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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051021
• Other study ID #: HUM00161399
• Status: Completed
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: January 5, 2021

Study information

• Verified date: January 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 5, 2021
• Est. primary completion date: November 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days spent at home within the first 30 days after surgery	Number of days spent at home compared between groups	up to 30 days after surgery
Primary	Number of days in the hospital after surgery		average 5-7 days
Primary	Number of days admitted to an extended care facility after discharge from the hospital		up to 30 days after surgery
Primary	Number of emergency room visits after discharge from the hospital		up to 30 days after surgery
Primary	Number and length of readmissions to the hospital following initial discharge after surgery		up to 30 days after surgery
Secondary	Brief pain inventory (short)	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.	hospital discharge (within 48 hours of time of hospital discharge)
Secondary	Postoperative Opioid and Pain Management Questionnaire	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.	approximately 30 days after discharge
Secondary	Picker Patient Experience Questionnaire (PPE-15)	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.	approximately 30 days after discharge
Secondary	Generalized Anxiety Disorder Scale (GAD-7)	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.	up to approximately 90 days after discharge
Secondary	Patient Health Questionnaire (PHQ-9)	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	up to approximately 90 days after discharge
Secondary	Impact of Events Scale-Revised (IES-R)	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).	approximately 30 days after discharge
Secondary	Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	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.	preoperative clinic visit, approximately 30 days after discharge