Status:

COMPLETED

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

Lead Sponsor:

University of Michigan

Collaborating Sponsors:

Blue Cross Blue Shield of Michigan Foundation

Conditions:

Cardiac Surgery

Eligibility:

All Genders

18+ years

Phase:

NA

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 healt...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

September 4 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 5 2021

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT04051021

Start Date

September 4 2019

End Date

January 5 2021

Last Update

February 1 2021

Active Locations (1)

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1

University of Michigan

Ann Arbor, Michigan, United States, 48109