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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2021-01-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Research assistants consenting patients and collecting and analyzing data will be blinded to the allocation.

Study Groups

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Usual Care

Group Type OTHER

Usual Care

Intervention Type OTHER

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

Comfort Coach

Group Type EXPERIMENTAL

Comfort Coach

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No