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

Completed · Not applicable

Conditions studied: Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT04051021

Run by

University of Michigan

People needed

160

Starts

2019-09-04

Expected to finish

2021-01-05

Last updated by the study team

2021-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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