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

NCT04051021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-02-01

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery

Interventions

BEHAVIORAL

Comfort Coach

A trained comfort coach will provide emotional and psychological interventions at six time points: preoperative clinic, day of surgery, extubation, chest tube removal, discharge, 30-day clinic follow-up, and 90-day post-discharge. Patients will also complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).

OTHER

Usual Care

Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).

Sponsors & Collaborators

Principal Investigators

  • Julie Piazza · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2020-11-08
Completion
2021-01-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051021 on ClinicalTrials.gov