The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Number of emergency room visits after discharge from the hospital
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Usual Care
Intervention: Usual Care (Other)
Comfort Coach
Intervention: Comfort Coach (Behavioral)
Outcomes
Primary Outcomes
Number of emergency room visits after discharge from the hospital
Time Frame: up to 30 days after surgery
Number of days in the hospital after surgery
Time Frame: average 5-7 days
Number of days admitted to an extended care facility after discharge from the hospital
Time Frame: up to 30 days after surgery
Number of days spent at home within the first 30 days after surgery
Time Frame: 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
Time Frame: up to 30 days after surgery
Secondary Outcomes
- Generalized Anxiety Disorder Scale (GAD-7)(up to approximately 90 days after discharge)
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(preoperative clinic visit, approximately 30 days after discharge)
- Postoperative Opioid and Pain Management Questionnaire(approximately 30 days after discharge)
- Picker Patient Experience Questionnaire (PPE-15)(approximately 30 days after discharge)
- Impact of Events Scale-Revised (IES-R)(approximately 30 days after discharge)
- Brief pain inventory (short)(hospital discharge (within 48 hours of time of hospital discharge))
- Patient Health Questionnaire (PHQ-9)(up to approximately 90 days after discharge)
Investigators
Julie Piazza
Project Manager
University of Michigan