Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients

Study Overview
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Brief Summary
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This study will assess whether non-pharmacological interventions by a comfort coach affect the amount of opioid pain medication used, as well as perceived physical pain and emotional anxiety and healthcare utilization for adult cardiac surgery patients. Participants that are eligible for the study will be randomized to the comfort coach arm or standard of care. Both groups will complete surveys at the specific time frames in order to compare their outcomes. The study hypothesis is that there will be a decrease in opioid use in the intervention group compared to the standard of care arm during the 90-day perioperative course, as well as a decrease in pain and anxiety along with a lower composite outcome of healthcare utilization.

Official Title
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The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Behavioral: Comfort Coach
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving a first-time elective status open heart cardiac surgery procedure in the Frankel Cardiovascular Center at Michigan Medicine during the recruitment period through a full or miniature sternotomy incision Opioid-naïve, defined as not taking a home opioid medication at time of preoperative H&P Exclusion Criteria: Patients undergoing cardiac transplantation, implantation of ventricular assist device, reoperation, and any planned use of circulatory arrest Chronic opioid users defined as taking an opioid at time of preoperative clinic visit Non-English speaking Inability to understand or complete surveys Pregnancy Unable to sign legal consent form (legal guardian signature not acceptable)

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br> | Other: Usual Care<br>* Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).<br>|
| Experimental: Comfort Coach<br> | Behavioral: Comfort Coach<br>* A trained comfort coach will provide emotional and psychological interventions at six time points: preoperative clinic, day of surgery, extubation, chest tube removal, discharge, 30-day clinic follow-up, and 90-day post-discharge. Patients will also complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days spent at home within the first 30 days after surgery | Number of days spent at home compared between groups | up to 30 days after surgery | 
| Number of days in the hospital after surgery |  | average 5-7 days | 
| Number of days admitted to an extended care facility after discharge from the hospital |  | up to 30 days after surgery | 
| Number of emergency room visits after discharge from the hospital |  | up to 30 days after surgery | 
| Number and length of readmissions to the hospital following initial discharge after surgery |  | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief pain inventory (short) | This is a 9-question inventory which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible. | hospital discharge (within 48 hours of time of hospital discharge) | 
| Postoperative Opioid and Pain Management Questionnaire | This is an 11-item questionnaire collecting data on opioids prescribed, opioids used, pain scores, opioid storage and disposal practices, and assessment of opioid education. | approximately 30 days after discharge | 
| Picker Patient Experience Questionnaire (PPE-15) | This is a 15-item questionnaire designed to capture the patient's inpatient experience. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains. | approximately 30 days after discharge | 
| Generalized Anxiety Disorder Scale (GAD-7) | This is a self-administered patient questionnaire with 7 items that measures generalized anxiety disorder. Through a 4-point Likert scale from 'not at all' to 'nearly every day', it is asked how often the patient has been bothered by any of the presented problems. The GAD-7 index is obtained by adding the scores from the questionnaire, after having assigned 0 to the least severe situation, 3 to the most severe one, and 1 and 2 to the intermediate ones. The cut off points 5, 10 and 15 allow to classify the anxiety as none/normal (0-4), mild (5-9), moderate (10-14), and severe (15-21). This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up. | up to approximately 90 days after discharge | 
| Patient Health Questionnaire (PHQ-9) | This is a self-administered instrument that will be used to measure depression in each subject. The PHQ-9 score can range from 0-27 with each of the 9 items can be scored from 0-3 corresponding to no at all, several days, more than half the days and nearly every day responses, respectively. This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up | up to approximately 90 days after discharge | 
| Impact of Events Scale-Revised (IES-R) | This is a 22-item self-report questionnaire measuring post traumatic stress disorder symptoms. Items are rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely). | approximately 30 days after discharge | 
| Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | This a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | preoperative clinic visit, approximately 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac, Surgery, Opioids, Anxiety