Cardiac Surgery
Conditions
Keywords
Surgery, Cardiac, Opioids, Anxiety
Brief summary
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.
Interventions
BEHAVIORALComfort Coach
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).
OTHERUsual Care
Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).
Sponsors
Blue Cross Blue Shield of Michigan Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Research assistants consenting patients and collecting and analyzing data will be blinded to the allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days spent at home within the first 30 days after surgery | up to 30 days after surgery | Number of days spent at home compared between groups |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Impact of Events Scale-Revised (IES-R) | approximately 30 days after discharge | 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). |
| Brief pain inventory (short) | hospital discharge (within 48 hours of time of hospital discharge) | 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. |
| Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) | preoperative clinic visit, approximately 30 days after discharge | 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. |
| Postoperative Opioid and Pain Management Questionnaire | approximately 30 days after discharge | 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. |
| Picker Patient Experience Questionnaire (PPE-15) | approximately 30 days after discharge | 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. |
| Generalized Anxiety Disorder Scale (GAD-7) | up to approximately 90 days after discharge | 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. |
| Patient Health Questionnaire (PHQ-9) | up to approximately 90 days after discharge | 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 |
Countries
United States
Outcome results
None listed