Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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