Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
- Conditions
- Cardiac Surgery
- Interventions
- Behavioral: Comfort CoachOther: Usual Care
- Registration Number
- NCT04051021
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comfort Coach Comfort Coach - Usual Care Usual Care -
- Primary Outcome Measures
Name Time Method 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 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 and length of readmissions to the hospital following initial discharge after surgery up to 30 days after surgery Number of emergency room visits after discharge from the hospital up to 30 days after surgery
- Secondary Outcome Measures
Name Time Method 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.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.
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.
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.
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
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States