Applying child life strategies across the age span can further enhance the human experience of health care [23].

We propose that providing a dedicated, trained comfort coach administering nonpharmacological interventions will improve cardiac surgery outcomes, including anxiety, self-reported pain, opioid use, and health care utilization. Periprocedural nonpharmacological approaches are well established in pediatrics [24,25], especially for needle-related pain [26]. Nonpharmacological approaches to acute pain management are rooted in the gate-control theory [27,28]. This theory suggests that descending nerve impulses from the brain, including thoughts, beliefs, emotions, and attention, can influence the ascending pain signal from tissue damage. In the context of surgery, anxiety may heighten pain, whereas attention focused on pleasant activity might decrease pain. In this context, many nonpharmacological interventions mitigate anxiety, which mediates pain perception, with both decreased anxiety and perception of pain affecting patient outcomes (Figure 1).

Approximately 300,000 adults undergo cardiac surgery in the United States each year [29], with 90-day episode payments combined to exceed US $15 billion [30-32]. Cardiac surgery through a sternotomy has been shown to cause severe anxiety and pain that persist in spite of pharmacologic pain control with opioids [5,33,34], with up to 81% reporting some pain at 1 month [35] and up to 43% reporting persistent pain at 1 year [36]. Rates of persistent opioid use and long-term opioid dependence in cardiac surgery patients have increased 8-fold over the past 15 years, resulting in higher postoperative complication rates, prolonged hospital length of stay, and increased health care costs [37]. Moreover, opioid prescription sizes remain high, and overprescribing is common [38-47]. Whereas assessments of individual nonpharmacological interventions such as preoperative education [48,49], massage [50], and music [34] have demonstrated an improvement in self-reported pain scores after cardiac surgery, differences in opioid use have not been reported. Furthermore, individualized nonpharmacological interventions by a comfort coach have been shown to reduce the length of hospital stay [15,51] and health care costs [52,53] in pediatric patients, prompting the establishment of child life services as a quality benchmark and indicator of excellence in pediatric care, [15,54]. In contrast, these techniques have not been studied in adult cardiac surgery patients.

Data generated by this study may highlight effective techniques and support a multidisciplinary approach to nonpharmacological interventions to decrease pain, opioid use, anxiety, and health care utilization while increasing patient comfort and overall satisfaction during the adult cardiac surgery patient experience.

We will perform a prospective, double-armed, randomized, controlled trial of 154 cardiac surgical patients at a large academic center to assess whether nonpharmacological interventions by a trained comfort coach affect patient experience, opioid use, and health care utilization as compared with usual care. The individualized comfort coach interventions will be administered at 6 time-points: (1) at the preoperative clinic, (2) on the day of surgery, (3) at extubation, (4) at chest tube removal, (5) at hospital discharge, and (6) at the 30-day clinic follow-up.

This study has 3 specific aims: (1) assess the effect of a comfort coach on patient experience, (2) measure differences in inpatient and outpatient opioid use and postsurgical health care utilization, and (3) qualitatively evaluate the effectiveness of the comfort coach intervention. Toward aim 1, we will use validated survey metrics to capture anxiety and depression (preoperative clinic, discharge, 30-day follow-up, and 90-day follow-up), functional status (preoperative clinic and 30-day follow-up), surgery-related psychological stress (30-day follow-up), patient-reported in-hospital pain (discharge), and patient experience (30-day follow-up). Toward aim 2, we will compare inpatient and postdischarge opioid use and patient-reported outcomes, including pain scores and pain management practices between groups. In addition, the composite primary endpoint of the study will be recorded as the total number of days spent at home out of the first 30 after surgery, incorporating hospital length of stay, readmissions, number of days in an extended care facility, emergency room, urgent care, and unplanned doctor visits. Aim 3 will include semistructured interviews of patients in the intervention group to understand the role, impact, and acceptability of a comfort coach.

All requirements for conducting human subjects research at the University of Michigan have been met. The study protocol has been reviewed, and the University of Michigan Institutional Review Board has approved this trial (quantitative, HUM00161399, and qualitative, HUM00170502). This clinical trial has been registered at ClinicalTrials.gov (NCT04051021).

Cardiac surgical patients will be recruited from the Frankel Cardiovascular Center (FCVC) at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery through a full median or miniature sternotomy beginning September 3, 2019, were screened for a targeted enrollment of 154 patients for randomization. Approximately 600 to 750 patients meeting these criteria underwent surgery at Michigan Medicine in 2017. Opioid-naive is defined as opioid-free at the time of preoperative clinic history and physical examination.

Patients lost to follow-up will be censored for data analysis, and missing individual intervention points will be dealt with by multiple imputations, as appropriate. We will compare the clinical and sociodemographic attributes of patients who decline participation and patients lost to follow-up with those of patients with complete follow-up to assess potential responder bias. We estimated a 20% rate of missingness, which was incorporated into our power calculation. On the basis of historical institutional data, we anticipated approaching 5 to 10 patients per week for potential enrollment, with an approximate 5 to 7 month enrollment period within a 12-month study period for completion of clinical follow-up, data analysis, and manuscript production. Although this timeline was affected by the COVID-19 pandemic forcing a pause in enrollment between March 14th and the time of writing, we were 93.5% (144/154) enrolled at the time of pausing and remained optimistic about completing enrollment within our 12-month study period. We used block randomization with randomly variable block sizes generated with Stata 15 software (StataCorp LLC, College Station, TX) and computer randomization occurred with the treatment assignment tool (Treatment Assignment Tool-University of Michigan [TATUM]) from the Michigan Institute for Clinical and Health Research.

Patients were approached, participated in the informed consent process, and were enrolled during the preoperative history and physical appointment, typically after being seen by a member of the advanced practice team. The study coordinator approached potential subjects either in exam rooms or in the clinic waiting room to describe the study and offer participation. Interested patients engaged with the study coordinator and gave informed consent, at which point the coordinator randomized and assigned a sequential subject identification number to each study patient using TATUM (Figure 2).

In this trial, the comfort coach is a trained Certified Child Life Specialist who provides therapeutic interventions that have been shown to reduce anxiety and pain medication use while increasing patient and family satisfaction [15]. Child life specialists use evidence-based nonpharmacological pain management techniques such as preparing patients for painful encounters, comforting and reassuring them, coping strategies such as distraction, and offering positive reinforcement to support patients undergoing painful procedures [55]. These interventions focus on improving patient experience, validating emotions, and offering an individualized approach with the goal of reducing pain and anxiety. Focused breathing and guided imagery with targeted relaxation and pain management outcomes will support patient choice and engagement to encourage sustainable coping skills.

Child life specialists are trained in lifespan development and family systems theories, specifically addressing pain and anxiety through individualized comfort techniques. Though they are trained specifically in pediatrics, these coping strategies translate across ages. Adults routinely express the desire for distraction techniques, guided imagery, and preparation procedures during procedural care [16,23]. Moreover, adults may benefit, similar to pediatric patients, from nonpharmacological interventions when undergoing cardiac surgery. Whereas adults may have more experience with anxiety and pain management than children, new perioperative experiences have the potential to raise anxiety levels that can be mitigated by simple comfort strategies. Thus, child life specialists are ideally equipped to address perioperative anxiety and painful situations in both children and adults. We performed an 11-patient feasibility study in patients who underwent open cardiac surgery at Michigan Medicine using certified child life specialists, which demonstrated that nonpharmacological comfort coach interventions were feasible.

In this study, patients randomized to the intervention group will meet the comfort coach in the preoperative clinic (#1), where the coach will perform an introductory emotional, medical, and psychosocial needs assessment to consider the impact of surgery on the patient. The comfort coach will also introduce a comfort menu (Multimedia Appendix 1) [56-63] for pain management. After the preoperative clinic visit, the comfort coach will see the patient 5 additional times: at the preoperative bay immediately before surgery (#2), at extubation in the intensive care unit (#3), at chest tube removal (#4), at discharge (#5), and at the 30-day clinic follow-up visit (#6). These points of intervention were defined through feedback provided during our initial 11-patient feasibility study. During these intervention points, patients will receive the comfort menu and choose individualized interventions, including guided imagery, guided visualization, focused breathing, distraction techniques, music, art, mindfulness, and patient positioning. Supplies used during comfort coach interventions commonly include music playlists, compassion cards, stress balls, iPad activities, and virtual reality goggles. Additional activities are listed in the comfort menu in Multimedia Appendix 1.

Screening, enrollment, randomization, and study design are summarized in Figure 3.

An 11-patient feasibility study in aortic surgery patients (HUM00138828) was performed at the FCVC, 6 of whom were randomized to the control and 5 to the intervention arm. Extremely useful insight from this feasibility trial included feedback from intervention patients regarding the time-points at which their dedicated, trained comfort coach was most beneficial. This feedback was used to solidify the 6 touchpoints for our full clinical trial. In addition, an assumption about utilizing nonpharmacological interventions was that pain management and recovery after surgery were individualized processes. In contrast, we received feedback that family and relatives are intimately involved in patients' healing and emotional well-being. Furthermore, some patients indicated that their family members benefited from the comfort coach interventions, in some instances, even more than the patient. In addition, family interaction and socialization during the perioperative process were identified as important to pain management.

Executing the feasibility trial also provided direct insights for our study team. Using certified child life specialists in dual roles as full-time specialists at the children’s hospital and on-call for the feasibility trial proved to be a barrier to effective intervention, primarily because of the distance between the hospitals creating time-related challenges for meeting each touchpoint. Accordingly, these experiences informed the development of the full clinical trial by highlighting the importance of hiring a full-time, dedicated comfort coach to enhance the number of touchpoints met and increase care continuity. Most importantly, this preliminary trial demonstrated that it would be feasible to perform the comfort coach study protocol at the University of Michigan.

After completing the feasibility study, the study team performed telephone interviews of study patients and former open-heart surgery patients through the FCVC’s Patient Family Advisory Council to gain further insight into the patient experience and use this input to select the most appropriate survey instruments for the full clinical trial.

Our clinical trial is funded by Blue Cross Blue Shield of Michigan Foundation, and enrollment is currently ongoing. As of June 2020, 144 patients have been enrolled and randomized in the trial, and 50 semistructured qualitative interviews have been performed. Since March 14, 2020, all survey touchpoints and interviews have been conducted remotely via telephone, online, or mail because of human subject research restrictions implemented at the University of Michigan to limit exposure to patients and staff during the COVID-19 pandemic. Comfort coach touchpoints for patients in the intervention group have continued during their inpatient hospitalization, whereas 30-day follow-up visits with the comfort coach are now conducted remotely. We have completed our qualitative interview process and are currently evaluating our coded data, with plans to publish our qualitative findings by the end of 2020. We anticipate that enrollment, data collection, and analysis will be completed by September 2020 and expect to submit our initial quantitative results for publication by the end of 2020.

This clinical trial aims to evaluate the impact of a comfort coach administering nonpharmacological interventions on patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. Findings from this study may serve as the foundation for a subsequent multicenter trial, establishment of this role in the adult setting, and broader dissemination of these techniques to other types of surgery.