Skip to main content
OpenTrials
Completed

NCT Number: NCT04051021

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comfort Coach

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).

Usual Care

Other

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

Primary outcomes

  1. 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

  2. Number of days in the hospital after surgery

    Time frame: average 5-7 days

  3. Number of days admitted to an extended care facility after discharge from the hospital

    Time frame: up to 30 days after surgery

  4. Number of emergency room visits after discharge from the hospital

    Time frame: up to 30 days after surgery

  5. Number and length of readmissions to the hospital following initial discharge after surgery

    Time frame: up to 30 days after surgery

Secondary outcomes

  1. Brief pain inventory (short)

    Time frame: hospital discharge (within 48 hours of time of hospital discharge)

    This is a 9-question inventory which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.

  2. Postoperative Opioid and Pain Management Questionnaire

    Time frame: approximately 30 days after discharge

    This is an 11-item questionnaire collecting data on opioids prescribed, opioids used, pain scores, opioid storage and disposal practices, and assessment of opioid education.

  3. Picker Patient Experience Questionnaire (PPE-15)

    Time frame: approximately 30 days after discharge

    This is a 15-item questionnaire designed to capture the patient's inpatient experience.

    Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.

  4. Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: up to approximately 90 days after discharge

    This is a self-administered patient questionnaire with 7 items that measures generalized anxiety disorder. Through a 4-point Likert scale from 'not at all' to 'nearly every day', it is asked how often the patient has been bothered by any of the presented problems. The GAD-7 index is obtained by adding the scores from the questionnaire, after having assigned 0 to the least severe situation, 3 to the most severe one, and 1 and 2 to the intermediate ones. The cut off points 5, 10 and 15 allow to classify the anxiety as none/normal (0-4), mild (5-9), moderate (10-14), and severe (15-21). This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up.

  5. Patient Health Questionnaire (PHQ-9)

    Time frame: up to approximately 90 days after discharge

    This is a self-administered instrument that will be used to measure depression in each subject. The PHQ-9 score can range from 0-27 with each of the 9 items can be scored from 0-3 corresponding to "no at all", "several days", "more than half the days" and "nearly every day" responses, respectively. This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up

  6. Impact of Events Scale-Revised (IES-R)

    Time frame: approximately 30 days after discharge

    This is a 22-item self-report questionnaire measuring post traumatic stress disorder symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely).

  7. Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    Time frame: preoperative clinic visit, approximately 30 days after discharge

    This a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Official study title

The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 9, 2019
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.