BACKGROUND
Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain which adversely impact outcomes. Prior work examining pediatric and non-surgical adult patients has documented the effectiveness of inexpensive non-pharmacological techniques to reduce anxiety and pain, as well as healthcare costs and length of hospitalization. However, the impact of non-pharmacological interventions administered by a dedicated “comfort coach” has not been evaluated in an adult surgical setting.
OBJECTIVE
The objective of this trial is to assess whether non-pharmacological interventions administered by a trained comfort coach impact patient experience, opioid use, and healthcare utilization compared to usual care in adult cardiac surgery patients. This study has three specific aims: (1) assess the effect of a comfort coach on patient experience, (2) measure differences in inpatient and outpatient opioid use and postoperative healthcare utilization, and (3) qualitatively evaluate the comfort coach intervention.
METHODS
To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a comfort coach (intervention) versus usual care (control). The individualized comfort coach interventions will be administered at six points: (1) preoperative outpatient clinic, (2) preoperative care unit on the day of surgery, (3) extubation, (4) chest tube removal, (5) hospital discharge, and (6) at 30-day clinic follow-up. To address aim 1, we will examine the effect of a comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction through validated surveys administered at (1) preoperative outpatient clinic, (2) discharge, (3) 30-day follow-up, and (4) 90-day follow-up. For aim 2, we will record inpatient opioid use and collect post-discharge opioid use and pain-related outcomes through an 11-item questionnaire administered at 30-day follow-up. Hospital length of stay, readmission, number of days in an extended care facility, emergency room, urgent care, and at an unplanned doctor’s office visit will be recorded as the primary composite endpoint defined as total days spent at home within the first 30 after surgery. For aim 3, we will perform semi-structured interviews with patients in the intervention arm to understand the comfort coach intervention through a thematic analysis.
RESULTS
This trial, funded by Blue Cross Blue Shield Foundation of Michigan in 2019, is presently enrolling patients with anticipated manuscript submissions Data generated from this mixed methods study will highlight effective non-pharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. Findings from this study may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.from our primary aims targeted for the end of 2020.
CONCLUSIONS
Data generated from this mixed methods study will highlight effective non-pharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. Findings from this study may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.
CLINICALTRIAL
ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021.
The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study (Preprint)
