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

The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Other: Usual Care; Behavioral: Comfort Coach

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care	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).
Experimental: Comfort Coach	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of days in the hospital after surgery		average 5-7 days
Number of days admitted to an extended care facility after discharge from the hospital		up to 30 days after surgery
Number of emergency room visits after discharge from the hospital		up to 30 days after surgery
Number and length of readmissions to the hospital following initial discharge after surgery		up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Blue Cross Blue Shield of Michigan Foundation
• Investigators: Principal Investigator: Julie Piazza, University of Michigan

Publications and helpful links

General Publications

• Brescia AA, Piazza JR, Jenkins JN, Heering LK, Ivacko AJ, Piazza JC, Dwyer-White MC, Peters SL, Cepero J, Brown BH, Longi FN, Monaghan KP, Bauer FW, Kathawate VG, Jafri SM, Webster MC, Kasperek AM, Garvey NL, Schwenzer C, Wu X, Lagisetty KH, Osborne NH, Waljee JF, Riba M, Likosky DS, Byrnes ME, Deeb GM. The Impact of Nonpharmacological Interventions on Patient Experience, Opioid Use, and Health Care Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Feb 16;10(2):e21350. doi: 10.2196/21350.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): November 8, 2020
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Anxiety; Surgery; Cardiac; Opioids
• Other Study ID Numbers: HUM00161399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No